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.
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Authors | R Luccioni |
Journal | Presse medicale (Paris, France : 1983)
(Presse Med)
Vol. 24
Issue 38
Pg. 1857-64
(Dec 09 1995)
ISSN: 0755-4982 [Print] France |
Vernacular Title | Evaluation pharmaco-épidémiologique de la rilmenidine chez 18,235 hypertendus. |
PMID | 8545441
(Publication Type: Clinical Trial, Journal Article, Multicenter Study)
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Chemical References |
- Antihypertensive Agents
- Oxazoles
- Rilmenidine
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Topics |
- Adult
- Aged
- Antihypertensive Agents
(administration & dosage, adverse effects, therapeutic use)
- Drug Administration Schedule
- Female
- Follow-Up Studies
- Heart Rate
(drug effects)
- Humans
- Hypertension
(drug therapy)
- Male
- Middle Aged
- Oxazoles
(administration & dosage, adverse effects, therapeutic use)
- Rilmenidine
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