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Polypharmacy

Polypharmacy, or the use of multiple medications to treat a patient, has negative connotations. When it comes to medications more doesn’t mean better. What is polypharmacy? The definition of polypharmacy varies and as concluded by What is polypharmacy? A systematic review of definitions article, there is no consensus definition for polypharmacy.

Polypharmacy is more common in patients with multiple co-morbidities and is associated with the use of multiple medicines. Polypharmacy refers to the use of many medications, commonly considered the use of five or more medications. Since polypharmacy is a consequence of having several underlying medical conditions, it is much more common in elderly patients. An estimated 30 to 40 percent of elderly patients take five or more medications.

Taking multiple medications, whether prescription drugs, OTC treatments, herbal or dietary supplements; is a burden for patients and it can be dangerous. Dangers such as unwanted drug interactions and decrease drug adherence to essential medicines.

In the longitudinal study: Changes in prescription and over-the-counter medication and dietary supplement use among older adults in the United States, 2005 vs 2011, found that 35.8% of adults in the United States were taking five or more medicines. Adverse drug events in ambulatory care, New England Journal of Medicine 2003; 348:1556–1564, a landmark study of adults receiving one or more prescriptions from their primary care physician.

The authors found that 25% of patients had an adverse drug reaction within three months of starting their prescriptions. While 39% of these were preventable errors, most were the result of inappropriate drugs or drug interactions. polypharmacy is the use of more medications than are clinically indicated, representing unnecessary drug use.

What are the reasons for polypharmacy?

• Many co-existing medical conditions. In the case of diseases such as heart failure and high blood pressure, combinations of two to three different medications are common and recommended.
• Medications added for symptomatic relief, medications prescribed to treat adverse effects of another drug.
• Seeing different physicians and being under the care of several specialists.
• Lack of documentation on the use of a medication is often missing in the medical record, making decisions to consider termination of treatment difficult to make later.

What are the consequences of polypharmacy?

The major consequence of polypharmacy to a patient is a much higher risk of adverse drug effects. Risk increases based on the number of medications prescribed and taken.

Adverse drug effects often require physician visits, emergency room visits or hospitalizations. It can be difficult figuring out which medication is causing the adverse effect, avoiding drug interactions and improving adherence.

Adverse drug events WHO: “Unintended and undesired effects of a medication at a normal dose”:
• Adverse Drug Reaction
• Medication Error
• Therapeutic Failure
• Adverse Drug Withdrawal Event
• Overdose

Polypharmacy makes it hard for the patients to remember when and how to take all prescribed medications. Multiple medications increase the risks of inappropriate medication use, non-adherence, adverse effects, and medical cost.

Physicians may hesitate to prescribe a new essential medication to a patient already on four or more medications. Polypharmacy can lead to under treatment.

Another consequence of overutilization is the soaring cost of health care in 2015, the U.S. spent $325 billion on retail prescription drugs (drugs purchased at pharmacies and through the mail), almost twice that of other developed countries. Higher expenditures can be justified if the health outcomes for U.S. patients measured as life expectancy, disease-specific mortality and other measures were more favorable but they are not.

Potentially inappropriate prescribing defined:

• Risk > Benefit
• Over‐prescribing
• Excessive doses/duration of medicines
• Polypharmacy
• Mis-prescribing Unfavorable choice of medicine, dose, or duration
• Under‐prescribing Not prescribing a clinically indicated medicine, despite the patient not having any contra‐indication to that medicine

Preventing and Reducing Polypharmacy

We strongly recommend medication review by a Pharmacist for patients prescribed a large number of medications. Other recommendations:

1) Primary care physician needs to coordinate the use of multiple medications.

2) Potentially Inappropriate Medications (PIMs):
Medications that pose more risks than benefits to older adults by themselves and considering the availability of alternative treatments.

3) Instead of adding a new medication to treat an unwanted side effect, stopping or changing the dose of the offending drug would solve the problem.

4) Medications lacking an indication, medications with limited value or are therapeutic duplication should be discontinued.

5) Always consider a new symptom as possible drug-induced (review chronology of medications)

6) Consider stopping/tapering medications

7) Consider reducing dose with age

8) Do a drug interaction check

9) Review the goals of care and treatment targets

10) Prescribe strategically (e.g. reduce pill burden, simplify regimen, use meds for more than one purpose)

Pearls for Decreasing Polypharmacy:

• Start low and go slow
• Don’t set it and forget it (PK)
• Ask about herbs, roots, nuts, berries
• Trust but verify
• Avoid narrow therapeutic index meds
• Review medication lists regularly
• Avoid too many changes at one time
• Begin with the end in mind
• Utilize Beers or START/STOP criteria for regular assessment

Decreasing medication use in the elderly can reduce adverse events (e.g. falls, hospitalizations), reduce pill burden and costs, increase adherence with remaining medications, Improve the quality of life. Patients, family members, and caretakers should be educated on the dangers of polypharmacy. for more information on patient education, see JAMA’s patient’s page on Polypharmacy.

Pharmacists, in general, are in the best position to help patients with polypharmacy. Ambulatory care pharmacists routinely see patients and should be conducted not only routine medication adherence but review for polypharmacy.

Implicit Bias in Healthcare

We all know what explicit bias is and some even have firsthand knowledge or experience. When we think about health care, we all would like to think that boas do not exist in the professions of healthcare. But nothing can be further from the truth. As a nation, we started to question systemic biases and here I want to explore implicit biases in Healthcare.

Why implicit biases? Because it is very rare to encounter explicit or all-out biases in healthcare.  Most of the time we face implicit or unconscious biases and most of the time we do not know what not do about them.

*The majority of the material for this presentation came from a Pri-Med presentation.

Implicit vs. Unconscious Bias

Implicit

• “implied though not plainly expressed”

• “inherent”

• “inbuilt”

• “understood”

Unconscious

• “inaccessible to the conscious mind”

• “done without realizing”

• “instinctive”

• “unthinking”

Implicit/Unconscious Bias:  We all have them. It is like a blind spot that most of the time we don’t see.

  • Hidden Biases of Good People − Mahzarin Banaji and Anthony Greenwald
  • Implicit Association Tests (Project Implicit®)

Often a result of our cultural conditioning or a byproduct of our societal norms. Often biases are contrary to our personal values and implicit bias:

  • Can be Personal: internalized, interpersonal
  • or systemic: institutionalized or structured

Assumptions: We have been socialized into a society in which there exists individual, institutional and societal biases associated with race, gender, and sexual orientation. None of us are immune from inheriting the biases of our ancestors, institutions, and society. It is not “old-fashioned” racism, sexism, and heterosexism that is most harmful to people of color, women, and LGBT persons but the contemporary forms known as microaggressions.

