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Dapagliflozin drives HbA1c, SBP, and weight down in DERIVE

Elvira Manzano
01 Jun 2018
Dr Siew-Pheng Chan

The use of the sodium/glucose cotransporter 2 (SGLT-2) inhibitor dapagliflozin in patients with type 2 diabetes (T2D) and moderate renal impairment provides benefits beyond glucose lowering, with no new safety signals, in the phase III DERIVE* study.

At 6 months, the primary endpoint of mean reduction in HbA1c level was greater by 0.34 percent in patients treated with dapagliflozin vs placebo (p< 0.001). There were also greater reductions in systolic blood pressure (SBP, 3.1 mm Hg; p<0.05) and mean body weight (1.25 percent, p< 0.001) with dapagliflozin. (APSC 2018, abstract S105-01)

“Dapagliflozin induces glycosuria and lowers blood glucose. However, the glycaemic efficacy of dapagliflozin is attenuated in patients with moderate renal impairment, for example in stage 3 CKD, because less glucose is cleared in the kidney in this group,” said Dr Siew-Pheng Chan, consultant endocrinologist at Subang Jaya Medical Centre in Subang Jaya, Malaysia, who is unaffiliated with the study.

Researchers led by Dr Paola Fioretto of the University of Padova in Padua, Italy conducted the DERIVE study to compare the efficacy and safety of dapagliflozin vs placebo in 321 patients with T2D (HbA1c of 7 –11 percent) and moderate renal impairment (stage 3A chronic kidney disease (CKD), estimated glomerular filtration rate (eGFR), 45 to <60 mL/min/1.73m2). Patients were randomized to either dapagliflozin 10 mg (n=160) or placebo (n=161) over 6 months. Randomization was stratified by background glucose-lowering medication. Both groups had similar baseline characteristics.

At 6 months, treatment with dapagliflozin resulted in a significant reduction in mean HbA1c (-0.37 percent vs -0.03 percent for placebo) and mean body weight (-3.17 vs -1.92 kg, respectively) from baseline. The mean fasting plasma glucose was also significantly reduced with dapagliflozin (-21.46 vs -4.87 mg/dL for placebo) as was mean SBP (-4.8 vs -1.7 mm Hg, respectively) from baseline to 6 months.

In terms of safety, mean eGFR was reduced with dapagliflozin (-3.23 mL/min/1.73m2) vs placebo (-0.63 mL/min/1.73m2). Urinary tract infection and genital infection were the most common adverse events of interest reported. Overall, the safety profile of dapagliflozin was consistent with previous reports seen for T2D. No bone fractures or amputations were reported.

Dapagliflozin is currently indicated as an adjunct to diet and exercise to improve glycaemic control in adults with T2D. Dapagliflozin remains contraindicated in patients with an eGFR <30 mL/min/1.73 m².

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Most Read Articles
Prof. Cheuk-Chun Szeto, Dr. Winston W. S. Fung, 25 Jan 2018
A 65-year-old lady with a background of type 2 diabetes, hyperlipidaemia and chronic immune thrombocytopenia presented to us with a 2-week history of generalized malaise and myalgia. Shortly after the onset of myalgia, she was noted to have reduced urine output and the urine was described as dark in colour. Her regular medications included prednisolone, danazol, simvastatin, metformin, and human insulin. Upon further questioning, the patient admitted that her compliance to simvastatin and danazol used to be poor. However, she recently started to take both medications regularly after repeated education.
Pearl Toh, 30 Jan 2018
Use of statins may not be neuroprotective, in contrast to findings from previous observational studies. On the contrary, fungus-derived or lipophilic statins appeared to be associated with a slightly increased risk of Alzheimer's disease (AD) compared with synthetic and hydrophilic statins, suggests a new study based on real-world clinical practice data.
26 Dec 2017
Supplementation with omega-3 fatty acids in combination with rosuvastatin may yield significant reductions in triglycerides and nonhigh-density lipoprotein (HDL) cholesterol as compared with rosuvastatin monotherapy, according to data from the ROMANTIC (rosuvastatin-omacor in residual hypertriglyceridemia) trial.
Hoo Yee Yin, 05 Jun 2018
Enteral nutrition (EN) is also known as tube feeding. It is nutrition provided through the gastrointestinal (GI) tract via a tube, catheter, or stoma that delivers nutrients distal to the oral cavity.