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Effectiveness and tolerability of second-line treatment with vildagliptin versus other oral drugs for type 2 diabetes in a real-world setting in the Middle East: results from the EDGE study

Type 2 diabetes mellitus (T2DM) is a chronic progressive disease that requires treatment intensification with antihyperglycemic agents due to progressive deterioration of β-cell function. A large observational study of 45,868 patients with T2DM across 27 countries (EDGE) assessed the effectiveness a...

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Published in:Vascular health and risk management 2015-01, Vol.11 (default), p.149-155
Main Authors: Saab, Charles, Al-Saber, Feryal A, Haddad, Jihad, Jallo, Mahir Khalil, Steitieh, Habib, Bader, Giovanni, Ibrahim, Mohamed
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container_title Vascular health and risk management
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Al-Saber, Feryal A
Haddad, Jihad
Jallo, Mahir Khalil
Steitieh, Habib
Bader, Giovanni
Ibrahim, Mohamed
description Type 2 diabetes mellitus (T2DM) is a chronic progressive disease that requires treatment intensification with antihyperglycemic agents due to progressive deterioration of β-cell function. A large observational study of 45,868 patients with T2DM across 27 countries (EDGE) assessed the effectiveness and safety of vildagliptin as add-on to other oral antidiabetic drugs (OADs) versus other comparator OAD combinations. Here, we present results from the Middle East countries (Bahrain, Jordan, Kuwait, Lebanon, Oman, Palestine, and the United Arab Emirates). Patients inadequately controlled with OAD monotherapy were eligible after the add-on treatment was chosen by the physician based on clinical judgment and patient need. Patients were assigned to either vildagliptin or comparator OADs (sulfonylureas, thiazolidinediones, glinides, α-glucosidase inhibitors, or metformin, except incretin-based therapies) based on the add-on therapy. The primary endpoint was the proportion of patients achieving a glycated hemoglobin (HbA1c) reduction of >0.3% without peripheral edema, hypoglycemia, discontinuation due to a gastrointestinal event, or weight gain≥5%. One of the secondary endpoints was the proportion of patients achieving HbA1c
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A large observational study of 45,868 patients with T2DM across 27 countries (EDGE) assessed the effectiveness and safety of vildagliptin as add-on to other oral antidiabetic drugs (OADs) versus other comparator OAD combinations. Here, we present results from the Middle East countries (Bahrain, Jordan, Kuwait, Lebanon, Oman, Palestine, and the United Arab Emirates). Patients inadequately controlled with OAD monotherapy were eligible after the add-on treatment was chosen by the physician based on clinical judgment and patient need. Patients were assigned to either vildagliptin or comparator OADs (sulfonylureas, thiazolidinediones, glinides, α-glucosidase inhibitors, or metformin, except incretin-based therapies) based on the add-on therapy. The primary endpoint was the proportion of patients achieving a glycated hemoglobin (HbA1c) reduction of &gt;0.3% without peripheral edema, hypoglycemia, discontinuation due to a gastrointestinal event, or weight gain≥5%. One of the secondary endpoints was the proportion of patients achieving HbA1c&lt;7% without hypoglycemia or weight gain. Change in HbA1c from baseline to study endpoint and safety were also assessed. Of the 4,780 patients enrolled in the Middle East, 2,513 received vildagliptin and 2,267 received other OADs. Overall, the mean (±standard deviation) age at baseline was 52.1±10.2 years, mean HbA1c was 8.5%±1.3%, and mean T2DM duration was 4.2±4.0 years. The proportion of patients achieving the primary (76.1% versus 61.6%, P&lt;0.0001) and secondary (54.8% versus 29.9%, P&lt;0.0001) endpoints was higher with vildagliptin than with the comparator OADs. The unadjusted odds ratios for the primary and secondary endpoints were 1.98 (95% confidence interval 1.75-2.25) and 2.8 (95% confidence interval 2.5-3.2), respectively, in favor of vildagliptin. Vildagliptin achieved a numerically greater reduction in HbA1c (1.7%) from baseline versus comparator OADs (1.4%). 