461 - Statins for Primary Prevention, UGI Bleed Prevention, Encouragement

New From the USPSTF

1)  Statin Use for Primary Prevention of CV Disease in Adults

According to 2020 data from the CDC’s National Center for Health Statistics, heart disease and cerebrovascular disease were the first and fifth leading causes of death in adults 65 years or older.  Indeed, cardiovascular disease (CVD) is the cause of greater than 25% of all adult deaths. 

The USPSTF recently updated its 2016 recommendation regarding the use of statin medications for the primary prevention (without known disease or signs/symptoms) of CVD in adults > 40.  

The USPSTF now recommends the following for the primary prevention of CVD:

·       Clinicians prescribe a statin for adults aged 40-75 who have 1 or more CVD risk factors (ie, dyslipidemia, diabetes, hypertension, or smoking) and an estimated 10-year CVD risk of 10% or greater. (B recommendation – moderate certainty of at least moderate new benefit)

·       Clinicians selectively offer a statin for adults age 40-75 who have 1 or more of these CVD risk factors and an estimated 10-year CVD risk of 7.5% to less than 10%. The likelihood of benefit is smaller in this group than those with a 10-year risk of 10% or greater. (C recommendation – moderate certainty of at least a small net benefit)

·       Concludes that the current evidence is insufficient to assess the balance of benefits and harms of initiating a statin for the primary prevention of CVD events and mortality in adults 76 years or older. (I statement)

The Task Force indicates that the American College of Cardiology/American Heart Association (ACC/AHA) Pooled Cohort Equations (PCE) may be used to estimate 10-year risk of CVD (ASCVD Risk Estimator Plus – see references).  Clinicians should recognize that predictions of 10-year CVD events using the PCE are estimates.  The ACC/AHA risk estimator is, to date, the only US-based CVD risk prediction tool that has published external validation studies in other US-based populations.  The estimator has separate equations based on sex and for Black persons and non-Black persons, which include the risk factors of age, cholesterol levels, systolic blood pressure level, antihypertension treatment, presence of diabetes, and smoking status, and focuses on hard clinical outcomes (myocardial infarction and death from coronary heart disease; ischemic stroke and stroke-related death) as the outcomes of interest.

Age is one of the strongest risk factors for CVD, and the 10-year CVD event risk estimated by the ACC/AHA risk estimator is heavily influenced by increasing age. The risk prediction equations generally show higher risk for Black persons than White persons.   Concerns about calibration of the PCE exist, with many external validation studies showing overprediction in broad populations (men and women across racial and ethnic groups).  However, Black and Hispanic adults, who have the highest prevalence of CVD, also have the lowest use of statins.  Limited evidence also suggests underprediction in disadvantaged communities that could lead to underutilization of preventive therapies.

There are limited data directly comparing the effects of different statin intensities on health outcomes.  A majority of the trials reviewed by the USPSTF used moderate-intensity statin therapy.  Based on available evidence, the Task Force concluded that the use of moderate-intensity statin therapy seems reasonable for the primary prevention of CVD in most persons when medication is indicated.

Mark’s Comments:

When it comes to the use of statins for the primary prevention of CVD, there are strong opinions as to whether we are overtreating, undertreating, or appropriately treating those at risk based on the 4 editorials were published in the various JAMA family of journals in conjunction with the release of this recommendation statement.  Using that as a gauge, perhaps the USPSTF got it right with their “show me the evidence” approach to creating their recommendations.  This doesn’t mean that we still shouldn’t customize our approach for an individual based on their specific context, but on a population scale, this seems a prudent and wise approach.  Appropriately treating those who are at risk based on these criteria would likely have a significant impact on CVD mortality, particularly for minority and socioeconomically disadvantaged persons.

References:

·       USPSTF.  Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: US Preventive Services Task Force Recommendation Statement. JAMA August 23/30 2022;328(8):746-753. Article

·       American College of Cardiology ASCVD Risk Estimator Plus: Website   App

·       See also “Statin Use in ASCVD – We Have a Long Way to Go.”  Take 3 May 6, 2022.  Pointer 2.  Link  AND “Coronary Calcium Scores – No Evidence They Help.”  Take 3 July 8, 2022.  Pointer 1.  Link

From the Literature

2)  Antisecretory Meds to Reduce UGI Bleed Risk from Anticoagulants

The decision to start chronic anticoagulation is a balance between risk of thrombosis and risk of bleeding. A patient’s risk of upper gastrointestinal (UGI) bleeding can stem from non-steroidal anti-inflammatory (NSAID) use, a history of acid peptic diseases, and a history of previous UGI bleeding. One way to tip that balance in favor of anticoagulation is to reduce bleeding risk.

The authors of a recent systematic review gathered the available evidence examining the effect of antisecretory agents (proton pump inhibitors (PPI) and H2-receptor antagonists (H2RA)) on UGI bleeding risk in patients who were anticoagulated. Their search was suitably comprehensive. They included both observational studies and trials but were careful to exclude observational studies that had insufficient controls for confounders. Interestingly, they included studies that used claims data to determine outcome. They appropriately assessed for risk of bias and heterogeneity in the included studies.

