The GLP-1 receptor agonists have been shown to decrease blood pressure (BP) in clinical trials using office BP measurements. However, the effect of GLP-1 agonist liraglutide on 24-hour ambulatory blood pressure and on the nocturnal BP decrease (dipping) have not been adequately assessed in large trials. To better characterize the effect of GLP-1 agonists on 24-hour ambulatory BP in subjects with T2DM we conducted a randomized controlled trial comparing the effects of liraglutide to placebo. Eleven subjects with T2DM (mean age 58.6±7.4 years, female 63.7%, African-American 72.7%) were randomized to 8 weeks of treatment with liraglutide (n=6) or placebo (n=5). ABPM and EndoPAT (Peripheral Arterial Tone) for assessment of endothelial dysfunction were done at baseline, 4 weeks and 8 weeks of therapy. Mixed models with repeated measures was used to estimate the treatment effect over time. Treatment with liraglutide was found to increase the nighttime SBP (LSM±SE): 135.3±4.3 vs. 102.1±4.5 (mmHg), p=0.0015), diastolic BP (DBP) (74.7±6.1 vs. 57.5±5.6 (mmHg), p=0.047) and increase daytime heart rate (109.5±9.2 vs. 77.1±7.9 (mmHg), p=0.021) after adjusting for age, race, history of hypertension, current use of ACE-I/ARBs and Reactive Hyperemia Index (RHI). There was no significant change in BMI between baseline and 8 weeks (1.5±2.4 vs. 1.0±2.5 (kg/m2), p=0.65). After adjustment for treatment and other covariates, abnormal RHI (≤ 1.67) was associated with decreased nighttime SBP (110.6±3.4 vs. 126.8±3.4 (mmHg), p=0.0003), and increased nighttime DBP (69.1±5.0 vs. 63.2±5.1 (mmHg), p=0.16) although lack of power to detect the statistical significance.
In conclusion, our study showed that treatment with liraglutide over 8 weeks was unable to correct the abnormal elevation in nocturnal BP known to occur in patients with T2DM. ABPM also confirmed the known side effect of increase in heart rate previously seen in other liraglutide trials. Abnormal RHI tended to be associated with all patients with high DBP.
D. Lovre: None. B. Katalenich: None. C. Carrion Olmeda: None. S.B. Camitta: None. A.N. Khan: None. V. Fonseca: Consultant; Self; Abbott. Board Member; Self; American Association of Clinical Endocrinologists. Consultant; Self; Eli Lilly and Company. Stock/Shareholder; Self; Amgen Inc.. Consultant; Self; Asahi Kasei Corporation, AstraZeneca, Novo Nordisk Inc., ADOCIA, Intarcia Therapeutics, Inc., Sanofi-Aventis. T.K. Thethi: None.