Department of Medicine Kwame Nkrumah University of Science and Technology Kumasi Ghana.
Komfo Anokye Teaching Hospital Kumasi Ghana.
J Am Heart Assoc. 2024 Aug 6;13(15):e034346. doi: 10.1161/JAHA.124.034346. Epub 2024 Jul 31.
Poststroke cognitive impairment is prevalent worldwide, with no satisfactory preventative therapeutic strategies. We report on the effect of a cardiovascular polypill on cognitive performance among recent stroke survivors.
The SMAART (Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment) trial was a phase II randomized trial primarily assessing the polypill versus usual care for secondary prevention after a recent ischemic stroke. Participants allocated to the experimental arm were provided 2 Polycaps taken orally once a day for 12 months. A capsule of Polycap contained aspirin 100 mg, simvastatin 20 mg, hydrochlorothiazide 12.5 mg, ramipril 5 mg, and atenolol 50 mg. Participants in the usual care arm received standard secondary prevention therapy. We compared slopes of the trajectory of raw scores in the executive, language, memory, and visuospatial cognitive domains and aggregated cognitive scores over 12 months via a linear mixed-effects model. We enrolled 148 eligible participants (n=74 in each arm) and 59 versus 64 participants in the polypill and usual care arms, respectively, at month 12. Compared with the usual care arm, the slopes of cognitive performance over 12 months in the polypill arm were steeper by 2.02 units (95% CI, 0.52-3.53), =0.009 in executive domain, 1.88 units (95% CI, 0.42-3.34), =0.012 in language domain, 2.60 (0.03-5.17), =0.049 in memory domain, 0.55 (-0.80 to 1.91), =0.42 in the visuospatial domain, and global cognitive performance 6.87 units (95% CI, 1.44-12.30), =0.013.
The cardiovascular polypill is associated with a signal of better cognitive performance over 12 months among stroke survivors. Further definitive trials are warranted.
URL: https://www.clinicaltrials.gov; Unique Identifier: NCT03329599.
全球范围内，卒中后认知障碍较为普遍，但目前尚无令人满意的预防治疗策略。我们报告了心血管复方药对近期卒中幸存者认知功能的影响。
SMAART 试验是一项评估近期缺血性卒中后二级预防中复方药与常规治疗的 2 期随机试验。试验组参与者每天口服 2 粒 Polycap，持续 12 个月。Polycap 胶囊含有阿司匹林 100mg、辛伐他汀 20mg、氢氯噻嗪 12.5mg、雷米普利 5mg 和阿替洛尔 50mg。常规治疗组参与者接受标准二级预防治疗。我们通过线性混合效应模型比较了 12 个月期间执行、语言、记忆和视空间认知域原始评分轨迹以及综合认知评分的斜率。共纳入 148 名符合条件的参与者（每组 74 名），第 12 个月时，复方药组分别有 59 名和 64 名参与者完成试验。与常规治疗组相比，复方药组在执行域认知功能方面的斜率在 12 个月内提高了 2.02 个单位（95%置信区间：0.52-3.53），=0.009；语言域提高了 1.88 个单位（95%置信区间：0.42-3.34），=0.012；记忆域提高了 2.60 个单位（0.03-5.17），=0.049；视空间域提高了 0.55 个单位（-0.80-1.91），=0.42；整体认知功能提高了 6.87 个单位（95%置信区间：1.44-12.30），=0.013。
心血管复方药与卒中幸存者 12 个月时认知功能改善有关。还需要进一步的确定性试验。
