As statins may contribute to plaque stabilisation, it is important to evaluate whether these drugs may modify arterial stiffness. In 23 patients, aged 32-70 years, with hypertension and hypercholesterolaemia, a double-blind randomised study vs placebo was performed to evaluate whether atorvastatin was able to modify aortic stiffness, measured from aortic pulse wave velocity (PWV), after a 12-week treatment. The results revealed that atorvastatin did not change blood pressure, significantly lowered (P<0.003; <0.002) plasma total and LDL cholesterol, and increased aortic PWV by +8% (vs -2% under placebo) (P<or=0.05). The percentage changes in plasma total and LDL cholesterol and in PWV were significantly and negatively correlated, independent of blood pressure level. The finding of increased aortic PWV after 12-week statin treatment agrees with studies in monkeys, indicating that, at the early phase of hypolipidaemic diet but not later, aortic PWV increases transiently as a consequence of the significant reduction of lipid vascular content. In conclusion, the present results support the possibility that statins might contribute to a change in arterial stiffness independent of blood pressure level, and suggest that long-term studies in humans are needed to evaluate the contribution of arterial elasticity to statin-induced vascular remodelling.