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, Göksun
dc.contributor.authorKeskin, Lezzan
dc.contributor.authorAkın, Fulya
dc.contributor.authorDökmetaş, Hatice Sebile
dc.contributor.authorTaşan, Ertuğrul
dc.contributor.authorAr, İdilhan Baloğlu
dc.contributor.authorYiğit, Zerrin
dc.date.accessioned2020-04-30T13:33:13Z
dc.date.available2020-04-30T13:33:13Z
dc.date.issued2015
dc.departmentDÜ, Tıp Fakültesien_US
dc.descriptionPubMed ID: 25697921en_US
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.en_US
dc.description.sponsorshipNovartis Novo Nordisk Boehringer Ingelheimen_US
dc.description.sponsorshipThe study was funded by Novartis Pharmaceuticals Turkey.en_US
dc.description.sponsorshipG.A. has disclosed that he has received sponsorship from Novartis and research grants from Novartis and Novo Nordisk; he is on Astra Zeneca’s Advisory Board and is a consultant to Eli Lilly; he is also on the Speakers’ Bureau of AstraZeneca, BMS and Merck. L.K. has disclosed that she has received sponsorship and research grants from Novartis. F.A. has disclosed that she has received research grants from Novartis, Boehringer Ingelheim and Novo Nordisk. H.S.D. has disclosed that she has received sponsorship from Novartis, and has received research grants from Novartis and Sanofi Aventis; she is also on the Speakers’ Bureau of Astra Zeneca. E.T. has disclosed that he has received research grants from Novartis, and is a consultant to Novartis and Astra Zeneca. I.B.A. and E.U. have disclosed that they are employees of Novartis.en_US
dc.description.sponsorshipThe authors thank Cagla Ayhan MD and Prof. Sule Oktay MD PhD from Kappa Consultancy Training Research Ltd, Istanbul, who provided editorial support, and Mehmet Berktas MD MICR from Kappa Consultancy Training Research Ltd, Istanbul, who performed statistical analysis funded by Novartis Pharmaceuticals Turkey.en_US
dc.identifier.doi10.1185/03007995.2015.1019609en_US
dc.identifier.endpage632en_US
dc.identifier.issn0300-7995
dc.identifier.issue4en_US
dc.identifier.scopusqualityN/Aen_US
dc.identifier.startpage623en_US
dc.identifier.urihttps://dx.doi.org/10.1185/03007995.2015.1019609
dc.identifier.urihttps://hdl.handle.net/20.500.12684/579
dc.identifier.volume31en_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherInforma Healthcareen_US
dc.relation.ispartofCurrent Medical Research and Opinionen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.subjectDPP-4; HbA1c; Real-life; Type 2 diabetes; Vildagliptinen_US
dc.titleReal-life safety and efficacy of vildagliptin as add-on to metformin in patients with type 2 diabetes in Turkey - GALATA studyen_US
dc.typeArticleen_US

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