title: Randomized study of antihypertensive efficacy and safety of combination aliskiren/valsartan vs valsartan monotherapy in hypertensive participants with type 2 diabetes mellitus.
abstract: In this double-blind study, 1143 hypertensive participants with type 2 diabetes and stage 1 or 2 chronic kidney disease (CKD) were randomized to receive combination aliskiren/valsartan 150/160 mg or valsartan 160 mg monotherapy for 2 weeks, with force-titration to 300/320 mg and 320 mg, respectively, for another 6 weeks. Ambulatory blood pressure (ABP), the primary outcome, was available for 665 participants. Reductions from baseline to week 8 in 24-hour ABP were -14.1/-8.7 mm Hg with aliskiren/valsartan vs -10.2/-6.3 mm Hg with valsartan (P<.001). Adverse events were reported in 202 participants (35.2%) taking aliskiren/valsartan and 182 participants (32.2%) taking valsartan. No participant had blood urea nitrogen values>40 mg/dL or serum creatinine values>2.0 mg/dL. There were no confirmed cases of serum potassium values≥6.0 mEq/L. Combination aliskiren/valsartan has additive effects on blood pressure reduction and tolerability similar to valsartan in hypertensive/diabetic participants with early-stage (stages 1 and 2) CKD.
authors: Department of Medicine, Comprehensive Hypertension Center, The University of Chicago Medicine, Chicago, IL 60637, USA. gbakris@gmail.com
authors: George L
authors: GL
authors: Bakris
authors: Suzanne
authors: S
authors: Oparil
authors: Das
authors: D
authors: Purkayastha
authors: Anthony M
authors: AM
authors: Yadao
authors: Thomas
authors: T
authors: Alessi
authors: James R
authors: JR
authors: Sowers
mesh_terms: D000368:Aged; D000577:Amides / Q000009:adverse effects / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000502:physiology; D001806:Blood Urea Nitrogen; D015897:Comorbidity; D003404:Creatinine / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000453:epidemiology*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005650:Fumarates / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000453:epidemiology* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D013777:Tetrazoles / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014633:Valine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000068756:Valsartan
chemical_list: D000577:Amides; D000959:Antihypertensive Agents; D005650:Fumarates; D013777:Tetrazoles; C446481:aliskiren; D000068756:Valsartan; D003404:Creatinine; D014633:Valine