Use of oral antidiabetic drugs in Japanese working-age patients with type 2 diabetes mellitus: dosing pattern for metformin initiators

Kameda, T; Kumamaru, Hiraku; Nishimura, Shiori; Kohsaka, Shun; Matsubara, Hiroaki

doi:10.1080/03007995.2020.1729710

Cited by 16 publications

(19 citation statements)

References 36 publications

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“…Third, the study duration was limited to only 24 weeks. Fourth, the dose of metformin was low; however, based on an administrative claims database linked to health check-up data in Japan, 72.9% of patients in whom metformin is initiated are prescribed 500 mg or less daily; only 2.0% are prescribed a daily dose [ 1000 mg [42]. Reportedly, the treatment of 1000 mg metformin cannot reduce visceral fat [43].…”

Section: Discussionmentioning

confidence: 99%

Comparison of Visceral Fat Reduction by Ipragliflozin and Metformin in Elderly Type 2 Diabetes Patients: Sub-Analysis of a Randomized-Controlled Study

et al. 2020

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Introduction: To compare the effects of ipragliflozin, a sodium-glucose transporter 2 inhibitor, with those of metformin on visceral fat (as well as muscles and bones) in Japanese elderly patients with type 2 diabetes (T2D), we conducted a sub-analysis of a prospective, multicenter, blinded-endpoint randomizedcontrolled study. Methods: In total, 103 patients with T2D (body mass index C 22 kg/m 2 ; glycated hemoglobin, 7-10%) and being treated with sitagliptin (a dipeptidyl peptidase-4 inhibitor) were included and randomized to receive ipragliflozin or metformin. The primary outcome was the change in visceral fat area measured using computed tomography 24 weeks following treatment. The secondary outcomes included changes in subcutaneous and total fat area, muscle volume, bone density measured using computed tomography, handgrip strength, bone markers, plasma glucose, insulin, homeostasis model assessment (HOMA)2-beta, HOMA2-R, glycated hemoglobin, lipid panel, Electronic supplementary material The online version of this article (

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Section: Discussionmentioning

confidence: 99%

Comparison of Visceral Fat Reduction by Ipragliflozin and Metformin in Elderly Type 2 Diabetes Patients: Sub-Analysis of a Randomized-Controlled Study

et al. 2020

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“…SGLT2 inhibitors also have beneficial effects on cardiometabolic outcomes, such as reductions in blood pressure, body weight and cardiovascular disease 2–4 . In contrast to many other countries, Japan has used SGLT2 inhibitors as a first‐line therapeutic option for type 2 diabetes mellitus (T2DM) since the initial launch of ipragliflozin in 2014 5,6 …”

Section: Introductionmentioning

confidence: 99%

“…[2][3][4] In contrast to many other countries, Japan has used SGLT2 inhibitors as a first-line therapeutic option for type 2 diabetes mellitus (T2DM) since the initial launch of ipragliflozin in 2014. 5,6 Because SGLT2 inhibitors promote glucosuria in patients with diabetes, there are concerns that these drugs may increase the risk of urinary tract infections (UTIs) by providing favourable conditions for bacterial growth. 7 In 2015, the US Food and Drug Administration issued a warning that SGLT2 inhibitor use is associated with severe UTIs, and revised the drug labels to specify these infections as a possible adverse event.…”

Section: Introductionmentioning

confidence: 99%

“…17,19 Target trial emulation methods have been previously employed in pharmacoepidemiological studies. 15,19 In addition to SGLT2 inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors are commonly prescribed as initial therapy for T2DM in Japan, 6 and biguanides are a recommended first-line antidiabetic treatment under American Diabetes Association guidelines. 20 In the present study, we performed a comparative assessment of the risk of UTI among initiators of SGLT2 inhibitors and DPP-4 inhibitors relative to initiators of biguanides in Japan using a nationwide administrative claims database.…”

Section: Introductionmentioning

confidence: 99%

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Sodium‐glucose cotransporter‐2 inhibitors and the risk of urinary tract infection among diabetic patients in Japan: Target trial emulation using a nationwide administrative claims database

