September 24, 2014
Polypill Increases Medication Adherence AfterNew York—How can medication adherence be improved after acute myocardial infarction (AMI)? One possible answer is providing patients a polypill, according to a new study.
The report, published recently in the Journal of the American College of Cardiology, notes that patients experiencing cardiovascular (CV) events have trouble keeping to their drug regimens after the first 6 months and sought to determine if the use of fixed-dose combinations (FDC) would be a possible solution.
For the first phase of the Fixed-dose Combination Drug for Secondary Cardiovascular Prevention (FOCUS) project, a study group led by researchers from the Icahn School of Medicine at Mount Sinai in New York looked at factors that interfere with appropriate adherence to CV medications for secondary prevention after an AMI. They then randomized 695 patients from Phase 1 into a controlled Phase 2 study to test the effect of a polypill containing 100 mg of aspirin, 40 mg of simvastatin, and 2.5, 5, or 10 mg of ramipril. Over 9 months of follow-up, the group using the combination drug then was compared to a group receiving the three drugs separately, measuring adherence, blood pressure (BP), and low-density lipoprotein cholesterol (LDL-C), as well as safety and tolerability.
In the first phase of the study conducted in five countries, overall CV medication adherence—defined as a Medication Adherence Questionnaire (MAQ) score of 20—was 45.5% with younger age, depression, being on a complex medication regimen, poorer health insurance coverage, and a lower level of social support linked to noncompliance.
In Phase 2, the polypill group showed improved adherence compared to the group receiving separate medications—65.7% versus 55.7%, respectively, using the primary endpoint based on MAQ and high pill count. Adherence also was higher in the FDC group when measured by MAQ alone, 68% versus 59%.
The study identified no treatment difference at follow-up in mean systolic blood pressure (129.6 vs. 128.6 mmHg), mean LDL-C levels (89.9 vs. 91.7 mg/dL), serious adverse events (23 vs. 21), or death (1, 0.2% in each group).
“For secondary prevention following AMI, younger age, depression, and a complex drug treatment plan are associated with lower medication adherence. Meanwhile, adherence is increased in patients with higher insurance coverage levels and social support,” the authors conclude. “Compared with the three drugs given separately, the use of a polypill strategy met the primary endpoint for adherence for secondary prevention following an AMI.”
Interestingly, an FDA advisory committee that took up the issue of polypills earlier this month was less than enthusiastic because of lack of evidence of efficacy.
“We believe there are patients in the USA for whom cardiovascular prevention therapy is appropriate but who cannot get the follow-up necessary for titration, for reasons that include geography, finances, and patient preference,” the FDA wrote in its briefing documents for its Cardiovascular and Renal Drugs Advisory Committee. “We are asking then whether people who are not, for whatever reason, going to receive regular follow-up are better off on some reasonable doses of drugs for secondary prevention of cardiovascular disease, rather than none, even if they are not getting what is believed to be optimal care.”
|U.S. Pharmacist Social Connect