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The purpose was to evaluate the antihypertensive effect, safety and tolerability of a candesartan cilexetil/hydrochlorothiazide (16/12,5 mg) combination tablet (Candes-HCT) in patients with mild to moderate primary hypertension insufficiently controlled on previous monotherapy, in comparison with that of a losartan/hydrochlorothiazide (50/12,5 mg) combination tablet (Los-HCT). Men and women, aged 20–80 years, with a sitting blood pressure (BP) #200/$90 and # 110 mmHg during treatment with any kind of antihypertensive monotherapy for at least 4 weeks were randomised to treatment with CandesHCT or Los-HCT once daily for 12 weeks. Efficacy analysis was performed according to intention to treat and last value carried forward. Mean and SD or CI are given. A total of 340 patients were enrolled, out of which 299 patients (144 women and 155 men, mean age 59.5 (10.5) yrs) were randomised to Candes-HCT (n 5 151) or Los-HCT (n 5 148). BPs at randomisation were 159.5 (15.4)/98.4 (5.8) and 160.5 (16.1)/98.5 (5.4) mmHg, respectively. There was a greater reduction of BP with Candes-HCT than with Los-HCT; diastolic BP 210.4 (211.8; 28.9) vs. 27.8 (29.3; 26.3), diff. 22.6 (24.7; 20.5) mmHg (p 5 0.016); systolic BP 219.4 (222.1; 216.7) vs. 213.7 (216.5; 210.9), diff. 25.7 (29.6; 21.8) mmHg (p 5 0.004). The proportion of patients achieving DBP ,90 mm Hg was greater in the Candes HCT group; 60.9 (53.1; 68.7) vs 49.3 (41.3; 57.4) % (p 5 0.044). There were 12 drop-outs in the Candes-HCT group of which 8 were due to adverse events, and 17 and 12, respectively, in the LosHCT group. The reduction in BP was independent of previous antihypertensive agent, gender and age of the patient. We conclude that the combination Candes-HCT reduced blood pressure effectively and was well tolerated. BP was normalised in 61% of these patients who had insufficient response to previous monotherapy. The reduction in blood pressure and proportion of patients with normalised BP was greater with Candes-HCT 16/12.5 mg than with Los-HCT 50/12.5 mg.

Candesartan cilexetil-HCT in primary hypertension insufficiently controlled on monotherapy—a comparison with losartan-HCT