Clinical Aspects of Antihypertensive Therapy with Urapidil

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Abstract
To define the efficacy and tolerability of urapidil as a monotherapy in ambulatory patients with hypertension, we compared urapidil with a standard first-line antihypertensive agent, hydrochlorothiazide (HCT), in a multicentre general practice trial. The study was an 8-week double-blind randomised parallel-group comparison, with a 3-week pretreatment phase (1 week of gradual reduction of antihypertensive agents, 2 weeks of placebo). Blood pressure and heart rate were monitored using an automatic device (boso-digital S II), in the morning after the last intake of medication in the evening before. The dosages of urapidil used were 30mg, 60mg or 90mg twice daily; the dosages of HCT were 12.5 mg/day or 12.5 or 25mg twice daily. If necessary, dosage adjustments were performed every 2 weeks. Data from 165 patients could be evaluated (urapidil, n=78; HCT, n=87). Sitting blood pressure was reduced significantly, by 9.4/7. lmm Hg with urapidil and by 20.7/ 11.2mm Hg by HCT. The effect of HCT on systolic (p<0.001) and diastolic (p<0.05) blood pressure was significantly more pronounced than that of urapidil. The response rates (diastolic blood pressure decreased to <90mm Hg or by ⩾ 10mm Hg) were 36% of patients with urapidil and 56% with HCT. Heart rate was not significantly affected by either treatment. Although serum potassium was significantly decreased (from 4.4 to 4.0 mmol/L) and low density lipoprotein (LDjL)-cholesterol as well as uric acid were significantly increased (from 142 to 153 mg/dl and from 4.8 to 5.7 mg/dl, respectively) with HCT treatment, no significant changes werej observed with urapidil. Urapidil was generally well tolerated and did not cause adverse metabolic effects, which might counterbalance the beneficial effects of blood pressure reduction.