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	1		Amlodipine, atorvastatin: therapeutic use Hypertension, lipid metabolism disorders RESPOND trial (801100024)

Amlodipine, atorvastatin: therapeutic use

Hypertension, lipid metabolism disorders
RESPOND trial

801100024
Best Evidence

Reference

Citation Details

Preston RA, Harvey P, Herfert O, Dykstra G, Jukema JW, Sun F, Gillen D. A randomized, placebo-controlled trial to evaluate the efficacy, safety, and pharmacodynamic interaction of coadministered amlodipine and atorvastatin in 1660 patients with concomitant hypertension and dyslipidemia: the Respond Trial. Journal of Clinical Pharmacology 47: 1555-1569, No. 12, Dec 2007 . Miller School of Medicine, Miami, Florida, USA; Pfizer, New York, New York, USA
Journal Fulltext.

Protocol / Study ID

Trial Acronym(s):

RESPOND

Adis Assessment

Outcome

Efficacy: amlodipine + atorvastatin > amlodipine, atorvastatin, placebo
Tolerability: amlodipine + atorvastatin = amlodipine, atorvastatin, placebo
.

Study Messages

Amlodipine and atorvastatin are well tolerated and lack pharmacodynamic interaction in patients with hypertension and lipid metabolism disorders.

Amlodipine + atorvastatin is more effective than amlodipine alone or atorvastatin alone in patients with hypertension and lipid metabolism disorders.

Adis Evaluation

Trial Design Score	89%	Positive features : randomised treatment allocation using computer-generated numbers; bias controlled using double-blind design; adequate controls for variation; well reported results and adverse events; primary and secondary endpoints stated; study power calculated Negative features : compliance checks not reported; limited reporting of patient inclusion/exclusion criteria
Clinical Relevance	B	Provides supporting evidence to the body of clinical data.

Study Details

Purpose

This study investigated the efficacy and tolerability of amlodipine and atorvastatin, alone and in combination, in patients with hypertension and lipid metabolism disorders. The primary endpoints were changes in systolic BP and low density lipoprotein (LDL) cholesterol levels.

Author Comments

"This study has demonstrated that the coadministration of amlodipine and atorvastatin across the dose ranges for both treatments is efficacious and safe in patients with hypertension and dyslipidemia. Importantly, this study has shown that there is no unexpected or adverse pharmacodynamic interaction between the 2 drugs. The Respond trial was therefore an important and necessary step in the successful development of amlodipine/atorvastatin single-pill therapy."

Details


Design:	Double-blind, multicentre, randomised
Control:	Baseline comparison, drug combination comparison, drug comparison, placebo comparison
Phase:	III
Location:	Multinational, Belgium, Brazil, Canada, Finland, France, Germany, Ireland, Netherlands, Norway, Poland, Russia, South Africa, Spain, United Kingdom, USA
Endpoints:	Framingham risk score, Low density lipoprotein cholesterol level, Systolic blood pressure

Subjects


Type	No	Sex	Age
patients	1660	male & female	18-75 (mean 58) years, adult, elderly

Co-Morbid Conditions: Diabetes-mellitus, Ischaemic-heart-disorders.

Patient Inclusion Criteria: Aged 18-75 years; concomitant hypertension and lipid metabolism disorders.

Patient Exclusion Criteria: History of intolerance to dihydropyridine calcium channel antagonists or HMG-CoA reductase inhibitors [statins]; any serious disease.

Treatments

Placebo
Placebo

Amlodipine


Drug/Treatment	Dose	Route	Frequency	Duration
Amlodipine	5 or 10 mg/day	PO	od	8 weeks

Atorvastatin


Drug/Treatment	Dose	Route	Frequency	Duration
Atorvastatin	10, 20, 40 or 80 mg/day	PO	od	8 weeks

Amlodipine + atorvastatin


Drug/Treatment	Dose	Route	Frequency	Duration
Amlodipine	5 or 10 mg/day	PO	od	8 weeks
Atorvastatin	10, 20, 40 or 80 mg/day	PO	od	8 weeks

Results

Results Highlights

efficacy: At 8 weeks, amlodipine + atorvastatin induced dose-related, significant reductions in systolic BP, low density lipoprotein cholesterol, and Framingham risk score, compared with placebo, amlodipine alone, and atorvastatin alone, in patients with hypertension and lipid metabolism disorders.

tolerability: Amlodipine and atorvastatin, alone or in combination, were well tolerated in patients with hypertension and lipid metabolism disorders. No adverse pharmacodynamic interaction was observed.

Results

At 8 weeks, amlodipine + atorvastatin induced dose-related, significant reductions in systolic BP, LDL cholesterol, and Framingham risk score, compared with placebo, amlodipine alone, and atorvastatin alone.

Adverse Events

Amlodipine + atorvastatin was generally well tolerated and showed no adverse pharmacodynamic interaction.

Descriptors & Links

Adis Descriptors

Amlodipine: therapeutic use
Atorvastatin: therapeutic use
Hypertension: treatment
Lipid-metabolism-disorders: treatment
Diabetes-mellitus: comorbid condition
Ischaemic-heart-disorders: comorbid condition

Associations

Pfizer