The beneficial effects of anti-hypertensive agents on the cardiovascular system can be counterbalanced by the induction of metabolic disorders, such as hyperlipidaemia. The present trial evaluated the effect of the angiotensin Il receptor antagonist, valsartan, on the lipid profile and glucose metabolism in patients with mild-to-moderate hypertension. This was a multicentre, randomized, double-blind, placebo-controlled study with a 3-week dietary run-in period under placebo; thereafter, patients received either valsartan. 80 mg orally once daily or placebo for 12 weeks. A total of 123 patients were randomized, of whom 112 patients completed the study. Valsartan significantly lowered systolic blood pressure by 14.1 +/- 12.8 mmHg and diastolic blood pressure by 9.0 +/- 6.6 mmHg. In the placebo group, the corresponding values were 7.8 +/- 14.9 mmHg and 6.2 +/- 7.3 mmHg, respectively. Additionally, in the valsartan group, there was a significant decrease in levels of both low-density lipoprotein (LDL) cholesterol (valsartan, -6.3 +/- 24.9 mg/dl; placebo, +4.2 +/- 27.0 mg/dl) and total cholesterol (valsartan, -7.1 +/- 28.1 mg/dI; placebo, +6.0 +/- 29.4 mg/dl) in comparison with placebo. No significant changes were observed in the levels of triglycerides, high-density lipoprotein cholesterol, very low-density lipoprotein (VLDL) triglycerides, VLDL cholesterol and apolipoprotein B after valsartan treatment. No effect of valsartan was found with respect to fasting plasma glucose and glycosylated haemoglobin levels. Valsartan therapy was safe and well tolerated in our patient population. In conclusion, in addition to the marked decrease in blood pressure, valsartan significantly reduces total and LDL cholesterol levels and is neutral on glucose metabolism.