Antihypertensive Effects and Tolerability of Candesartan Cilexetil Alone and in Combination with Amlodipine
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This study aimed to compare the antihypertensive effect and tolerability of candesartan cilexetil, an angiotensin II type 1 (AT1) receptor blocker with a dose-dependent and long-lasting antihypertensive effect, with that of amlodipine, a widely used long-acting dihydropyridine calcium antagonist, and with that of a combination of candesartan cilexetil and amlodipine.
Multicentre, randomised, double-blind, placebo-controlled parallel-group study.
42 general practice centres in France, Hungary, Poland, South Africa and the United Kingdom.
341 men and women, aged 21 to 81 years, with primary hypertension and a sitting diastolic blood pressure (DBP) of 95 to 114mm Hg.
After a 4-week placebo run-in period, patients were randomised to once-daily treatment with candesartan cilexetil 8mg (n = 85), amlodipine 5mg (n = 84), candesartan cilexetil 8mg plus amlodipine 5mg (n = 89), or placebo (n = 83) for 8 weeks.
Main Outcome Measures
Differences between treatments in change in blood pressure from randomisation to the end of the study were evaluated using analysis of covariance.
All active treatment regimens resulted in marked reductions in sitting and standing blood pressures compared with placebo (p < 0.001). Co-administration of candesartan cilexetil and amlodipine resulted in statistically significant and clinically important greater blood pressure reductions than either drug alone, with differences in adjusted mean systolic blood pressure (SBP)/DBP reductions of 5.6/2.0mm Hg (sitting) and 6.7/3.4mm Hg (standing) vs amlodipine; and of 5.8/0.8mm Hg (sitting) and 6.8/3.9mm Hg (standing) vs candesartan cilexetil (p < 0.05 for combination therapy vs both monotherapies, except for sitting DBP; not significant). All treatments were well tolerated.
This study not only confirms the efficacy and tolerability of candesartan cilexetil and amlodipine in patients with primary hypertension, but also shows that their combination results in a clinically important enhancement of antihypertensive effect while maintaining tolerability.
KeywordsDiastolic Blood Pressure Angiotensin Converting Enzyme Calcium Antagonist Amlodipine Candesartan
This study was supported by Astra Hässle AB, Mölndal, Sweden.
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