The use of a single-pill calcium channel blocker/statin combination in the management of hypertension and dyslipidemia: a randomized, placebo-controlled, multicenter study.
Poor control of hypertension or dyslipidemia may at least in part be due to these risk factors being treated in isolation. The Caduet in Untreated Subjects Population (CUSP) trial was an 8-week, randomized, double-blind, placebo-controlled trial evaluating the efficacy/safety of the combination of a calcium channel blocker (amlodipine besylate) and a statin (atorvastatin calcium) in a single-pill form (5/20 mg) plus therapeutic lifestyle changes (TLC) compared with placebo plus TLC in patients with comorbid hypertension and dyslipidemia without evidence of cardiovascular disease. At week 4, additional antihypertensive/lipid-lowering medication was permitted. The primary end point was the proportion of patients in whom the dual goal of blood pressure (<140/90 mm Hg) and low-density lipoprotein cholesterol control (<100 mg/dL) was met at week 4. This dual goal attainment was significantly greater with amlodipine/atorvastatin plus TLC compared with placebo plus TLC at week 4 (47.6% vs 1.7%; P<.001), with further improvements at week 8. Most adverse events were mild to moderate. Therapy with single-pill amlodipine/atorvastatin plus TLC in these patients significantly increased dual blood pressure/low-density lipoprotein cholesterol goal attainment compared with placebo plus TLC.
Neutel
Joel M
JM
Orange County Research Center, Tustin, CA 92780, USA. jmneutel@aol.com
Bestermann
William H
WH
Dyess
Eric M
EM
Graff
Alan
A
Kursun
Attila
A
Sutradhar
Santosh
S
Yunis
Carla
C
D017311:Amlodipine / Q000008:administration & dosage*; D000704:Analysis of Variance; D000069059:Atorvastatin; D002121:Calcium Channel Blockers / Q000008:administration & dosage*; D004311:Double-Blind Method; D004338:Drug Combinations; D050171:Dyslipidemias / Q000150:complications / Q000188:drug therapy*; D005260:Female; D006538:Heptanoic Acids / Q000008:administration & dosage*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage*; D006973:Hypertension / Q000150:complications / Q000188:drug therapy*; D008019:Life Style; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011758:Pyrroles / Q000008:administration & dosage*; D016896:Treatment Outcome
D002121:Calcium Channel Blockers; D004338:Drug Combinations; D006538:Heptanoic Acids; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D010919:Placebos; D011758:Pyrroles; D017311:Amlodipine; D000069059:Atorvastatin