[Tolerance to valsartan in office practice in 3,197 hypertensive patients (the VALSE study)]

Valsartan, an angiotensin II antagonist with a potent and highly selective effect on AT1 receptors, has been found effective and safe in several randomized, controlled studies versus a placebo, other antihypertensive agents, or other angiotensin II antagonists. An eight-week, open-label, multicenter, prospective, pragmatic, phase IV trial was conducted by office-based cardiologists to evaluate the clinical safety and efficacy of valsartan 80 mg in everyday practice. The efficacy analysis included 3084 patients given valsartan alone for four weeks then, during the next four weeks, either valsartan alone or, if the diastolic blood pressure was still > or = 90 mmHg, valsartan in combination with another antihypertensive agent. The valsartan dosage was 80 mg/day. On day 28, 64% of patients were controlled and 78% were responders. The safety analysis included 3,108 patients. Of the 239 medical adverse events ascribed by the investigators to the study treatment, 72 led to premature study discontinuation. This figure translated into a 2.68% rate among treated patients, which is similar to the 2.3% rate recorded during the placebo-controlled trials performed as part of the valsartan clinical development program. These results confirm the outstanding safety profile of valsartan.