Gotto A M, Breen W J, Corder C N, Dunn J K, Goldberg A, Knopp R H, Schrott H, Sprecher D
Baylor College of Medicine, Houston, Texas 77030.
Am J Cardiol. 1993 May 1;71(12):1057-63. doi: 10.1016/0002-9149(93)90573-u.
This randomized, parallel-group, multicenter clinical trial compared a newly developed, once-daily, extended-release formulation of gemfibrozil (Lopid SR) and gemfibrozil twice daily (Lopid) in terms of lipid-regulating effects and toxicity. Patients were men and women with elevations of low-density lipoprotein cholesterol and low levels of high-density lipoprotein cholesterol. The trial consisted of a 1-week screening period, an 8-week diet baseline period (Step One Diet), and a 24-week double-blind treatment period (extended-release gemfibrozil 1,200 mg once daily vs gemfibrozil 600 mg twice daily). At the end of the trial, the 2 treatment groups showed comparable improvements in all primary lipid factors: mean percent changes in triglyceride, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol were -32, +10 and -10% for extended release (n = 325) and -36, +11 and -10% for twice daily (n = 330). The 90% confidence interval for the relative difference between the treatment means fell within the equivalence bounds of +/- 35% for all 3 factors, demonstrating equivalence of efficacy. Adverse events were reported at low rates and were similarly distributed in frequency and intensity between treatment groups; they were preponderantly mild or moderate, and gastrointestinal effects were the most frequent. The once-daily formulation of gemfibrozil may afford better control of dyslipidemia through improved compliance by patients who have this asymptomatic disease.
这项随机、平行组、多中心临床试验比较了新开发的每日一次的吉非贝齐缓释制剂（Lopid SR）和每日两次的吉非贝齐（Lopid）在血脂调节作用和毒性方面的差异。患者为低密度脂蛋白胆固醇升高且高密度脂蛋白胆固醇水平较低的男性和女性。该试验包括1周的筛查期、8周的饮食基线期（第一步饮食）和24周的双盲治疗期（缓释吉非贝齐每日1200毫克与吉非贝齐每日600毫克，分两次服用）。在试验结束时，两个治疗组在所有主要血脂指标上均显示出相当的改善：缓释组（n = 325）甘油三酯、高密度脂蛋白胆固醇和低密度脂蛋白胆固醇的平均百分比变化分别为-32%、+10%和-10%，每日两次组（n = 330）分别为-36%、+11%和-10%。所有3个指标的治疗均值相对差异的90%置信区间均落在±35%的等效范围内，表明疗效相当。不良事件报告率较低，且在治疗组之间的频率和强度分布相似；主要为轻度或中度，胃肠道影响最为常见。吉非贝齐的每日一次制剂可能通过提高患有这种无症状疾病患者的依从性，更好地控制血脂异常。
