Should my dad be taking Lipitor?

I recently received a text from my friend asking, “Should my dad be on Lipitor? His cardiologist hold him that all of his numbers looked good. And at the end of the visit, they told him that he should start taking Lipitor. Seemed kind of like as an afterthought as he was walking out the door.”

It’s an incredibly common situation: a doctor recommends a statin and a patient wonders whether any thought when into the decision at all. After all, doctors often say, “everything looks good” when things are suboptimal as long as there isn’t anything that puts you in imminent danger. Plus, it’s easier to just tell someone that they need to be on a medication than to counsel them about their individual risk factors and how best to modify them?

This decision is generally straightforward if you’ve had a heart attack – being on a statin is probably the right choice.

But for preventing a first heart attack? It’s a more difficult decision and one that’s fraught with a lot of misinformation as well as doctors who don’t interpret cholesterol panels with depth or nuance (or more importantly, don’t order the correct tests to begin with).

Wrong decision making goes in both directions here – there are a lot of people who are taking statins who do not need to be on them and a lot of people who should be on them that aren’t taking them.

How do we think about risk?

There are a number of standard heart disease risk factors that every doctor looks at – blood pressure, blood sugar, cholesterol, family history, smoking, obesity. Some of these are modifiable through lifestyle choices and some are not.

There are also a number of non-standard risk factors that we evaluate – metabolic syndrome, chronic kidney disease, autoimmune disease or chronic infection (diseases with increased inflammation), lipoprotein (a), premature menopause, and preeclampsia.

Huge amounts can be written on all of these individually, but I think that most of the medical decision making (and personal decision making!) about what to do boils down to the decision my friend asked me about above – should you be on a statin?

Statins are the most prescribed drugs in the world and Lipitor (atorvastatin) alone has made Pfizer almost $100 billion in revenue over the past 20 years. Even now that Lipitor has been off-patent for 8 years, it still generates $2 billion a year in revenue.

The numbers are insane. I suspect the fact that there are so many people prescribed statins who haven’t manifested heart disease helps to explain the proliferation of skeptics about their widespread use.

The ways we measure risk are imperfect

We use a few different methods to attempt to quantify a patient’s individual cardiac risk. There are a number of calculators that can be used to calculate approximate 10 year cardiovascular risk – meaning estimate your chance of having a heart attack over the next 10 years.

There’s one from the American Heart Association and American College of Cardiology (AHA/ACC). There are other ones based on large cardiovascular clinical trials such as the Multi Ethnic Study of Atherosclerosis (MESA) or Framingham.

While these are great for predicting risk across a population, they miss a lot of important aspects of individual risk. None of them incorporate all of the factors that increase your own personal risk. We certainly have a good sense of accuracy on the very high end and the very low end, but it’s the folks in the middle where the risk stratification becomes less reliable.

And when you’re thinking about taking a medicine everyday indefinitely, you really want information to personalize your own risk.

So when I’m talking to my patients about this decision – the ones who haven’t had a heart attack but may have some risk factors – I generally recommend additional individualized stratification.

A coronary calcium score is a great tiebreaker for this decision

A coronary artery calcium (CAC) score is a low radiation CT scan that lets us look to see if there is any calcium built up in the arteries around the heart.

You may have heard the term “hardening of the arteries” before. That’s calcification.

Any calcium in the coronary arteries – that is, a calcium score of any number over 0 – implies heart disease is present. Of course, there is a gradation in risk based on the amount of calcium (hence, calcium score), where higher numbers = greater risk.

CAC is better at reclassifying someone’s risk as either low (maybe ok to hold off on meds) or high (maybe it’s time to start something) than any other test that we have. Since it provides quantitative information about your own cardiac anatomy, this test can help to frame your own personal risk-benefit analysis.

So back to my friend’s question, “should my dad be on a statin?”

The answer is: it depends on a lot of factors – your own values and risk tolerance as well as all of your biomarkers and family history – but getting a coronary artery calcium score is a helpful piece of figuring out your own personalized risk.

by Gregory Katz, MD

This post originally appeared on gregorykatzmd.com on 07/15/2020.

