Boissel J P, Meillard O, Perrin-Fayolle E, Ducruet T, Alamercery Y, Sassano P, Benghozi R
SANDOZ, Rueil-Malmaison, France.
Eur J Clin Pharmacol. 1996;50(1-2):63-7. doi: 10.1007/s002280050070.
To compare compliance with an antihypertensive treatment administered either twice daily or three times daily. The two formulations of the antihypertensive treatment used (nicardipine) "regular tablets" (t.d.) and "slow release tablets" (b.d.) are bioequivalent at the daily dosage used in the study.
Open, controlled, parallel designed study with centralised, randomised allocation to the treatment groups: TID group: A nicardipine 20 mg tablet, three times daily for 3 months. BID group: A capsule of slow release (SR) nicardipine, 50 mg twice daily for 3 months.
7274 hypertensive patients were investigated by 2.651 general practitioners. Compliance with the nicardipine was assessed by means of standardised interviews with the patients and by a questionnaire for the investigators.
Compliance was slightly higher in the BID than in the TID group; 71.2% and 24.5% of patients in the first group declared their compliance was 100% and 80% compared to 82.3% and 15% in the second group. A statistically significant relationship was shown between compliance with nicardipine and the decrease in blood pressure after three months of therapy. However, no significant difference was noticed between the two groups of patients in the absolute decrease in blood pressure after the treatment period: 25.7/14.7 mm Hg in the TID group compared with 25.9/15.0 mm Hg in the BID group.
A difference in compliance between the bioequivalent BID and TID formulations of the same active agent was shown in hypertensive patients. However, the difference was not large enough to lead to a difference either in the number of controlled patients or in the decrease in blood pressure. Reducing the number of daily doses does not automatically lead to greater efficacy of treatment.
比较每日服用两次或三次的抗高血压治疗的依从性。所使用的抗高血压治疗的两种制剂（尼卡地平）“普通片剂”（每日三次）和“缓释片剂”（每日两次）在研究中使用的每日剂量下生物等效。
开放、对照、平行设计研究，采用集中随机分配至治疗组：每日三次组：尼卡地平20毫克片剂，每日三次，共3个月。每日两次组：缓释（SR）尼卡地平胶囊，50毫克，每日两次，共3个月。
2651名全科医生对7274名高血压患者进行了调查。通过对患者进行标准化访谈以及向研究者发放问卷来评估尼卡地平的依从性。
每日两次组的依从性略高于每日三次组；第一组中71.2%和24.5%的患者宣称其依从性为100%和80%，而第二组分别为82.3%和15%。在治疗三个月后，尼卡地平的依从性与血压下降之间显示出统计学上的显著关系。然而，在治疗期后两组患者血压的绝对下降值之间未观察到显著差异：每日三次组为25.7/14.7毫米汞柱，每日两次组为25.9/15.0毫米汞柱。
在高血压患者中，同一活性剂的生物等效的每日两次和每日三次制剂在依从性上存在差异。然而，这种差异不足以导致在血压得到控制的患者数量或血压下降方面产生差异。减少每日服药次数并不会自动带来更高的治疗效果。