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A large observational study of 45,868 patients with T2DM across 27 countries (EDGE) assessed the effectiveness and safety of vildagliptin as add-on to other oral antidiabetic drugs (OADs) versus other comparator OAD combinations. Here, we present results from the Middle East countries (Bahrain, Jordan, Kuwait, Lebanon, Oman, Palestine, and the United Arab Emirates). Patients inadequately controlled with OAD monotherapy were eligible after the add-on treatment was chosen by the physician based on clinical judgment and patient need. Patients were assigned to either vildagliptin or comparator OADs (sulfonylureas, thiazolidinediones, glinides, α-glucosidase inhibitors, or metformin, except incretin-based therapies) based on the add-on therapy. The primary endpoint was the proportion of patients achieving a glycated hemoglobin (HbA1c) reduction of &gt;0.3% without peripheral edema, hypoglycemia, discontinuation due to a gastrointestinal event, or weight gain≥5%. One of the secondary endpoints was the proportion of patients achieving HbA1c&lt;7% without hypoglycemia or weight gain. Change in HbA1c from baseline to study endpoint and safety were also assessed. Of the 4,780 patients enrolled in the Middle East, 2,513 received vildagliptin and 2,267 received other OADs. Overall, the mean (±standard deviation) age at baseline was 52.1±10.2 years, mean HbA1c was 8.5%±1.3%, and mean T2DM duration was 4.2±4.0 years. The proportion of patients achieving the primary (76.1% versus 61.6%, P&lt;0.0001) and secondary (54.8% versus 29.9%, P&lt;0.0001) endpoints was higher with vildagliptin than with the comparator OADs. The unadjusted odds ratios for the primary and secondary endpoints were 1.98 (95% confidence interval 1.75-2.25) and 2.8 (95% confidence interval 2.5-3.2), respectively, in favor of vildagliptin. Vildagliptin achieved a numerically greater reduction in HbA1c (1.7%) from baseline versus comparator OADs (1.4%). The overall incidence of adverse events was comparable between studied cohorts. In real life, treatment with vildagliptin was associated with a higher proportion of patients with T2DM achieving better glycemic control without tolerability issues in the Middle East.</abstract><cop>New Zealand</cop><pub>Dove Medical Press Limited</pub><pmid>25750538</pmid><doi>10.2147/VHRM.S73703</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record>
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recordid cdi_doaj_primary_oai_doaj_org_article_0c30047b44e34b30a0008e0a64254b8d
source Open Access: PubMed Central; Publicly Available Content Database (Proquest) (PQ_SDU_P3); Taylor & Francis Open Access
subjects Adamantane - administration & dosage
Adamantane - adverse effects
Adamantane - analogs & derivatives
Adult
Antidiabetics
Biomarkers - blood
Blood Glucose - drug effects
Blood Glucose - metabolism
Care and treatment
Clinical medicine
Clinical trials
Developing countries
Diabetes
Diabetes Mellitus, Type 2 - blood
Diabetes Mellitus, Type 2 - diagnosis
Diabetes Mellitus, Type 2 - drug therapy
Diabetes Mellitus, Type 2 - epidemiology
dipeptidyl peptidase-4
Dipeptidyl-Peptidase IV Inhibitors - administration & dosage
Dipeptidyl-Peptidase IV Inhibitors - adverse effects
Drug dosages
Drug therapy
Drug Therapy, Combination
Endocrinology
Female
Glycated Hemoglobin A - metabolism
Hospitals
Humans
Hypoglycemia
Hypoglycemic agents
Internal medicine
LDCs
Logistic Models
Male
Middle Aged
Middle East
Middle East - epidemiology
Nitriles - administration & dosage
Nitriles - adverse effects
Odds Ratio
oral antidiabetic drugs
Original Research
Patient outcomes
Patients
Peptides
Prevalence
Pyrrolidines - administration & dosage
Pyrrolidines - adverse effects
Ramadan
real world
Systematic review
Time Factors
Treatment Outcome
Type 2 diabetes
type 2 diabetes mellitus
Vildagliptin
title Effectiveness and tolerability of second-line treatment with vildagliptin versus other oral drugs for type 2 diabetes in a real-world setting in the Middle East: results from the EDGE study
url http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-05T12%3A22%3A00IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_doaj_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Effectiveness%20and%20tolerability%20of%20second-line%20treatment%20with%20vildagliptin%20versus%20other%20oral%20drugs%20for%20type%202%20diabetes%20in%20a%20real-world%20setting%20in%20the%20Middle%20East:%20results%20from%20the%20EDGE%20study&rft.jtitle=Vascular%20health%20and%20risk%20management&rft.au=Saab,%20Charles&rft.date=2015-01-01&rft.volume=11&rft.issue=default&rft.spage=149&rft.epage=155&rft.pages=149-155&rft.issn=1178-2048&rft.eissn=1178-2048&rft_id=info:doi/10.2147/VHRM.S73703&rft_dat=%3Cgale_doaj_%3EA449108758%3C/gale_doaj_%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c614t-8b7b128086eba764b8cd5b811f56d36598033214296c2314ef8f394c1d1957823%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=2229663420&rft_id=info:pmid/25750538&rft_galeid=A449108758&rfr_iscdi=true