Twenty-Four-Hour Blood Pressure–Lowering Effect of a Sodium-Glucose Cotransporter 2 Inhibitor in Patients With Diabetes and Uncontrolled Nocturnal Hypertension
Key result
Empagliflozin did not significantly reduce nighttime systolic blood pressure compared to placebo (between-group difference -4.3 mm Hg; P=0.159).
Why the study?
The risk of cardiovascular disease and mortality is high in salt-sensitive patients with diabetes mellitus and uncontrolled nocturnal hypertension, prompting investigation into the blood pressure effects of adding empagliflozin to existing antihypertensive therapy.
Does empagliflozin 10 mg once daily reduce nighttime blood pressure in adult patients with type 2 diabetes mellitus and uncontrolled nocturnal hypertension?
Comparison
Empagliflozin 10 mg once daily vs placebo
Design
Multicenter, double-blind, parallel randomized trial
Follow-up
12 weeks
Authors
Discussion
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Implication
Empagliflozin does not reduce nighttime SBP; challenges uniform 24-hour BP lowering and leaves nocturnal hypertension control open.
Study Design
Type
RCT (n=132)
Blinding
Double-blind
Randomization
randomized
Multicenter
Yes
Structured PICO
Does empagliflozin 10 mg once daily reduce nighttime blood pressure in adult patients with type 2 diabetes mellitus and uncontrolled nocturnal hypertension?
P
Population
132 older patients with type 2 diabetes mellitus and uncontrolled nocturnal hypertension on stable antihypertensive therapy including ARBs, followed for 12 weeks.
I
Intervention
Empagliflozin 10 mg once daily added to existing antihypertensive and antidiabetic therapy for 12 weeks
C
Comparator
Placebo added to existing antihypertensive and antidiabetic therapy for 12 weeks
O
Outcome
Change from baseline in nighttime blood pressure measured by ambulatory BP monitoring at 12 weekssurrogate
Main Result
Mean Difference: -4.3
p-value: p=0.159
In older patients with type 2 diabetes and uncontrolled nocturnal hypertension, empagliflozin significantly reduced daytime and 24-hour systolic blood pressure, though the reduction in nighttime systolic blood pressure was not statistically significant compared to placebo.
Cite This Study
Kario et al. (2019) conducted an RCT in type 2 diabetes mellitus and uncontrolled nocturnal hypertension (n=132). Empagliflozin vs. Placebo was evaluated on change from baseline in nighttime BP (ambulatory BP monitoring) (MD -4.3 mm Hg, p=0.159). Empagliflozin did not significantly reduce nighttime systolic blood pressure compared to placebo (between-group difference -4.3 mm Hg; P=0.159).