Effectiveness and Tolerability of Vildagliptin and the Single Pill Combination of Vildagliptin and Metformin in "Real-World" Management of Type 2 Diabetes Mellitus: The G-FORCE Study
AuthorVan Gaal, Luc
Hermans, Michel P
De Meester, Lut
AffiliationUniv Arizona, Ctr Hlth Outcomes & Pharmacoecon Res
Univ Arizona, Dept Pharm Practice & Sci
Univ Arizona, Dept Family & Community Med
MetadataShow full item record
CitationVan Gaal, L., Hermans, M. P., Daci, E., Denhaerynck, K., De Meester, L., MacDonald, K., ... & Maris, M. (2019). Effectiveness and Tolerability of Vildagliptin and the Single Pill Combination of Vildagliptin and Metformin in “Real-World” Management of Type 2 Diabetes Mellitus: The G-FORCE Study. Diabetes Therapy, 10(3), 965-979.
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AbstractIntroduction: Randomized clinical trials showed that vildagliptin is well tolerated and leads to clinically meaningful decreases in glycated hemoglobin (HbA1c) and fasting plasma glucose (FPG) both in monotherapy and as add-on therapy in inadequately controlled type 2 diabetes mellitus (T2DM) patients. Nevertheless, there is an increased interest for real-life studies to confirm the clinical trial findings in the setting of a daily clinical practice. The aim of this study was to evaluate the effectiveness and tolerability of vildagliptin in a real-life clinical setting and to explore factors determining drug adherence and T2DM management. Methods: G-FORCE was a prospective, observational, open-label, multi-center study in which T2DM patients were prescribed de novo vildagliptin. Clinical effectiveness was determined by changes in HbA1c and FPG and by the proportion of patients reaching glycemic goal. Data were collected at baseline, after 10515 days and after 18015 days. Results: A total of 1230 patients were included in this analysis. Mean age was 63.9 +/- 10.8years, and mean HbA1c and FPG levels were 8.2 +/- 1.3% and 171.0 +/- 53.3mg/dL, respectively. At 180days of treatment, HbA1c and FPG levels decreased to 7.2 +/- 1.0% and 141.1 +/- 44.0mg/dL, respectively, while the proportion of patients reaching HbA1c and FPG goals rose from 8.6 to 44.6% and from 14.2 to 42.8%, respectively. Conclusion: In this real-world study, vildagliptin was an effective and safe treatment for T2DM patients already treated with metformin, while the single pill combination of vildagliptin and metformin provides a convenient alternative while ensuring comparable effectiveness and tolerability. Funding: Novartis Pharma.
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