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

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Abstract
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 Candes-HCT 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 = 151) or Los-HCT (n = 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 −10.4 (−11.8; −8.9) vs. −7.8 (−9.3; −6.3), diff. −2.6 (−4.7; −0.5) mmHg (p = 0.016); systolic BP −19.4 (−22.1; −16.7) vs. −13.7 (−16.5; −10.9), diff. −5.7 (−9.6; −1.8) mmHg (p = 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 = 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 Los-HCT 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.

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