Older Adults and Telehealth

A recent piece in JAMA Internal Medicine by Roberts and Mehrotra underscores that even in our connected age, many older adults have difficulty accessing technology. While telemedicine has been widely deployed in the setting of COVID-19, these individuals are therefore unable to achieve many of its benefits. Their main findings, in a survey of 638,830 Medicare beneficiaries, were the following:

– Over 40% lacked access to a desktop or laptop computer with high-speed internet;
– Similarly, over 40% lacked a smartphone with wireless data plan;
– Over 1 in 4 people (26%) lacked both (no computer or smartphone);
– Digital access was lower among people age 85 or older, and among those who were widowed, had lower education, were Black or Hispanic, received Medicaid, or had a disability.

macbook pro iphone cup desk

Their findings are in line with my own clinical experience over recent months – while telemedicine has provided a critical way to maintain care for some patients, others are simply unable to engage. Related to the work by Roberts and Mehrotra, we published a recent piece in JAMA Health Forum outlining how “digital health” may actually worsen health disparities – if adopted by younger populations who are already reasonably healthy. Both articles underscore that patients most at risk for poor health outcomes are also the least likely to have access to the new era of digital medicine. While improving digital access among these populations is challenging, it is also essential.

 

By: John Dodson, MD

“I didn’t have a choice” – Shared Decision Making in Older Adults with Acute MI

In our article recently published in Medical Decision Making, we qualitatively explored the experience of shared-decision making (SDM) in the setting of acute myocardial infarction (AMI), from the point of view of both cardiologists and patients. We conducted 20 interviews with older adults (age ≥70) who had been hospitalized with AMI, and 20 interviews with cardiologists. Six major themes emerged from our analysis:

1) patients felt their only choice was to undergo an invasive procedure;
2) patients placed a high level of trust and gratitude toward physicians;
3) patients wanted to be more informed about the procedures they underwent;
4) for cardiologists, age was not a major contraindication to intervention, while cognitive impairment and functional limitation were;
5) while cardiologists intuitively understood the concept of SDM, interpretations varied;
6) cardiologists considered SDM to be useful in the setting of non-ST elevated myocardial infarction (NSTEMI) but not ST-elevated myocardial infarction (STEMI).

Our most salient finding was that patients felt they had no choice but to undergo intervention, whereas cardiologists stated there was a need for deliberate shared decision making about intervention in older adults with NSTEMI because of the increased risks involved with catheterization in older patients who present with greater comorbidities.

This discrepancy suggests that, from the patient perspective, conversations in practice were often inadequate to be fully informational. Solutions to this shortfall are complex, especially in light of time constraints in current inpatient settings. However, we suggest in our article that a decision aid may help to provide standardized information to patients, as well as individualized risk prediction (e.g., for risk of contrast-related acute kidney injury). This may alleviate some of the stress and uncertainty involved in discussing evidence-based risks for physicians, and it could increase patients’ awareness of a choice.

Our study had several limitations, including the typical bias in research studies of enrolling “healthier” participants (e.g. cognitively intact) who may have had the most to gain from an intervention. Moreover nearly all patients interviewed underwent invasive coronary angiography (rather than conservative management with medications alone), which omits the decisional needs of patients who chose to decline the procedure. This finding likely reflects a combination of institutional practice, national trends toward more invasive procedures in older adults, and selection bias.

Despite these limitations, to our knowledge this is the first study of SDM in the setting of AMI that incorporates both patient and cardiologist perspectives. We hope (1) it highlights the importance of capturing this dual perspective when discussing SDM and (2) SDM can be made more effective for older adults with NSTEMI with the implementation of a decision aid to help physicians faced with a lack of clear evidence for this older population, and patients who may benefit from being more informed.

Eleanore Grant

By Eleonore Grant, MD Candidate 2022
Perelman School of Medicine at the University of Pennsylvania

Fear of Hospitals

The past month has been a crash course for me in telemedicine, as my geriatric cardiology practice went from fully in-person to fully “virtual” in light of the COVID-19 pandemic. Despite the abrupt startup and inevitable bumps along the way, many of my older patients have successfully transitioned to video encounters for the time being. And I’ve noticed a recurring theme during many of these video conversations: people tell me that they’re terrified of coming to the hospital, even in an emergency.

