Madrid, Spain—Pharmacotherapy can be very effective for secondary prevention of CV disease, yet the incidence of recurrent ischemic events remains high. At least part of the explanation is that patient adherence to secondary prevention medications has been estimated at approximately 50%.
One contributor is treatment complexity, according to a new study that noted adherence is decreased with an increased frequency of dosing and treatment complexity.
The report in the New England Journal of Medicine discusses the benefits of a polypill that includes key medications associated with improved outcomes (i.e., aspirin, angiotensin-converting enzyme inhibitors, and statins). That formulation has been proposed as a simple approach to the secondary prevention of CV death and complications after myocardial infarction (MI), according to international researchers with the SECURE (Secondary Prevention of Cardiovascular Disease in the Elderly) Trial.
The phase III, randomized, controlled clinical trial assigned patients with MI within the previous 6 months to either usual care or a polypill-based strategy—a combination of aspirin (100 mg), ramipril (2.5 mg, 5 mg, or 10 mg), and atorvastatin (20 mg or 40 mg).
The primary composite outcome was defined as CV death, nonfatal type 1 MI, nonfatal ischemic stroke, or urgent revascularization. A composite of cardiovascular death, nonfatal type 1 myocardial infarction, or nonfatal ischemic stroke was the most important secondary endpoint.
The study team randomized 2,499 patients and followed them for a median of 36 months. The results showed that a primary-outcome event occurred in 118 of 1,237 patients (9.5%) in the polypill group and in 156 of 1229 (12.7%) in the usual-care group (hazard ratio [HR], 0.76; 95% CI, 0.60-0.96; P = .02).
The authors reported that a key secondary-outcome event occurred in 101 patients (8.2%) in the polypill group and 144 (11.7%) in the usual-care group (HR, 0.70; 95% CI, 0.54-0.90; P = .005).
"The results were consistent across prespecified subgroups," the researchers pointed out. "Medication adherence as reported by the patients was higher in the polypill group than in the usual-care group. Adverse events were similar between groups."
The study concluded that treatment with a polypill containing aspirin, ramipril, and atorvastatin within 6 months after MI "resulted in a significantly lower risk of major adverse cardiovascular events than usual care."
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