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首页> 外文期刊>Drug safety: An international journal of medical toxicology and drug experience >Comparative safety and tolerability of clopidogrel and aspirin: results from CAPRIE. CAPRIE Steering Committee and Investigators. Clopidogrel versus aspirin in patients at risk of ischaemic events.
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Comparative safety and tolerability of clopidogrel and aspirin: results from CAPRIE. CAPRIE Steering Committee and Investigators. Clopidogrel versus aspirin in patients at risk of ischaemic events.

机译：氯吡格雷和阿司匹林的相对安全性和耐受性：CAPRIE结果。 CAPRIE指导委员会和研究人员。有缺血事件风险的患者使用氯吡格雷与阿司匹林比较。

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OBJECTIVE: The objective of this study was to provide a comprehensive comparison of the long term safety and tolerability of clopidogrel, a new adenosine diphosphate (ADP) receptor antagonist that inhibits platelet activation induced by ADP, and aspirin (acetylsalicylic acid). PATIENTS AND METHODS: The study population comprised 19,185 patients with symptomatic atherosclerosis manifested as recent ischaemic stroke, recent myocardial infarction or symptomatic peripheral arterial disease. Patients were randomised to receive clopidogrel 75 mg/day or aspirin 325 mg/day for a minimum of 1 year and a maximum of 3 years. RESULTS: Compared with aspirin, clopidogrel reduced the combined risk of ischaemic stroke, myocardial infarction or vascular death by 8.7% (p = 0.043). The incidence of early permanent discontinuations of the study drug due to adverse events was almost identical in both treatment groups (11.94% for clopidogrel vs 11.92% for aspirin). Reported neutropenia was similar in the clopidogrel and aspirin groups (0.10 vs 0.17%, respectively) with corresponding rates (0.05 vs 0.04%, respectively) for severe neutropenia. Thrombocytopenia was identical in the clopidogrel and aspirin groups (0.26%), with the rates of severe thrombocytopenia being 0.19 vs 0.10%, respectively. None of these observed differences was statistically significant. The overall incidence of haemorrhagic events did not differ statistically significantly between treatment groups (9.27% for clopidogrel vs 9.28% for aspirin; p = 0.98). There was a trend towards a lower incidence of intracranial haemorrhage in the clopidogrel group (0.31%) compared with the aspirin group (0.42%). Any reported gastrointestinal haemorrhage was significantly less frequent with clopidogrel (1.99%) than with aspirin (2.66%) [p < 0.002]. The corresponding data for severe gastrointestinal bleeding were 0.49 vs 0.71%; p < 0.05. Overall, there were significantly fewer gastrointestinal adverse events with clopidogrel than with aspirin (27.1 vs 29.8%; p < 0.001), with less abdominal pain, dyspepsia, constipation, or peptic, gastric, or duodenal ulceration with clopidogrel. Diarrhoea was significantly more common in the clopidogrel group (4.46 vs 3.36%; p < 0.001), although the incidence of severe diarrhoea (0.23 vs 0.11%) was low and was not significantly different between groups. There were significantly more patients with rash in the clopidogrel group (6.0%) compared with the aspirin group (4.6%) [p < 0.001]. However, these events were generally mild and transient in nature. CONCLUSION: Given the favourable benefit/risk ratio, clopidogrel represents a clinically important advance in the treatment of patients with manifest atherosclerotic disease.
机译：目的：本研究的目的是对氯吡格雷，一种新的抑制人ADP诱导的血小板活化的新型二磷酸腺苷（ADP）受体拮抗剂氯吡格雷和阿司匹林（乙酰水杨酸）的长期安全性和耐受性进行全面比较。患者与方法：研究人群包括19185例有症状的动脉粥样硬化，表现为近期缺血性中风，近期心肌梗塞或有症状的外周动脉疾病。患者随机接受氯吡格雷75毫克/天或阿司匹林325毫克/天，为期最少1年，最多3年。结果：与阿司匹林相比，氯吡格雷将缺血性中风，心肌梗塞或血管死亡的综合风险降低了8.7％（p = 0.043）。在两个治疗组中，由于不良事件导致的研究药物的早期永久停药率几乎相同（氯吡格雷为11.94％，阿司匹林为11.92％）。在氯吡格雷和阿司匹林组中报告的中性粒细胞减少症相似（分别为0.10和0.17％），严重中性粒细胞减少症的发生率分别为（0.05和0.04％）。氯吡格雷和阿司匹林组的血小板减少症相同（0.26％），重度血小板减少症的发生率分别为0.19％和0.10％。这些观察到的差异均无统计学意义。治疗组之间出血事件的总发生率无统计学差异（氯吡格雷为9.27％，阿司匹林为9.28％; p = 0.98）。与阿司匹林组（0.42％）相比，氯吡格雷组（0.31％）的颅内出血发生率有降低的趋势。氯吡格雷（1.99％）的发生率比阿司匹林（2.66％）的发生率要低得多（p <0.002）。严重胃肠道出血的相应数据为0.49比0.71％; p ＜0.05。总体而言，氯吡格雷的胃肠道不良事件显着少于阿司匹林（27.1 vs 29.8％; p <0.001），氯吡格雷的腹部疼痛，消化不良，便秘或消化性，胃或十二指肠溃疡的发生率更低。尽管严重腹泻的发生率较低（0.23 vs 0.11％），但氯吡格雷组的腹泻明显更为常见（4.46 vs 3.36％; p <0.001），两组之间无显着差异。与阿司匹林组（4.6％）相比，氯吡格雷组（6.0％）患皮疹的患者明显更多[p <0.001]。但是，这些事件通常是温和且短暂的。结论：鉴于有利的风险比，氯吡格雷代表着明显的动脉粥样硬化性疾病患者的临床重要进展。

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