FOCUS: Polypill improved adherence to treatment after MI

Issue: November 2014

BARCELONA, Spain — The use of a polypill containing aspirin, ramipril and simvastatin was associated with increased medication adherence for secondary prevention after acute MI compared with use of the three drugs separately.

Perspective from Alfred A. Bove, MD, PhD, MACC

Valentin Fuster, MD, PhD, presented new data from the two-phase FOCUS study at ESC Congress. The study was undertaken at 64 clinical sites in Argentina, Brazil, Italy, Paraguay and Spain.

“FOCUS Phase 1 is the first study to systematically carry out an in-depth assessment of the factors that contribute to nonadherence to evidence-based CV medications in a post-MI [setting]. FOCUS Phase 2 is the first randomized controlled trial to objectively analyze the impact of a polypill strategy … on adherence in post-MI patients,” Fuster, physician in chief at Mount Sinai Medical Center and director of the Mount Sinai Heart Institute, said during a press conference. Phase 1 included 2,188 patients; 695 patients from Phase 1 were also randomly assigned into the Phase 2 controlled trial.

Valentin Fuster

The primary endpoint was treatment adherence, which was measured at the final visit using the self-reported Morisky-Green questionnaire (MAQ) and pill counts.

In Phase 1, overall CV medication adherence, defined as a MAQ score of 20, was 45.5%. The FOCUS researchers identified five factors that interfere with appropriate adherence to CV medications for secondary prevention after an acute MI:

Age
Complexity of treatment
Insurance status
Depression
Social support

In Phase 2, compared with the three drugs given separately, the polypill strategy met the primary endpoint. After 9 months of follow-up, adherence was 50.8% vs. 41% in the intention-to-treat population (P=.019) and 65.7% vs. 55.7% in the per-protocol population (P=.012). Results also showed higher adherence in the polypill group when measured by MAQ alone (68% vs. 59%; P=.049). The researchers found no treatment differences during follow-up in the rate of serious adverse events (23 vs. 21), death (0.2% vs. 0.2%), mean systolic BP (129.6 mm Hg vs. 128.6 mm Hg) or mean LDL (89.9 mg/dL vs. 91.7 mg/dL).

The findings were consistent across the countries included in this study.

“In the future, this is our question: What is the effect, post MI, of a polypill strategy on cardiovascular outcomes?” Fuster said.

The polypill contained aspirin 100 mg, ramipril 2.5 mg, 5 mg or 10 mg, and simvastatin 40 mg. The drug used in the study was Trinomia, which is currently approved in 11 countries, according to Fuster. – by Katie Kalvaitis

For more information:

Fuster V. Clinical Trial Update. Presented at: the European Society of Cardiology Congress; Aug. 30-Sept. 3, 2014; Barcelona, Spain.

Castellano JM. J Am Coll Cardiol. 2014;doi:10.1016/j.jacc.2014.08.021.

Disclosure: Fuster reports no relevant financial disclosures.

Perspective

Alfred A. Bove, MD, PhD, MACC

In my opinion, use of a polypill is a good idea across all populations. Practicing in inner-city Philadelphia, I see the same issues with adherence. Dr. Fuster’s group has studied use of a polypill in South America and another group did some research in India. The data all show better adherence with a polypill. In FOCUS, there was an improvement in patient adherence; I am surprised that it wasn’t better than 50.8% vs. 41% [in favor of polypill]. However, we do not see any real outcomes data from the standpoint of long-term BP and so on, which is a different piece of the study.

Alfred A. Bove, MD, PhD, MACC

Professor Emeritus, Temple University, Philadelphia

Past President, American College of Cardiology

Disclosures: Bove reports no relevant financial disclosures.