Multicap to improve adherence after acute coronary syndromes: results of a randomized controlled clinical trial

Javier Mariani, Andrés Rosende, Maximiliano De Abreu, Gabriel Gonzalez Villa Monte, Heraldo D'Imperio, Laura Antonietti, Gabriela Lemonnier, Alejandra de Bonis, Carlos Tajer, Javier Mariani, Andrés Rosende, Maximiliano De Abreu, Gabriel Gonzalez Villa Monte, Heraldo D'Imperio, Laura Antonietti, Gabriela Lemonnier, Alejandra de Bonis, Carlos Tajer

Abstract

Background: Adherence to treatment after a myocardial infarction (MI) is poor, even in the early postinfarction period. Combining evidence-based drugs into a multicap could improve adherence in this population. No previous randomized trial assessing fixed-dose combination therapy has included patients early after a MI. We aimed to assess if a multicap containing four secondary prevention drugs increases adherence to treatment at 6 months after MI hospitalization. The study was designed as a randomized, parallel, open-label, controlled trial.

Methods: Patients were randomized within 7 days of a MI to either multicap or control group. The multicap group received a capsule containing aspirin, atenolol, ramipril, and simvastatin. The control group received each drug in separate pills. The primary outcome was adherence at 6 months. We also measured blood pressure, heart rate, serum cholesterol levels, C-reactive protein, and platelet aggregation.

Results: The study was stopped prematurely when 100 patients were included for futility. At 6 months, 92 (95.8%) patients were adherent to medical treatment: 98.0% in the multicap group and 93.5% in the control group [relative risk (RR) 1.05; 95% confidence interval (CI) 0.96-1.14; p = 0.347]. There were no differences between groups in systolic blood pressure (p = 0.662), diastolic blood pressure (p = 0.784), heart rate (p = 0.533), total cholesterol (p = 0.760), LDL-c (p = 0.979), C-reactive protein (p = 0.399), or in the proportion of patients with adequate platelet aggregation inhibition (p = 0.600).

Conclusions: The study did not find any improvement in the adherence at 6 months after a MI with a multicap-based strategy (Multicap for Increase Adherence After Acute Myocardial Infarction; [ ClinicalTrials.gov identifier: NCT02271178]).

Keywords: coronary heart disease; fixed-dose combination therapy; multicap; myocardial infarction; polypill; secondary prevention.

Conflict of interest statement

Conflict of interest statement: The authors declare that there is no conflict of interest.

Figures

Figure 1.
Figure 1.
Study flow.
Figure 2.
Figure 2.
Blood pressure and heart rate during follow up.

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