Comparison of the AT(1)-receptor blocker, candesartan cilexetil, and the ACE inhibitor, lisinopril, in fixed combination with low dose hydrochlorothiazide in hypertensive patients

Aim: To compare candesartan cilexetil and lisinopril in fixed combination w ith hydrochlorothiazide with respect to antihypertensive efficacy and toler ability. Methods: This was a double-blind (double-dummy), randomised, parallel group comparison in patients with a mean sitting diastolic blood pressure 95-115 mm Hg on prior antihypertensive monotherapy. Treatments were candesartan c ilexetil/hydrochlorothiazide 8/12.5 mg once daily (n = 237) and lisinopril/ hydrochlorothiazide 10/12.5 mg once daily (n = 116) for 26 weeks. The prima ry efficacy variable was change in trough sitting diastolic blood pressure. Results: Changes in mean sitting diastolic blood pressure did not differ si gnificantly between the groups (mean difference 0.5 mm Hg; 95% confidence i nterval -1.6, 2.7, P = 0.20). No significant differences between the groups was found for other haemodynamic variables (sitting systolic blood pressur e, standing blood pressure, sitting/erect heart rate, and proportion of res ponders and controlled patients). Both drugs were well tolerated but the pr oportion of patients with at least one adverse event was significantly grea ter in the lisinopril group (80% vs 69%, P = 0.020). The proportion of pati ents spontaneously reporting cough (23.1% vs 4.6%) and discontinuing therap y due to adverse events (12.0% vs 5.9%) was also higher in the lisinopril g roup compared with the candesartan cilexetil group. Conclusions: The fixed combinations of candesartan cilexetil and hydrochlor othiazide 8/12.5 mg and lisinopril and hydrochlorothiazide 10/12.5 mg once daily are equally effective as antihypertensive agents. The fixed combinati on containing candesartan cilexetil is better tolerated than that containin g lisinopril.