Polypill Strategy in Secondary Cardiovascular Prevention

Abstract

BACKGROUNDA polypill that includes key medications associated with improved outcomes (aspirin, angiotensin-converting-enzyme [ACE] inhibitor, and statin) has been proposed as a simple approach to the secondary prevention of cardiovascular death and complications after myocardial infarction. METHODSIn this phase 3, randomized, controlled clinical trial, we assigned patients with myocardial infarction within the previous 6 months to a polypill-based strategy or usual care. The polypill treatment consisted of aspirin (100 mg), ramipril (2.5, 5, or 10 mg), and atorvastatin (20 or 40 mg). The primary composite outcome was cardiovascular death, nonfatal type 1 myocardial infarction, nonfatal ischemic stroke, or urgent revascularization. The key secondary end point was a composite of cardiovascular death, nonfatal type 1 myocardial infarction, or nonfatal ischemic stroke. RESULTSA total of 2499 patients underwent randomization and were followed for a median of 36 months. A primary-outcome event occurred in 118 of 1237 patients (9.5%) in the polypill group and in 156 of 1229 (12.7%) in the usual-care group (hazard ratio, 0.76; 95% confidence interval [CI], 0.60 to 0.96; P = 0.02). A key secondaryoutcome event occurred in 101 patients (8.2%) in the polypill group and in 144 (11.7%) in the usual-care group (hazard ratio, 0.70; 95% CI, 0.54 to 0.90; P = 0.005). The results were consistent across prespecified subgroups. 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. CONCLUSIONSTreatment with a polypill containing aspirin, ramipril, and atorvastatin within 6 months after myocardial infarction resulted in a significantly lower risk of major adverse cardiovascular events than usual care. (Funded by the European Union Horizon 2020; SECURE ClinicalTrials.gov number, NCT02596126; EudraCT number, 2015 -002868 -17.

Use of a Polypill to Reduce Cardiovascular Risk Factors in Primary and Secondary Prevention: Review and Use Guidelines

“…Combined pharmacological treatment is a common practice in secondary cardiovascular prevention, including in geriatric patients 4 and its benefits in morbidity and mortality are widely documented; 4 however, the complexity of the therapeutic regimen often means that: 1) Professionals tend not to implement a complete preventive regimen, with lack of adherence to clinical guidelines, 5 2) Professionals do not question the patient about their adherence to treatment 6 and, in turn, that 3) Patients show poor adherence to the therapeutic regimen with multiple medications; 3 in these cases adherence to the therapeutic regimen is usually low after 6 months after an acute myocardial infarction (AMI), 7 while the use of a polypill after this period reduces the rate of major cardiovascular events. 8,9 The consequences of this lack of therapeutic adherence are increase in the rate of major cardiovascular (CV) episodes 2 and, consequently, of morbidity and mortality in both primary and secondary prevention, non-adherence to the treatments of other related diseases, or its delayed diagnosis due to less frequent medical consultations (such as diabetes), all of which lead to an increase in the care burden and an increase in healthcare costs. Thus, therapeutic adherence is a key factor to ensure the sustainability of the healthcare system since non-adherence is linked to worse health outcomes and higher costs for the system.…”

“…peripheral) 12 , diabetes with at least one RCV factor 12 , AMI with clinical signs of heart failure (when treatment begins 48 hours after the AMI) ▪ Secondary prevention after an acute myocardial infarction: reduction of mortality in the acute phase of myocardial infarction in patients with clinical signs of heart failure here when your treatment starts 48 hours after the acute myocardial infarction and when it is established up to 6 months later. 8,9 o Other evidence: ▪ Only telmisartan and ramipril are indicated to reduce RCV, based on the available clinical trials. 12 OPPORTUNITIES of the polypill: 12,18 the change to a polypill can increase the use of AAS and modify more favorably the levels of total cholesterol, 10 LDL-cholesterol, 10,29 HDL-cholesterol 10 and blood pressure 10,14 than in patients who were following treatment with three separate drugs, 30 especially in: patients with a history of non-adherence or who have any of the factors predictive of pharmacological non-adherence, patients who are not well controlled with equipotent doses and with problems of adherence, patients who are controlled with individual drugs, and patients with comorbidities and polymedicated patients.…”

UpToDate®

“…In a trial that randomly assigned nearly 2500 older patients with an MI in the prior six months to either a polypill (containing aspirin, ramipril, and atorvastatin) or usual care, those receiving a polypill had a lower rate of a composite of cardiovascular events (death, nonfatal MI, nonfatal ischemic stroke, or urgent revascularization; 9.5 versus 12.7 percent) over a mean of 36 months. 3 Blood pressure, low-density lipoprotein cholesterol levels, and adverse events were similar between the two groups, and medication adherence was higher in the polypill group. While these DOI-10.1097/01.NPR.0000884884.08980.16 results are promising, further studies are needed to confi rm these fi ndings.…”

Highlights of Cardiovascular Disease Prevention Studies Presented at the 2022 European Society of Cardiology Congress

“…This study randomized patients from seven different countries with MI within the previous 6 months to a fixed dose combination polypill consisting of aspirin (100 mg), rampril (2.5, 5, or 10 mg), and atorvastatin (20 or 40 mg) or standard care consisting of treatment according to current clinical guideline. The primary composite outcome was CV death, nonfatal type 1 MI, nonfatal ischemic stroke, or urgent revascularization, and the key secondary endpoint was a composite of CV death, nonfatal type 1 MI, or nonfatal ischemic stroke [16].…”