“Old Fashion Racism” or Microassaults: it is uncommon, it is usually deliberate, conscious, and explicit. It often has the intention to hurt, oppress, or discriminate.  Examples:  −Refusing service to minorities −Displaying the hood of the Ku Klux Klan

Microaggressions

Microaggressions are constant and continual without an end date (an everyday hassle may be time-limited). Microaggressions are cumulative and anyone may represent the feather that breaks the camel’s back.  Microaggressions must be deciphered because they contain double messages (especially micro invalidations). Microaggressions are constant reminders of a person’s second-class status in society. Microaggressions symbolize past historic injustices.

Micro insults and Microinvalidations

•Not Intentional−Typically occur due to underlying biases and prejudices outside of awareness

• Microinsults −Convey insensitivity, are rude, or demean an individual’s identity or heritage

• Microinvalidations−Exclude, negate or nullify an individual’s thoughts or feelings

Definition of Microaggressions

“Microaggressions are brief and commonplace verbal, behavioral, and environmental indignities, whether intentional or unintentional, that communicate hostile, derogatory, or negative slights and insults that potentially have harmful or unpleasant psychological impact on the target person or group.”

Could be based on race, income, social capital, religion, ableness, gender, immigration status, sexual orientation, and/or other characteristics

Sue DW, et al. Racial Microaggressions in Everyday Life. Implications for Clinical Practice. Am Pschol. 2007;62(4):271-276.

Examples of Microaggressions

“Are you a nurse?” to a female physician examining a patient?
“Are you the sitter?” to a black physician walking into a patient room?
“You look too masculine,” to a self-identified lesbian physician.
“Minorities are still hung up on race” to a fellow physician.
“Your people must be so proud of you” to a physician with an accent.

“You speak English really well,” to someone born and raised in the United States.

Montenegro RE. My Name Is Not “Interpreter”. JAMA. 2016.

Psychological Consequences of Microaggressions

Many times, the person at the receiving end is not aware in the moment of the consequences of the microaggression but as time pass they may feel anxious or depressed. Many times we internalize these feelings to be our own thoughts and feelings without realizing where they came from.

•Anxiety

•Depression

•Sleep difficulties

•Diminished confidence

•Helplessness

•Loss of Drive

Cumulative Consequences

  • Assail the mental health of recipients (Sue, Capodilupo, & Holder, 2008),
  • Create a hostile and invalidating campus climate (Solórzano, Ceja, & Yosso, 2000),
  • Perpetuate stereotype threat (Steele, Spencer, & Aronson, 2002),
  • Create physical health problems (Clark, Anderson, Clark, & Williams, 1999),
  • Saturate the broader society with cues that signal devaluation of social group identities (Purdie-Vaughns, Steele, Davies, & Ditlmann, 2008),
  • Lower work productivity and problem-solving abilities (Dovidio, 2001; Salvatore & Shelton, 2007).
  • Responsible for creating inequities in education, employment and health care (Purdie- Vaughns, et al, 2008; Sue, 2010).

Managing Microaggressions in the Moment Use of the Interrupt Framework

The following is a framework on how to handle microaggressions without attacking the person but rather guide them to understand that their words are hurtful:

  • The “Interrupt” framework can help observers to respectfully address microaggressions in the moment:

− Inquire
− Nonthreatening
− Take responsibility
− Empower
− Reframe
− Redirect
− Use impact questions

− Paraphrase
− Teach using “I” phrases

       Inquire

Ask the speaker to elaborate on what they meant −Helps us understand their perspective

Examples:
− “I’m curious. What makes you ask that?”

− “What makes you believe that?”

Avoid “Why?” questions as can increase defensiveness

Paraphrase/reflect

Same skills we use in motivational interviewing

•Demonstrates understanding

Reduces defensiveness in rest of conversation

Examples:
− “You’re saying…”
− “So it sounds like you think…”

Re-direct

Shift the focus to a different person

−Particularly helpful when someone is asked to speak for his/her entire race, cultural group, etc.

Examples:

− “Let’s shift the conversation…”

− “Let’s open up this question to others and see what they think.”

Use Impact and “I” Statements

A clear, nonthreatening way to directly address these issues on behalf of oneself

  • It communicates the impact of the situation while avoiding blaming
  • Examples:
    • “I felt … when you said … and it ….(describe impact on you)”

Use Preference Statements

Clearly communicate one’s preferences rather than stating them as demands or having another guess what is needed

  • Examples:
    −In response to racist, sexist, homophobic, etc. jokes
    • “I don’t think this is funny. I would like you to stop.” −“It would be helpful to me…”

Use strategic questions

The skill of asking questions that will make a difference

  • A question that creates motion and options can lead to transformation
    • Examples:
      − “How might we examine our implicit bias to ensure that gender plays no part in this and we have a fair process.
    • What do we need to be aware of?”
      − “What would you need to approach this situation differently next time?”

Revisit

Even if the moment of the microaggression has passed, go back and address it. Research indicates that an unaddressed microaggression can leave just as much of a negative impact as the microaggression itself.

  • Examples:
    − “I want to go back to something that was brought up in our meeting…”

Individual Response


•Assume offense was not the intent.

•Explain how the slight was interpreted.

•Ask a follow up question.

•Identify and talk to individuals with whom you feel comfortable

When You Meet Resistance

•Will further conversation be beneficial and productive?

•What is my current level of stress?

•Am I able to respond non-emotionally?

• Reiterate that you are not blaming the person, only expressing the way the comment/action made you feel.

•Explain the cumulative effect of these occurrences.

Final Thoughts

Microaggressions are unfortunately present in our health and health education systems. As healthcare professionals and educators, we can employ tools to address implicit bias and microaggressions when encountered. As healthcare leaders, we can work to reduce the occurrence of microaggressions with a systems-based approach.

References

  • Microaggressions: Understanding What They Are, Why They Are Harmful and How to Manage Them Aarati Didwania, MD, MSCI, FACP Primary Care NOW July 2020
  • Banks, B. M. (2015). Microaggressions directed at Black college women: The moderating role of racial identity on self-control depletion.
  • Murphy, M. C., Richeson, J. A., Shelton, J. N., Rheinschmidt, M. L., & Bergsieker, H. B. (2012). Cognitive costs of contemporary prejudice. Group Processes & Intergroup Relations, 1-12.
  • Sue, D. W. (2010). Microaggressions in everyday life: Race, gender, and sexual orientation. John Wiley & Sons.
  • Sue, D. W., Capodilupo, C. M., & Holder, A. (2008). Racial microaggressions in the life experience of Black Americans. Professional Psychology: Research and Practice, 39, 329-336.
  • Sue, D. W., Capodilupo, C. M., Torino, G. C., Bucceri, J. M., Holder, A. M., Nadal, K. L., & Esquilin, M. (2007). Racial microaggressions in everyday life. American Psychologist, 62, 271-286.
  • White AA, Logghe HJ, Goodenough DA, et al. Self-Awareness and Cultural Identity as an Effort to Reduce Bias in Medicine. J Racial and Ethnic Health Disparities. 5 (1):34-49, Feb 2018.
  • Wong-Padoongpatt G, Zane N, Okazaki S, et al. Decreases in implicit self-esteem explain the racial impact of microaggressions among Asian Americans. J of Counseling Psychology, 64(5), 574-583.

