Is Long-Term Use of CV Drugs Safe?

It may not be safe to take commonly used cardiovascular drugs beyond five to ten years, according to a review paper published Sept. 7 in the Journal of the American College of Cardiology.

In the  review, Xavier Rossello, MD, from Centro Nacional de Investigaciones Cardiovasculares Carlos III in Madrid and Hatter Cardiovascular Institute, University College London, and colleagues focus on aspirin, statins, beta-blockers, and angiotensin-converting enzyme (ACE) inhibitors given to patients after myocardial infarction (MI). According to the authors, there is no clear evidence for how long these drugs should be prescribed, and there are concerns over long-term use of aspirin and statins, specifically in elderly populations. The introduction of the fixed-dose polypill as potential life-long therapy in post-MI patient has led to additional concerns. There has not been enough consideration for the use of drugs over decades and trialists have used “long-term” to mean “not very short-term.” However, the use of “long-term” in real-world settings relates to much longer periods, with some patients on drugs for decades without evidence that this is beneficial. While trials provide evidence for the safety and efficacy of a drug, there are limitations to how much these results can be applied to long-term use.

They explain that pharmaceutical trials often only test new drugs in order to gain approval. There is a lack of head-to-head trials in patients with coronary heart disease that would replace old drugs with newer ones, rather than just continually adding new drugs. The authors write that to combat this, they “encourage regulators to take a broader vision of patient care, recognizing the dangers of polypharmacy; this could entail a thorough review of the merits and hazards of the current overall drug regime each time a new drug is added to the armamentarium.” Polypharmacy can become complicated as different comorbidities have their own guideline-recommended medications. The number of drugs taken by patients is increasing dramatically and cardiovascular drugs are the most commonly used in polypharmacy cohorts. Polypharmacy increases health care costs, the risks of noncompliance and of adverse drug reactions.

Further, they explain that the American population is aging rapidly, and with that comes comorbidities and frailty, which lead to “potentially excessive” polypharmacy. As the body ages, the way the body reacts to medications can change, including a reduction in renal and hepatic clearance and increased body fat, leading to altered distribution, metabolism, and elimination of cardiovascular drugs, particularly with beta-blockers and ACE inhibitors. Changes also increase the risk of statin-related adverse events in older adults, including cognitive impairment, falls, neuropathy, and muscle damage. They argue that when making treatment decisions, clinicians should consider whether results of a particular trial can reasonably be applied to an elderly patient, as older people are often underrepresented in studies. Additionally, most trials do not pay enough attention to symptom relief and quality of life, which may be of greater concern among older patients.

Rossello and colleagues also discuss the process of discontinuing treatments in order to improve outcomes. This process is not usually described in guidelines and is left to the judgement of the clinician.

Finally, the authors look at the responsibilities of regulators and other stakeholders in tackling this issue.  Moving forward, they urge professional societies to push for studies and other actions that could lead to guidelines on long-term drug use. They note that providers also need to be more rigorous in their monitoring of patients’ drug use over the long term, and encourage patients to participate in the decisions related to medication. 

Clinical Topics: Dyslipidemia, Nonstatins, Novel Agents, Statins

Keywords: Adipose Tissue, Adrenergic beta-Antagonists, Angiotensin-Converting Enzyme Inhibitors, Aspirin, Cardiovascular Agents, Coronary Artery Disease, Drug-Related Side Effects and Adverse Reactions, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Myocardial Infarction, Patient Care, Polypharmacy

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