Eprosartan Provides Safe and Effective Long-term Maintenance of Blood Pressure Control in Patients with Mild to Moderate Essential Hypertension

Control of hypertension is hindered by the incidence of adverse events associated with therapy, which can result in low patient compliance. Specific angiotensin II receptor subtype AT1 blockers offer an alternative to the angiotensin converting enzyme inhibitors in the treatment of hypertension, as the incidence of side-effects may be lower. This open-label study was designed to investigate the long-term safety and efficacy of the AT1 receptor blocker, eprosartan, in patients with mild to moderate essential hypertension (sitting diastolic blood pressure > or = 95 mmHg and < or = 114 mmHg). 706 patients from 55 centres in the USA and three centres in Canada were randomised to receive once-daily eprosartan (400-800 mg) alone or in combination with hydrochlorothiazide (HCTZ). The study consisted of five periods: screening (day 1), run-in (2-4 weeks), titration (3-15 weeks), maintenance (12-24 months) and follow-up (5-7 days). Safety evaluations included incidences of adverse events and changes in laboratory tests, vital signs and electrocardiograms. Efficacy assessments included effects on blood pressure (BP) and fasting concentrations of lipids and glucose. The maintenance period was completed at 12 months by 583 (83.3%) patients and at 24 months by 311 (44.4%) patients. In total, 396 (56.1%) patients completed the study according to protocol. Once-daily eprosartan was well tolerated either alone or in combination with HCTZ, irrespective of the study dose administered. Patients treated with eprosartan had a safety profile similar to that reported in short-term placebo-controlled studies. The most frequently reported adverse event was upper respiratory tract infection. The incidence of adverse events was not affected by age or race, and, although events increased with the addition of HCTZ, they were generally not severe. The beneficial effect on BP was maintained throughout treatment. For the majority of patients, HDL cholesterol, triglyceride and glucose levels remained within the reference levels at all doses and timepoints. In summary, eprosartan provides reliable blood pressure control in a high proportion of patients, with a safety profile similar to that seen with placebo in short-term, placebo-controlled trials. By providing long-term safety and efficacy, eprosartan may have the potential to increase patient compliance, a significant issue in the treatment of hypertension in all patient types.