Practical Diabetes Pearls

One of the hardest barriers to treat diabetes is the fear of starting insulin on patients. Not only do you have patient barriers but you may also have provider barriers. Her will discuss mainly patient barriers to starting insulin.

Addressing insulin fears

Patients come into the visit with many pre-conceived ideas about medications but especially insulin. The first step is to try to find out why they don’t want insulin, is it fear of needles or is it fear of insulin itself?

Is it fear of needles or fear of insulin?

Determining the root cause of patients’ fears or ambivalence toward insulin therapy can allow for more specific discussion, intervention and resolution.

Fear of needles:

Fear of pain or discomfort
  • Compare the sensation to the current experience.
  • Perform a mock injection with saline and an insulin syringe, and share your personal experience (if any) with subcutaneous injections. If appropriate, go through the exercise with the patient in the office with saline
Fear of exposures
  • Review low risk for infection, explain the sterility of products and educate on safe injection techniques

Fear of insulin:

• Associating need for insulin with personal failure

Have frequent discussions and provide reassurances that the progression of diabetes and need for insulin is normal, and not a reflection of personal failure.

• Worry about side effects, costs, interference with life/routine, whether insulin will work or “fail”, and others

Early conversations can elucidate concerns, and allows time for patient-centered discussions and interventions to address worries and fears.

Include family members and other team members to address specific needs.

• Former experience with a friend or loved-one, e.g. “My uncle started insulin and then he needed to have his leg amputated.”

Review importance of balancing personalized goals of therapy with quality of life and show commitment to shared-decision making.

As part of early education, patients should be introduced to the possibility of insulin for treatment. Weather is because their disease state has progressed or they are sick and in the hospital or they have symptoms suggestive of insulin deficiency (weight loss, polyuria/polydipsia)

Fear of Hypoglycemia

Many times they feel anxious and feel like they may even die. When patients develop this fear, they will often skip their insulin doses or even reduce doses to avoid low blood sugars. In the same way they may not want to restart insulin if they had a bad hypoglycemic episode.

Many patients once they have experienced hypoglycemia will become very afraid of the feeling they get during low blood sugars.

Reassure patients that this time you will start the dosing low and go slow, review what to do if they get a low blood sugars

Talking Points For When You Start Insulin

  • When insulin is indicated, explain why and how it will be helpful. Reinforce that the need for insulin does not represent a personal failure.
  • Keep the conversation(s) dynamic and patient-centered. Use open-ended questions and reflective listening to learn the patient’s expectations, impressions, and fears about insulin. Tailor the conversation to their needs.
  • Share your opinion as their provider, and show that you find value in the patient’s perspective.
  • Involve the patient’s caregivers and all members of the patient’s care team in the conversation(s) (nurses, medical assistance, support staff, etc).

“Many patients have told me that once they get the hang of it, injecting the insulin is actually easier and less painful than checking your blood sugar with the fingerstick. I even tried it myself!”

Many times Provider barriers can also become a problem. Providers can delay starting insulin for fear of complications like severe hypoglycemia, lack of time for teaching or close follow-up, unsure how to start or adjust insulin, and complexity of newer insulins. This is where Pharmacists can have a role to help educate not only the patients but also the providers. Pharmacists can also help adjust insulin doses and monitor patients closely to avoid complications or side effects.

Pharmacist in the Age of Covid-19

This is an unprecedented time for all of us but even more for healthcare workers.  As part of the health care team, pharmacist finds themselves in the front lines. Pharmacists are among the nation’s most accessible healthcare professionals, with 90% of Americans living within 5 miles of a community pharmacy. They are medication experts, providing patient care in a variety of settings, including hospitals, clinics, community pharmacies, long-term care, the medical home, and physician offices. 

Biggest Challenge

Covid-19 is one of the most challenging events of modern times. This event has taken away the sense of order and control that most health care workers like to have. This event has overwhelmed the health care system in the United States.  The major challenge is the speed at which the situation is changing. Many of the changes deal with the changing information about the virus itself and how to treat it. On the other side, health care workers are also dealing with closings of ambulatory care sites, redistribution of staff and new roles.

Pharmacist as Front-Line Responders

As the coronavirus spreads throughout the country and the supply of qualified healthcare providers becomes limited, pharmacists are at the front-line providing essential patient care services. As highly trusted and trained healthcare professionals, pharmacists play a critical role in patient care and public health. 

In a growing number of states pharmacists currently have the authority to test for and treat infectious diseases, such as influenza and strep infections. For example, in Idaho, pharmacists are authorized to prescribe products to treat strep/flu pursuant to a rapid diagnostic test using an evidence-based protocol. Florida recently passed a law permitting pharmacists to test and treat for strep, flu and other non-chronic ailments. However, pharmacists’ authorities to test and treat are inconsistent across the states. At this time of need, we need consistency in authority across the country for pharmacists to use their training, expertise, and knowledge to test and treat patients. 

Barriers in Workflow and Workforce

Telehealth: allowing Pharmacists to conduct telehealth visits for chronic diseases and reimburse them for the services provided.  Authorize retail pharmacists to conduct routine pharmacy tasks remotely as necessary (i.e. prescription data entry and script verification, medication review, and reconciliation. 

Inability to expand the Authority of technicians in all practice settings under a Pharmacist’s supervision. Things like the ability to transfer prescriptions (excluding controlled substances); conduct technician product verification for refills (i.e., tech-check-tech); and administer rapid diagnostic tests for infectious diseases, including flu, strep, and COVID-19 tests, under the supervision of the pharmacist, and ensure that only the pharmacist interprets test results. 

Flexible Medication fills/refills. Allow any pharmacy to provide early refills; prescriptions for greater than 30 days’ supply and emergency fill for non-controlled medications without a prescription when no refills remain.

Adequate Workforce Protection: ensure the provision of appropriate and effective personal protective equipment (N-95 masks, gloves, etc.) when necessary, for pharmacists, pharmacy personnel and all other health care professionals providing direct patient care to individuals (including screening and testing), handling hazardous substances and compounding. 

Federal, state, or public-private partnership funding for childcare and/or eldercare services for clinicians and pharmacy personnel who are unable to make alternative arrangements (e.g., those with school-age children whose schools have been closed) to ensure adequate staffing levels. 

