Vivian A Fonseca1, J Hans Devries2, Robert R Henry3, Morten Donsmark4, Henrik F Thomsen5, Jorge Plutzky6. 1. Tulane University, New Orleans, LA, USA. Electronic address: vfonseca@tulane.edu. 2. Academic Medical Centre, University of Amsterdam, Netherlands. 3. University of California San Diego and VA San Diego Healthcare System, San Diego, CA, USA. 4. Novo Nordisk A/S, Soeborg, Denmark. 5. Novo Nordisk A/S, Aalborg Øst, Denmark. 6. Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Abstract
AIMS: To quantify the effect of liraglutide on systolic blood pressure (SBP) and pulse in patients with type 2 diabetes (T2D), and assess the influence of covariates on observed SBP reductions. METHODS: A patient-level pooled analysis of six phase 3, randomized trials was conducted. RESULTS: The analysis included 2792 randomized patients. In the intention-to-treat population (n=2783), mean [±SE] SBP reductions from baseline with liraglutide 1.2 mg (2.7 [0.8] mmHg) and 1.8 mg (2.9 [0.7] mmHg) once daily were significantly greater than with placebo (0.5 [0.9] mmHg; P=0.0029 and P=0.0004, respectively) after 26 weeks, and were evident after 2 weeks. Liraglutide was also associated with significantly greater SBP reductions than glimepiride and, at a dose of 1.8 mg, insulin glargine and rosiglitazone. SBP reductions with liraglutide weakly correlated with weight loss (Pearson's correlation coefficient: 0.08-0.12; P≤0.0148). No dependence of these reductions on concomitant antihypertensive medications was detected (P=0.1304). Liraglutide 1.2 and 1.8 mg were associated with mean increases in pulse of 3 beats per minute (bpm), versus a 1 bpm increase with placebo (P<0.0001 for each dose versus placebo). CONCLUSIONS:Liraglutide reduces SBP in patients with T2D, including those receiving concomitant antihypertensive medication.
RCT Entities:
AIMS: To quantify the effect of liraglutide on systolic blood pressure (SBP) and pulse in patients with type 2 diabetes (T2D), and assess the influence of covariates on observed SBP reductions. METHODS: A patient-level pooled analysis of six phase 3, randomized trials was conducted. RESULTS: The analysis included 2792 randomized patients. In the intention-to-treat population (n=2783), mean [±SE] SBP reductions from baseline with liraglutide 1.2 mg (2.7 [0.8] mmHg) and 1.8 mg (2.9 [0.7] mmHg) once daily were significantly greater than with placebo (0.5 [0.9] mmHg; P=0.0029 and P=0.0004, respectively) after 26 weeks, and were evident after 2 weeks. Liraglutide was also associated with significantly greater SBP reductions than glimepiride and, at a dose of 1.8 mg, insulinglargine and rosiglitazone. SBP reductions with liraglutide weakly correlated with weight loss (Pearson's correlation coefficient: 0.08-0.12; P≤0.0148). No dependence of these reductions on concomitant antihypertensive medications was detected (P=0.1304). Liraglutide 1.2 and 1.8 mg were associated with mean increases in pulse of 3 beats per minute (bpm), versus a 1 bpm increase with placebo (P<0.0001 for each dose versus placebo). CONCLUSIONS: Liraglutide reduces SBP in patients with T2D, including those receiving concomitant antihypertensive medication.
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