They found 7 studies (2 case-control, 4 retrospective cohort, 1 RCT) all of which studied PPIs and one of which included H2RAs. The studies were all at low risk of bias. Meta-analysis was performed using 5 of the studies; one study was excluded because its sample overlapped with another included study, and one was excluded because its results could not be statistically combined. The pooled relative risk of UGI bleeding in patients on antisecretory agents was 0.67 (95% CI 0.61, 0.74), with low heterogeneity (I² = 15%). The authors performed a sensitivity analysis excluding the single RCT - because all its participants were felt to be at low risk for bleeding - and found a similar effect. The meta-analysis was dominated by a large retrospective cohort study of Medicare beneficiaries using claims data for outcome determination.

The authors conclude that antisecretory agents reduce the risk of UGI bleeding especially in patients at a high risk for bleeding – NSAID use or concomitant antiplatelet therapy.

John’s Comments:

The authors worry that a conclusive RCT on this topic will not be performed because it is “standard of care” to give PPIs for anticoagulated patients with a high risk of UGI bleeding. While the authors did a respectable job with the data they found, I am concerned that the largest weight study in the meta-analysis is one that uses claim data for its outcomes, especially since the single RCT included in this review found no effect (attributed to the very low risk population in the RCT). We have been led down the primrose path of relying on observational data to make guidelines many times before. The authors’ suggestion to use antisecretory therapy mainly with patients at elevated risk of UGI bleeding is not controversial, and is probably good practice in the interim, but the evidence is not yet clear.

Reference:

·       Kurlander JE, Barnes GD, Fisher A, et al. Association of Antisecretory Drugs with Upper Gastrointestinal Bleeding in Patients Using Oral Anticoagulants: A Systematic Review and Meta-Analysis. Am J Med. Published online June 7, 2022:S0002-9343(22)00433-8. doi:10.1016/j.amjmed.2022.05.031  Link

From PeerRxMed ( www.PeerRxMed.org )

3)  It’s Time to Get Serious About Addressing the Deficit!

“It appears next to impossible to over-encourage someone, so why not try to see if you can achieve the impossible.”  Me

This past week I received a very thoughtful LinkedIn message from a colleague I hadn’t heard from for 3 years expressing appreciation for a recent AMA "Moving Medicine" podcast interview I had given on peer-to-peer support.  I was both flattered and touched, and her words of encouragement provided an incredible emotional “boost” for me that has persisted.  In her words I also heard the echoes of the encouragement that so many others have provided to me over the years that helped put me in a position to even be a guest on a podcast.  

The Oxford Dictionary defines encouragement as “the action of giving someone support, confidence, or hope.”  The word “encourage” originates from the Lain “cor” (heart) and prefix “en” (to cause to be in).  To cause to be in heart.  To encourage someone helps them live with more authenticity, bravery, creativity, tenacity, adventurousness, and wholeheartedness – with a “larger heart.”  When feeling encouraged, one has a much greater chance of achieving success in whatever they are attempting.  Who couldn’t use more of that?!

As a long-time “student of encouragement, a question I ask frequently when facilitating leadership development or well-being workshops is, “How many of you regularly feel like you are ‘over-encouraged?’”  The various “don’t be ridiculous” looks I consistently receive followed by uncomfortable laughter confirms that most of us live with a significant “encouragement deficit.”  Think of all the squandered potential in our midst!  The fact is that no matter how much one has achieved and regardless of how successful they are, encouragement still matters – greatly!

Given the pervasive encouragement deficit, you could likely use a bit more yourself.  The good news is that it’s readily available.  The bad news is that you might have to make yourself a bit vulnerable by asking for it.  How might you help others become better encouragers for you?  The first step is to ask yourself, “How do I like to be encouraged?”  It may surprise you that we all hear encouragement in different ways, and many have never considered that they prefer some approaches much more than others.  The next step would be to invite others to offer it to you in a way that will be most effective; “If you want to encourage me, here’s how best to do it.”   The final step would be to share with them exactly where you would most benefit from being encouraged;  “This is where I presently could really use your encouragement.”   And then reverse this process and return the favor by asking them, “How do you like to be encouraged and where could you use some right now?”

If we truly want to help bring out the best in each other, it will be essential provide encouragement generously and frequently.  Perhaps you could start by practicing with your PeerRxMed partner!  Since encouragement helps us all live with “larger hearts,” it is vital that we don’t “save” it for another time.  Enlarged hearts, after all, create enlarged lives, which will create an enlarged world.  We could sure use as much of that as we can get right now.  

PS:  And when you reach that point of “encouragement saturation,” please write and let me know what it feels like …

______________

Mark and John

Carilion Clinic Department of Family and Community Medicine

Feel free to forward Take 3 to your colleagues. Glad to add them to the distribution list.

Email: mhgreenawald@carilionclinic.org