Self-Care

In a professional level, when you find yourself having to wear masks, gloves at work all the time and social distancing; the danger really becomes real and can be very scary. The implications of the current situation for health care workers and what it means to your sense of safety. The amount of change, the increasing amount of work, having this virus affect colleagues and people you know, all can have an effect on our mental status. On a more personal level, we worry about bringing the virus home, if you are working from home then you feel guilty you are not in harm’s way when your colleagues and friends are.

What can you do to selfcare at this time? 

Most of us are quite busy, there are still some things we can do to self-care that do not take a lot of time. An app like called Headspace, which is being offered free to healthcare providers to teach meditation and relaxation. Try a yoga or meditation video, just doing some breathing exercises can help reduce stress. Practice gratitude, either by journaling or just start your day of what you are grateful for like your health and your family. Reach out to your co-workers, family, friends, supervisors if you need help r just to check-in to see how they are doing.

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Who is Protecting the Health Care Workers?

As patients get sick and they start to worry about the possibility of having Covid-19, they seek help from their Primary Care Doctors and clinics. Health care workers on the front lines expect to treat patients with Covid-19, many health care systems and many states are reported to be unprepared. Nurses accept risks as part of their daily work with patients and families, as do ER physicians, nurses’ aides, paramedics, physical and occupational therapists, and other health care workers such as Pharmacists who are on the front lines. But what degree of risks should they accept when resources are limited or not available?

health care workers often don’t receive the equipment and training they need, or they use the equipment improperly. How can they protect themselves?

More than 3,000 health care workers in China have been infected with the coronavirus, and their colleagues must care for them, but they must feel distress and have fear that the systems are not providing them with enough support.  Health care workers also have to think about protecting their own families once they go home.

A recent nursing survey exposed the worries that nurses share about Covid-19: About half didn’t have information on how to recognize or respond to Covid-19, about one in four didn’t know if a plan was in place to isolate Covid-19 patients, and only about two-thirds reported having access to N95 masks. And, many didn’t know if there was a policy in place for co-workers who were sick or otherwise exposed to Covid-19. We need to do better.

As ambulatory care Pharmacist we also come in contact with the highest risks patients and like all health care workers, we must think about how to not only protect the patients but for ourselves as well. Making sure we have the supplies necessary to keep ourselves safe is paramount. In many cases, lack of masks and even gloves are worrisome circumstances that as health workers we need to deal with.

The public has been asked to save masks for health care workers. Why do health care workers need masks, but the public has been told they’re not helpful?

There are no data to suggest that for regular people who are not sick, wearing a mask in public will do anything to reduce exposure to the virus. But, for health care workers, we need this workforce to stay healthy and prevent transmission to other, vulnerable patients. There are already reports of potential shortages in particular areas, so we have to be really thoughtful about how we use the supply that we have. The best use right now is for health care workers who have to go patient-to-patient and who, in the long run, will have to care for sick patients for months and months.

What kind of equipment keeps health care workers safe?

The most important thing is to wash your hands thoroughly with soap and water. Use a hand gel with 60% or higher alcohol concentration if soap and water aren’t available. For appropriate respiratory protection, the current recommendation from CDC is for health care workers to wear a gown, gloves, N-95 or higher-level respirator, and eye protection for patients with presumed or confirmed COVID-19. After removing the equipment carefully to avoid contamination, wash hands again. Unless you are told otherwise by the CDC, reusing personal protective equipment is not recommended.

How can patients safely interact with health care providers?

The most important thing a patient can do is alert the health care team they’re having respiratory symptoms immediately. The health care provider can put a mask on the patient, apply their own equipment, and alert the rest of the health care team.

As health care workers, many times we ourselves fall on the highest risk group. Having the necessary equipment, being educated on how to use equipment properly, protocols and guidance are extremely important to keep our health care work force healthy. Pharmacist are part of the health care workforce, we often interact face to face with patients, we need to know how to protect ourselves while taking care of our patients.

We can also help educate patients about the best ways to stay healthy, the importance of following the guidance from the CDC and the importance of making sure health care workers have access to the equipment they need. Patients do not need to wear masks, as they do not protect them. It is more important for them to wash their hands often and practice social isolation.

Travelers Diarrhea

The most travel season is the Summer, but a close second is the holidays which is almost here. As part of my clinical practice, I see patients who are traveling. The travel clinic looks at what immunizations the patient will need for the travels and we definitely need to address Traveler’s diarrhea.

Bacterial and viral Traveler’s Diarrhea (TD) presents with the sudden onset of bothersome symptoms that can range from mild cramps and urgent loose stools to severe abdominal pain, fever, vomiting, and bloody diarrhea, although with norovirus vomiting may be more prominent. Protozoal diarrhea, such as that caused by Giardia intestinalis or E. histolytica, generally has a more gradual onset of low-grade symptoms, with 2–5 loose stools per day. The incubation period between exposure and clinical presentation can be a clue to the etiology:

  • Bacterial toxins generally cause symptoms within a few hours.
  • Bacterial and viral pathogens have an incubation period of 6–72 hours.
  • Protozoal pathogens generally have an incubation period of 1–2 weeks and rarely present in the first few days of travel. An exception can be Cyclospora cayetanensis, which can present quickly in areas of high risk.

Untreated bacterial diarrhea usually lasts 3–7 days. Viral diarrhea generally lasts 2–3 days. Protozoal diarrhea can persist for weeks to months without treatment.

Traveler’s Diarrhea (TD) recent updates

•Traveler’s diarrhea is the most predictable travel-related illness and affects 30%-70% of international travelers.

•Usually consists of 4-6 days of loose stools, sometimes accompanied by low-grade fever, nausea, abdominal cramping, headache, and/or general malaise

•Antibiotic-mediated disruption of the microbiome and subsequent colonization with resistant organisms

•Pre-travel counseling should include the risks and benefits of antibiotic use.

Destination Matters

Knowing where the patient is going is important, that will tell you what the risks are depending on the destination.

•Low risk: US, Canada, Australia, Japan, Northern and Western Europe

•Intermediate risk: Eastern Europe, South Africa, some Caribbean islands

•High risk: Asia, Middle East, Africa, Mexico, Central and South America  

In destinations in which effective food handling courses have been provided, the risk for TD has been demonstrated to decrease. However, even in developed countries, pathogens such as Shigella sonnei have caused TD linked to handling and preparation of food in restaurants.

TD occurs equally in male and female travelers and is more common in young adult travelers than in older travelers. In short-term travelers, bouts of TD do not appear to protect against future attacks, and >1 episode of TD may occur during a single trip.

