Misra K P, Joglekar S J, Mukherjee S, Nanivadekar A S
Department of Cardiology, Apollo Hospitals, Madras 600006.
J Assoc Physicians India. 1998;Suppl 1:30-40.
To compare the long-term antihypertensive efficacy, tolerability, and metabolic effects of prazosin GITS and a sustained release (SR) preparation of nifedipine.
Randomized, controlled, multicenter study of 26 weeks duration.
Office practices of 24 physicians in Chennai, Tamil Nadu, India.
Males and females, aged 30 to 70 yrs, with hypertension of JNC V stage 1 or 2 at the end of a 2-week placebo run-in period, and an abnormal lipid profile. Sufficient number of patients recruited so that at least 60 complete the entire study.
Prazosin GITS (Minipress XL, 2.5-5 mg once daily) or sustained release nifedipine (Nicardia Retard 10-20 mg twice daily) for upto 6 weeks, continued upto 24 weeks in those showing a pre-defined response (SBP and/or DBP normalized, or DBP fall of at least 10 mm Hg with actual value of DBP < 95 mm Hg). Patients allocated to either of the two interventions by randomization.
Percent patients showing pre-defined BP response at week 6; percent patients with DBP < 90 mm Hg, SBP < 140 mm Hg, and both; percent patients with DBP fall > or = 10 mm Hg; mean fall in BP among those receiving treatment for 24 weeks; mean change in blood glucose and serum lipids at the end of weeks 8, 16, and 24 of treatment; frequency and intensity of adverse events judged probably or definitely related to the drug.
54 patients randomized to prazosin GITS group and 52 to nifedipine SR group. Of these, 39 in prazosin GITS group (M 23, F 16; mean age-50. 6 yr, SEM 1.66) and 36 in nifedipine SR group (M 20, F 16; mean age-52.3 yr, SEM 1.71) completed the study. Percent patients with DBP < 90 mm Hg at 24 weeks: prazosin GITS--100%, nifedipine SR--100%; SBP < 140 mm Hg: prazosin GITS--94.9%, nifedipine SR--91.7%; both DBP < 90 mm Hg and SBP < 140 mm Hg: prazosin GITS--92.3%, nifedipine SR--91.7%; percent patients with DBP fall of 10 mm Hg or more at 24 weeks: prazosin GITS--76.9%, nifedipine SR--83.3%. The mean fall in the systolic and diastolic blood pressure from the end-of-placebo-phase values to all the other time points was comparable in the 2 groups. Treatment with prazosin GITS did not produce any statistically or clinically significant change in the metabolic parameters at the end of 24 weeks, while with nifedipine SR there was a significant increase in the serum LDL values at 24 weeks (p = 0.009). Adverse events probably or definitely related to the drug: prazosin GITS--1.9%, nifedipine SR--2.1%.
Both drugs were equally effective and well tolerated. While prazosin GITS was neutral on serum lipids, use of nifedipine SR was associated with a significant increase in serum LDL cholesterol at the end of 24 weeks.
比较哌唑嗪控释片（GITS）与硝苯地平缓释制剂的长期降压疗效、耐受性及代谢影响。
为期26周的随机对照多中心研究。
印度泰米尔纳德邦金奈24位医生的门诊。
年龄在30至70岁之间的男性和女性，在为期2周的安慰剂导入期结束时患有美国国家联合委员会（JNC）V期1级或2级高血压且血脂异常。招募足够数量的患者以便至少60人完成整个研究。
哌唑嗪控释片（脉优锭XL，每日一次，2.5 - 5毫克）或硝苯地平缓释片（尼卡地平缓释片，每日两次，10 - 20毫克），治疗长达6周，对显示出预定义反应（收缩压和/或舒张压正常化，或舒张压下降至少10毫米汞柱且舒张压实际值<95毫米汞柱）的患者持续治疗至24周。通过随机化将患者分配至两种干预措施中的任何一种。
在第6周时显示出预定义血压反应的患者百分比；舒张压<90毫米汞柱、收缩压<140毫米汞柱以及两者均达标的患者百分比；舒张压下降≥10毫米汞柱的患者百分比；接受24周治疗患者的平均血压下降幅度；治疗第8周、16周和24周结束时血糖和血脂的平均变化；判断可能或肯定与药物相关的不良事件的频率和强度。
54例患者随机分配至哌唑嗪控释片组，52例患者随机分配至硝苯地平缓释片组。其中，哌唑嗪控释片组39例（男性23例，女性16例；平均年龄50.6岁，标准误1.66），硝苯地平缓释片组36例（男性20例，女性16例；平均年龄52.3岁，标准误1.71）完成了研究。在24周时舒张压<90毫米汞柱的患者百分比：哌唑嗪控释片组为100%，硝苯地平缓释片组为l00%；收缩压<140毫米汞柱的患者百分比：哌唑嗪控释片组为94.9%，硝苯地平缓释片组为91.7%；舒张压<90毫米汞柱且收缩压<140毫米汞柱的患者百分比：哌唑嗪控释片组为92.3%，硝苯地平缓释片组为91.7%；在24周时舒张压下降10毫米汞柱或更多的患者百分比：哌唑嗪控释片组为76.9%，硝苯地平缓释片组为83.3%。两组从安慰剂期末值到所有其他时间点的收缩压和舒张压平均下降幅度相当。哌唑嗪控释片治疗在24周结束时未使代谢参数产生任何具有统计学意义或临床意义的变化，但硝苯地平缓释片在24周时血清低密度脂蛋白（LDL）值显著升高（p = 0.009）。可能或肯定与药物相关的不良事件：哌唑嗪控释片组为1.9%，硝苯地平缓释片组为2.1%。
两种药物疗效相当且耐受性良好。哌唑嗪控释片对血脂无影响，而硝苯地平缓释片在24周结束时与血清LDL胆固醇显著升高有关。
