Lowering of blood pressure and pulse rate by switching from DPP-4 inhibitor to luseogliflozin in patients with type 2 diabetes complicated with hypertension: A multicenter, prospective, randomized, open-label, parallel-group comparison trial (LUNA study)

Reina Hashimoto-Kameda,Kyu Yong Cho,Hiroshi Nomoto,Akinobu Nakamura,Kazuno Omori,So Nagai,Sachiko Edagawa,Shinichiro Kawata,Jun Takeuchi,Hiraku Kameda,Yoshio Kurihara,Shin Aoki,Tatsuya Atsumi,Hideaki Miyoshi

doi:10.1016/j.diabres.2021.109069

Reina Hashimoto-Kameda, Kyu Yong Cho + Show 12 more

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https://doi.org/10.1016/j.diabres.2021.109069

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Abstract

AimsSodium-glucose cotransporter-2 inhibitor (SGLT2i) reduces clinic blood pressure (BP), but the effects on BP circadian rhythm remain unclear. The present study aimed to determine the nighttime antihypertensive effect of SGLT2i compared with dipeptidyl peptidase-4 inhibitor (DPP-4i) in patients with type 2 diabetes and hypertension. Materials and MethodsIn this randomized, open-label, parallel-group trial, patients treated with DPP-4i were either switched to luseogliflozin 2.5 mg/day (Luseo group;n = 30) or continued DPP-4i (DPP-4i group;n = 26). The patients undertook 24-h ambulatory BP monitoring before and 8 weeks after the group allocation. The primary endpoint was mean change in nighttime systolic BP (SBP). ResultsNighttime SBP, as well as daytime SBP, was significantly reduced in the Luseo group compared with the DPP-4i group (nighttime, −4.0 ± 11.4 vs. 3.6 ± 10.7 mmHg,P = 0.01; daytime, −4.4 ± 10.9 vs. 3.7 ± 11.9 mmHg,P = 0.01). Similarly, nighttimepulse rate(PR) was significantly reduced in the Luseo group (−2.0 ± 4.8 vs. 0.9 ± 4.8 bpm,P = 0.03). The proportion of patients with abnormal BP circadian rhythms (non-dipper pattern plus riser pattern) was significantly lower in the Luseo group (36.6% vs. 56.7%,P < 0.05). ConclusionsSwitching from DPP-4i to luseogliflozin decreased nighttime SBP and PR; moreover, BP circadian rhythm was improved.

Highlights

Patients with type 2 diabetes are at high risk for cardiovascular disease and cardiovascular mortality [1]
The present study investigated the significance of switching from dipeptidyl peptidase-4 inhibitor (DPP-4i) to luseogliflozin on the changes in ambulatory blood pressure monitoring (ABPM) parameters in patients with type 2 diabetes complicated with hypertension in a randomized clinical trial (RCT) (LUNA study) [21]
The LUNA study is the first RCT to investigate the changes in nighttime blood pressure (BP) after switching from DPP-4i to sodium-glucose cotransporter-2 inhibitor (SGLT2i) luseogliflozin in patients with type 2 diabetes and hypertension

Summary

Introduction

Patients with type 2 diabetes are at high risk for cardiovascular disease and cardiovascular mortality [1]. In the guideline for hypertension, the target values were sequentially set for clinical blood pressure (BP) and home BP measurements [6]; these measurements are not appropriate to identify nighttime hypertension, a strong predictor of cardiovascular disease in type 2 diabetes patients [7,8]. Evaluation of 24-h BP using ambulatory blood pressure monitoring (ABPM) devices can detect nighttime hypertension [9] in individual patients, as well as relevant information including BP variability over 24 h. ABPM provides information on pulse rate (PR), given that elevated nighttime PR was identified as an independent risk for cardiovascular mortality in hypertensive patients with normal daytime PR [11]

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