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

PubMed ID: 25697921Objective: 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% (p65 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.Novartis Novo Nordisk Boehringer IngelheimThe study was funded by Novartis Pharmaceuticals Turkey.G.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.The 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

Categorization of COPD patients in Turkey via GOLD 2013 strategy document: ALPHABET study

WOS: 000366030500001PubMed ID: 26622176Objective: To determine distribution of COPD assessment categories and physicians' adherence to Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2013 strategy in Turkish COPD patients. Methods: A total of 1,610 COPD patients (mean [standard deviation] age: 62.6 [9.9] years, 85.7% were males) were included in this multicenter, non-interventional, cross-sectional study. Patients were categorized via GOLD 2013 strategy document. Consistency between reported and re-classified GOLD categories, and measures used for symptom evaluation and exacerbation was analyzed. Results: Overall, 41.1% of patients were assigned to GOLD A, while 13.2% were assigned to GOLD C categories. Long-acting beta-2 agonist + long-acting muscarinic antagonist + inhaled corticosteroid regimen was the most common treatment (62.0%). Over-treatment was noted in > 70% of GOLD A, B, and C patients. A high consistency between measures of symptom evaluation (Kappa coefficient = 0.993, P < 0.0001) and a low-moderate consistency between exacerbation risk measures (Kappa coefficient = 0.237, P < 0.0001) were noted. Conclusion: Our findings revealed GOLD A as the most prevalent category in Turkish cohort of COPD patients. Group assignment was altered depending on the chosen measure for symptom and risk assessment. Physician non-adherence to treatment recommendations in GOLD 2013 document leading to over-treatment in patients assigned to GOLD A, B, and C categories was also detected.Novartis Pharmaceuticals TurkeyThe study is funded by Novartis Pharmaceuticals Turkey. We 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

Categorization of COPD patients in Turkey via GOLD 2013 strategy document: ALPHABET study

Objective: To determine distribution of COPD assessment categories and physicians' adherence to Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2013 strategy in Turkish COPD patients. Methods: A total of 1,610 COPD patients (mean {[}standard deviation] age: 62.6 {[}9.9] years, 85.7\% were males) were included in this multicenter, non-interventional, cross-sectional study. Patients were categorized via GOLD 2013 strategy document. Consistency between reported and re-classified GOLD categories, and measures used for symptom evaluation and exacerbation was analyzed. Results: Overall, 41.1\% of patients were assigned to GOLD A, while 13.2\% were assigned to GOLD C categories. Long-acting beta-2 agonist + long-acting muscarinic antagonist + inhaled corticosteroid regimen was the most common treatment (62.0\%). Over-treatment was noted in > 70\% of GOLD A, B, and C patients. A high consistency between measures of symptom evaluation (Kappa coefficient = 0.993, P < 0.0001) and a low-moderate consistency between exacerbation risk measures (Kappa coefficient = 0.237, P < 0.0001) were noted. Conclusion: Our findings revealed GOLD A as the most prevalent category in Turkish cohort of COPD patients. Group assignment was altered depending on the chosen measure for symptom and risk assessment. Physician non-adherence to treatment recommendations in GOLD 2013 document leading to over-treatment in patients assigned to GOLD A, B, and C categories was also detected

Long-Term Omalizumab Treatment: A Multicenter, Real-Life, 5-Year Trial

Background: Omalizumab has demonstrated therapeutic benefits both in controlled clinical trials and real-life studies. However, research concerning the long-term effects and tolerability of omalizumab is needed. The main objective of this study was to evaluate the effectiveness and tolerability of treatment with omalizumab for up to 5 years. Methods: A multicenter, retrospective, chart-based study was carried out to compare documented exacerbations, hospitalizations, systemic steroid requirement, FEV1, and asthma control test (ACT) results during 1 year prior to omalizumab treatment versus at 1, 3, and 5 years of treatment. Adverse events and reasons for discontinuation were also recorded at each time point. Results: Four hundred and sixty-five patients were enrolled in the study. Outcome variables had improved after the 1st year and were sustained after the 3rd and 5th years of treatment with omalizumab. Omalizumab treatment reduced the asthma exacerbation rate by 71.3% (p < 0.001) at 1 year, 64.3% (p < 0.001) at 3 years, and 54.8% (p = 0.002) at 5 years. The hospitalization rate also decreased; by the 5th year of the treatment no patients were hospitalized. ACT results had also improved significantly: 12 (p < 0.001) at 1 year, 12 (p < 0.001) at 3 years, and 12 (p = 0.002) at 5 years. Overall, 12.7% of patients reported adverse events (most of these were mild-to-moderate) and the overall dropout rate was 9.0%. Conclusion: Omalizumab had a significant effect on asthma outcomes and this effect was maintained over 5 years. The drug was found to be generally safe and treatment compliance was good. (C) 2018 S. Karger AG, Base

Long-Term Omalizumab Treatment: A Multicenter, Real-Life, 5-Year Trial

WOS: 000438864700007PubMed ID: 29772578Background: Omalizumab has demonstrated therapeutic benefits both in controlled clinical trials and real-life studies. However, research concerning the long-term effects and tolerability of omalizumab is needed. The main objective of this study was to evaluate the effectiveness and tolerability of treatment with omalizumab for up to 5 years. Methods: A multicenter, retrospective, chart-based study was carried out to compare documented exacerbations, hospitalizations, systemic steroid requirement, FEV1, and asthma control test (ACT) results during 1 year prior to omalizumab treatment versus at 1, 3, and 5 years of treatment. Adverse events and reasons for discontinuation were also recorded at each time point. Results: Four hundred and sixty-five patients were enrolled in the study. Outcome variables had improved after the 1st year and were sustained after the 3rd and 5th years of treatment with omalizumab. Omalizumab treatment reduced the asthma exacerbation rate by 71.3% (p < 0.001) at 1 year, 64.3% (p < 0.001) at 3 years, and 54.8% (p = 0.002) at 5 years. The hospitalization rate also decreased; by the 5th year of the treatment no patients were hospitalized. ACT results had also improved significantly: 12 (p < 0.001) at 1 year, 12 (p < 0.001) at 3 years, and 12 (p = 0.002) at 5 years. Overall, 12.7% of patients reported adverse events (most of these were mild-to-moderate) and the overall dropout rate was 9.0%. Conclusion: Omalizumab had a significant effect on asthma outcomes and this effect was maintained over 5 years. The drug was found to be generally safe and treatment compliance was good. (C) 2018 S. Karger AG, BaselNovartis Pharmaceuticals Ltd.; NovartisNovartisThe study was sponsored by Novartis Pharmaceuticals Ltd. The sponsor was involved in the design of the study and conducted the analysis according to a detailed analysis agreed by the investigators. The interpretation of the results is that of the author of this paper. Arzu Yorgancioglu, Ferda Oner Erkekol, Dilsad Mungan, Munevver Erdinc, Bilun Gemicioglu, Zeynep Ferhan Ozseker, Papatya Bayrak, Sibel Atis Nayci, Aykut Cilli, Cengiz Kirmaz, Dane Ediger, Arzu Didem Yalcin, Suna Buyukozturk, Sami Ozturk, Rana Isik, Fuat Kalyoncu, and Yavuz Havlucu received grant/research support for consultations, speaking at conferences and for support to attend international conferences from Novartis. Fusun Erdenen, Mustafa Gulec, Ozlem Goksel, Omur Aydin do not have conflict of interest. Idilhan Baloglu Ar, Ahmet Erdogdu work for the Medical Department of Novartis Pharmaceuticals, Istanbul, Turkey