[Pharmaco-epidemiologic evaluation of rilmenidine in 18,235 hypertensive patients]

Abstract

Objectives: Assess the effects of rilmenidine in routine clinical practice.

Methods: 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.

Results: 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.

Conclusions: 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.