Midtbo K A, Hals O, Lauve O
J Clin Hypertens. 1986 Sep;2(3 Suppl):125S-132S.
The study was carried out in 24 patients with mild to moderate essential hypertension to assess the antihypertensive efficiency and tolerability of a new sustained-release formulation of verapamil (tablets containing 240 mg). The trial was conducted as a single-blind crossover study for periods of 4 weeks, preceded by a 2-week placebo period, comparing sustained-release verapamil twice daily with instant-release verapamil (conventional tablets of 80 mg) mg) 160 mg twice daily. Both regimens induced a significant reduction in blood pressure and heart rate, and this effect was (particularly for sustained-release verapamil) significant from the very first day of treatment. Both formulations were well tolerated. The pharmacokinetic data obtained and the even blood pressure reduction achieved demonstrate that this new verapamil formulation has sustained-release characteristics and is sufficient as a twice-daily medication in mild/moderate essential hypertension.
该研究针对24例轻至中度原发性高血压患者开展，以评估一种新的维拉帕米缓释制剂（含240毫克片剂）的降压效果及耐受性。试验采用单盲交叉研究，为期4周，之前有2周的安慰剂期，比较每日两次服用维拉帕米缓释片与每日两次服用速释维拉帕米（80毫克常规片剂）160毫克的效果。两种治疗方案均使血压和心率显著降低，且（特别是维拉帕米缓释片）从治疗第一天起效果就很显著。两种制剂耐受性均良好。所获得的药代动力学数据以及实现的血压平稳降低表明，这种新的维拉帕米制剂具有缓释特性，作为轻/中度原发性高血压的每日两次用药足够有效。
