Sodium-Glucose Cotransporter 2 Inhibitors and Risk of Hyperkalemia in People With Type 2 Diabetes: A Meta-Analysis of Individual Participant Data From Randomized, Controlled Trials
Hyperkalemia increases risk of cardiac arrhythmias and death and limits the use of renin-angiotensin-aldosterone system inhibitors and mineralocorticoid receptor antagonists, which improve clinical outcomes in people with chronic kidney disease or systolic heart failure. Sodium-glucose cotransporter...
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| Published in: | Circulation (New York, N.Y.) Vol. 145; no. 19; p. 1460 |
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| Main Authors: | , , , , , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
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United States
10.05.2022
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| Subjects: | |
| ISSN: | 1524-4539, 1524-4539 |
| Online Access: | Get more information |
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| Abstract | Hyperkalemia increases risk of cardiac arrhythmias and death and limits the use of renin-angiotensin-aldosterone system inhibitors and mineralocorticoid receptor antagonists, which improve clinical outcomes in people with chronic kidney disease or systolic heart failure. Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of cardiorenal events in people with type 2 diabetes at high cardiovascular risk or with chronic kidney disease. However, their effect on hyperkalemia has not been systematically evaluated.
A meta-analysis was conducted using individual participant data from randomized, double-blind, placebo-controlled clinical outcome trials with SGLT2 inhibitors in people with type 2 diabetes at high cardiovascular risk or with chronic kidney disease in whom serum potassium levels were routinely measured. The primary outcome was time to serious hyperkalemia, defined as central laboratory-determined serum potassium ≥6.0 mmol/L, with other outcomes including investigator-reported hyperkalemia events and hypokalemia (serum potassium ≤3.5 mmol/L). Cox regression analyses were performed to estimate treatment effects from each trial with hazards ratios and corresponding 95% CIs pooled with random-effects models to obtain summary treatment effects, overall and across key subgroups.
Results from 6 trials were included comprising 49 875 participants assessing 4 SGLT2 inhibitors. Of these, 1754 participants developed serious hyperkalemia, and an additional 1119 investigator-reported hyperkalemia events were recorded. SGLT2 inhibitors reduced the risk of serious hyperkalemia (hazard ratio, 0.84 [95% CI, 0.76-0.93]), an effect consistent across studies (
=0.71). The incidence of investigator-reported hyperkalemia was also lower with SGLT2 inhibitors (hazard ratio, 0.80 [95% CI, 0.68-0.93];
=0.21). Reductions in serious hyperkalemia were observed across a range of subgroups, including baseline kidney function, history of heart failure, and use of renin-angiotensin-aldosterone system inhibitor, diuretic, and mineralocorticoid receptor antagonist. SGLT2 inhibitors did not increase the risk of hypokalemia (hazard ratio, 1.04 [95% CI, 0.94-1.15];
=0.42).
SGLT2 inhibitors reduce the risk of serious hyperkalemia in people with type 2 diabetes at high cardiovascular risk or with chronic kidney disease without increasing the risk of hypokalemia. |
|---|---|
| AbstractList | Hyperkalemia increases risk of cardiac arrhythmias and death and limits the use of renin-angiotensin-aldosterone system inhibitors and mineralocorticoid receptor antagonists, which improve clinical outcomes in people with chronic kidney disease or systolic heart failure. Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of cardiorenal events in people with type 2 diabetes at high cardiovascular risk or with chronic kidney disease. However, their effect on hyperkalemia has not been systematically evaluated.
A meta-analysis was conducted using individual participant data from randomized, double-blind, placebo-controlled clinical outcome trials with SGLT2 inhibitors in people with type 2 diabetes at high cardiovascular risk or with chronic kidney disease in whom serum potassium levels were routinely measured. The primary outcome was time to serious hyperkalemia, defined as central laboratory-determined serum potassium ≥6.0 mmol/L, with other outcomes including investigator-reported hyperkalemia events and hypokalemia (serum potassium ≤3.5 mmol/L). Cox regression analyses were performed to estimate treatment effects from each trial with hazards ratios and corresponding 95% CIs pooled with random-effects models to obtain summary treatment effects, overall and across key subgroups.