Prophylaxis for TD

•Do not routinely use antibiotics for prophylactic treatment in travelers

To prevent overuse of antibiotics the panel strongly recommends against routine use of antibiotics.

Prophylactic antibiotics can prevent some TD, the emergence of antimicrobial resistance has made the decision of how and when to use antibiotic prophylaxis for TD difficult. Controlled studies have shown that use of antibiotics reduces diarrhea attack rates by 90% or more. The prophylactic antibiotic of choice has changed over the past few decades as resistance patterns have evolved. Fluoroquinolones have been the most effective antibiotics for the prophylaxis and treatment of bacterial TD pathogens but increasing resistance to these agents among Campylobacter and Shigella species globally limits their potential use. In addition, fluoroquinolones are associated with tendinitis and an increased risk of Clostridioides difficile infection, and current guidelines discourage their use for prophylaxis. Alternative considerations include azithromycin and rifaximin.

How to Prevent TD

•Advise patient to research the safety of water at destination, and if not safe…

–Refrain from drinking tap water

–Avoid food washed in tap water

–Be careful when choosing restaurants

You can find information regarding the water at the CDC- traveler website. Lack of safe water may lead to contaminated foods and drinks prepared with such water; inadequate water supply may lead to shortcuts in cleaning hands, surfaces, utensils, and foods such as fruits and vegetables. In addition, handwashing may not be a social norm and could be an extra expense; thus, there may be no handwashing stations in food preparation areas. In destinations in which effective food handling courses have been provided,

Consider Prophylaxis for TD

•Bismuth subsalicylate (BSS) may be considered for any traveler

Bismuth subsalicylate (BSS), is the active ingredient in adult formulations of Pepto-Bismol and Kaopectate.  Travelers with aspirin allergy, renal insufficiency, and gout, and those taking anticoagulants, probenecid, or methotrexate should not take BSS. In travelers taking aspirin or salicylates for other reasons, the use of BSS may result in salicylate toxicity. 

•Consider antibiotics for travelers at high risk of health-related complications of TD

–Rifaximin should be prescribed for all regions

–Fluoroquinolones (FQ) are no longer recommended for prophylaxis

Prophylactic antibiotics may be considered for short-term travelers who are high-risk hosts (such as those who are immunosuppressed or with significant medical comorbidities) or those who are taking critical trips (such as engaging in a sporting event) without the opportunity for time off in the event of sickness.

Treatment

Fluids and electrolytes are lost during TD, and replenishment is important, especially in young children or adults with chronic medical illness. In adult travelers who are otherwise healthy, severe dehydration resulting from TD is unusual unless vomiting is prolonged. Nonetheless, replacement of fluid losses remains an adjunct to other therapy and helps the traveler feel better more quickly. Travelers should remember to use only beverages that are sealed, treated with chlorine, boiled, or are otherwise known to be purified.

Treatment Based on Classification 

FDA warns that the potentially serious side effects of fluoroquinolones may outweigh their benefit in treating uncomplicated respiratory and urinary tract infections; however, because of the short duration of therapy for TD, these side effects are not believed to be a significant risk.

A potential alternative to fluoroquinolones is azithromycin, although enteropathogens with decreased azithromycin susceptibility have been documented in several countries. Rifaximin has been approved to treat TD caused by noninvasive strains of E. coli. However, since it is often difficult for travelers to distinguish between invasive and noninvasive diarrhea, and since they would have to carry a backup drug in the event of invasive diarrhea, the overall usefulness of rifaximin as empiric self-treatment remains to be determined.

Single-dose regimens are equivalent to multi­dose regimens and may be more convenient for the traveler. Single-dose therapy with a fluoroquinolone is well established, both by clinical trials and clinical experience. The best regimen for azithromycin treatment may also be a single dose of 1,000 mg, but side effects (mainly nausea) may limit the acceptability of this large dose. Giving azithromycin as 2 divided doses on the same day may limit this adverse event.

Classification

•Mild: Tolerable, not distressing, and does not interfere with planned activities–Supportive: Rehydration, BSS or loperamide–No antibiotics

•Moderate: Distressing or interferes with planned activities–Azithromycin–Rifaximin–FluoroQuinolones (FQs) may be used outside of Southeast and South Asia

•Severe: Incapacitating or completely prevents planned activities; all dysentery–Azithromycin: First line for dysentery or febrile diarrhea–FQs and rifaximin: Severe, non-dysenteric TD

•Single-dose antibiotics should be use

–Treat moderate or severe TD

–Azithromycin and FQs: Single dose for 3 days

•Adjunct therapy: Loperamide

–Moderate-to-severe TD: Symptomatic relief with curative treatment

–Moderate TD: Monotherapy

If symptoms have not resolved after 24 hours, the full course of antibiotics should be use for the three days

Persistent Diarrhea after Returning

Persistent Diarrhea:  is diarrhea lasting >2 weeks

–Functional bowel disease may occur after bouts of TD 

–May meet Rome III or IV criteria for irritable bowel syndrome

•Follow-up diagnostic testing

–Consider microbiological testing in returning travelers with severe or persistent symptoms, bloody/mucous diarrhea, or in those who fail empiric therapy

–Molecular testing: Preferred when rapid results are clinically important or nonmolecular tests have failed to establish a diagnosis

•Prebiotic or probiotic: Insufficient evidence for prevention or treatment

Take Home Points

  • Prophylaxis should be considered only in high-risk groups; rifaximin is the first choice, and BSS is a second option
  • Review the severity classification with travelers
  • Travelers to destinations in developing countries should be provided with loperamide and an antibiotic for self-treatment
  • Antibiotic choice is destination-dependent 
  • If symptoms do not improve within 24-36 hours of beginning antibiotic therapy, may need to seek medical attention

References:

  1. Centers for Disease Control and Prevention (CDC). https://wwwnc.cdc.gov/travel/yellowbook/2020/preparing-international-travelers/travelers-diarrhea. Updated June 24, 2019.Accessed July 29, 2019.CDC. 
  2. https://wwwnc.cdc.gov/travel/yellowbook/2020/preparing-international-travelers/perspectives-antibiotics-in-travelers-diarrhea-balancing-the-risks-and-benefits. Updated June 24, 2019. Accessed July 29, 2019.Riddle MS, et al. J Travel Med. 2017;24(suppl 1):S57-S74.
  3. CDC-https://wwwnc.cdc.gov/travel/yellowbook/2020/preparing-international-travelers/travelers-diarrhea. Updated June 24, 2019. Accessed July 29, 2019.

Why is The Anticoagulation Patient on Aspirin?

Anticoagulation patients should routinely be assessed for drug interactions and warfarin and aspirin should be one of them. Many patients are on both aspiring and warfarin, but do they need to be?

