Messerli FH, Bakris GL, Ferrera D, Houston MC, Petrella RJ, Flack JM, Sun W, Lee EM, Neutel JM

Efficacy and safety of coadministered amlodipine and atorvastatin in patients with hypertension and dyslipidemia: results of the AVALON trial

J Clin Hypertens 2006;8:571–81

Hypertension, dyslipidaemia

To evaluate efficacy and safety of treatment with amlodipine plus atorvastatin compared to either agent alone in patients with concomitant hypertension and dyslipidaemia

Randomised, double-blind, double-dummy, placebo-controlled (phase 1), single-blind (phase 2), open (phases 3 and 4)

8, 16, 28 and 92 weeks

847 patients (201 amlodipine, 200 atorvastatin, 207 amlodipine plus atorvastatin, 239 placebo), aged 18–75 years, with hypertension as defined by the Sixth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure, and dyslipidaemia as defined by the NCEP Adult Treatment Panel III

Phase 1: amlodipine, 5 mg/day, or atorvastatin, 10 mg/day, or both, or placebo, for 8 weeks
Phase 2: amlodipine, 5 mg/day, plus atorvastatin, 10 mg/day, for 8 weeks
Phase 3: amlodipine, 5–10 mg/day, plus atorvastatin, 10–80 mg/day, to target BP and LDL-cholesterol goals, for 12 weeks
Phase 4: amlodipine, 5–10 mg/day, plus atorvastatin, 10–80 mg/day, for 64 weeks

At the end of phase 1, 45.5% of combination-treatment patients reached their goals for both BP and LDL cholesterol, compared to 8.3% of amlodipine-only patients (p < 0.001), 28.6% of atorvastatin-only patients (p < 0.001) and 3.5% of placebo patients. At the end of each of phases 2 and 3, there were no significant differences in goal attainment when patients were stratified by their original randomisation treatment. The proportion of patients who experienced ≥ 1 treatment-related adverse event was similar across the four treatment groups. Phase 4 results not yet available

Data from a substudy evaluating the effects of treatment on arterial wall compliance have been published in Am J Hypertens 2009;22:137–44