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Title:
Effects of SGLT-2 inhibitors on mortality and cardiovascular events: a comprehensive meta-analysis of randomized controlled trials | Acta Diabetologica
Description:
EMPAREG OUTCOME study showed a reduction in cardiovascular events in patients treated with the sodium-glucose transporter 2 inhibitor (SGLT2i) empagliflozin, as compared to placebo. Other drugs of the same class are currently been investigated for cardiovascular outcomes. In the meanwhile, a re-analysis of data collected in available studies can add relevant insight. A MEDLINE search for SGLT-2 inhibitors (dapagliflozin, empagliflozin, canagliflozin, ipragliflozin, ertugliflozin, luseogliflozin) was performed, collecting all randomized trials up to November 16, 2015. All trials with a duration of treatment â„12 weeks, enrolling patients with type 2 diabetes, comparing a SGLT2i with placebo or other comparators were included. The principal outcome was the effect of SGLT2i on all-cause and cardiovascular mortality. Secondary endpoints were myocardial infarction and stroke. MantelâHaenszel odds ratio with 95 % confidence interval (MH-OR) was calculated. A total of 71 trials were included (31,199 and 16,088 patients in SGLT2i and comparator groups). Treatment with SGLT2i was associated with a significant reduction in all-cause mortality (MH-OR 0.70 [0.59â0.83], p < 0.001), cardiovascular mortality (MH-OR 0.43 [0.36â0.53], p < 0.001), and myocardial infarction (MH-OR 0.77 [0.63â0.94], p < 0.01), but not stroke (MH-OR 1.09 [0.86â1.38], p = 0.50), with no apparent difference across molecules (after excluding cardiovascular outcome trials). Available data suggest that the beneficial action observed with empagliflozin on all-cause and cardiovascular mortality in EMPAREG OUTCOME study is a class effect. The present meta-analysis showed a significantly reduction in myocardial infarction, with no increased risk of stroke.
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eu/docs/en_gb/document_library/epar_-_public_assessment_report/human/002649/wc500156457 eu/docs/en_gb/document_library/epar_-_product_information/human/002677/wc500168592 eu/docs/en_gb/document_library/epar_-_product_information/human/002322/wc500136026 gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinologicandmetabolicdrugsadvisorycommittee/ucm339293 month download article/chapter ilaria dicembrini & edoardo mannucci gov/ct2/show/nct01137474 placebo-controlled dose-finding study present meta-analysis showed gov/ct2/show/nct01649297 term=nct01340664&rank=1 kaku mantelâhaenszel odds ratio understanding empa-reg outcome gov/ct2/show/nct01032629 gov/ct2/show/nct01730534 gov/ct2/show/nct01986881 gov/drugsatfda_docs/nda/2013/204042orig1s000medr gov/drugsatfda_docs/nda/2014/204629orig1s000medr gov/drugsatfda_docs/nda/2014/202293orig1s000medr platelet iib/iiia antagonist gov/ct2/show/nct01340664 sodium-glucose cotransporter-2 inhibitors sodium-glucose cotransport inhibition azienda ospedaliero-universitaria careggi edoardo mannucci designed term=canvas&rank=1 term=ertugliflozin+cardiovascular&rank=1 placebo-controlled clinical trial term=declare+dapagliflozin&rank=1 empareg outcome study blood pressure-lowering effect sodium-glucose cotransporter 2 double-blind clinical trial wilding jp drug-naive asian patients privacy choices/manage cookies author information authors network meta-analysis national research committee full article pdf edoardo mannucci dose-finding study beneficial action observed comprehensive meta-analysis meta-analysis detected long-term study adequate glycemic control improve glycemic control article monami glucose-regulating drug
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- Gov/ct2/show/NCT01032629?
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headline:Effects of SGLT-2 inhibitors on mortality and cardiovascular events: a comprehensive meta-analysis of randomized controlled trials
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EMPAREG OUTCOME study showed a reduction in cardiovascular events in patients treated with the sodium-glucose transporter 2 inhibitor (SGLT2i) empagliflozin, as compared to placebo. Other drugs of the same class are currently been investigated for cardiovascular outcomes. In the meanwhile, a re-analysis of data collected in available studies can add relevant insight.
A MEDLINE search for SGLT-2 inhibitors (dapagliflozin, empagliflozin, canagliflozin, ipragliflozin, ertugliflozin, luseogliflozin) was performed, collecting all randomized trials up to November 16, 2015. All trials with a duration of treatment â„12 weeks, enrolling patients with type 2 diabetes, comparing a SGLT2i with placebo or other comparators were included. The principal outcome was the effect of SGLT2i on all-cause and cardiovascular mortality. Secondary endpoints were myocardial infarction and stroke. MantelâHaenszel odds ratio with 95 % confidence interval (MH-OR) was calculated. A total of 71 trials were included (31,199 and 16,088 patients in SGLT2i and comparator groups). Treatment with SGLT2i was associated with a significant reduction in all-cause mortality (MH-OR 0.70 [0.59â0.83], p < 0.001), cardiovascular mortality (MH-OR 0.43 [0.36â0.53], p < 0.001), and myocardial infarction (MH-OR 0.77 [0.63â0.94], p < 0.01), but not stroke (MH-OR 1.09 [0.86â1.38], p = 0.50), with no apparent difference across molecules (after excluding cardiovascular outcome trials).
Available data suggest that the beneficial action observed with empagliflozin on all-cause and cardiovascular mortality in EMPAREG OUTCOME study is a class effect. The present meta-analysis showed a significantly reduction in myocardial infarction, with no increased risk of stroke.
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Cardiovascular events
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EMPAREG OUTCOME study showed a reduction in cardiovascular events in patients treated with the sodium-glucose transporter 2 inhibitor (SGLT2i) empagliflozin, as compared to placebo. Other drugs of the same class are currently been investigated for cardiovascular outcomes. In the meanwhile, a re-analysis of data collected in available studies can add relevant insight.
A MEDLINE search for SGLT-2 inhibitors (dapagliflozin, empagliflozin, canagliflozin, ipragliflozin, ertugliflozin, luseogliflozin) was performed, collecting all randomized trials up to November 16, 2015. All trials with a duration of treatment â„12 weeks, enrolling patients with type 2 diabetes, comparing a SGLT2i with placebo or other comparators were included. The principal outcome was the effect of SGLT2i on all-cause and cardiovascular mortality. Secondary endpoints were myocardial infarction and stroke. MantelâHaenszel odds ratio with 95 % confidence interval (MH-OR) was calculated. A total of 71 trials were included (31,199 and 16,088 patients in SGLT2i and comparator groups). Treatment with SGLT2i was associated with a significant reduction in all-cause mortality (MH-OR 0.70 [0.59â0.83], p < 0.001), cardiovascular mortality (MH-OR 0.43 [0.36â0.53], p < 0.001), and myocardial infarction (MH-OR 0.77 [0.63â0.94], p < 0.01), but not stroke (MH-OR 1.09 [0.86â1.38], p = 0.50), with no apparent difference across molecules (after excluding cardiovascular outcome trials).
Available data suggest that the beneficial action observed with empagliflozin on all-cause and cardiovascular mortality in EMPAREG OUTCOME study is a class effect. The present meta-analysis showed a significantly reduction in myocardial infarction, with no increased risk of stroke.
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SGLT-2 inhibitors
Cardiovascular events
Mortality
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