Increased Risk of Acute Pancreatitis in Patients with Type 2 Diabetes: An Observational Study Using a Japanese Hospital Database

Abstract

BackgroundIncreased risks of acute pancreatitis in patients with type 2 diabetes mellitus have been reported recently in several countries. We aimed to estimate the risks of acute pancreatitis in Japanese patients with diabetes mellitus.Methods/FindingsWe examined a large-scale hospital administrative database consisting of one million patients in 16 secondary medical care hospitals, from 2003 to 2010. The incidence rates of acute pancreatitis were estimated with cohort design; the odds ratios associated with diabetes mellitus and other comorbid risk factors were estimated with separate case-control analyses.In cohort analysis, the incidence of acute pancreatitis was higher in 14,707 diabetic patients than in 186,032 non-diabetic patients (4.75 vs. 1.65 per 1,000 patient-years) and increased in male patients and as age advanced. The adjusted odds ratio of acute pancreatitis in patients with diabetes mellitus was 1.86 (P<0.001) compared with non-diabetic patients in case-control analysis from 1,372 cases and 5,469 matched controls, which is consistent with the ones reported in previous studies. Alcoholism and gallstones were associated with a large increase in the risk of acute pancreatitis (adjusted odds ratio 13.40 and 14.29, respectively, P<0.001), although dyslipidemia was associated with significant risk reduction (adjusted odds ratio 0.62, P<0.001).ConclusionsThis observational study ascertained the elevated incidence rates and risk of acute pancreatitis in Japanese patients with diabetes. The risk estimates in Japanese patients with diabetes were in agreement with the ones reported in previous studies, and the elevated risk of acute pancreatitis in patients with diabetes would be generalized in different locations/populations.

Associations of Polyethylenimine-Coated AN69ST Membrane in Continuous Renal Replacement Therapy with the Intensive Care Outcomes: Observations from a Claims Database from Japan

“…Data are extracted directly from electronic information systems of hospital participating in the data-sharing networks (177 hospitals, consisting of 21 hospitals with <200 beds; 110 hospitals with 200-499 beds; and 46 hospitals with ≥500 beds). Medical Data Vision Co., Ltd is a well-established data source for epidemiological and pharmacoeconomic studies from that country [9,10,11,12,13,14,15,16,17,18,19,20,21]. Medical Data Vision Co., Ltd collects data only from consenting hospitals, and these data are de-identified at source with guaranteed anonymity.…”

Incretin-Based Therapy and Risk of Acute Pancreatitis: A Nationwide Population-Based Case-Control Study

“…In humans, a signal of pancreatitis associated with incretin use was detected by adverse event reports (10)(11)(12). However, spontaneous reports may be partially driven by professional and lay publications, while type 2 diabetes per se may increase the risk of acute pancreatitis 1.5-fold to 2-fold (13)(14)(15)(16)(17)(18). Sitagliptin and exenatide increased the odds ratio (OR) for pancreatitis sixfold compared with that for other antidiabetic therapies, in a study from the U.S. Food and Drug Administration database (6).…”

Pancreatic safety in Japanese patients with type 2 diabetes treated with once weekly dulaglutide 0.75 mg up to 52 weeks in phase 3 clinical trials

“…One of the cases was considered related to treatment with dulaglutide by the investigator; the other was considered to be iatrogenic, due to the procedure of examination for pancreatic tumors. The exposure-adjusted incidence rate of acute pancreatitis in dulaglutide-treated patients with T2D in the 3 Japanese phase 3 studies was 2.651 patients/1,000 patient-years; the reported incidence in an observational study in Japanese patients with T2D was 4.75 patients/1,000 patient-years [13]. Rates of acute pancreatitis reported in observational studies in patients with T2D in other countries include the following: Taiwan: 2.77 patients/1,000 patient-years [28]; Canada, United States, and the United Kingdom: 1.49 patients/1,000 patient-years [29].…”

“…The incidence of acute pancreatitis has been found to be higher in patients with T2D compared to healthy individuals (4.75 vs. 1.65 patients/1,000 patient-years, respectively, in Japan [13]). Because the incidence overall is very low, evaluating the risk for its occurrence in clinical trials with limited exposure is challenging.…”