[Nationwide drug surveillance project on slow-release nicardipine in the short-term therapy of light/moderate arterial hypertension].
This trial was designed to confirm the hypotensive action and safety of slow-release nicardipine, as a single drug or together with other hypotensive drugs, for the short-term treatment of mild-to-moderate hypertension, on a large case list of patients in 57 centers throughout Italy. A total of 1011 patients (502 M, 509 F) were admitted, mean age 58.6 +/- 9.1 years (range 25-87), mean weight 72.7 +/- 11.1 kg (range 43-128), with essential (972 cases) or secondary hypertension (39 cases). Nicardipine was given orally at a mean daily dosage of 80 mg (range 40-120), for four weeks. Clinically and statistically significant reductions in systolic and diastolic BP were observed at the end of treatment, with no noteworthy changes in heart rate. Nicardipine single-drug therapy restored normal blood pressure in 79.7% of patients with essential hypertension, and in 72.0% of those with secondary hypertension; nicardipine associated with other hypotensive agents achieved normal blood pressure in respectively 65.9% and 42.9%. Blood pressure returned to normal in 77.3% of patients with essential hypertension aged 65 years or under, and in 66.9% of those over 65 years old. These figures were respectively 70.8% and 46.7% for patients with secondary hypertension. The treatment was very well tolerated by 86.2% of patients; 140 (13.8%) presented adverse reactions, requiring dose reductions in 12, and discontinuation of treatment only in 24 cases. Five patients taking nicardipine together with another drug presented adverse reactions. These results confirm that slow-release nicardipine is effective and extremely well tolerated in the treatment of mild-to-moderate essential or secondary hypertension, in adults and the elderly.
Benvenuti
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Guerini Rocco
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Trezzi
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D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000959:Antihypertensive Agents / Q000627:therapeutic use; D002121:Calcium Channel Blockers / Q000627:therapeutic use; D003692:Delayed-Action Preparations / Q000627:therapeutic use; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D007558:Italy; D008297:Male; D008875:Middle Aged; D009529:Nicardipine / Q000627:therapeutic use*; D011358:Product Surveillance, Postmarketing
D000959:Antihypertensive Agents; D002121:Calcium Channel Blockers; D003692:Delayed-Action Preparations; D009529:Nicardipine
Progetto nazionale di farmacovigilanza sulla nicardipina a lenta liberazione nel trattamento a breve termine dell'ipertensione arteriosa lieve/moderata.