Takeuchi

Kumamaru

Hagiwara

et al. 2021

Diabetes Obesity Metabolism

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Aim To assess the risk of urinary tract infection (UTI) occurrence associated with sodium‐glucose cotransporter‐2 (SGLT2) inhibitor use relative to biguanide use in diabetes in a population‐based cohort study using a target trial emulation framework. Methods Using a Japanese nationwide administrative claims database, we constructed a cohort of patients aged ≥40 years who were dispensed SGLT2 inhibitors, dipeptidyl peptidase‐4 (DPP‐4) inhibitors or biguanides between April 2014 and March 2015. For computational ease, we randomly sampled 100% of SGLT2 inhibitor users, 3% of DPP‐4 inhibitor users, and 20% of biguanide users; new antidiabetic drug initiators were analysed. We estimated the intention‐to‐treat (ITT) hazard ratios (HRs) of UTI with inverse probability of treatment (IPT)‐weighted Coxʼs proportional hazards models that ignored subsequent treatment changes. Treatment weights were computed using patient sex, age, medications, medical history and hospitalization history. We also estimated per‐protocol (PP) HRs using IPT‐ and inverse probability of censoring‐weighted Coxʼs models that adjusted for nonrandom treatment changes. Results We analysed 11 364 SGLT2 inhibitor initiators, 9035 DPP‐4 inhibitor initiators, and 10 359 biguanide initiators. When compared with biguanide initiators, SGLT2 inhibitor initiators had a crude HR of 1.14 (95% confidence interval [CI] 1.05‐1.24), an ITT HR of 0.94 (95% CI 0.86‐1.03), and a PP HR of 0.90 (95% CI 0.78‐1.03); and DPP‐4 inhibitor initiators had a crude HR of 1.13 (95% CI 1.04‐1.23), an ITT HR of 0.85 (95% CI 0.77‐0.94), and a PP HR of 0.83 (95% CI 0.71‐0.95). Conclusion Use of SGLT2 inhibitors or DPP‐4 inhibitors did not increase the risk of UTI compared with biguanide use. Accounting for treatment changes did not substantially influence the estimated effects.

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“…In 2010, the recommended dosage levels of metformin were revised in Japan, with the normal maintenance dose increased to 750–1500 mg/day and the maximum prescription dose increased to 2250 mg/day. However, the average daily prescription dose has continued to at < 1000 mg/day in many patients in clinical settings [ 5 , 6 ].…”

Section: Introductionmentioning

confidence: 99%

A Claims Database Analysis of Dose-Dependency of Metformin and Incidence of Lactic Acidosis in Japanese Patients with Type 2 Diabetes

Nagai

Kazumori

Takeshima³

et al. 2021

Diabetes Ther

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Introduction: Patients with type 2 diabetes (T2D) in Japan are prescribed a lower dose of metformin that their counterparts in Western countries due to concerns for the risk of lactic acidosis incidence. Here we report our study on the association between high-dose metformin administration and the incidence of lactic acidosis in Japanese patients with T2D. Methods: A Japanese claims database (April 2008-November 2018) was analyzed. Factors associated with the incidence of lactic acidosis were first identified from the database records by conducting a case-control study, and these were then used as confounding factors in subsequent analyses. The association between high-dose metformin administration (C 1000 mg/day) and the incidence of lactic acidosis was compared with that between lowdose metformin (\ 1000 mg/day) or no metformin administration and lactic acidosis incidence by using the following approaches: a logistic regression analysis hypothesizing that metformin-associated lactic acidosis is short term; a time-dependent proportional hazard model hypothesizing that the influence of metformin is cumulative; and a case-control study in which lactic acidosis incidence was the case and metformin administration within 3 months prior to the incidence of lactic acidosis (or corresponding date for the control) was the exposure. Results: Prescriptions for biguanide and vitamin B complex and volume depletion were identified as factors associated with the incidence of lactic acidosis. The incidence rate was higher in patients prescribed metformin than in those not receiving metformin; however, it was not higher in those prescribed high-dose metformin compared to those prescribed low-dose metformin. The estimated regression coefficient for high-dose metformin administration was 0.816 (p \ 0.001); this was not higher than those for low-dose metformin (1.047), vitamin B complex (2.725) and volume depletion (3.301). The time-dependent proportional hazard analysis did not indicate any effect of metformin prescription.

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Use of oral antidiabetic drugs in Japanese working-age patients with type 2 diabetes mellitus: dosing pattern for metformin initiators

Cited by 16 publications

References 36 publications

Comparison of Visceral Fat Reduction by Ipragliflozin and Metformin in Elderly Type 2 Diabetes Patients: Sub-Analysis of a Randomized-Controlled Study

Comparison of Visceral Fat Reduction by Ipragliflozin and Metformin in Elderly Type 2 Diabetes Patients: Sub-Analysis of a Randomized-Controlled Study

Sodium‐glucose cotransporter‐2 inhibitors and the risk of urinary tract infection among diabetic patients in Japan: Target trial emulation using a nationwide administrative claims database

A Claims Database Analysis of Dose-Dependency of Metformin and Incidence of Lactic Acidosis in Japanese Patients with Type 2 Diabetes

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