Drugs

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Drugs

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If you – like me – have had a heart attack, you are now likely taking a fistful of medications each morning, everything from anti-platelet drugs to help prevent a new blockage from forming inside your metal stent to meds that can help lower your blood pressure. All of these cardiac drugs have been studied by researchers before being approved by government regulators as being safe and effective for us to take every day.

But one particular study on this subject published in the Journal of the American College of Cardiology raised a unique point:

“Little is known about the benefits and risks of longterm use of cardiovascular drugs. Clinical trials rarely go beyond a few years of follow-up, but patients are often given continuous treatment with multiple drugs well into old age.”

You too may have been told that many of your meds will become part of a morning routine for the rest of your natural life. Heart disease, unlike an acute medical crisis such as appendicitis, means a chronic and progressive diagnosis. Doctors can stent us or bypass us or zap our electrical circuits or replace wonky bits with implantable marvels, but those are short-term solutions. They cannot fix what damaged our precious hearts in the first place, often decades earlier.

And one of the biggest risk factors for having another heart attack down the road is having already had one – hence your doctor’s concern that you take your current cardiac meds exactly as directed. It’s also why drugs remain the first-line tools in the physician’s toolbox.

The lead author of this particular study in JACC is Professor Desmond Julian, a distinguished U.K. cardiologist credited with establishing the world’s first ever Cardiac Care Unit in Sydney, Australia. It turns out that Professor Julian had a uniquely personal reason for worrying about just how safe cardiac drugs are over the long term.

Nine months before the JACC paper was published, he described his own medical experience, in correspondence with the British medical journal, Lancet. Professor Julian had experienced “two potentially fatal events” which he also describes as “almost certainly due to taking beta blockers” for 15 years (drugs usually prescribed to control heart rhythm, treat angina, or reduce high blood pressure). After the first event, he developed severely low blood pressure when exercising; after the second, he was diagnosed with an abnormally slow heart rate due to a cardiac rhythm problem called sinoatrial heart block. Both abnormalities ceased when his beta blockers were ultimately stopped.

But he had also developed a debilitating cough from taking medications called ACE inhibitors for 10 years, and aspirin-induced gastrointestinal bleeding after being on that drug for 15 years. As Professor Julian wrote:

“We suspect such risks are not uncommon. The two episodes due to the beta blocker could have been fatal if immediate help had not been available, and the death would NOT have been attributed to the drug.

“Therefore, we feel it is important to challenge the assumption that the efficacy and safety of drugs given in the relatively short term remain the same over the long term and into old age.”

“Although there is abundant evidence of the value of four groups of drugs (aspirin, beta-blockers, statins, and angiotensin-converting enzyme [ACE] inhibitors) in the prevention and treatment of heart disease in the first few years after an acute coronary event, there is inadequate evidence for the continuation of these drugs beyond that time.

“Millions of patients with coronary heart disease have been receiving cardiovascular drugs for years, in the absence of any evidence from clinical research trials to justify their use beyond 5-10 years.

“Additional concerns have arisen with the introduction of the fixed-dose polypill as a potential life-long therapy. Reliable evidence on withdrawal versus continuation of drugs is also needed, so we can establish when to stop long-term use of cardiovascular drugs that are effective and safe in the short term.”

Professor Julian and his team concluded their paper with a number of recommendations related both to future research and to improvements in patient care:

  1. The gap in knowledge regarding the long term efficacy and safety of cardiovascular drugs needs wider recognition. Their study cited drug trials in which the term “long-term use” referred to a median 33 months of follow-up, or worse, a real-world Swedish registry in post-heart attack patients defined a long term perspective as only one year of follow-up.
  2. The untested assumption that short-term drug benefit over a few years post-MI extends into long-term follow up and older age needs to be challenged.
  3. The trial evidence for beta blockers, which began before the introduction of primary PCI, is outdated, meaning their role particularly needs to be questioned. They propose a potential randomized trial for gradual withdrawal of beta-blockers
  4. We need to encourage more Randomized Controlled Trials (RCTs) to continue into long-term follow-up, and to reflect real-world practice, such as including increased numbers of older patients.
  5. Regulatory placebo-controlled trials tend to lead to a growing list of approved drugs, so a new paradigm (e.g., more head-to-head trials) is needed.
  6. The problems of polypharmacy need to be tackled.
  7. Deprescribing should be considered more often, and requires more objective evidence for its practice.
  8. RCTs that study withdrawal of long term medication are needed; the case for a withdrawal trial of beta-blockers is particularly pertinent.
  9. More research on the effectiveness and potential harms of cardiovascular drugs is needed in older patients, who often have co-morbidities and are sometimes frail.
  10. Regulators, professional societies, the cardiology research community, and health care providers all need to engage with these problems of long-term prescribing of multiple drugs.
  11. Both cardiologists and primary care physicians should pay greater attention to each patient’s long term needs, by regularly reviewing, for example, whether multiple long-term medications are truly of benefit.

If you’re a heart patient wondering how long it might take for any or all of these recommendations to be acted upon, do not hold your breath.

We know that the lag time between emerging research and resulting evidence-based changes in how medicine is practiced can take years. The delay has been called “change implementation failure” among health care organizations; it’s generally estimated that it takes an average of 17 years for research evidence to actually reach clinical practice at the bedside. Prescribing these drugs to virtually all heart attack survivors is a well-established and popular medical practice, and this practice will not go away quietly. And the powerful drug industry will hardly sit by in the face of any recommendation to support reducing the pool of potential sales.

So what can patients do while we wait? First, if you have been taking beta blockers for several years, ask your own physician to review this new Norwegian study on heart attack patients that suggests there is no association between beta blockers and all-cause mortality. It explains why decades of routine clinical practice recommending these drugs has been based on older studies performed in a pre-bypass surgery/pre-stent era when heart attack patients were treated with only bed rest and morphine.

Source: Carolyn Thomas, Our cardiac meds – in real life, not just in studies, Heart Sisters, September 16, 2018.

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Last Updated : Friday, January 4, 2019