Results from 6 trials were included comprising 49 875 participants assessing 4 SGLT2 inhibitors. Of these, 1754 participants developed serious hyperkalemia, and an additional 1119 investigator-reported hyperkalemia events were recorded. SGLT2 inhibitors reduced the risk of serious hyperkalemia (hazard ratio, 0.84 [95% CI, 0.76-0.93]), an effect consistent across studies (
=0.71). The incidence of investigator-reported hyperkalemia was also lower with SGLT2 inhibitors (hazard ratio, 0.80 [95% CI, 0.68-0.93];
=0.21). Reductions in serious hyperkalemia were observed across a range of subgroups, including baseline kidney function, history of heart failure, and use of renin-angiotensin-aldosterone system inhibitor, diuretic, and mineralocorticoid receptor antagonist. SGLT2 inhibitors did not increase the risk of hypokalemia (hazard ratio, 1.04 [95% CI, 0.94-1.15];
=0.42).
SGLT2 inhibitors reduce the risk of serious hyperkalemia in people with type 2 diabetes at high cardiovascular risk or with chronic kidney disease without increasing the risk of hypokalemia. Hyperkalemia increases risk of cardiac arrhythmias and death and limits the use of renin-angiotensin-aldosterone system inhibitors and mineralocorticoid receptor antagonists, which improve clinical outcomes in people with chronic kidney disease or systolic heart failure. Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of cardiorenal events in people with type 2 diabetes at high cardiovascular risk or with chronic kidney disease. However, their effect on hyperkalemia has not been systematically evaluated.BACKGROUNDHyperkalemia increases risk of cardiac arrhythmias and death and limits the use of renin-angiotensin-aldosterone system inhibitors and mineralocorticoid receptor antagonists, which improve clinical outcomes in people with chronic kidney disease or systolic heart failure. Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of cardiorenal events in people with type 2 diabetes at high cardiovascular risk or with chronic kidney disease. However, their effect on hyperkalemia has not been systematically evaluated.A meta-analysis was conducted using individual participant data from randomized, double-blind, placebo-controlled clinical outcome trials with SGLT2 inhibitors in people with type 2 diabetes at high cardiovascular risk or with chronic kidney disease in whom serum potassium levels were routinely measured. The primary outcome was time to serious hyperkalemia, defined as central laboratory-determined serum potassium ≥6.0 mmol/L, with other outcomes including investigator-reported hyperkalemia events and hypokalemia (serum potassium ≤3.5 mmol/L). Cox regression analyses were performed to estimate treatment effects from each trial with hazards ratios and corresponding 95% CIs pooled with random-effects models to obtain summary treatment effects, overall and across key subgroups.METHODSA meta-analysis was conducted using individual participant data from randomized, double-blind, placebo-controlled clinical outcome trials with SGLT2 inhibitors in people with type 2 diabetes at high cardiovascular risk or with chronic kidney disease in whom serum potassium levels were routinely measured. The primary outcome was time to serious hyperkalemia, defined as central laboratory-determined serum potassium ≥6.0 mmol/L, with other outcomes including investigator-reported hyperkalemia events and hypokalemia (serum potassium ≤3.5 mmol/L). Cox regression analyses were performed to estimate treatment effects from each trial with hazards ratios and corresponding 95% CIs pooled with random-effects models to obtain summary treatment effects, overall and across key subgroups.Results from 6 trials were included comprising 49 875 participants assessing 4 SGLT2 inhibitors. Of these, 1754 participants developed serious hyperkalemia, and an additional 1119 