Relative risk of acute pancreatitis in initiators of exenatide twice daily compared with other anti-diabetic medication: A follow-up study

Diabetic Medicine

Volumn 29, Issue 11, 2012, Pages 1412-1418

  Wenten, M ^a   Gaebler, J A ^a   Hussein, M ^b   Pelletier, E M ^b   Smith, D B ^b   Girase, P ^b   Noel, R A ^c   Braun, D K ^c   Bloomgren, G L ^a  

^a AMYLIN PHARMACEUTICALS INC   (United States)

^b IQVIA   (United States)

^c ELI LILLY AND COMPANY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; ALPHA GLUCOSIDASE INHIBITOR; EXENDIN 4; INSULIN; MEGLITINIDE; METFORMIN; PRAMLINTIDE; SITAGLIPTIN; SULFONYLUREA DERIVATIVE;

ACUTE PANCREATITIS; ADULT; AGED; ANALYTIC METHOD; ARTICLE; BILLING AND CLAIMS; COHORT ANALYSIS; CONTROLLED STUDY; DATA BASE; DISEASE ASSOCIATION; DISEASE SEVERITY; DRUG EXPOSURE; FEMALE; FOLLOW UP; HEALTH CARE PLANNING; HEALTH INSURANCE; HOSPITALIZATION; HUMAN; ICD-9; INCIDENCE; MAJOR CLINICAL STUDY; MALE; NON INSULIN DEPENDENT DIABETES MELLITUS; PROPENSITY SCORE; RETROSPECTIVE STUDY; RISK FACTOR; SECONDARY ANALYSIS; SURVIVAL TIME; UNITED STATES;

ACUTE DISEASE; ADOLESCENT; ADULT; AGED; CHILD; CHILD, PRESCHOOL; DIABETES MELLITUS, TYPE 2; DRUG ADMINISTRATION SCHEDULE; FEMALE; FOLLOW-UP STUDIES; HUMANS; HYPOGLYCEMIC AGENTS; INFANT; INFANT, NEWBORN; INSURANCE, HEALTH; INTERNATIONAL CLASSIFICATION OF DISEASES; MALE; MIDDLE AGED; PANCREATITIS; PEPTIDES; RETROSPECTIVE STUDIES; RISK; UNITED STATES; VENOMS; YOUNG ADULT;

EID: 84867212961     PISSN: 07423071     EISSN: 14645491     Source Type: Journal    
DOI: 10.1111/j.1464-5491.2012.03652.x     Document Type: Article

References (30)

