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Use of the Japanese health insurance claims database to assess the risk of acute pancreatitis in patients with diabetes: comparison of DPP-4 inhibitors with other oral antidiabetic drugs.

ABSTRACT: This study was initiated to evaluate the association of acute pancreatitis (AP) with the use of dipeptidyl peptidase-4 (DPP-4) inhibitors among patients with diabetes in Japan. A retrospective cohort study of a large medical and pharmacy claims database was performed to compare the incidence of AP among those receiving DPP-4 inhibitors and those receiving other oral antidiabetic drugs. The incidence of all AP and hospitalizations for AP was similar between the two groups. Previous exposure to DPP-4 inhibitors did not affect occurrence of AP in patients on other oral antidiabetic drugs. The Kaplan-Meier curve for time to AP was similar between the two groups, and was not affected by previous exposure to DPP-4 inhibitors. The Cox proportional hazard models showed the incidence of AP was not significantly higher in those receiving DPP-4 inhibitors. Despite numerous, important limitations related to claims database-based analyses, our results indicate that there is no increased risk of AP with use of DPP-4 inhibitors among patients with diabetes in Japan.

SUBMITTER: Yabe D

PROVIDER: S-EPMC4409841 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

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Use of the Japanese health insurance claims database to assess the risk of acute pancreatitis in patients with diabetes: comparison of DPP-4 inhibitors with other oral antidiabetic drugs.

Yabe D D Kuwata H H Kaneko M M Ito C C Nishikino R R Murorani K K Kurose T T Seino Y Y

Diabetes, obesity & metabolism 20140917 4

This study was initiated to evaluate the association of acute pancreatitis (AP) with the use of dipeptidyl peptidase-4 (DPP-4) inhibitors among patients with diabetes in Japan. A retrospective cohort study of a large medical and pharmacy claims database was performed to compare the incidence of AP among those receiving DPP-4 inhibitors and those receiving other oral antidiabetic drugs. The incidence of all AP and hospitalizations for AP was similar between the two groups. Previous exposure to DP ...[more]

PMID: 25146418

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Project description:IntroductionTwo studies were carried out to investigate the efficacy and safety of luseogliflozin added to existing oral antidiabetic drugs (OADs) in Japanese type 2 diabetic patients inadequately controlled with OAD monotherapy.Materials and methodsIn the trial involving add-on to sulfonylureas (study 03-1), patients were randomly assigned to receive luseogliflozin 2.5 mg or a placebo for a 24-week double-blind period, followed by a 28-week open-label period. In the open-label trial involving add-on to other OADs; that is, biguanides, dipeptidyl peptidase-4 inhibitors, thiazolidinediones, glinides and α-glucosidase inhibitors (study 03-2), patients received luseogliflozin for 52 weeks.ResultsIn study 03-1, luseogliflozin significantly decreased glycated hemoglobin at the end of the 24-week double-blind period compared with the placebo (-0.88%, P < 0.001), and glycated hemoglobin reduction from baseline at week 52 was -0.63%. In study 03-2, luseogliflozin added to other OADs significantly decreased glycated hemoglobin from baseline at week 52 (-0.52 to -0.68%, P < 0.001 for all OADs). Bodyweight reduction was observed in all add-on therapies, even with agents associated with weight gain, such as sulfonylureas and thiazolidinediones. Most adverse events were mild in severity. When added to a sulfonylurea, incidences of hypoglycemia during the double-blind period were 8.7% and 4.2% for luseogliflozin and placebo, respectively, but no major hypoglycemic episodes occurred. The frequency and incidences of adverse events of special interest for sodium glucose cotransporter 2 inhibitors and adverse events associated with combined OADs were acceptable.ConclusionsAdd-on therapies of luseogliflozin to existing OADs improved glycemic control, reduced bodyweight and were well tolerated in Japanese type 2 diabetic patients. These trials were registered with the Japan Pharmaceutical Information Center (add on to sulfonylurea: JapicCTI-111507; add on to other OADs: JapicCTI-111508).

Project description:ObjectiveTo compare risk of reintervention, long-term clinical outcomes, and health care utilization among women who have bulk symptoms from leiomyoma and who underwent the following procedures: hysterectomy, myomectomy, uterine artery embolization, and magnetic resonance-guided, focused ultrasound surgery.MethodsThis was a retrospective analysis of administrative claims from a large U.S. commercial insurance database. Women aged 18-54 years undergoing any of the previously mentioned leiomyoma procedures between 2000 and 2013 were included. We assessed the following outcome measures: risk of reintervention between uterine-sparing procedures, risk of other surgical procedures or complications of the index procedure, 5-year health care utilization, pregnancy rates, and reproductive outcomes. Propensity score matching along with Cox proportional hazard models were used to adjust for differences in baseline characteristics between study cohorts.ResultsAmong the 135,522 study-eligible women with mean follow-up of 3.4 years, hysterectomy was the most common first-line procedural therapy (111,324 [82.2%]) followed by myomectomy (19,965 [14.7%]), uterine artery embolization (4,186 [3.1%]) and magnetic resonance-guided focused ultrasound surgery (47 [0.0003%]). Small but statistically significant differences were noted for uterine artery embolization and myomectomy in reintervention rate (17.1% compared with 15.0%, P=.02), subsequent hysterectomy rates (13.2% compared with 11.1%, P<.01) and subsequent complications from index procedures (18.1% compared with 24.6%, P<.001). During follow-up, women undergoing myomectomy had lower leiomyoma-related health care utilization, but had higher all-cause outpatient services. Pregnancy rates were 7.5% and 2.2% among myomectomy and uterine artery embolization cohorts, respectively (P<.001) with both cohorts having similar rates of adverse reproductive outcome (69.4%).ConclusionsAlthough the overwhelming majority of women having leiomyoma with bulk symptoms underwent hysterectomy as their first treatment procedure, among those undergoing uterine-sparing index procedures, approximately one seventh had a reintervention, and one tenth ended up undergoing hysterectomy during follow-up. Compared with women undergoing myomectomy, women undergoing uterine artery embolization had a higher risk of reintervention, lower risk of subsequent complications, but similar rate of adverse reproductive outcomes.

Dataset Information

Use of the Japanese health insurance claims database to assess the risk of acute pancreatitis in patients with diabetes: comparison of DPP-4 inhibitors with other oral antidiabetic drugs.

Publications

Use of the Japanese health insurance claims database to assess the risk of acute pancreatitis in patients with diabetes: comparison of DPP-4 inhibitors with other oral antidiabetic drugs.

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