Abstract
Introduction
Sitagliptin, an oral dipeptidyl peptidase-4 inhibitor, and exenatide, an injectable glucagon-like peptide-1 receptor agonist, are incretin-based therapies for the treatment of type 2 diabetes. This study examined differences in baseline characteristics between patients with type 2 diabetes initiating sitagliptin vs. exenatide treatment in clinical practice settings in the US.
Methods
The General Electric Healthcare’s Clinical Data Services electronic medical records database, covering 12 million US patients of all ages from 49 states, was used to identify patients with type 2 diabetes, aged ≥30 years, who received their first sitagliptin or exenatide prescription between October 1, 2006 and June 30, 2008 (index period). Patient’s medical records, including demographics, diagnoses, procedures, prescriptions, and laboratory results were extracted for the 12-month period (baseline) prior to the date of the first prescription of sitagliptin or exenatide (ie, the index date). Patient baseline profiles were stratified by mono-, dual, or triple therapy and compared between regimens with sitagliptin or exenatide.
Results
A total of 9543 patients initiated therapy with sitagliptin (n=5589) or exenatide (n=3954) during the index period. For those initiating monotherapy, 876 patients initiated sitagliptin and 476 initiated exenatide. Compared with patients initiating exenatide at baseline, patients on sitagliptin were older (64 vs. 55 years), more likely to be men (45% vs. 35%), and less likely to be obese (60% vs. 87%), and had higher hemoglobin A1c (HbA1c; 7.1% vs. 6.9%), a higher serum creatinine (1.2 mg/dL vs. 1.0 mg/dL), and a higher prevalence of pre-existing cardiovascular complications or microvascular conditions (all P<0.01 for sitagliptin vs. exenatide). For dual therapy, 1885 were prescribed sitagliptin and 1392 were prescribed exenatide. For triple therapy, 2828 were prescribed sitagliptin and 2086 were prescribed exenatide. The observed patient profile differences with dual and triple therapy were generally consistent with those observed with monotherapy.
Conclusion
In a clinical practice setting, there are differences in the baseline characteristics of patients with type 2 diabetes who are prescribed sitagliptin relative to those prescribed exenatide. These findings have important implications for conclusions drawn from observational studies using medical record or claim databases, as estimated clinical and health outcomes measures may be biased due to channeling of patients to different therapies based on different baseline characteristics.
Similar content being viewed by others
References
Chia CW, Egan JM. Incretin-based therapies in type 2 diabetes mellitus. J Clin Endocrinol Metab. 2008;93:3703–3716.
Drucker DJ, Nauck MA. The incretin system: glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors in type 2 diabetes. Lancet. 2006;368:1696–1705.
Herman GA, Bergman A, Stevens C, et al. Effect of single oral doses of sitagliptin, a dipeptidyl peptidase-4 inhibitor, on incretin and plasma glucose levels after an oral glucose tolerance test in patients with type 2 diabetes. J Clin Endocrinol Metab. 2006;91:4612–4619.
Gentilella R, Bianchi C, Rossi A, Rotella CM. Exenatide: a review from pharmacology to clinical practice. Diabetes Obes Metab. 2009;11:544–556.
Williams-Herman D, Round E, Swern AS, et al. Safety and tolerability of sitagliptin in patients with type 2 diabetes: a pooled analysis. BMC Endocr Disord. 2008;8:14.
Karasik A, Aschner P, Katzeff H, Davies MJ, Stein PP. Sitagliptin, a DPP-4 inhibitor for the treatment of patients with type 2 diabetes: a review of recent clinical trials. Curr Med Res Opin. 2008;24:489–496.
Norris SL, Lee N, Thakurta S, Chan BK. Exenatide efficacy and safety: a systematic review. Diabet Med. 2009;26:837–846.
Lage MJ, Fabunmi R, Boye KS, Misurski DA. Comparison of costs among patients with type 2 diabetes treated with exenatide or sitagliptin therapy. Adv Ther. 2009;26:217–229.
Lobo FS, Wagner S, Gross CR, Schommer JC. Addressing the issue of channeling bias in observational studies with propensity scores analysis. Res Social Adm Pharm. 2006;2:143–151.
McAdam-Marx C, Ye X, Sung JC, Brixner DI, Kahler KH. Results of a retrospective, observational pilot study using electronic medical records to assess the prevalence and characteristics of patients with resistant hypertension in an ambulatory care setting. Clin Ther. 2009;31:1116–1123.
American Diabetes Association. Economic costs of diabetes in the U.S. in 2007. Diabetes Care. 2008;31:596–615.
Gandra SR, Lawrence LW, Parasuraman BM, Darin RM, Sherman JJ, Wall JL. Total and component health care costs in a non-Medicare HMO population of patients with and without type 2 diabetes and with and without macrovascular disease. J Manag Care Pharm. 2006;12:546–554.
O’Brien JA, Patrick AR, Caro J. Estimates of direct medical costs for microvascular and macrovascular complications resulting from type 2 diabetes mellitus in the United States in 2000. Clin Ther. 2003;25:1017–1038.
Sullivan PW, Ghushchyan V, Ben-Joseph RH. The effect of obesity and cardiometabolic risk factors on expenditures and productivity in the United States. Obesity (Silver Spring). 2008;16:2155–2162.
Nichols GA, Brown JB. The impact of cardiovascular disease on medical care costs in subjects with and without type 2 diabetes. Diabetes Care. 2002;25:482–486.
Brown JB, Nichols GA, Glauber HS, Bakst AW. Type 2 diabetes: incremental medical care costs during the 8 years following diagnosis. Diabetes Care. 1999;22:1116–1124.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Zhang, Q., Rajagopalan, S., Mavros, P. et al. Differences in baseline characteristics between patients prescribed sitagliptin versus exenatide based on a US electronic medical record database. Adv Therapy 27, 223–232 (2010). https://doi.org/10.1007/s12325-010-0024-7
Received:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s12325-010-0024-7