The long-term efficacy and tolerability of candesartan cilexetil was assessed in two open-label, prospective multicentre studies in patients with mild to moderate essential hypertension. When administered in a flexible dosage regimen of 4-16 mg once-daily, candesartan cilexetil effectively lowered blood pressure (BP) and maintained its antihypertensive effects over the long term (< or =12 months). At the end of treatment, 81.1% of patients showed a clinically significant response (reduction in sitting diastolic BP of > or =10 mm Hg or reduction to <90 mm Hg), and 73.8% experienced normalisation of sitting diastolic BP (<90 mm Hg). Only a small proportion (10.7%) of patients prematurely discontinued treatment due to lack of efficacy. Candesartan cilexetil was well tolerated and was devoid of clinically relevant biochemical, haematological or cardiac effects. Only 12% of adverse events were judged to be causally related to the drug and only about 5% of patients withdrew from therapy due to adverse events. The most common adverse events were typical of hypertensive patients in general. Most adverse events appeared during the first 3 months of treatment and their incidence decreased steadily with time. Tolerability was unrelated to gender, age (<65 vs > or =65 years) or dosage. These results demonstrate that candesartan cilexetil maintains its antihypertensive effects and tolerability during long-term administration.

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