It turns out that a third of patients on warfarin are on aspirin for no good reason. The problem is that patients on aspirin and warfarin have a higher risk of bleeding. Including, major bleeds and hospitalizations compared to those who are on warfarin alone. 

A cohort study of adults enrolled at 6 anticoagulation clinics. They enrolled patients at 6 anticoagulation clinics in Michigan from January 2010-2017. And looked at individuals who were receiving warfarin therapy for Afib or for venous thromboembolism, DVT, and/or pulmonary embolus, without any documentation of a recent heart attack or valve replacement, people who don’t have an additional indication to be on aspirin.

They looked at greater than 6,500 patients with an average age of 66 years. It turns out that about a third of them had no clear therapeutic indication to being on aspirin addition to their warfarin. The outcomes when someone is enrolled in an anticoagulation clinic are usually better than the rest of the wide world out there.

At 1 year, patients receiving combination therapy with warfarin and aspirin compared to those who received warfarin alone had higher rates of overall bleeding, 26% vs 20%; higher rates of major bleeding, the warfarin vs aspirin group 5.7% vs 4.6% in the aspirin alone group; a higher rate of emergency department visits, 13% vs 9.8%; a higher rate of hospitalizations for bleeding, 8.1% vs 5.2%.

It’s about a 50% higher rate of hospitalization for bleeding but no improvement in the rate of thrombosis. The take-home point here is a real clear one. We need to look when patients are on warfarin. We need to make sure they’re not also on aspirin if there is no clear indication. Aspirin used to be recommended routinely for primary prevention of stroke and of heart attack. Unless someone has a clear and compelling indication for aspirin, when they’re on warfarin get them off the aspirin.

References:
Tillman H, et al. Risk for Major Hemorrhages in Patients Receiving Clopidogrel and Aspirin Compared With Aspirin Alone After Transient Ischemic Attack or Minor Ischemic Stroke: A Secondary Analysis of the POINT Randomized Clinical Trial. JAMA Neurol. 2019 Apr 29 [Epub ahead of print]. doi:10.1001/jamaneurol.2019.0932

Check Vitamin B12 Levels on Metformin Patients

Patients who use metformin might experience reduced levels of Vitamin B12.  Older patients in particularly can have a decrease in cognitive performance, according to study results published in The Journal of Endocrinology & Metabolism.

Long-term metformin use has been associated with B12 vitamin deficiency. The goal of the study was to investigate the effects of hyperglycemia and metformin use on folate-related B vitamin biomarkers and cognitive performance in older adults.  Researchers assessed 4160 community-dwelling older people (average age, 74.1 years) for biomarkers of folate, vitamin B12, vitamin B6, and riboflavin.

Classified as normoglycemic (n = 1856) or hyperglycemic with (n = 318) or without (n = 1986) metformin treatment, each participant was assessed for cognitive ability according to the Repeatable Battery for Assessment of Neuropsychological Status and the Frontal Assessment Battery.

On average, patients with hyperglycemia were older, more overweight, and had worse renal function than patients who were normoglycemic. All groups demonstrated normal mean scores on all cognitive tests.

Compared with patients with normoglycemia and patients with hyperglycemia not treated with metformin, patients with hyperglycemia who received metformin treatment were at greater risk for deficiency in vitamin B12 (combined B12 index ≤-1; odds ratio, 1.45) and B6 levels (plasma pyridoxal 5-phosphate <30 nmol/L; odds ratio, 1.48).

After adjusting for various confounding factors, results from the Repeatable Battery for Assessment of Neuropsychological Status and Frontal Assessment Battery tests demonstrated that metformin use was associated with elevated risk for cognitive dysfunction (1.36 and 1.34, respectively).

Because of the cross-sectional nature of this study, the researchers noted an inability to confirm causal relationships between diabetes/metformin use and B-vitamin deficiency.

From the ADA 2019 guidelines, “A recent randomized trial confirmed previous observations that metformin use is associated with vitamin B12 deficiency and worsening of symptoms of neuropathy (43). This is compatible with a recent report from the Diabetes Prevention Program Outcomes Study (DPPOS) suggesting periodic testing of vitamin B12 (44)”. The recommendation is to test Vitamin B12 periodically, like once a year to make sure patients have not develop Vitamin B12 deficiencies.

Thromboembolism in AF

stroke journal
WebMD
  • Cardioembolism: due to blood stasis primarily in left atrial appendage
  • AF significantly increases risk of thromboembolic ischemic stroke 5 times compared to patients in sinus rhythm
    • 4 times greater risk of recurrent stroke
    • More severe disability
    • 2 times higher mortality

Most serious common complication of AF is arterial thromboembolism, most notably an ischemic stroke. Due to formation of atrial thrombi from blood stasis.

Thromboembolism occurring with AF is associated with greater risk of recurrent stroke, more severe disability, and mortality. Embolization of atrial thrombi can occur with any form of AF. Embolic risk leads to chronic oral anticoagulation.

Oral anticoagulants have been shown to lower the risk of clinical thromboembolism in nearly all patients with AF, at all levels of risk and irrespective of its classification

Estimation of Thromboembolism

CHA2DS2 VASc

January CT, et al. J Am Coll Cardiol. 2014;64:21  

In patients with nonvalvular AF, the CHA2DS2-VASc score is recommended for assessment of stroke risk

To assess stroke risk

0 = no antithrombotic therapy

1: no treatment or ASA

Oral anticoagulation recommended in score 2 or more

Antithrombotic Therapy

ACC/AHA Guidelines

Chest Guidelines

Anticoagulation: warfarin, dabigatran, apixaban, rivaroxaban, betrixaban

Other Factor Xa inhibitors (edoxaban, betrixaban) not approved at time of guidelines

CHADS 0: ASA may prevent 2 nonfatal strokes per 1000 pt

1: asa + clopidogrel for those unsuitable for/choose not to take AC for reasons other than bleeding (difficult maintaining stable INR, lifestyle limitations regular monitoring, costs)

HAS-BLED

Pisters R, et al. Chest. 2010;138:5

Bleeding risk scores to quantify hemorrhage risk

Other bleeding risk scoring systems: RIETE, HEMORR2HAGES, ATRIA

Helpful in defining patient at elevated bleeding risk, but clinincal utilily is insufficient for use as evidence for recommendations in guideline

Low risk: 0

Moderate: 1-2

A score >/3 indicates potentially “high risk” for bleeding and may require closer observation of a patient for adverse risks, closer monitoring of INRs, or differential dose selections of oral anticoagulants or aspirin

HAS-BLED > CHADS2 Score

  1. HAS-BLED score ≥3 indicates “high risk” of bleeding
    1. Caution and regular review needed following initiation of AC
    1. Address correctable bleeding risk factors (eg. uncontrolled hypertension, co-administration of NSAIDs or aspirin, etc).
  2. If HAS-BLED score exceeds CHADS2 score, the risk of major bleeding may outweigh potential benefit of AC
    1. Use in the Euro Heart Survey on AF population could have prevented 12.1% (4/33) of major bleeds (Pisters R, et al. Chest. 2010;138:1093).
  3. Requires validation in other cohorts of patients with AF
    1. Not yet adopted by the ACC/AHA/HRS AF guidelines AC = oral anticoagulation

Camm AJ, et al. Eur Heart J. 2010;31(19):2369-2429. Pisters R, et al. Chest. 2010;138:1093-1100.

