Abstract
TOGETHER investigated whether targeting multiple cardiovascular (CV) risk factors using single-pill amlodipine/atorvastatin (AML/ATO) and therapeutic lifestyle changes (TLC) results in greater blood pressure (BP)/lipid control and additional reduction in estimated cardiovascular disease (CVD) risk compared with blood pressure intervention only using amlodipine (AML) + TLC. TOGETHER was a 6-week, randomized, double-blind, double-dummy trial using hypertensive participants with additional CV risk factors without CVD/diabetes. Participants were randomized to either AML/ATO (5 to 10/20 mg) + TLC or AML (5 to 10 mg) + TLC. The primary end point was the difference in proportion of participants attaining both BP (<140/90 mm Hg) and low-density lipoprotein cholesterol (LDL-C) (<100 mg/dL) goals at week 6. At week 6, 67.8% of participants receiving AML/ATO + TLC attained the combined BP/LDL-C goal versus 9.6% with AML + TLC (RD [A-B]: 58.2; 95% CI [48.1 to 68.4] P < 0.001; OR: 19.0; 95% CI 9.1 to 39.6; P < 0.001). Significant reductions from baseline in LDL-C, total cholesterol and triglycerides and estimated 10-year Framingham risk were also observed. Treatment with AML/ATO was well tolerated. In conclusion, a multifactorial CV management approach is more effective in achieving combined BP/LDL-C targets as well as CV risk reduction compared with BP intervention only in this patient population.
Keywords:
blood pressure; calcium channel blocker; low-density lipoprotein cholesterol; statin.
Publication types
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Multicenter Study
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Administration, Oral
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Adult
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Aged
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Aged, 80 and over
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Amlodipine / administration & dosage*
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Amlodipine / adverse effects
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Antihypertensive Agents / administration & dosage*
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Antihypertensive Agents / adverse effects
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Biomarkers / blood
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Blood Pressure / drug effects*
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Calcium Channel Blockers / administration & dosage*
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Calcium Channel Blockers / adverse effects
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Cardiovascular Diseases / blood
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Cardiovascular Diseases / etiology
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Cardiovascular Diseases / physiopathology
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Cardiovascular Diseases / prevention & control*
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Double-Blind Method
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Drug Combinations
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Dyslipidemias / blood
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Dyslipidemias / complications
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Dyslipidemias / drug therapy*
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Dyslipidemias / physiopathology
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Female
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Heptanoic Acids / administration & dosage*
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Heptanoic Acids / adverse effects
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Humans
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Hydroxymethylglutaryl-CoA Reductase Inhibitors / administration & dosage*
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Hydroxymethylglutaryl-CoA Reductase Inhibitors / adverse effects
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Hypertension / blood
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Hypertension / complications
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Hypertension / drug therapy*
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Hypertension / physiopathology
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Lipids / blood*
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Male
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Middle Aged
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Odds Ratio
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Prospective Studies
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Pyrroles / administration & dosage*
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Pyrroles / adverse effects
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Risk Assessment
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Risk Factors
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Risk Reduction Behavior
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Tablets
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Time Factors
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Treatment Outcome
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United States
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Young Adult
Substances
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Antihypertensive Agents
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Biomarkers
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Calcium Channel Blockers
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Drug Combinations
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Heptanoic Acids
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Hydroxymethylglutaryl-CoA Reductase Inhibitors
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Lipids
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Pyrroles
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Tablets
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amlodipine, atorvastatin drug combination
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Amlodipine