Hung M J, Lin F C, Cherng W J, Wang C H, Hung K C, Hsieh I C, Wen M S, Wu D
Department of Medicine, Chang Gung Memorial Hospital, Keelung, Taiwan.
J Formos Med Assoc. 1999 Jun;98(6):403-9.
Appropriate control of blood pressure has been shown to reduce morbidity and mortality in patients with hypertension. Losartan potassium, a selective antagonist of the angiotensin II type 1 (AT1) receptor, has been shown to lower blood pressure in patients with hypertension. The purpose of this study was to compare the efficacy and tolerability of losartan and extended-release (ER) felodipine in Taiwanese patients with mild to moderate hypertension. Patients with mild to moderate hypertension (sitting diastolic blood pressure, 95-115 mm Hg) were enrolled in this prospective, randomized, parallel study. Sitting blood pressure, heart rate, adverse reactions, and serum biochemistry values were assessed during 2 weeks of placebo and 12 weeks of active treatment. Each patient received 50 mg of losartan or 5 mg of felodipine ER once daily, and the dosage was adjusted to double the initial level at week 6 if necessary. Of the 44 patients randomly allocated to receive losartan (n = 23) or felodipine (n = 21) therapy, 37 completed the study; three patients in the losartan group and four in the felodipine group withdrew because of adverse experiences, or were lost to follow-up. The mean reductions in sitting diastolic blood pressure at 6 and 12 weeks were significant with both losartan (-8.6 and -11.38 mm Hg, respectively) and felodipine (-9.2 and -10.69 mm Hg, respectively), and did not differ significantly between the two groups. Both losartan and ER felodipine were well tolerated by patients. However, the ER felodipine group had a significantly higher rate of drug-related flushing than the losartan group (24% vs 0%, p = 0.022). The results indicate that once-daily administration of losartan is as effective and well tolerated as once-daily ER felodipine in blood pressure reduction.
已证实适当控制血压可降低高血压患者的发病率和死亡率。氯沙坦钾是一种血管紧张素II 1型（AT1）受体的选择性拮抗剂，已被证明可降低高血压患者的血压。本研究的目的是比较氯沙坦和缓释非洛地平在台湾轻至中度高血压患者中的疗效和耐受性。轻至中度高血压患者（坐位舒张压为95 - 115 mmHg）被纳入这项前瞻性、随机、平行研究。在2周的安慰剂期和12周的积极治疗期内评估坐位血压、心率、不良反应和血清生化值。每位患者每日服用50 mg氯沙坦或5 mg缓释非洛地平，必要时在第6周将剂量调整至初始水平的两倍。在随机分配接受氯沙坦（n = 23）或非洛地平（n = 21）治疗的44例患者中，37例完成了研究；氯沙坦组3例患者和非洛地平组4例患者因不良事件退出或失访。氯沙坦（分别为-8.6和-11.38 mmHg）和非洛地平（分别为-9.2和-10.69 mmHg）在第6周和第12周时坐位舒张压的平均降低均显著，两组之间无显著差异。氯沙坦和缓释非洛地平在患者中耐受性均良好。然而，缓释非洛地平组与药物相关的面部潮红发生率显著高于氯沙坦组（24% 对0%，p = 0.022）。结果表明，每日一次服用氯沙坦在降低血压方面与每日一次服用缓释非洛地平同样有效且耐受性良好。
