Abstract
IntroductionHyperkalemia risk is increased in diabetes, particularly in patients with renal impairment or those receiving angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs) or potassium-sparing diuretics. Conversely, other diuretics can increase hypokalemia risk. We assessed the effects of the sodium glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin on serum potassium levels in a pooled analysis of clinical trials in patients with type 2 diabetes mellitus (T2DM).MethodsFourteen randomized, placebo-controlled, double-blind T2DM studies were analyzed: pooled data from 13 studies of ≤24 weeks’ duration (dapagliflozin 10 mg, N = 2360; placebo, N = 2295); and one 52-week moderate renal impairment study in patients with baseline eGFR ≥30 to <60 mL/min/1.73 m2 (dapagliflozin 10 mg, N = 85; placebo, N = 84). Central laboratory serum potassium levels were determined at each study visit.ResultsNo clinically relevant mean changes from baseline in serum potassium ≤24 weeks were reported for dapagliflozin 10 mg [−0.05 mmol/L; 95% confidence interval (CI) −0.07, −0.03] versus placebo (−0.02 mmol/L; 95% CI −0.04, 0.00) in the pooled population or in the renal impairment study (−0.03 mmol/L; 95% CI −0.14, 0.08 vs. −0.02 mmol/L; 95% CI −0.13, 0.09, respectively). The incidence rate ratio for serum potassium ≥5.5 mmol/L over 24 weeks for dapagliflozin 10 mg versus placebo was 0.90 (95% CI 0.74, 1.10) in the pooled population; with no increased risk in patients receiving ARBs/ACE inhibitors, or potassium-sparing diuretics, or in those with moderate renal impairment. Slightly more patients receiving dapagliflozin 10 mg had serum potassium ≤3.5 mmol/L versus placebo (5.2% vs. 3.6%); however, no instances of serum potassium ≤2.5 mmol/L were reported.ConclusionDapagliflozin is not associated with an increased risk of hyperkalemia or severe hypokalemia in patients with T2DM.FundingBristol-Myers Squibb and AstraZeneca.Electronic supplementary materialThe online version of this article (doi:10.1007/s13300-015-0150-y) contains supplementary material, which is available to authorized users.
Highlights
Hyperkalemia risk is increased in diabetes, in patients with renal impairment or those receiving angiotensin-converting enzyme (ACE)inhibitors, angiotensin receptor blockers (ARBs) or potassium-sparing diuretics.other diuretics can increase hypokalemia risk
A high proportion of patients received an ACE inhibitor or ARB (65.9% in the dapagliflozin group and 68.2% in the placebo group) whereas only a small proportion of patients were treated with a potassium-sparing diuretic (5.0% with dapagliflozin vs. 5.6% with placebo)
The majority of patients treated with a potassium-sparing diuretic received an ACE inhibitor or ARB (82.4% with dapagliflozin and 80.5% with placebo)
Summary
Hyperkalemia risk is increased in diabetes, in patients with renal impairment or those receiving angiotensin-converting enzyme (ACE)inhibitors, angiotensin receptor blockers (ARBs) or potassium-sparing diuretics.other diuretics can increase hypokalemia risk. Hyperkalemia risk is increased in diabetes, in patients with renal impairment or those receiving angiotensin-converting enzyme (ACE). Hyperkalemia, defined as a serum potassium level of greater than 5.5 mmol/L [1], is a potentially life-threatening condition that causes increased cardiac depolarization and can lead to rapid electrocardiographic changes and an increased risk of arrhythmias [2]. Hypokalemia is defined as a serum potassium level of less than 3.5 mmol/L (mild) [3] or less than 2.5 mmol/L (severe) [4] and can lead to an increase in the risk of cardiac arrhythmias [3]. Diabetes is associated with a high incidence of renal impairment, which in turn is an independent risk factor for hyperkalemia [9]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
