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Rigshospitalet - en del af Københavns Universitetshospital
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The effect of sodium-glucose transport protein 2 inhibitors on mortality and heart failure in randomized trials versus observational studies

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

DOI

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Vis graf over relationer

AIM: Randomized clinical trials (RCTs) allocating type 2 diabetes patients to treatment with sodium-glucose transport protein 2 (SGLT-2) inhibitors or placebo have found significant effects on the risk of heart failure and modest effects on mortality. In the wake of the first trials, a number of observational studies have been conducted, some of these reporting a mortality reduction of 50% compared to active comparators. In this review, we systematically assess and compare the results on all-cause mortality, cardiovascular mortality and heart failure hospitalization observed in RCTs with the results obtained in observational studies.

METHOD: We performed a systematic bibliographical search including cardiovascular outcome trials and observational studies assessing the effect of SGLT-2 inhibitors on mortality and heart failure.

RESULTS: Seven RCTs and 23 observational studies were included in the current review. The observed heterogeneity between study results for all-cause mortality (p-interaction < 0.001) and cardiovascular mortality (p-interaction < 0.001) was explained by study type, whereas this was not the case for heart failure (p-interaction = 0.18).

CONCLUSION: Methodological considerations such as the omission of important confounders, immortal-time bias and residual confounding such as unmeasured social economic inequality may be the cause of the inflated results observed in observational studies and that calls for caution when observational studies are used to guide treatment of patients with type 2 diabetes.

OriginalsprogEngelsk
Artikelnummere14600
TidsskriftDiabetic medicine : a journal of the British Diabetic Association
Vol/bind38
Udgave nummer9
Sider (fra-til)e14600
ISSN0742-3071
DOI
StatusUdgivet - sep. 2021

Bibliografisk note

© 2021 Diabetes UK.

ID: 73470318