Efficacy and safety of dapagliflozin as monotherapy in patients with type 2 diabetes mellitus

Jul 27, 2019Medicine

Effectiveness and safety of dapagliflozin alone in treating type 2 diabetes: A combined analysis of clinical trials

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Abstract

Dapagliflozin monotherapy resulted in a 0.60% reduction in glycosylated hemoglobin A1c () in patients with type 2 diabetes.

A total of 2033 patients from six randomized controlled trials were included in the analysis.
Dapagliflozin was associated with a decrease in fasting plasma glucose by 1.30 mmol/L.
Body weight decreased by 1.50 kg with dapagliflozin treatment.
An increased risk of urinary tract infections was noted, with a relative risk of 1.74.
Genital tract infections were also more common, with a relative risk of 3.52.
The treatment was well tolerated and did not lead to increased hypoglycemia.

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BACKGROUND: Dapagliflozin, a novel inhibitor of sodium-glucose cotransporter-2 (SGLT-2), lowers blood glucose level by specifically inhibiting the activity of SGLT-2. Previous studies showed efficacy and safety of dapagliflozin combined with other antihyperglycemic agents in type 2 diabetes (T2DM), however, there are few studies for dapagliflozin as monotherapy. The aim of this study was to assess the efficacy and safety of dapagliflozin as a monotherapy in T2DM and provide theoretical basis for clinical rational use of drugs.

METHODS: We did a systematic review and meta-analysis of randomized, placbo-controlled clinical studies in patients with type 2 diabetes. We searched PubMed, Embase, Cochrane Library, CNKI, Wanfang, and VIP database through October 2018, we also manually screened list of references to the previous meta-analysis of dapagliflozin in the treatment of type 2 diabetes. Data search and extraction were completed with a standardized data form and any discrepancies were resolved by consensus. A meta-analysis was conducted by using RevMan 5.3 software.

RESULTS: Six randomized controlled trials (RCTs) including 2033 patients were analyzed. Compared with placebo, dapagliflozin monotherapy was associated with a reduction in glycosylated hemoglobin A1c () (weighted mean difference [WMD]: -0.60%; 95% confidence interval [CI]: -0.67%, -0.52%; P < .00001), fasting plasam glucose (FPG) (WMD: -1.30 mmol/L; 95% CI: -1.52, -1.08; P < .00001), and body weight (WMD: -1.50 kg; 95% CI: -1.67, -1.32; P < .00001). Dapagliflozin was associated with an increased risk of urinary tract infections (relative risk [RR]: 1.74; 95% CI: 1.21, 2.49; P = .003) and genital tract infections (RR: 3.52; 95% CI: 2.06, 6.03; P < .00001).

CONCLUSIONS: Dapagliflozin monotherapy was well tolerated and effective in reducing the level of HbA1c, FPG, and body weight in patients with T2DM without increasing hypoglycaemia, although it may increase the risk of urinary tract infections and genital tract infections. This meta-analysis provides an evidence for the treatment in patients with T2DM. However, more randomized clinical evidences are still needed to verify the results.

Key numbers

-0.60%

Decrease in

Comparison of dapagliflozin monotherapy vs. placebo

-1.30 mmol/L

Decrease in Fasting Plasma Glucose

Comparison of dapagliflozin monotherapy vs. placebo

-1.50 kg

Decrease in Body Weight

Comparison of dapagliflozin monotherapy vs. placebo

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Efficacy and safety of dapagliflozin as monotherapy in patients with type 2 diabetes mellitus

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