Efficacy and Tolerability of a Combination Tablet of Candesartan Cilexetil and Hydrochlorothiazide in Insufficiently Controlled Primary Hypertension - Comparison with a Combination of Losartan and Hydrochlorothiazide

This randomized, double-blind study compared the antihypertensive effect, safety and tolerability of a candesartan cilexetil/hydrochlorothiazide (candesartan/HCT, 16/12.5 mg) combination tablet with that of a losartan/HCT (50/12.5 mg) combination tablet in patients with mild-to-moderate primary hypertension insufficiently controlled on previous monotherapy. Men and women, aged 20-80 years, with a sitting diastolic blood pressure (DBP) greater than or equal to 90 and less than or equal to 110 mmHg and sitting systolic blood pressure (SBP) less than or equal to 200 mmHg during treatment with any kind of antihypertensive monotherapy for at least 4 weeks were randomized to candesartan/HCT or losartan/HCT once daily for 12 weeks. All BP measurements were performed 24 h after previous dose. Mean values and standard deviations (SD) or confidence intervals (CI) are given. A total of 340 patients were enrolled, of whom 299 (144 women and 155 men, mean age 59.5 [10.5] years) were randomized to candesartan/HCT (n = 151) or losartan/HCT (n = 148). BPs at randomization were 159.5 (15.4)/98.4 (5.8)mmHg and 160.5 (16.1)/98.5 (5.4) mmHg, respectively. There was a greater reduction in BP with candesartan/HCT than with losartan/HCT: DBP -10.4 (-11.8, -8.9) vs -7.8 (-9.3, -6.3) mmHg, difference between treatments -2.6 (-4.7, -0.5)mmHg (p = 0.016), SBP -19.4 (-22.1, -16.7) vs -13.7 (-16.5, -10.9) mmHg, difference between treatments -5.7 (-9.6, -1.8)mmHg (p = 0.004). The proportion of patients achieving a DBP less than or equal to 90 mmHg was greater in the candesartan/HCT group: 60.9 (53.1, 68.7) vs 49.3 (41.3, 57.4)% (p = 0.044). There were 12 withdrawals in the candesartan/HCT group, of which 8 were due to adverse events, and 17 and 12, respectively in the losartan/HCT group. We conclude that the combination of candesartan and HCT reduces BP effectively and is well tolerated. BP was normalized in 61% of these patients who had insufficient response to previous monotherapy. The reduction in BP and the proportion of patients with normalized BP were greater with the candesartan/HCT 16/12.5 mg combination than with the losartan/HCT 50/12.5 mg combination.