Real-life safety and efficacy of vildagliptin as add-on to metformin in patients with type 2 diabetes in Turkey - GALATA study

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dc.contributor.authorAyvaz G.
dc.contributor.authorKeskin L.
dc.contributor.authorAkin T.F.
dc.contributor.authorDokmetas H.S.
dc.contributor.authorTasan E.
dc.contributor.authorAr I.B.
dc.contributor.authorUren E.
dc.contributor.authorAkber T.
dc.contributor.authorAkdeniz Y.
dc.contributor.authorBambul N.
dc.contributor.authorBayraktaroglu T.
dc.contributor.authorBorlu F.
dc.contributor.authorBoz M.
dc.contributor.authorBozoglu E.
dc.contributor.authorBuyukbese M.A.
dc.contributor.authorCanberk A.
dc.contributor.authorComlekci A.
dc.contributor.authorDelibasi T.
dc.contributor.authorDemir S.
dc.contributor.authorEskioglu E.
dc.contributor.authorGuler S.
dc.contributor.authorGulkan S.
dc.contributor.authorHekimsoy Z.
dc.contributor.authorKaraca Z.
dc.contributor.authorKeskin M.
dc.contributor.authorKoca N.
dc.contributor.authorKorkmaz H.
dc.contributor.authorOnder E.
dc.contributor.authorOzisik L.
dc.contributor.authorPeru C.
dc.contributor.authorSahin M.
dc.contributor.authorSaygili F.
dc.contributor.authorSerin S.
dc.contributor.authorSezer H.
dc.contributor.authorSezgin G.
dc.contributor.authorTasci I.
dc.contributor.authorTasliyurt T.
dc.contributor.authorTorun A.N.
dc.contributor.authorTura Bahadir C.
dc.contributor.authorGursoy Yener G.
dc.contributor.authorYigit Z.
dc.date.accessioned2024-07-22T08:13:44Z
dc.date.available2024-07-22T08:13:44Z
dc.date.issued2015
dc.description.abstractObjective: To evaluate tolerability/safety and the efficacy of the combination of vildagliptin plus metformin in a real-life population of patients with type 2 diabetes mellitus (T2DM). Research design and methods: This multicenter, single-arm, 6 month, observational, prospective cohort study was conducted at 39 centers across Turkey. T2DM patients on vildagliptin and metformin for ≤4 weeks were enrolled regardless of their previous antidiabetic therapy. Main outcome measures: Efficacy was evaluated by measuring hemoglobin A1c (HbA1c) levels. Tolerability/safety parameters evaluated included hypoglycemic events, gastrointestinal events, peripheral edema and weight gain. Results: This study enrolled 665 patients with a mean±standard deviation (SD) age of 55.1±10.2 years and female predominance (n=394, 59.2%). Safety was assessed in all enrolled patients. Hypoglycemia was reported in 10 (1.5%) patients (95% confidence interval = 0.8-2.7%). Efficacy was assessed in 289 (43.5%) patients treated for 6±1 months; these patients showed a mean decrease in HbA1c of 0.8% from baseline value of 7.8% (p<0.001). The percentages of patients who achieved HbA1c targets of ≤6.5% and ≤7.0% were significantly increased, from 10.7% to 33.6% and from 22.1% to 52.6%, respectively (p<0.001 each). The decrease in HbA1c was independent of baseline HbA1c (≤8% vs. 8-10% vs. ≥10%), age (≤65 vs. >65 years) and body mass index (<30 vs. ≥30 kg/m2) (p<0.001 each). In total, 136 adverse events (AEs) were observed in 71 (10.7%) patients; 10 (1.5%) patients experienced hypoglycemia and gastrointestinal AEs were most commonly reported (n=29, 4.4%). Conclusions: In a 'real-life' setting, the vildagliptin and metformin combination was associated with significant improvements in reaching target HbA1c levels, even in elderly and obese patients with T2DM. Moreover, vildagliptin and metformin demonstrated a good overall tolerability/safety profile. © 2015 All rights reserved: reproduction in whole or part not permitted.
dc.identifier.DOI-ID10.1185/03007995.2015.1019609
dc.identifier.issn03007995
dc.identifier.urihttp://akademikarsiv.cbu.edu.tr:4000/handle/123456789/16388
dc.language.isoEnglish
dc.publisherInforma Healthcare
dc.subjectAdamantane
dc.subjectBody Mass Index
dc.subjectCohort Studies
dc.subjectDiabetes Mellitus, Type 2
dc.subjectDipeptidyl-Peptidase IV Inhibitors
dc.subjectDrug Monitoring
dc.subjectDrug Therapy, Combination
dc.subjectFemale
dc.subjectHemoglobin A, Glycosylated
dc.subjectHumans
dc.subjectHypoglycemia
dc.subjectHypoglycemic Agents
dc.subjectMale
dc.subjectMetformin
dc.subjectMiddle Aged
dc.subjectNitriles
dc.subjectProspective Studies
dc.subjectPyrrolidines
dc.subjectTreatment Outcome
dc.subjectTurkey
dc.subjecthemoglobin A1c
dc.subjectliver enzyme
dc.subjectmetformin
dc.subjectvildagliptin
dc.subjectadamantane
dc.subjectantidiabetic agent
dc.subjectdipeptidyl peptidase IV inhibitor
dc.subjectglycosylated hemoglobin
dc.subjectmetformin
dc.subjectnitrile
dc.subjectpyrrolidine derivative
dc.subjectvildagliptin
dc.subjectadd on therapy
dc.subjectadult
dc.subjectArticle
dc.subjectbody mass
dc.subjectconstipation
dc.subjectdiarrhea
dc.subjectdrug efficacy
dc.subjectdrug safety
dc.subjectdrug tolerability
dc.subjecteye disease
dc.subjectfemale
dc.subjectgastrointestinal symptom
dc.subjectheart disease
dc.subjecthuman
dc.subjecthypoglycemia
dc.subjectkidney disease
dc.subjectmajor clinical study
dc.subjectmale
dc.subjectmental disease
dc.subjectmetabolic disorder
dc.subjectmiddle aged
dc.subjectmulticenter study
dc.subjectnausea
dc.subjectnon insulin dependent diabetes mellitus
dc.subjectperipheral edema
dc.subjectskin manifestation
dc.subjectTurkey (republic)
dc.subjectvascular disease
dc.subjectweight reduction
dc.subjectanalogs and derivatives
dc.subjectchemically induced
dc.subjectclinical trial
dc.subjectcohort analysis
dc.subjectDiabetes Mellitus, Type 2
dc.subjectdrug combination
dc.subjectdrug monitoring
dc.subjecthypoglycemia
dc.subjectprospective study
dc.subjecttreatment outcome
dc.subjectTurkey
dc.titleReal-life safety and efficacy of vildagliptin as add-on to metformin in patients with type 2 diabetes in Turkey - GALATA study
dc.typeArticle

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