ambulance architecture building business

This fear has been reported in both the scientific literature and the lay press – with a precipitous drop in hospitalizations for emergent conditions ranging from acute coronary syndrome (ACS) to stroke. For example, Metzler et al. reported that in Austria, from the beginning to the end of March 2020, ACS hospitalizations decreased by nearly 40% – far outside the range of normal variation. The authors hypothesized that “the strict instructions to stay at home as well as the fear of infection in a medical facility may have…prevented patients with an ACS from going to a hospital.” Similarly, a study in the U.S. of several high-volume cardiac catheterization laboratories found a 38% reduction in emergent activations for ACS due to ST segment elevation myocardial infarction after March 1. In the setting of ACS, failure to present due to fear of hospitals may lead to multiple consequences including fatal arrhythmias, heart failure, and death. And based on the data, it’s highly likely that many patients are suffering through ACS and other emergent conditions at home.

What steps can we take? COVID-19 has created an unprecedented challenge to modern healthcare, and there’s no consensus even among experts. In my own practice, I emphasize to my patients there are certain symptoms – persistent chest pain, shortness of breath at rest, new speech difficulty – that require them to go to the emergency room; the consequences of failing to act are too great. Letting patients know about new telemedicine options (e.g. virtual “urgent care” 24 hours a day) may help them to know there are options between staying home and calling an ambulance, so that their symptoms can be appropriately triaged. Finally, as the effects of social distancing take hold and COVID-19 cases decline, fear of hospitals may decrease. But for now, the problem is very real, and can be considered as one of the many negative consequences of the pandemic.

 

By: John Dodson, MD

Managing Older Adults with COVID-19

Megan Rau HeadshotOn March 11, 2020 the World Health Organization declared COVID-19 a global pandemic. SARS-CoV-2, the virus that causes COVID-19, was initially recognized in China in December 2020 then over the course of three short months has brought the hustle and bustle of NYC to a grinding halt. Terms such as “social distancing”, “flattening the curve”, and “hydroxychloroquine”, are now spoken causally in everyday conversation. The rapid evolution and spread of the virus has been accompanied by a mounting body of experimental protocols aimed to treat those infected, a large proportion who are over the age of 65.

One such treatment protocol is the use of azithromycin and hydroxychloroquine to treat symptomatic hospitalized patients with supplemental oxygen requirements. This treatment strategy is currently off label and is based on a small French study showing decreased viral burden. Additionally, the use of hydroxychloroquine alone is based on limited data including a study showing inhibition of the virus in vitro, meaning in the laboratory. These off label treatments, based on limited evidence, are being widely used across the United States to treat patients hospitalized with COVID-19. While there is hope for benefit, there is also potential harm due to adverse drug events, especially in older adults. While large randomized trials of these medications will provide definitive evidence, they will also require more time.

In those age 65 years and older it is necessary to critically examine the potential deadly cardiac side effect commonly known to be associated with azithromycin and hydroxychloroquine, QTc prolongation. This prolongation can lead to deadly ventricular arrhythmias. The QTc is the QT interval on an ECG corrected for heart rate. Studies have shown that, as chronological age increases, so does the QTc interval. Theories for this phenomenon include increased myocardial fibrosis altering the myocardium and changes to the sympathetic and parasympathetic tone effecting myocardial repolarization. This can result in increased susceptibility to events and medications, which may further prolong the QT interval.

ECG Phases

Figure 1. ECG Phases

Recently the Canadian Heart Rhythm Society published a treatment guideline aimed to minimize the risk of drug-induced ventricular arrhythmias. The article acknowledged that the use of certain antimicrobials to treat COVID-19 has uncertain benefits but may increase the risk of QT prolongation. They proposed an algorithm that included obtaining a baseline ECG and electrolyte panel, as well as a subsequent ECG 48 hours after initiation of therapy. The guidelines recommend that QT prolonging antimicrobial agents should generally be stopped in the setting of a QTc >500. An article in press from investigators at the Mayo Clinic makes similar recommendations.

The rapid spread and deadly devastation of COVID-19 has resulted in clinical momentum to find a definitive treatment. However, combining two medications, azithromycin and hydroxychloroquine, in the off label treatment of COVID-19 and administering them to a vulnerable patient population must be performed with extreme caution, even if the risk to the general population is low. We must continue to uphold the principles of evidence-based medicine even in a time of a global pandemic.

 

By: Megan E. Rau, MD, MPH

Dr. Rau is a practicing physician at NYU Langone Health who specializes in geriatrics and palliative care & hospice.