Clinical Profile, Comorbidities and Therapies in Type 2 Diabetes Patients on Sitagliptin-Based Therapy in Indian Outpatient Setting.

Objectives The study was conducted to generate real-world data on prescription patterns and patient profiles for sitagliptin-based therapies in real-world outpatient settings across India. Method A cross-sectional, observational, multicenter, real-world prescription event monitoring (PEM) study was conducted at 1058 sites across India over six months, from 1 August 2023 to 16 January 2024. Adult type 2 diabetes patients receiving sitagliptin-based mono or combination therapies were included in the study. Primary outcomes assessed included the dosage of sitagliptin and other medications and the specific drugs combined with sitagliptin. Secondary outcomes included demographic profiles, medication history, comorbidities, and glycemic parameters. Results A total of 10210 patients (n=6398 males; n=3812 females) completed the study. Duration of diabetes was available for 5422 patients, of which nearly half of the patients had diabetes for 1-5 years, while around 42.3% (n=2294) of the patients had diabetes for more than five years. Comorbidities were present in 36.02% (n=3678) of the patients. Hypertension and dyslipidemia were the most common comorbidities reported in 25.3% (n=2584) and 10.42% (n=1064), respectively. Sitagliptin was administered as monotherapy or in combination with other medications. Dual combination therapy was most common, with sitagliptin 50 mg+metformin 500 mg being the predominantly prescribed regimen. Triple combination therapy with sitagliptin+dapagliflozin+metformin was also prescribed in a substantial proportion of the patients. Variations in preferred regimens were observed among patients with different comorbid conditions, with sitagliptin 100 mg+dapagliflozin 10 mg being preferred in patients with established cardiovascular disease and heart failure and sitagliptin 50 mg+metformin 500 mg in diabetic patients with hypertension, dyslipidemia, and renal disease. Conclusion The study findings highlighted the preferences for the use of sitagliptin and its dual as well as triple combinations as integral components of diabetes management strategies in clinical practice in Indian outpatient settings. The study also found that diabetes with ASCVD and CV risk factors influence the use of sitagliptin and dapagliflozin in combination.