Mariani Javier, Rosende Andrés, De Abreu Maximiliano, Gonzalez Villa Monte Gabriel, D'Imperio Heraldo, Antonietti Laura, Lemonnier Gabriela, de Bonis Alejandra, Tajer Carlos
Cardiology Department, Hospital El Cruce, Avenida Calchaquí 5401, Florencio Varela, Buenos Aires, CP 1888, Argentina.
Cardiology Department, Hospital El Cruce, Florencio Varela, Buenos Aires, Argentina.
Ther Adv Cardiovasc Dis. 2020 Jan-Dec;14:1753944720912071. doi: 10.1177/1753944720912071.
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.
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.
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; = 0.347]. There were no differences between groups in systolic blood pressure ( = 0.662), diastolic blood pressure ( = 0.784), heart rate ( = 0.533), total cholesterol ( = 0.760), LDL-c ( = 0.979), C-reactive protein ( = 0.399), or in the proportion of patients with adequate platelet aggregation inhibition ( = 0.600).
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]).
心肌梗死（MI）后治疗依从性较差，即使在心肌梗死后早期也是如此。将循证药物组合成多效胶囊可能会提高该人群的依从性。以往尚无评估固定剂量联合疗法的随机试验纳入心肌梗死后早期的患者。我们旨在评估一种包含四种二级预防药物的多效胶囊能否提高心肌梗死住院后6个月时的治疗依从性。该研究设计为随机、平行、开放标签的对照试验。
患者在心肌梗死后7天内随机分为多效胶囊组或对照组。多效胶囊组服用一种含有阿司匹林、阿替洛尔、雷米普利和辛伐他汀的胶囊。对照组每种药物分别服用片剂。主要结局是6个月时的依从性。我们还测量了血压、心率、血清胆固醇水平、C反应蛋白和血小板聚集情况。
纳入100例患者后，由于无效性该研究提前终止。6个月时，92例（95.8%）患者坚持治疗：多效胶囊组为98.0%，对照组为93.5%[相对危险度（RR）1.05；95%置信区间（CI）0.96 - 1.14；P = 0.347]。两组间收缩压（P = 0.662）、舒张压（P = 0.784）、心率（P = 0.533）、总胆固醇（P = 0.760）、低密度脂蛋白胆固醇（P = 0.979）、C反应蛋白（P = 0.399）或血小板聚集抑制充分的患者比例（P = 0.600）均无差异。
该研究未发现基于多效胶囊策略在心肌梗死后6个月时的依从性有任何改善（急性心肌梗死后提高依从性的多效胶囊；[ClinicalTrials.gov标识符：NCT02271178]）。
