A cardiovascular polypill for secondary stroke prevention in a tertiary centre in Ghana (SMAART): a phase 2 randomised clinical trial.
A cardiovascular polypill for secondary stroke prevention in a tertiary centre in Ghana (SMAART): a phase 2 randomised clinical trial.
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DOI：
10.1016/s2214-109x(23)00347-9
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发表时间：
2023-10
影响因子：
34.3
通讯作者：
Ovbiagele, Bruce
中科院分区：
文献类型：
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作者：
Sarfo, Fred Stephen;Voeks, Jenifer;Adamu, Sheila;Agyei, Benedict Apaw;Agbenorku, Manolo;Adu-Darko, Nyantakyi;Oteng, Mercy Adomah;Obese, Vida;Gyamfi, Rexford Adu;Mensah, Nathaniel Adusei;Tagge, Raelle;Ampofo, Michael;Kontoh, Samuel Amoabeng;Nguah, Samuel Blay;Ovbiagele, Bruce
含有仿制药的心血管复方药可能有助于持续实施和坚持循证治疗，特别是在资源有限的环境中。然而，心血管复方药丸在减轻中风幸存者动脉粥样硬化风险方面的影响尚未得到评估。我们的目的是比较多药丸疗法与常规护理对缺血性卒中后颈动脉内膜中层厚度（CIMT）回归的影响。在 SMAART 中，一项 2 期平行、开放标签、评估者屏蔽的随机临床试验，我们使用计算机生成的随机序列 (1:1) 将过去 2 个月内患有缺血性中风的个体（年龄≥18 岁）随机分配到加纳三级中心的复方药组或常规护理组。复方药丸方案是固定剂量药丸，含有 5 mg 雷米普利、50 mg 阿替洛尔、12·5 mg 氢氯噻嗪、20 mg 辛伐他汀和 100 mg 阿司匹林，每天服用两粒胶囊，持续 12 个月。常规护理是根据指南推荐的二级预防药物量身定制的。主要结果是在第 12 个月时对所有参与者使用 ANCOVA 与完整数据进行比较，并调整基线值后 12 个月内 CIMT 的变化。对所有随机分配的参与者进行安全性分析。该试验已在 ClinicalTrials.gov 注册（NCT03329599）并已完成。 2019年2月12日至2020年12月4日期间，我们随机分配了148名参与者（74名至常规护理组，74名至复方药组），其中74名（50%）为男性，74名（50%）为女性。常规护理组 74 名参与者中的 62 名 (84%) 和复方药组 74 名参与者中 59 名 (80%) 接受了 CIMT 评估；失访的主要原因是参与者没有完成研究。第12个月时，常规护理组的平均CIMT变化为-0·092 mm（95% CI -0·130至-0·051），而复方避孕药组为-0·017 mm（-0·067至0·034），调整后的平均差异为0·049（-0·008至0·109；p=0·11）。常规护理组的两名 (3%) 参与者和复方药组的八名 (11%) 参与者发生了严重不良事件 (p=0·049)。复方药丸方案与定制的药物方案相比，在亚临床动脉粥样硬化和许多二级和三级结果指标方面产生了类似的消退作用，但不良事件更严重。有必要进行更大规模、更长期、基于事件的研究，包括初级保健机构中的中风患者。美国国立卫生研究院。
A cardiovascular polypill containing generic drugs might facilitate sustained implementation of and adherence to evidence-based treatments, especially in resource-limited settings. However, the impact of a cardiovascular polypill in mitigating atherosclerotic risk among stroke survivors has not been assessed. We aimed to compare a polypill regimen with usual care on carotid intima-media thickness (CIMT) regression after ischaemic stroke. In SMAART, a phase 2 parallel, open-label, assessor-masked, randomised clinical trial, we randomly allocated individuals (aged ≥18 years) who had an ischaemic stroke within the previous 2 months, using a computer-generated randomisation sequence (1:1), to either a polypill or usual care group at a tertiary centre in Ghana. The polypill regimen was a fixed-dose pill containing 5 mg ramipril, 50 mg atenolol, 12·5 mg hydrochlorothiazide, 20 mg simvastatin, and 100 mg aspirin administered as two capsules once per day for 12 months. Usual care was tailored guideline-recommended secondary prevention medications. The primary outcome was the change in CIMT over 12 months with adjustment for baseline values, compared using ANCOVA in all participants with complete data at month 12. Safety was analysed in all randomly assigned participants. This trial is registered at ClinicalTrials.gov, NCT03329599, and is completed. Between Feb 12, 2019, and Dec 4, 2020, we randomly assigned 148 participants (74 to the usual care group and 74 to the polypill group), 74 (50%) of whom were male and 74 (50%) female. CIMT was assessed in 62 (84%) of 74 participants in the usual care group and 59 (80%) of 74 participants in the polypill group; the main reason for loss to follow-up was participants not completing the study. The mean CIMT change at month 12 was −0·092 mm (95% CI −0·130 to −0·051) in the usual care group versus −0·017 mm (−0·067 to 0·034) in the polypill group, with an adjusted mean difference of 0·049 (−0·008 to 0·109; p=0·11). Serious adverse events occurred among two (3%) participants in the usual care group, and eight (11%) participants in the polypill group (p=0·049). The polypill regimen resulted in similar regression in subclinical atherosclerosis and many secondary and tertiary outcome measures as the tailored drug regimen, but with more serious adverse events. Larger, longer-term, event-based studies, including patients with stroke in primary care settings, are warranted. US National Institutes of Health.
DOI：
10.1177/1744987121993505
发表时间：
2021-09
期刊：
Journal of research in nursing : JRN
影响因子：
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作者：
Gibson J;Coupe J;Watkins C
通讯作者：
Watkins C
影响因子：
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作者：
Sarfo FS;Ovbiagele B;Akassi J;Kyem G
通讯作者：
Kyem G