investigator-reported hyperkalemia events were recorded. SGLT2 inhibitors reduced the risk of serious hyperkalemia (hazard ratio, 0.84 [95% CI, 0.76-0.93]), an effect consistent across studies (Pheterogeneity=0.71). The incidence of investigator-reported hyperkalemia was also lower with SGLT2 inhibitors (hazard ratio, 0.80 [95% CI, 0.68-0.93]; Pheterogeneity=0.21). Reductions in serious hyperkalemia were observed across a range of subgroups, including baseline kidney function, history of heart failure, and use of renin-angiotensin-aldosterone system inhibitor, diuretic, and mineralocorticoid receptor antagonist. SGLT2 inhibitors did not increase the risk of hypokalemia (hazard ratio, 1.04 [95% CI, 0.94-1.15]; Pheterogeneity=0.42).RESULTSResults from 6 trials were included comprising 49 875 participants assessing 4 SGLT2 inhibitors. Of these, 1754 participants developed serious hyperkalemia, and an additional 1119 investigator-reported hyperkalemia events were recorded. SGLT2 inhibitors reduced the risk of serious hyperkalemia (hazard ratio, 0.84 [95% CI, 0.76-0.93]), an effect consistent across studies (Pheterogeneity=0.71). The incidence of investigator-reported hyperkalemia was also lower with SGLT2 inhibitors (hazard ratio, 0.80 [95% CI, 0.68-0.93]; Pheterogeneity=0.21). Reductions in serious hyperkalemia were observed across a range of subgroups, including baseline kidney function, history of heart failure, and use of renin-angiotensin-aldosterone system inhibitor, diuretic, and mineralocorticoid receptor antagonist. SGLT2 inhibitors did not increase the risk of hypokalemia (hazard ratio, 1.04 [95% CI, 0.94-1.15]; Pheterogeneity=0.42).SGLT2 inhibitors reduce the risk of serious hyperkalemia in people with type 2 diabetes at high cardiovascular risk or with chronic kidney disease without increasing the risk of hypokalemia.CONCLUSIONSSGLT2 inhibitors reduce the risk of serious hyperkalemia in people with type 2 diabetes at high cardiovascular risk or with chronic kidney disease without increasing the risk of hypokalemia. |
| Author | Langkilde, Anna Maria Wanner, Christoph Heerspink, Hiddo J L Perkovic, Vlado Pong, Annpey Sabatine, Marc S Neal, Bruce Raz, Itamar Mahaffey, Kenneth W Arnott, Clare Wheeler, David C Neuen, Brendon L Oshima, Megumi Agarwal, Rajiv Edwards, Robert McGuire, Darren K Toyama, Tadashi Cherney, David Z Zinman, Bernard Wiviott, Stephen D |
| Author_xml | – sequence: 1 givenname: Brendon L orcidid: 0000-0001-9276-8380 surname: Neuen fullname: Neuen, Brendon L organization: The George Institute for Global Health, University of New South Wales, Sydney, Australia (B.L.N., C.A.) – sequence: 2 givenname: Megumi surname: Oshima fullname: Oshima, Megumi organization: Department of Nephrology and Laboratory Medicine, Kanazawa University, Japan (M.O., T.T.) – sequence: 3 givenname: Rajiv orcidid: 0000-0001-8355-7100 surname: Agarwal fullname: Agarwal, Rajiv organization: Indiana University School of Medicine and VA Medical Center, Indianapolis (R.A.) – sequence: 4 givenname: Clare orcidid: 0000-0001-9370-9913 surname: Arnott fullname: Arnott, Clare organization: Sydney Medical School, University of Sydney, Australia (C.A.) – sequence: 5 givenname: David Z orcidid: 0000-0003-4164-0429 surname: Cherney fullname: Cherney, David Z organization: Department of Medicine and Department of Physiology, Division of Nephrology, University Health Network, University of Toronto, Ontario, Canada (D.Z.C.) – sequence: 6 givenname: Robert surname: Edwards fullname: Edwards, Robert organization: Janssen Research & Development, LLC, Raritan, NJ (R.E.) – sequence: 7 givenname: Anna Maria surname: Langkilde fullname: Langkilde, Anna Maria organization: AstraZeneca, Gothenburg, Sweden (A.M.L.) – sequence: 8 givenname: Kenneth W surname: Mahaffey fullname: Mahaffey, Kenneth W organization: Stanford Center