Lip GY, et al. Am J Med.2010;123(6):484-488.

Why Is AF Undertreated from an Anticoagulation Standpoint?

•Patient intolerance or poor adherence

•Under-recognition of AF itself

•Physician treatment bias:

–Inclination to correlate burden of AF with stroke risk

–Belief that aspirin is an acceptable protective alternative to oral anticoagulants

–Medical liability: 27% of patients decline OAC based on shared decision-making (i.e., fear of complications)

De Breucker S, et al. Drugs Aging. 2010;27(10):807-813. Why Is AF Undertreated from an Anticoagulation Standpoint?

Percutaneous Left Atrial Appendage Closure (LAAC)

•Treatment strategy to reduce the risk of LAA blood clots from entering the bloodstream and potentially causing stroke in nonvalvular AF patients

•Randomized data only available for WatchmanTM procedure –Only FDA-approved device

•AmuletTM is being studied

•Lariat procedure is a commercially available closure device –FDA approval only for “approximation of soft tissue” but not LAA closure for stroke prevention Percutaneous Left Atrial Appendage Closure (LAAC)

Watchman Procedure

Watchman Device

Patient Selection

•Appropriate patients:

–Increased risk for stroke CHADS >1 or CHA2DS2-VASc ≥2

–Deemed suitable for warfarin

–Have appropriate rationale to seek nonpharmacologic alternative to warfarin

•Contraindicated:

–Do not use if thrombus visualized on TEE imaging

–Prior atrial septal defect (ASD) or patent foramen ovale (PFO) repair or closure device

–Contraindications to use of warfarin, aspirin, or clopidogrel

Additional Considerations

•Risks include bleeding, perforation, pericardial effusion, tamponade, stroke, and death

•Complication rate of 2-3%

•A shared medical consensus between 2 physicians and the patient is required to qualify for insurance coverage

PASS Criteria

•Position

–Position relative to the ostium of the left atrial appendage

•Anchor

–Are the fixation anchors engaged?

•Size

 –Device should be compressed 8-20% of original size

•Seal

–Device should span entire ostium and all lobes should be covered

Watchman device placement

Postprocedure Anticoagulation Protocol

Key Points

•Oral anticoagulation is the preferred therapy to reduce stroke risk in patients with AF…

•…but overall compliance with warfarin and DOACs is poor (~50%), especially among those at highest risk for stroke

•LAAC is a second-line therapy for stroke prevention in patients with AF and is reasonable alternative for patients. ineligible for long-term oral anticoagulation

Next article: Up next anticoagulation treatment

What is Atrial Fibrillation

January C.T, et al. J. Am Coll Cardio. 2014:21

What is Atrial Fibrillation?

  • Supraventricular arrhythmia:
    • Supraventricular—originate above bundle of His, char by abnormal P waves w/ normal QRS and QTc intervals
  • Uncoordinated atrial activation and ineffective atrial contraction
  • Irregularly, irregular pulse

Atrial Fibrillation (or A. Fib)

  • Most common cardiac arrhythmia
  • EKG: irregular R-R intervals, no distinct repeating p waves, and irregular atrial activity
  • Worldwide: 33.5 million, ~3-6 million in US
  • Prevalence increases with age (>65), 3% of men and 2% of women
  • Contributes to >99,000 deaths per year
  • 20% of patients who have a stroke associated with AF receive an AF diagnosis at the time of stroke or shortly thereafter

Annual Death Rates from AF (2015)

•AF was the underlying cause of death in ~24,000 people and listed on ~150,000 US death certificates

•In adjusted analyses from the Framingham Heart Study, AF was associated with an increased risk of death in both males (OR, 1.5; 95% CI, 1.2-1.8) and females (OR, 1.9; 95% CI, 1.5-2.2)

–AF diminishes the survival advantage typically observed in females

Classification

  • Paroxysmal (occasional)
    • Terminates spontaneously or with intervention within 7 days
  • Persistent
    • Continuous—sustained > 7 days
  • Longstanding persistent
    • Continuous— > 12 months in duration
  • Permanent
    • Acceptance of AF: Permanent: when patient and doctor make joint decision to stop further attempts to restore and/or maintain sinus rhythm
    • Represents a therapeutic attitude vs. an inherent pathophysiologic attribute of AF
  • Attitudes and acceptance of AF may change as symptoms, efficacy of therapies, and patient/clinician preferences evolve

Nonvalvular

  • In absence of rheumatic mitral stenosis, mechanical/bioprosthetic heart valve, or mitral valve repair
  • Important because it guides therapy

January CT, et al. J Am Coll Cardiol. 2014;64:21

Strokes in AF Lead to More Disability

Lin HJ, et al. Stroke 1996;27(10):1760-1764. Tu HT, et al. Cerebrovasc Dis. 2010;30(4):389-395.

  • Larger infarcts (52 vs. 15 ml, P=0.05)
  • Higher mortality (HR= 1.84)
  • More severe hemorrhagic transformation (29% vs. 5%, P=0.002)

Risk Factors and Underlying Comorbidities to Address in Chronic AF Management

Major risk factors

  • Older age
  • Obesity
  • (Borderline) hypertension

Other risk factors

•(Pre) diabetes

•Heart failure

•Prior cardiothoracic surgery

•Smoking

•Prior stroke

•Obstructive sleep apnea

•Drug use Alcohol consumption

•Vascular disease

•Hyperthyroidism

•Lipid profile

•Coronary artery disease

•Physical inactivity

•Chronic kidney disease

•COPD

•Valve disease

•Inflammatory diseases

Brandes A, et al. Arrhythm Electrophysiol Rev.2018;7(2):118-127.Steinhubl S, et al. JAMA. 2018;320(2):146-155.

Pathophysiology

AF occurs when structural and/or electrophysiological abnormalities alter atrial tissue to promote abnormal impulse formation and/or propagation.

