Ottervanger J P, Valkenburg H A, Grobbee D E, Stricker B H
Netherlands Centre for Monitoring of Adverse Reactions to Drugs, Rijswijk, The Netherlands.
Arch Neurol. 1997 Nov;54(11):1387-92. doi: 10.1001/archneur.1997.00550230054017.
Serious cardiac adverse reactions, including myocardial infarction, have been attributed to the antimigraine drug sumatriptan succinate. Chest pain is considered to be a relatively common adverse reaction to sumatriptan.
Postmarketing study.
The study was a part of a national cohort study on adverse reactions to sumatriptan, which was performed with the assistance of drug-dispensing general practitioners in the Netherlands. After data were collected on observed adverse reactions, the patients received a second questionnaire, with specific questions regarding the adverse event, and questions regarding medical history, other health complaints, and smoking habits. Furthermore, they had a physical examination and a blood cholesterol measurement.
A total of 137 patients with chest pain associated with intake of sumatriptan were identified and compared with 229 consumers of sumatriptan without this adverse reaction. After multivariate analysis, young age, hypertension, general complaints of abdominal pain, and a family history of myocardial infarction were associated with an increased risk of chest pain attributed to sumatriptan. Hypertension in particular was a risk factor for sumatriptan-induced chest pain in men (relative risk, 8.0; 95% confidence interval, 1.8-40) compared with hypertension as a risk factor in women (relative risk, 1.63; 95% confidence interval, 0.9-3.1).
Young age, hypertension, general complaints of abdominal pain, and a family history of myocardial infarction are associated with an increased risk of chest pain attributed to sumatriptan. Sex is an effective modifier of risk factors of sumatriptan-induced chest pain. In particular, hypertension is a strong risk factor in men.
严重的心脏不良反应,包括心肌梗死,已被归因于抗偏头痛药物琥珀酸舒马曲坦。胸痛被认为是舒马曲坦相对常见的不良反应。
上市后研究。
该研究是一项关于舒马曲坦不良反应的全国队列研究的一部分,在荷兰的配药全科医生的协助下进行。在收集了观察到的不良反应数据后,患者收到第二份问卷,其中包含关于不良事件的具体问题,以及关于病史、其他健康问题和吸烟习惯的问题。此外,他们还接受了体格检查和血液胆固醇测量。
共识别出137例与服用舒马曲坦相关的胸痛患者,并与229例无此不良反应的舒马曲坦使用者进行了比较。多变量分析后,年轻、高血压、腹痛的一般主诉以及心肌梗死家族史与舒马曲坦所致胸痛风险增加相关。特别是,与女性相比,高血压是男性舒马曲坦诱发胸痛的危险因素(相对风险,8.0;95%置信区间,1.8 - 40),而女性高血压作为危险因素的相对风险为1.63(95%置信区间,0.9 - 3.1)。
年轻、高血压、腹痛的一般主诉以及心肌梗死家族史与舒马曲坦所致胸痛风险增加相关。性别是舒马曲坦诱发胸痛危险因素的有效调节因素。特别是,高血压在男性中是一个强烈的危险因素。