A <scp>P</scp>hase <scp>IIb</scp>, randomized, placebo‐controlled study of the <scp>SGLT2</scp> inhibitor empagliflozin in patients with type 2 diabetes

Ferrannini, Ele; Seman, Leo; Seewaldt-Becker, Elke; Hantel, Stefan; Pinnetti, Sabine; Woerle, Hans-Juergen

doi:10.1111/dom.12081

Cited by 171 publications

(195 citation statements)

References 15 publications

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“…The large placebo-controlled 24-week study by Roden and colleagues 4 confirms these favourable effects with empagliflozin 10 and 25 mg compared to placebo in patients treated with diet alone, and reproduces results of a previous smaller and shorter trial 5 . Adverse events are those expected from this new pharmacological class, with a slightly increased incidence of genital and benign urinary infections 3 .…”

supporting

confidence: 62%

SGLT2 versus DPP4 inhibitors for type 2 diabetes

Scheen

2013

The Lancet Diabetes & Endocrinology

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Management of hyperglycaemia in type 2 diabetes (T2DM) remains challenging despite increasing pharmacological opportunities 1 . The old drug metformin remains the first-line therapy in all guidelines. However, a significant number of patients cannot tolerate the biguanide because of gastrointestinal adverse events or may have contraindications to its use. Which drug to be prescribed to those patients or to those not well controlled with metformin monotherapy is still controversial. Advantages and disadvantages of specific glucose-lowering drugs for each patient should be considered 1 . Dipeptidyl peptidase-4 (DPP-4) inhibitors (gliptins) offer some advantages over classical sulphonylureas (no weight gain, no hypoglycaemia), but are more expensive 2 . A new class of glucose-lowering therapies is emerging with the recent launch of two inhibitors of sodium-glucose cotransporters type 2 (SGLT-2) (dapagliflozin and canagliflozin), and the expected commercialisation of a third one, empagliflozin, in a near future. These agents

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supporting

confidence: 62%

SGLT2 versus DPP4 inhibitors for type 2 diabetes

Scheen

2013

The Lancet Diabetes & Endocrinology

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“…Data were sorted by first author, year of publication, country of the study, design, age range of the participants, total sample size, SGLT2 inhibitor, comparator, number of patients, dosage, and follow‐up duration (Table 1). 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55 …”

Section: Methodsmentioning

confidence: 99%

Effect of Sodium‐Glucose Cotransport‐2 Inhibitors on Blood Pressure in People With Type 2 Diabetes Mellitus: A Systematic Review and Meta‐Analysis of 43 Randomized Control Trials With 22 528 Patients

Mazidi

Rezaie

Gao

et al. 2017

JAHA

257

174

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BackgroundThe sodium‐glucose cotransporter 2 (SGLT2) inhibitors are a class of oral hypoglycemic agents. We undertake a systematic review and meta‐analysis of prospective studies to determine the effect of SGLT2 on blood pressure (BP) among individuals with type 2 diabetes mellitus.Methods and ResultsPubMed‐Medline, Web of Science, Cochrane Database, and Google Scholar databases were searched to identify trial registries evaluating the impact of SGLT2 on BP. Random‐effects models meta‐analysis was used for quantitative data synthesis. The meta‐analysis indicated a significant reduction in systolic BP following treatment with SGLT2 (weighted mean difference −2.46 mm Hg [95% CI −2.86 to −2.06]). The weighted mean differences for the effect on diastolic BP was −1.46 mm Hg (95% CI −1.82 to −1.09). In these subjects the weighted mean difference effects on serum triglycerides and total cholesterol were −2.08 mg/dL (95% CI −2.51 to −1.64) and 0.77 mg/dL (95% CI 0.33‐1.21), respectively. The weighted mean differences for the effect of SGLT2 on body weight was −1.88 kg (95% CI −2.11 to −1.66) across all studies. These findings were robust in sensitivity analyses.ConclusionsTreatment with SGLT2 glucose cotransporter inhibitors therefore has beneficial off‐target effects on BP in patients with type 2 diabetes mellitus and may also be of value in improving other cardiometabolic parameters including lipid profile and body weight in addition to their expected effects on glycemic control. However, our findings should be interpreted with consideration for the moderate statistical heterogeneity across the included studies.

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“…It has been found that surrogate markers of beta cell function including homeostasis model assessment-β were also improved. In addition, a modest but a signifi cant decrease in body weight has also been noted, 7 and studies have also confi rmed that the weight reduction was due to decreased body fat rather than due to dehydration, and was explained by loss of glucose via the kidney. 8 The glucosuria that occurs due to SGLT inhibition is accompanied by mild diuresis which contributes to an additional benefi t of a sustained and moderate reduction in blood pressure (BP).…”

Section: Mechanism Of Actionmentioning

confidence: 94%