Effectiveness and tolerability of second-line therapy with vildagliptin vs. other oral agents in type 2 diabetes: A real-life worldwide observational study (EDGE)
| Autor: | Wolfgang Kothny, Emmanouil Pagkalos, R Göke, Nicolaas C. Schaper, J J de Castro, Helmut Brath, E Márquez Rodriguez, Ignacio Conget, Chantal Mathieu, P. M. Nilsson, S K Wangnoo, A Penfornis, Giovanni Bader, Anthony H. Barnett |
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| Přispěvatelé: | MUMC+: MA Endocrinologie (9), Interne Geneeskunde, RS: CARIM School for Cardiovascular Diseases |
| Jazyk: | angličtina |
| Rok vydání: | 2013 |
| Předmět: |
Male
medicine.medical_specialty Pyrrolidines METFORMIN Administration Oral Adamantane Type 2 diabetes Medicine General & Internal Pharmacotherapy Endocrinology General & Internal Medicine Internal medicine Nitriles medicine Humans Hypoglycemic Agents Vildagliptin Pharmacology & Pharmacy Prospective Studies COMBINATION Prospective cohort study Glycated Hemoglobin COMPLICATIONS Science & Technology BLOOD-GLUCOSE CONTROL business.industry ADVERSE DRUG-REACTIONS General Medicine Odds ratio Middle Aged EFFICACY medicine.disease Hypoglycemia Surgery PROPENSITY SCORE Regimen Tolerability Diabetes Mellitus Type 2 SAFETY Cohort PIOGLITAZONE Drug Therapy Combination Female business Life Sciences & Biomedicine CLINICAL-TRIALS medicine.drug |
| Zdroj: | International Journal of Clinical Practice, 67(10), 947-956. Wiley International Journal of Clinical Practice |
| ISSN: | 1368-5031 |
| DOI: | 10.1111/ijcp.12252 |
| Popis: | Aim Real-life studies are needed to confirm the clinical relevance of findings from randomised controlled trials (RCTs). This study aimed to assess the effectiveness and tolerability of vildagliptin add-on vs. other oral antihyperglycaemic drugs (OADs) added to OAD monotherapy in a real-life setting, and to explore the advantages and limitations of large-scale ‘pragmatic’ trials. Methods EDGE was a prospective, 1-year, worldwide, real-life observational study in which 2957 physicians reported on the effects of second-line OADs in 45,868 patients with T2DM not reaching glycaemic targets with monotherapy. Physicians could add any OAD, and patients entered either vildagliptin or (pooled) comparator cohort. The primary effectiveness and tolerability end-point (PEP) evaluated proportions of patients decreasing HbA1c > 0.3%, without hypoglycaemia, weight gain, peripheral oedema or gastrointestinal side effects. The most clinically relevant secondary end-point (SEP 3) was attainment of end-point HbA1c |
| Databáze: | OpenAIRE |
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