1. Noel RA, Braun DK, Patterson RE, Bloomgren G. Increased risk of acute pancreatitis and biliary disease observed in patients with type2 diabetes: a retrospective, cohort study. Diabetes Care 2009; 32: 834-838.
2. Girman CJ, Kou TD, Cai B, Alexander CM, O'Neill EA, Williams-Herman DE et al.Patients with type2 diabetes mellitus have higher risk for acute pancreatitis compared with those without diabetes. Diabetes Obes Metab 2010; 12: 766-771.
3. Garg R, Chen W, Pendergrass M. Acute pancreatitis in type2 diabetes treated with exenatide or sitagliptin: a retrospective observational pharmacy claims analysis. Diabetes Care 2010; 33: 2349-2354.
4. Blomgren KB, Sundstrom A, Steineck G, Wiholm BE. Obesity and treatment of diabetes with glyburide may both be risk factors for acute pancreatitis. Diabetes Care 2002; 25: 298-302.
5. Torgerson JS, Lindroos AK, Näslund I, Peltonen M. Gallstones, gallbladder disease, and pancreatitis: cross-sectional and 2-year data from the Swedish Obese Subjects (SOS) and SOS Reference Studies. Am J Gastroenterol 2003; 98: 1032-1041.
6. Suazo-Barahona J, Carmona-Sanchez R, Robles-Diaz G, Milke-Garcia P, Vargas-Vorackova F, Uscanga-Dominguez L et al.Obesity: a risk factor for severe acute biliary and alcoholic pancreatitis. Am J Gastroenterol 1998; 93: 1324-1328.
7. Butler AE, Galasso R, Matveyenko A, Rizza RA, Dry S, Butler PC.Pancreatic duct replication is increased with obesity and type2 diabetes in humans. Diabetologia 2010; 53: 21-26.
8. Butler PC, Dry S, Elashoff R. GLP-1-based therapy for diabetes: what you do not know can hurt you. Diabetes Care 2010; 33: 453-455.
9. Butler PC, Matveyenko AV, Dry S, Bhushan A, Elashoff R. Glucagon-like peptide-1 therapy and the exocrine pancreas: innocent bystander or friendly fire?Diabetologia 2010; 53: 1-6.
10. Matveyenko AV, Dry S, Cox HI, Moshtaghian A, Gurlo T, Galasso R et al.Beneficial endocrine but adverse exocrine effects of sitagliptin in the human islet amyloid polypeptide transgenic rat model of type2 diabetes: interactions with metformin. Diabetes 2009; 58: 1604-1615.
11. Nachnani JS, Bulchandani DG, Nookala A, Herndon B, Molteni A, Pandya P et al.Biochemical and histological effects of exendin-4 (exenatide) on the rat pancreas. Diabetologia 2010; 53: 153-159.
12. Koehler JA, Baggio LL, Lamont BJ, Ali S, Drucker DJ. Glucagon-like peptide-1 receptor activation modulates pancreatitis-associated gene expression but does not modify the susceptibility to experimental pancreatitis in mice. Diabetes 2009; 58: 2148-2161.
13. US Food and Drug Administration. Summary Basis of Approval for BYETTA (NDA21-773): Pharmacology Review. 2005. Available at http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021773_Byetta_pharmr.PDF Last accessed 26 August 2010.
14. Bruce S, MacConell LA, Brown C, Han J, Nicewarner D, Braun DK et al.Safety and tolerability of exenatide BID in patients with type2 diabetes: integrated analysis of 3834 patients from 11 comparator-controlled clinical trials. Diabetes 2009; 58: A155-A156.
15. Klonoff DC, Buse JB, Nielsen LL, Guan X, Bowlus CL, Holcombe JH et al.Exenatide effects on diabetes, obesity, cardiovascular risk factors and hepatic biomarkers in patients with type2 diabetes treated for at least 3years. Curr Med Res Opin 2008; 24: 275-286.
16. Shen L, Han J, Yushmonova I, Bruce S, Porter L. Cardiovascular safety of exenatide BID: an integrated-analysis from long- term controlled clinical trials in subjects with type2 diabetes. Diabetes 2009; 58: A96-A97.
17. Bloomgren G, Dore D, Patterson R, Noel R, Braun D, Seeger J.Incidence rates for acute pancreatitis in patients with type2 diabetes initiating exenatide BID compared to initiating other antidiabetic agents. Diabetes 2009; 58: A41.
18. Kurth T, Walker AM, Glynn RJ, Chan KA, Gaziano JM, Berger K et al.Results of multivariable logistic regression, propensity matching, propensity adjustment, and propensity-based weighting under conditions of non-uniform effect. Am J Epidemiol 2006; 163: 262-270.
19. D'Agostino R. Tutorial on biostatistics: propensity score methods for bias reduction in the comparison of a treatment to a non-randomized control group. Stat Med 1998; 17: 2265-2281.
20. Rosenbaum P, Rubin D. The central role of the propensity score in observational studies for causal effects. Biometrika 1983; 70: 41-55.
21. Ohman EM. Risk stratification and therapeutic decision making in acute coronary syndromes. J Am Med Assoc 2000; 284: 876-878.
22. Peterson ML, Wang Y, van der Laan MJ, Guzman D, Riley E, Bangsberg DR.Pillbox organizers are associated with improved adherence to HIV antiretroviral therapy and viral suppression: a marginal structural model analysis. Clin Infect Dis 2007; 45: 908-915.
23. Curtis LH, Hammill BG, Eisenstein EL, Kramer JM, Anstrom KJ. Using inverse probability-weighted estimators in comparative effectiveness analyses with observational databases. Med Care 2007; 45: S103-S107.
24. Yadav D, Rohtashav D. How accurate are ICD-9 codes for acute (AP) and chronic (CP) pancreatitis?-A large VA hospital experience. Pancreas 2006; 33: 508.
25. Floyd A, Pedersen L, Nielsen GL, Thorlacius-Ussing O, Sorensen HT. Secular trends in incidence and 30-day case fatality of acute pancreatitis in North Jutland County, Denmark: a register-based study from 1981-2000. Scand J Gastroenterol 2002; 37: 1461-1465.
26. Eland IA, Alvarez CH, Stricker BHC, Garcia-Rodriguez LA. The risk of acute pancreatitis associated with acid-supressing drugs. Br J Clin Pharmacol 2000; 49: 473-478.
27. Dore D, Chaudhry S, Hoffman C, Seeger JD. Stratum-specific positive predictive values of claims for acute pancreatitis among commercial health insurance plan enrollees with diabetes mellitus. Pharmacoepidemiol Drug Saf 2011; 20: 209-213.
28. Dore DD, Seeger JD, Arnold Chan K. Use of a claims-based active drug safety surveillance system to assess the risk of acute pancreatitis with exenatide or sitagliptin compared to metformin or glyburide. Curr Med Res Opin 2009; 25: 1019-1027.
29. McKenzie DA, Semradek J, McFarland BH, Mullooly JP, McCamant LE. The validity of Medicaid pharmacy claims for estimating drug use among elderly nursing home residents: the Oregon experience. J Clin Epidemiol 2000; 53: 1248-1257.
30. Frossard JL, Steer ML, Pastor CM. Acute pancreatitis. Lancet 2008; 371: 143-152.