Effectiveness and safety of Vildagliptin Monotherapy or in combination with other Antihyperglycemic agents in patients with T2DM: A real-world observational study in the Philippines
- Author:
Reynaldo Rosales
1
;
Cyril Joseph Tolosa
2
Author Information
- Publication Type:Clinical Trial
- Keywords: Monotherapy; Combination therapy
- MeSH: Diabetes Mellitus, Type 2; Observational Study
- From: Philippine Journal of Internal Medicine 2019;57(1):59-65
- CountryPhilippines
- Language:English
-
Abstract:
Introduction:There is an ever-increasing prevalence of type 2 diabetes mellitus (T2DM) in the Philippines. This observational study aimed to evaluate the effectiveness and safety of vildagliptin as monotherapy or combination therapy in patients with T2DM in a real-life setting from the Philippines.
Methods:This 24-week, non-interventional study enrolled adult T2DM patients, receiving vildagliptin either as monotherapy or dual/triple combination therapy. The primary endpoint was change in HbA1c from baseline to week 24. The secondary endpoints included proportion of patients achieving the glycemic goals HbA1c ≤6.5% and ≤7.0%, and safety assessment at week 24.
Results:Of the 385 patients enrolled, 267 (69.35%) completed the study. The mean±standard deviation age was 54.72±11.06 years, HbA1c, body mass index, and diabetes duration were 8.54±1.81%, 27.35±5.58 kg/m2 and 3.04±4.88 years, respectively. Overall, treatment with vildagliptin resulted in HbA1c reduction of 2.02±1.68 (p<0.0001) from baseline to week 24. At week 24, 60.64% and 74.47% of the patients achieved the glycemic target of HbA1c ≤6.5% and ≤7.0% respectively. Seven serious adverse events (AEs) unrelated to the study drug were reported, most of which (24/28) were mild or moderate in severity; 85.71% of the AEs reported were not drug related. One hypoglycemic event (with vildagliptin/metformin single pill combination [SPC]) and one death (with vildagliptin/metformin free dose and SPC, due to severe pneumonia) were reported at week 12.
Discussion:This observational study showed that treatment with vildagliptin monotherapy or combination therapy for 24 weeks in patients with T2DM in the Philippines provided statistically significant reductions in HbA1c. Overall, vildagliptin (mono or dual/triple therapy) was well-tolerated and demonstrated a favorable safety profile with no new safety signal.
Conclusion:Treatment with vildagliptin as monotherapy or in combination with other antihyperglycemic agents resulted in good glycemic control and was well-tolerated in patients with T2DM in the Philippines, under real-world settings. - Full text:FINAL_2018-030_Effectiveness.pdf
