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Administration Time-Dependent Efficacy of Valsartan-Atorvastatin Combination in Hyperlipidaemic Patients With Essential Hypertension: Presented at EMH

By Chris Berrie

MILAN, ITALY -- June 22, 2005 -- Co-administration of the statin atorvastatin with valsartan at bedtime significantly enhances the antihypertensive effect of treatment, improving control of nocturnal blood pressure in patients with essential hypertension.

Results from a randomised study were presented here June 20^th at the 15^th European Meeting on Hypertension (EMH) by principal investigator Ramón Hermida, PhD, Director, Bioengineering and Chronobiology Laboratories, University of Vigo, Vigo, Spain.

Previous research demonstrated that the cholesterol-lowering drug atorvastatin has some impact on blood pressure, potentially due to its regulatory effect on endothelial cell function.

Researchers are also evaluating whether the time of day of valsartan administration affects the efficacy and secondary protective effects of this angiotensin II receptor blocker, Dr Hermida said.

Thus, the administration of valsartan at bedtime promotes a more dipper-like pattern of the day/night blood pressure ratio of patients with essential hypertension, and Dr Hermida stressed that, "This is particularly relevant as nocturnal pressure by itself has been identified in different trials as potentially the best marker of future cardiovascular mortality."

This study enrolled 80 patients with a mean age of 56.9 years, 40%of them male, and with grade 1-2 essential hypertension and primary hypercholesterolaemia. Forty patients were randomised to take their 160-mg/day dose of valsartan on awakening and 40 to take the same dose at bedtime.

Half of the patients in each valsartan group were also randomly assigned to take 10 mg/day of atorvastatin at bedtime. Because of the minimal dose of atorvastatin taken in this study, the researchers observed no significant differences in lipid profiles between patients who took atorvastatin and those who did not, Dr. Hermida said.

At baseline and after 3 months of treatment, the researchers obtained patients' blood pressure levels at 20-minute intervals during the day (07.00 to 23.00 hours) and at 30-minute intervals during the night, for 48 consecutive hours. Using wrist actigraphy, the researchers also monitored patients' physical activity at 1-minute intervals to accurately calculation diurnal and nocturnal blood pressures on a per patient basis.

The results show that combination treatment significantly improved systolic/diastolic blood pressure levels (SBP/DBP) compared to monotherapy (17.1/10.7 vs. 13.9/9.6 mm Hg; P = .027). The same benefit was seen in terms of pulse pressure (6.4 vs. 4.3 mm Hg; P = .02).

With respect to valsartan dosing times in combination with atorvastatin, the reductions in diurnal SBP and DBP and pulse pressure values did not change significantly for the morning/bedtime dosing with valsartan.

However, there were large significant increases in efficacy seen with the valsartan/atorvastatin combination dosed at night versus morning (SBP, 23.5 vs. 11.0 mm Hg; DBP, 15.9 vs. 6.8 mm Hg; pulse pressure, 7.8 vs. 4.1 mm Hg; P < .001).

This increased efficacy of the valsartan/atorvastatin combination given at bedtime was reflected in the 24-hour recordings, and resulted in a significant increase (P < .001) in the daytime to night-time blood pressure ratios (giving SBP and DBP ratios of 5.5 and 8.0), and thus promoting a more dipper-like blood pressure profile for these patients.

This dosing approach provides much better regulation of nocturnal blood pressure, which might decrease cardiovascular risk for these patients, and improves blood pressure control in general, Dr Hermida said. The more simplified regimen would also likely be associated with better patient compliance with treatment, he added.


[Study title: Administration-Time-Dependent Efficacy of Valsartan-Atorvastatin Combination in Hyperlipidaemic Patients With Essential Hypertension. Abstract P3.363]

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