FOCUS: More MI Survivors Adhere to Polypill Than Three Pills

Marlene Busko

September 08, 2014

BARCELONA, SPAIN — The international Fixed Dose Combination Drug for Secondary Cardiovascular Prevention (FOCUS) trial of patients who had survived an MI identified five key factors that predict whether they skip pills or stop taking them[1]. It also showed that taking a fixed-dose combination aspirin/simvastatin/ramipril polypill (Trinomia, CNIC/Ferrer) ups the odds of perfect pill compliance; however, only about half of the patients were consistently taking the polypill at the nine-month study end.

Dr Valentin Fuster (Mount Sinai Hospital, New York, and Centro Nacional de Investigaciones Cardiovasculares [CNIC], Madrid, Spain) presented FOCUS in a press briefing and at a clinical-trial-update session at the European Society of Cardiology (ESC) 2014 Congress , and the study was simultaneously published in the Journal of the American College of Cardiology.

Being severely depressed, age 40 to 50, or having a complex drug regimen (including drugs that require injections) predicted poor compliance with therapy, whereas enjoying good social support and having better insurance coverage predicted better compliance, Fuster said.

About half (50.8%) of the patients who received the polypill vs 41.0% of patients who received the three component drugs separately were compliant at the nine-month study end, in the intention-to-treat population (p=0.019).

Commenting to heartwire , Fuster said, "Adherence is one of the great problems that we have in our specialty [cardiology], regardless of the disease entity. We are beginning to understand the reasons, and now, the [challenge] is how to attack the reasons."

This study showed that "despite adherence being relatively low after myocardial infarction, the polypill improves adherence," he added. "What we don't have yet is the data for how this is going to be translated into a decrease in events, and this is [a follow-up] study that we are now planning."

FOCUS investigated a polypill comprising 100-mg aspirin, 40-mg simvastatin, and 2.5-, 5-, or 10-mg ramipril, which is licensed in 11 countries, including Spain, Romania, Greece, Sweden, Mexico, and Central American countries. Ferrer is also applying for regulatory approval from the US Food and Drug Administration, Fuster said.

Poor Adherence to Preventive Meds After MI

About half of the reduction in CVD mortality in the past 20 years in Western countries is likely related to the appropriate use of preventive medications after an initial CV event, the authors write. However, within two years of such an event, almost half of the patients have stopped taking their prescribed drugs.

The first phase of the trial enrolled 2118 predominantly male patients age 40 and older (mean, 64 years) with a history of MI at 64 sites in Spain, Italy, Argentina, Brazil, and Paraguay from 2011 to 2014. The time since their MI averaged 3.5 years.

At entry their pill intake averaged 7.2 per day. Of the cohort, 95% had been prescribed aspirin, 96% a statin, 87% a beta-blocker, and 68% an ACE inhibitor

However, at nine months, based on their replies to the Morisky-Green medication adherence questionnaire (MAQ), only 45.5% of patients were compliant. That is, these patients had a perfect score of 20; they reported that they never forgot to take their pills, miss a dose, stop when they feel better, or stop when they feel worse.

Being a current smoker, sedentary, illiterate; treated by a general practitioner (vs a cardiologist) or in a private center; or having to take more than 10 pills/day were predictors of noncompliance.

In the trial’s second phase, 695 patients from the first phase (from Italy, Spain, Paraguay, and Argentina) were were randomized to take the polypill or to receive its components as separate pills. Both groups received free medications and an identical visit plan.

The patients who received the polypill were more likely to be compliant—which was defined as attending the nine-month trial visit, having an MAQ score of 20, and having a pill count of 80% to 110%.

There was no between-group treatment difference in systolic blood pressure, mean LDL-cholesterol levels, serious adverse events (around 22 events), or death (one patient in each group).

Titrate Components First, Then Prescribe the Polypill?

"For sure, if you can improve compliance to medication, we'll have a benefit," ESC spokesperson Prof Eric Van Belle (University of Lille, France) commented to heartwire .

However, "in everyday practice, you don't start the three medications at one [final] dose," he noted. "You have to titrate or increase a little bit over time. . . . Maybe one option is to start with the medications separately, and when you are sure of what is the right dose, you shift to a combination [drug]."

Nevertheless, "even with a polypill, we have a lot of patients not taking the medication—it's not a magic bullet," he said.

"Ideally [the polypill] should be of value everywhere" and not only low- and middle-income countries, Dr Salim Yusuf (McMaster University, Hamilton, ON), the assigned discussant, commented to heartwire .

The study was funded by the Seventh Framework Programme European Commission Consortium, CNIC, Instituto Damic, Istituto di Ricerche Farmacologiche Mario Negri, Fundació Clinic per la Recerca Biomèdica, World Heart Federation, Federación Argentina de Cardiología, Ferrer Internacional, Instituto de Salud Carlos III, and ARTTIC. Fuster has no conflicts of interest. Disclosures for the coauthors are listed in the article.

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