for Clinical Research, Stanford University School of Medicine, CA (K.W.M.) – sequence: 9 givenname: Darren K orcidid: 0000-0002-6412-7989 surname: McGuire fullname: McGuire, Darren K organization: Department of Internal Medicine, University of Texas Southwestern Medical Center, and Parkland Health and Hospital System, Dallas (D.K.M.) – sequence: 10 givenname: Bruce orcidid: 0000-0002-0490-7465 surname: Neal fullname: Neal, Bruce organization: Department of Epidemiology and Biostatistics, Imperial College London, UK (B.N.) – sequence: 11 givenname: Vlado orcidid: 0000-0002-4257-7620 surname: Perkovic fullname: Perkovic, Vlado organization: Faculty of Medicine, University of New South Wales, Sydney, Australia (V.P.) – sequence: 12 givenname: Annpey surname: Pong fullname: Pong, Annpey organization: Merck & Co Inc, Kenilworth, NJ (A.P.) – sequence: 13 givenname: Marc S orcidid: 0000-0002-0691-3359 surname: Sabatine fullname: Sabatine, Marc S organization: TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (M.S.S., S.D.W.) – sequence: 14 givenname: Itamar orcidid: 0000-0003-0209-4453 surname: Raz fullname: Raz, Itamar organization: Diabetes Unit, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Israel (I.R.) – sequence: 15 givenname: Tadashi orcidid: 0000-0003-0162-6286 surname: Toyama fullname: Toyama, Tadashi – sequence: 16 givenname: Christoph surname: Wanner fullname: Wanner, Christoph organization: Division of Nephrology, Department of Medicine, Würzburg University Clinic, Germany (C.W.) – sequence: 17 givenname: David C orcidid: 0000-0003-0745-3478 surname: Wheeler fullname: Wheeler, David C organization: Department of Renal Medicine, UCL Medical School, London, UK (D.C.W.) – sequence: 18 givenname: Stephen D orcidid: 0000-0002-4922-9880 surname: Wiviott fullname: Wiviott, Stephen D organization: TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (M.S.S., S.D.W.) – sequence: 19 givenname: Bernard surname: Zinman fullname: Zinman, Bernard organization: Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Ontario, Canada (B.Z.) – sequence: 20 givenname: Hiddo J L orcidid: 0000-0002-3126-3730 surname: Heerspink fullname: Heerspink, Hiddo J L organization: Department of Clinical Pharmacy and Pharmacology, University of Groningen, the Netherlands (H.J.L.H.) |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/35394821$$D View this record in MEDLINE/PubMed |
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| Keywords | heart failure sodium-glucose transporter 2 inhibitors potassium type 2 renal insufficiency hyperkalemia diabetes mellitus chronic |
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| PublicationTitle | Circulation (New York, N.Y.) |
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| PublicationYear | 2022 |
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| Snippet | Hyperkalemia increases risk of cardiac arrhythmias and death and limits the use of renin-angiotensin-aldosterone system inhibitors and mineralocorticoid... |
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| SubjectTerms | Antihypertensive Agents - therapeutic use Diabetes Mellitus, Type 2 - complications Diabetes Mellitus, Type 2 - drug therapy Female Glucose Humans Hyperkalemia - chemically induced Hyperkalemia - epidemiology Hypokalemia - chemically induced Hypokalemia - epidemiology Male Mineralocorticoid Receptor Antagonists - adverse effects Potassium Randomized Controlled Trials as Topic Renal Insufficiency, Chronic - drug therapy Renal Insufficiency, Chronic - epidemiology Sodium Sodium-Glucose Transporter 2 Inhibitors - adverse effects |
| Title | Sodium-Glucose Cotransporter 2 Inhibitors and Risk of Hyperkalemia in People With Type 2 Diabetes: A Meta-Analysis of Individual Participant Data From Randomized, Controlled Trials |
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