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Effects of ipragliflozin versus metformin in combination with sitagliptin on bone and muscle in Japanese patients with type 2 diabetes mellitus: Sub-analysis of a prospective, randomized, controlled study (PRIME-V study).
Journal of Diabetes Investigation 2020 July 5
INTRODUCTION: Recent randomized clinical trials have suggested that sodium-glucose co-transporter-2 (SGLT2) inhibitors may reduce cardiovascular events and heart failure and have renal protective effects. Despite these remarkable benefits, the effects of SGLT2 inhibitors on bone and muscle are unclear.
METHODS: A sub-analysis of a randomized controlled study was performed to evaluate the effects of the SGLT2 inhibitor, ipragliflozin, versus metformin on bone and muscle in Japanese patients with type 2 diabetes mellitus (baseline BMI ≥ 22 kg/m2 and HbA1c 7-10 %) who were already receiving sitagliptin. These patients were randomly administered ipragliflozin 50 mg or metformin 1000-1500 mg daily. The effects of these medications on the bone formation marker, bone alkali phosphatase (BAP); the bone resorption marker, tartrate-resistant acid phosphatase 5b (TRACP-5b); handgrip strength; abdominal cross-sectional muscle area; and bone density of the fourth lumbar vertebra were evaluated.
RESULTS: After 24 weeks of treatment, the changes in bone density of the fourth lumbar vertebra, handgrip strength, and abdominal cross-sectional muscle area were not significantly different between the two groups. However, TRACP-5b levels increased in patients treated with ipragliflozin compared to patients treated with metformin (median 11.94 % vs. -10.30 %, P < 0.0001), indicating that ipragliflozin can promote bone resorption.
CONCLUSIONS: There were no adverse effects on bone or muscle when sitagliptin was used in combination with either ipragliflozin or metformin. However, ipragliflozin combination increased the levels of TRACP-5b. A long-term study is needed to further understand the effects of this TRACP-5b increase caused by ipragliflozin.
CLINICAL TRIAL REGISTRATION: https://www.umin.ac.jp/ctr/ (UMIN-ID: UMIN 000015170).
METHODS: A sub-analysis of a randomized controlled study was performed to evaluate the effects of the SGLT2 inhibitor, ipragliflozin, versus metformin on bone and muscle in Japanese patients with type 2 diabetes mellitus (baseline BMI ≥ 22 kg/m2 and HbA1c 7-10 %) who were already receiving sitagliptin. These patients were randomly administered ipragliflozin 50 mg or metformin 1000-1500 mg daily. The effects of these medications on the bone formation marker, bone alkali phosphatase (BAP); the bone resorption marker, tartrate-resistant acid phosphatase 5b (TRACP-5b); handgrip strength; abdominal cross-sectional muscle area; and bone density of the fourth lumbar vertebra were evaluated.
RESULTS: After 24 weeks of treatment, the changes in bone density of the fourth lumbar vertebra, handgrip strength, and abdominal cross-sectional muscle area were not significantly different between the two groups. However, TRACP-5b levels increased in patients treated with ipragliflozin compared to patients treated with metformin (median 11.94 % vs. -10.30 %, P < 0.0001), indicating that ipragliflozin can promote bone resorption.
CONCLUSIONS: There were no adverse effects on bone or muscle when sitagliptin was used in combination with either ipragliflozin or metformin. However, ipragliflozin combination increased the levels of TRACP-5b. A long-term study is needed to further understand the effects of this TRACP-5b increase caused by ipragliflozin.
CLINICAL TRIAL REGISTRATION: https://www.umin.ac.jp/ctr/ (UMIN-ID: UMIN 000015170).
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