title: Reductions in Mean 24-Hour Ambulatory Blood Pressure After 6-Week Treatment With Canagliflozin in Patients With Type 2 Diabetes Mellitus and Hypertension.
abstract: This randomized, double-blind, placebo-controlled study evaluated the early effects of canagliflozin on blood pressure (BP) in patients with type 2 diabetes mellitus (T2DM) and hypertension. Patients were randomized to canagliflozin 300 mg, canagliflozin 100 mg, or placebo for 6 weeks and underwent 24-hour ambulatory BP monitoring before randomization, on day 1 of treatment, and after 6 weeks. The primary endpoint was change in mean 24-hour systolic BP (SBP) from baseline to week 6. Overall, 169 patients were included (mean age, 58.6 years; glycated hemoglobin, 8.1%; seated BP 138.5/82.7 mm Hg). At week 6, canagliflozin 300 mg provided greater reductions in mean 24-hour SBP than placebo (least squares mean -6.2 vs -1.2 mm Hg, respectively; P=.006). Numerical reductions in SBP were observed with canagliflozin 100 mg. Canagliflozin was generally well tolerated, with side effects similar to those reported in previous studies. These results suggest that canagliflozin rapidly reduces BP in patients with T2DM and hypertension.
authors.affiliation: University of Pennsylvania, Philadelphia, PA.
authors.forename: Raymond R
authors.initials: RR
authors.lastname: Townsend
authors.affiliation: Canvas Clinical Research, Lake Worth, FL.
authors.forename: Israel
authors.initials: I
authors.lastname: Machin
authors.affiliation: Janssen Pharmaceuticals, Inc., Raritan, NJ.
authors.forename: Jimmy
authors.initials: J
authors.lastname: Ren
authors.affiliation: Angelina L. Trujillo, MD, LLC, La Pine, OR.
authors.forename: Angelina
authors.initials: A
authors.lastname: Trujillo
authors.affiliation: JCHO Yufuin Hospital, Oita, Japan.
authors.forename: Masato
authors.initials: M
authors.lastname: Kawaguchi
authors.affiliation: Janssen Research & Development, LLC, Raritan, NJ.
authors.forename: Ujjwala
authors.initials: U
authors.lastname: Vijapurkar
authors.affiliation: Janssen Research & Development, LLC, Raritan, NJ.
authors.forename: Chandrasekharrao V
authors.initials: CV
authors.lastname: Damaraju
authors.affiliation: Janssen Pharmaceuticals, Inc., Raritan, NJ.
authors.forename: Michael
authors.initials: M
authors.lastname: Pfeifer
mesh_terms: D001794:Blood Pressure / Q000187:drug effects; D018660:Blood Pressure Monitoring, Ambulatory; D000068896:Canagliflozin / Q000008:administration & dosage* / Q000009:adverse effects; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D006973:Hypertension / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged
chemical_list: D000068896:Canagliflozin; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents