Kim Y S, Park H S, Sunwoo S, Byeon J J, Song Y M, Seo H G, Kim C H, Cheon K S, Yoo S M, Lee J K
Pharmacoepidemiol Drug Saf. 2000 Dec;9(7):603-9. doi: 10.1002/pds.554.
In order to assess the short-term safety and tolerability of newly prescribed antihypertensive monotherapies in Korean patients, a prospective study was carried out.
A total of 1181 patients were observed from July 1997 to August 1999. At 2, 4, 8 and 12 weeks after initiation of antihypertensive monotherapy, the patients were evaluated for whether treatment was to be continued and the development of any adverse reactions.
During the first 12 weeks, the percentage of subjects continuing with their initial angiotensin converting enzyme inhibitors (ACEI) (40.7%) was substantially lower than that of subjects continuing with angiotensin II receptor antagonists (ARA) (66.2%), alpha-blockers (63.0%), calcium channel blockers (CCB) (61.3%), beta-blockers (55.8%), and diuretics (53.5%), respectively (P < 0.01). The following adverse reactions were detected: cough (7.5%), headache (6.1%), dizziness (3.9%), flushing (3.7%) and impotence (2.4%). Cough, headache, and flushing were more frequent in women, and impotence and loss of libido were more frequent in men (P < 0.05). The incidence of cough associated with ACEI (27.9%) was higher than that associated with the other classes of drugs (P < 0.01).
The tolerability of antihypertensive medication was highest in Korean patients treated with ARAs, followed by CCBs, beta-blockers, diuretics, alpha-blockers, and ACEIs. The incidences of adverse reactions were different by sex, age and drug class.
为评估新处方的抗高血压单药疗法在韩国患者中的短期安全性和耐受性,开展了一项前瞻性研究。
1997年7月至1999年8月共观察了1181例患者。在开始抗高血压单药治疗后的2周、4周、8周和12周,评估患者是否继续治疗以及是否出现任何不良反应。
在最初的12周内,继续使用初始血管紧张素转换酶抑制剂(ACEI)的受试者百分比(40.7%)显著低于继续使用血管紧张素II受体拮抗剂(ARA)(66.2%)、α受体阻滞剂(63.0%)、钙通道阻滞剂(CCB)(61.3%)、β受体阻滞剂(55.8%)和利尿剂(53.5%)的受试者百分比(P<0.01)。检测到以下不良反应:咳嗽(7.5%)、头痛(6.1%)、头晕(3.9%)、脸红(3.7%)和阳痿(2.4%)。咳嗽、头痛和脸红在女性中更常见,而阳痿和性欲减退在男性中更常见(P<0.05)。与ACEI相关的咳嗽发生率(27.9%)高于与其他类药物相关的咳嗽发生率(P<0.01)。
在接受ARA治疗的韩国患者中,抗高血压药物的耐受性最高,其次是CCB、β受体阻滞剂、利尿剂、α受体阻滞剂和ACEI。不良反应的发生率因性别、年龄和药物类别而异。