Division of Pharmacology and Therapeutics, Graduate School of Pharmaceutical Sciences, Center for Clinical Pharmaceutical Sciences, Kumamoto University, 5-1 Oe-honmachi, Chuo-ku, Kumamoto, 862-0973, Japan.
Clin Drug Investig. 2014 Jun;34(6):431-5. doi: 10.1007/s40261-014-0191-4.
Adequate control of blood pressure in younger females is of crucial importance, because they are at higher risk of hypertensive target organ damage compared with males of similar age. In addition, female sex is a risk factor for adverse effects of antihypertensive drugs, especially dihydropyridines. This study set out to assess the incidence of adverse reactions during dihydropyridine use in a real-life clinical setting, focusing on the influence of female sex and age.
The incidence of adverse reactions to dihydropyridine calcium channel blockers were investigated in 11,918 Japanese patients who participated in the Drug Event Monitoring project of the Japan Pharmaceutical Association conducted in Kumamoto prefecture. A multiple logistic regression analysis was used to determine the association between the incidence of adverse symptoms and female sex, with adjusted odds ratios (ORs) and 95% confidence intervals (95% CIs).
Vasodilation-related adverse symptoms occurred significantly more often in females than in males (OR 1.87, 95% CI 1.28-2.71, p=0.001). Furthermore, among females only, the younger age group (<50 years) complained of vasodilation-related symptoms more frequently (OR 2.39, 95% CI 1.02-5.59, p=0.045) and the older age group (≥80 years) complained of vasodilation-related symptoms less frequently (OR 0.56, 95% CI 0.33-0.95, p=0.030) than the middle age group (50-79 years).
To the best of our knowledge, this is the first report showing that younger females are at high risk for vasodilation-related adverse symptoms during dihydropyridine use in a real-life clinical setting. These results should be verified in clinical studies using larger samples of young patients and more parameters.
年轻女性的血压得到充分控制至关重要，因为与同龄男性相比，她们发生高血压靶器官损害的风险更高。此外，女性是降压药物不良反应的一个危险因素，尤其是二氢吡啶类药物。本研究旨在评估在真实临床环境中使用二氢吡啶类药物时不良反应的发生率，重点关注女性性别和年龄的影响。
在日本九州地区开展的日本制药协会药物事件监测项目中，纳入 11918 例日本患者，调查二氢吡啶类钙通道阻滞剂的不良反应发生率。采用多因素逻辑回归分析确定不良反应症状与女性性别之间的关联，采用调整后的比值比（OR）及其 95%置信区间（95%CI）。
血管扩张相关不良反应在女性中明显比男性更常见（OR 1.87，95%CI 1.28-2.71，p=0.001）。此外，仅在女性中，年龄较小的组（<50 岁）更频繁地报告血管扩张相关症状（OR 2.39，95%CI 1.02-5.59，p=0.045），而年龄较大的组（≥80 岁）更不频繁地报告血管扩张相关症状（OR 0.56，95%CI 0.33-0.95，p=0.030），与年龄较大的组（50-79 岁）相比。
据我们所知，这是第一项报告显示，在真实临床环境中，年轻女性在使用二氢吡啶类药物时发生血管扩张相关不良反应的风险较高。这些结果应在使用更大的年轻患者样本和更多参数的临床研究中进行验证。
