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Effect of the SGLT2 Inhibitor Dapagliflozin on Potassium Levels in Patients with Type 2 Diabetes Mellitus: A Pooled Analysis
INTRODUCTION: Hyperkalemia 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....
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer Healthcare
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4801817/ https://www.ncbi.nlm.nih.gov/pubmed/26758563 http://dx.doi.org/10.1007/s13300-015-0150-y |
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author | Yavin, Yshai Mansfield, Traci A. Ptaszynska, Agata Johnsson, Kristina Parikh, Shamik Johnsson, Eva |
author_facet | Yavin, Yshai Mansfield, Traci A. Ptaszynska, Agata Johnsson, Kristina Parikh, Shamik Johnsson, Eva |
author_sort | Yavin, Yshai |
collection | PubMed |
description | INTRODUCTION: Hyperkalemia 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). METHODS: Fourteen 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 m(2) (dapagliflozin 10 mg, N = 85; placebo, N = 84). Central laboratory serum potassium levels were determined at each study visit. RESULTS: No 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. CONCLUSION: Dapagliflozin is not associated with an increased risk of hyperkalemia or severe hypokalemia in patients with T2DM. FUNDING: Bristol-Myers Squibb and AstraZeneca. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s13300-015-0150-y) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-4801817 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-48018172016-04-06 Effect of the SGLT2 Inhibitor Dapagliflozin on Potassium Levels in Patients with Type 2 Diabetes Mellitus: A Pooled Analysis Yavin, Yshai Mansfield, Traci A. Ptaszynska, Agata Johnsson, Kristina Parikh, Shamik Johnsson, Eva Diabetes Ther Original Research INTRODUCTION: Hyperkalemia 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). METHODS: Fourteen 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 m(2) (dapagliflozin 10 mg, N = 85; placebo, N = 84). Central laboratory serum potassium levels were determined at each study visit. RESULTS: No 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. CONCLUSION: Dapagliflozin is not associated with an increased risk of hyperkalemia or severe hypokalemia in patients with T2DM. FUNDING: Bristol-Myers Squibb and AstraZeneca. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s13300-015-0150-y) contains supplementary material, which is available to authorized users. Springer Healthcare 2016-01-12 2016-03 /pmc/articles/PMC4801817/ /pubmed/26758563 http://dx.doi.org/10.1007/s13300-015-0150-y Text en © The Author(s) 2016 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) ), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Original Research Yavin, Yshai Mansfield, Traci A. Ptaszynska, Agata Johnsson, Kristina Parikh, Shamik Johnsson, Eva Effect of the SGLT2 Inhibitor Dapagliflozin on Potassium Levels in Patients with Type 2 Diabetes Mellitus: A Pooled Analysis |
title | Effect of the SGLT2 Inhibitor Dapagliflozin on Potassium Levels in Patients with Type 2 Diabetes Mellitus: A Pooled Analysis |
title_full | Effect of the SGLT2 Inhibitor Dapagliflozin on Potassium Levels in Patients with Type 2 Diabetes Mellitus: A Pooled Analysis |
title_fullStr | Effect of the SGLT2 Inhibitor Dapagliflozin on Potassium Levels in Patients with Type 2 Diabetes Mellitus: A Pooled Analysis |
title_full_unstemmed | Effect of the SGLT2 Inhibitor Dapagliflozin on Potassium Levels in Patients with Type 2 Diabetes Mellitus: A Pooled Analysis |
title_short | Effect of the SGLT2 Inhibitor Dapagliflozin on Potassium Levels in Patients with Type 2 Diabetes Mellitus: A Pooled Analysis |
title_sort | effect of the sglt2 inhibitor dapagliflozin on potassium levels in patients with type 2 diabetes mellitus: a pooled analysis |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4801817/ https://www.ncbi.nlm.nih.gov/pubmed/26758563 http://dx.doi.org/10.1007/s13300-015-0150-y |
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