Simultaneous treatment to attain blood pressure and lipid goals and reduced CV
risk burden using amlodipine/atorvastatin single-pill therapy in treated
hypertensive participants in a randomized controlled trial.
Author(s): Grimm R, Malik M, Yunis C, Sutradhar S, Kursun A; TOGETHER Investigators.
Collaborators: Shapiro J, Oberoi MS, Kubala GS, Drummond W, Dinh DV, Shirley ME,
Imiolek PZ, Brockmyre A, Roth EM, Manlove-Simmons K, Wilson MF, Lodewick PA,
Budoff MJ, Hager SP, Phillips FC, Skloven ZD, Bernard JV, Mullen JA, Carr AA,
Seidner MR, Strout CB, Lucas ME, Chappel CM, Yates SW, Weiss RJ, Cottiero RA,
Levit S, Kripsak JP, Gupta P, Smallow SA, Schoenwalder M, Singh VN, Corder CN,
Meyer BS, Ashley RG, Peters PH, Ramirez HG, Levin PA, Marple RN, Riff DS, Nguyen
VQ, Craven RA, Marino L, Weinstein JR, Helman M, Tannenggee F, Ronald A RA,
Hoffman AS, Jarrett WG.
Affiliation(s): Berman Center for Outcomes and Clinical Research, University of Minnesota,
Minneapolis, MN 55404, USA. email@example.com
Publication date & source: 2010, Vasc Health Risk Manag. , 6:261-71
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.