Heart has Purkinje fibers (specialized cardiac muscle fibers that rapidly transmit impulses from the atrioventricular node to the ventricles)

  • Fibers are split into 2 branches

Normal

  • Electrical impulse (action potential) travels down both branches
  • Meet in the connecting p/w and cancel each other out

Reentry

  • When there is a block in one of the branches, the AP only travels down one branch leads to No longer canceled out
  • Travels retrograde through the block and can then travel down the 1st branch again
  • leads to indefinite propagation leads to abnormal impulses in AF

These abnormalities are caused by diverse pathophysiological mechanisms

A.Fib Normal vs re-entry

AF begets AF

Atrial structural abnormal

  • Any disturbance in atrial structure that increases susceptibility to AF
  • Most commonly d/t extracardiac factors that increases left atrium pressure, cause atrial dilation and alter wall stress
  • Structural abnormal à alter impulse conduction/refractoriness

Mechanisms of AF

Mechanism of A. Fib

Electrophysiological mech

  • Triggers of AF
    • Abnormal focal discharges initiate AF
    • Rapidly firing foci most commonly from left atrium
    • Conduction abnormal that promote reentry d/t depolarized resting potentials that promote sodium channel inactivation
    • Abnormal intracellular calcium handling d/t diastolic calcium leak from sarcoplasmic reticulum, which can trigger delayed after-depolarization
  • ANS
    • Activation of para and/or sympathetic NS can provoke atrial arrhythmias
    • Sympathetic: activates beta-1 adrenergic R
      • Cardiac excitatory effects: increased conduction, contraction, irritability of foci
    • Parasympathetic: activates cholinergic R
      • Cardiac inhibitory effects:

Pathophysiological mechanisms

  • Atrial tachycardia remodeling: AF begets AF
  • Inflammation and ox stress
    • Inflammationà increased concentration of C-reactive protein (marker of inflammation, high-sensitivity C-rp assay can determine risk for CAD)
  • RAAS
    • Angiotensin II, ACE and aldosterone are synthesized locally in atrial myocardium and are increased during AF

Automaticity: ability of cardiac muscle to spontaneously depolarize in a reg constant manner

Key Points

•AF is common

•Prevalence increases with age

•Proper diagnosis and classification are key to properly manage arrhythmia and minimize stroke risk

Symptoms

  • Fluttering in the chest
  • Feeling faint, weakness, syncope

A.Fib increases your risk of thromboembolic stroke

Treatment

  • Rate Control
    • Control ventricular rate with beta blockers or non-DHP calcium channel blockers and AV nodal ablation
      • Medications
      • Arteriovenous (AV) junction ablation + pacemaker (PPM)
  • No attempt made to restore SR
  • Rhythm Control
    • Long-term management with cardioversion, antiarrhythmics, and radiofrequency catheter ablation
    • Attempt made to restore SR
  • Anticoagulation
    • Prevention of thromboembolism

BB: block sympathetic tone (atenolol, metoprolol, nadolol, propranolol, carvedilol)

CCB: direct AV nodal effects, block L-type Ca channels (diltiazem, verapamil)

January CT, et al. J Am Coll Cardiol. 2014;64:21

What Is AF Ablation?

•Cardiac ablation: Procedure using energy to create lesions (resulting in scarring) in the atria with the goal of stopping abnormal electrical conduction

•Pulmonary vein (PV) isolation: Electrical isolation of the PVs, which are well-known triggers for AF and are the key lesion set for an AF ablation

•Cavo-tricuspid isthmus ablation: Done in patients with concomitant atrial flutter

•Types of ablation:

–Catheter-based: Minimally invasive

–Surgical: Maze, minimally invasive, usually concomitant with open-heart surgeries (e.g., CABG)

–Hybrid approach: Catheter-based + minimally invasive surgery

Calkins H, et al. Heart Rhythm. 2017;14(10);e275-e444.

AADs

•Recurrence rates

–Amiodarone: 35%

–Sotalol: 63%

–Propafenone: 63%

•Adverse events

–Amiodarone: 18%

–Sotalol/propafenone: 11%

 Singh BN, et al. N Engl J Med. 2005;352:1861-1872.Pedersen OD, et al. Circulation. 2001;104:292-296.Freemantle N, et al. Europace. 2011;13:329-345.Piccini JP, et al. J Am Coll Cardiol. 2009;54:1089-1095.The AFFIRM First Antiarrhythmic Drug Substudy Investigators.J Am Coll Cardiol. 2003;42:20-29.Lafuente-Lafuente C, et al.Cochrane Database Syst Rev. 2007;(4):CD005049.

Key Points

•Rate control is an option for patients with few symptoms and in whom maintaining SR will be risky, challenging, or unsuccessful

–Can be achieved with medications or AV junction ablation and pacing

•Rhythm control is an option for symptomatic patients, or those who develop a cardiomyopathy–Better option for younger patients with less advanced heart disease

–Can be achieved with AADs or catheter ablation

Should Statins Be Used in Patients Older Than 75 Years of Age as a Primary Prevention?

A recent article in the Lanceton the efficacy and safety of statin therapy in older adults. It was a meta-analysis of individual participant data from 28 randomized trials. The article brings into question the practice of using statins for primary prevention in older adults, those aged 70-75 years.

The authors remarkably analyzed individual participant data from 22 trials of over 130,000 individuals. They also included detailed summary data from one trial of over 12,000 individuals, as well as trials of statin therapy, high-dose vs low-dose, which was another 40,000 individuals. So, almost 200,000 individuals were enrolled in randomized, blinded control studies. 

Approximately 8% of those individuals, over 14,000 people, were older than 75 years of age at the time of randomization. The median duration of follow-up was about 5 years.

Overall, statin therapy worked very well at reducing future major vascular events. There was also a 21% reduction in major vascular events for every 40 mg/dL decrease in LDL cholesterol.

However, the benefit was seen in people who had a history of vascular events. But, when looking at people older than 70-75 years of age, who had no history of previous vascular events, the authors noted the use of statin therapy showed no evidence of benefit on cardiac endpoints. In other words, statin therapy for primary prevention in those >70-75 years of age did not appear to be beneficial in this meta-analysis.

Take-away message

Well, greater than 30% of individuals over 70 years of age are currently on statins. This analysis suggests that we should really use a shared decision-making model when discussing the use of statin therapy in individuals >70-75 years of age who don’t have a history of previous vascular events.

For secondary prevention, statins work. Patients who have had an MI or a stroke, regardless of age, should be on a statin. But, for healthy patients without a history of vascular events, the pooled cohort equation and traditional thinking of “if someone has a >7.5% 10-year risk of cardiac disease, they should be on a statin,” does not necessarily apply to this older age group.

Is this a practice changer?

This meta-analysis clearly shows that statin therapy as primary prevention in individuals >70-75 years of age may not be beneficial, and we should use a shared decision-making model when considering the addition of statin.

References:
Cholesterol Treatment Trialists’ Collaboration. Lancet. 2019;393(10170):407-415. doi:10.1016/S0140-6736(18)31942-1.