Volume 16, Issue 5 p. 457-466
ORIGINAL ARTICLE

Efficacy and safety of sodium glucose co-transport-2 inhibitors in type 2 diabetes: a meta-analysis of randomized clinical trials

M. Monami

M. Monami

Geriatric Cardiology, Careggi Teaching Hospital, Florence, Italy

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C. Nardini

C. Nardini

Geriatric Cardiology, Careggi Teaching Hospital, Florence, Italy

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E. Mannucci

Corresponding Author

E. Mannucci

Diabetes Agency, Careggi Teaching Hospital, Florence, Italy

Correspondence to: Edoardo Mannucci, MD, Diabetes Agency, Azienda Ospedaliero-Universitaria Careggi, Via delle Oblate 4, 50141 Florence, Italy.

E-mail: edoardo.mannucci@unifi.it

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First published: 05 December 2013
Citations: 205

Abstract

Aims

Sodium glucose co-transport-2 (SGLT-2) inhibitors, a new class of glucose-lowering agents, reduce tubular glucose reabsorption, producing a reduction of blood glucose without stimulating insulin release. The aim of the present meta-analysis is the assessment of the overall efficacy and safety profile of these drugs.

Methods

A meta-analysis was performed including all trials with a duration of at least 12 weeks, comparing a SGLT-2 inhibitor with a non-SGLT-2 inhibitor agent in type 2 diabetes. The principal outcome of this analysis was the effect of SGLT-2 inhibitors on HbA1c at 12, 24 and 52 weeks. Hypoglycaemia, genital and urinary infections were retrieved and combined to calculate Mantel–Haenszel odds ratio (MH-OR). Furthermore, data on body mass index (BMI), endpoint fasting plasma glucose, systolic and diastolic blood pressure, creatinine, hematocrit and lipid profile were collected.

Results

Among placebo-controlled trials, HbA1c reduction at 12, 24 and 52 weeks was 0.5 [0.4; 0.6], 0.6 [0.6; 0.5] and 0.6 [0.7; 0.5]%. In placebo-controlled studies, 24-week reduction of HbA1c with SGLT-2 inhibitors was greater in trials enrolling patients with a lower mean age and duration of diabetes, and a higher baseline BMI, HbA1c and fasting glucose. In placebo-controlled trials, SGLT-2 inhibitors determined a weight loss during the first 24 weeks, which was maintained up to 52 weeks.

Conclusions

SGLT-2 inhibitors are effective in the treatment of type 2 diabetes, providing additional benefits, such as weight loss, reduction of blood pressure and increase in high-density lipoprotein (HDL)-cholesterol. Apart from genital and urinary infections, rather frequent but usually mild, SGLT-2 inhibitors appear to be well tolerated.