Luccioni R
Service de Cardiologie, Centre Hospitalier Universitaire de la Timone, Chemin de l'Armée d'Afrique, Marseille.
Presse Med. 1995 Dec 9;24(38):1857-64.
Assess the effects of rilmenidine in routine clinical practice.
18,235 patients with high blood pressure--mean age 61.2 years, arterial systolic pressure in supine position (SSP) over arterial diastolic pressure in supine position (SDP) at day 0: 174.58 +/- 0.12/101.51 +/- 0.06 mmHg--were followed by 2,072 general physicians. Treatment was initiated with a daily dose of 1 mg rilmenidine which was adapted as needed at different times in the study. At inclusion, diastolic pressure was between 90 and 115 mmHg in 84.5% of the patients; 1,126 patients had severe hypertension (SDP > or = 115 mmHg); 16,496 of these patients (81.5%) were followed for one year.
Mean fall in blood pressure between day 0 and month 12 was -28.7/-19.3 mmHg in the overall study population and -27.4/-18.9 mmHg in patients treated with 1 mg/day. Mean fall in blood pressure was comparable in the 8 risk populations identified. The percentage of patients who achieved normalized blood pressure status was 96.2% (SDP < or = 90 mmHg); 59.1% with a 1 mg daily dose, 23.7% with 2 mg/day, 11.6% with two-drug treatment and 1.8% with three-drug treatment. Acceptability, taking into account all possible imputabilities (more than 35,000 coprescriptions) and associated diseases, the incidence of undesirable side effects never exceeded 5.6% of the overall study population (5.2% in single-drug treatment, 8.3% in two- or three-drug treatment) and only 3.6% of the patients withdrew from the study due to an undesirable effect whether imputable to the treatment or not. There was little change in heart rate (mean--3 beats per minute between day 0 and month 12); variations observed depended on the rate at study onset. Laboratory tests (blood glucose, cholesterol, triglycerides, potassium, creatinine, uric acid) were not changed in any of the population groups.
This pharmaco-epidemiologic study showed that the benefit/acceptability ratio for rilmenidine is quite satisfactory and confirms the contribution of rilmenidine as first line treatment for hypertension.
评估利美尼定在常规临床实践中的效果。
2072名普通内科医生对18235例高血压患者进行随访，患者平均年龄61.2岁，第0天仰卧位动脉收缩压（SSP）/仰卧位动脉舒张压（SDP）为174.58±0.12/101.51±0.06mmHg。治疗起始剂量为每日1mg利美尼定，在研究的不同时间根据需要进行调整。纳入时，84.5%的患者舒张压在90至115mmHg之间；1126例患者患有重度高血压（SDP≥115mmHg）；其中16496例患者（81.5%）接受了一年的随访。
在整个研究人群中，第0天至第12个月血压平均下降-28.7/-19.3mmHg，每日服用1mg的患者血压平均下降-27.4/-18.9mmHg。在确定的8个风险人群中，血压平均下降幅度相当。血压恢复正常的患者百分比为96.2%（SDP≤90mmHg）；每日剂量1mg的患者占59.1%，2mg/天的患者占23.7%，联合两种药物治疗的患者占11.6%，联合三种药物治疗的患者占1.8%。考虑到所有可能的归因情况（超过35000份联合处方）和相关疾病，不良副作用的发生率从未超过整个研究人群的5.6%（单药治疗为5.2%，联合两种或三种药物治疗为8.3%），只有3.6%的患者因不良影响退出研究，无论该影响是否可归因于治疗。心率变化不大（第0天至第12个月平均每分钟下降3次）；观察到的变化取决于研究开始时的心率。各人群组的实验室检查（血糖、胆固醇、甘油三酯、钾、肌酐、尿酸）均无变化。
这项药物流行病学研究表明，利美尼定的效益/可接受性比率相当令人满意，并证实了利美尼定作为高血压一线治疗药物的作用。
