The Effects of Candesartan Cilexetil in Isolated Systolic Hypertension: A Clinical Experience Trial.

An 8-week, multicenter, open-label, clinical experience trial evaluated the efficacy of candesartan cilexetil either alone (34%) or as add-on therapy (66%) in 1014 patients with untreated or uncontrolled isolated systolic hypertension defined as systolic blood pressure 140-179 mm Hg/diastolic less than 90 mm Hg. Candesartan cilexetil 16 mg once daily was given initially and was up-titrated to 32 mg once daily at week 2 or week 4 if systolic blood pressure remained at or above 140 mm Hg. Overall, candesartan cilexetil reduced both blood pressures by 16.5Â+/-0.6/4.5Â+/-0.2 mm Hg from 158Â+/-0.4/81Â+/-0.2 to 142Â+/-0.6/76Â+/-9.6 mm Hg with a control rate (systolic blood pressure less than 140 mm Hg) of 49%. Of the 492 (51%) patients remaining on the lower dose of candesartan cilexetil (40% as monotherapy; 60% as add-on), candesartan cilexetil 16 mg reduced blood pressure by 19.7Â+/-1.0/5.5Â+/-0.3 mm Hg and 62% of patients were controlled. For the 475 (49%) patients uncontrolled on candesartan cilexetil 16 mg and titrated to 32 mg (30% as monotherapy, 70% as add-on), the dose increase further reduced blood pressure by 8.9Â+/-0.4/3.8Â+/-0.1 mm Hg at week 8, and 36% of patients not responsive to the lower dose achieved blood pressure control on the higher dose. This dose response from candesartan cilexetil 16 mg to 32 mg was seen across age, sex, and race. Overall, tolerability was well maintained. Most adverse events were relatively infrequent, and only 8% withdrew due to adverse events; the most frequent adverse effects were dizziness (7%), headache (6%), and upper respiratory tract infection (5%). In conclusion, in this clinical experience trial for patients with isolated systolic hypertension, candesartan cilexetil 16 mg to 32 mg once daily produced a dose-related decrease in systolic blood pressure with a lesser decrease in diastolic blood pressure, resulting in a substantial decrease in pulse pressure. The dose response without dose dependent adverse effects was consistent across age, sex, and race, demonstrating that candesartan cilexetil is a therapeutic option for patients with isolated systolic hypertension. (c)2000 by Le Jacq Communications, Inc.

RCT Entities:   Population Interventions Outcomes