title: Effectiveness and safety of vildagliptin and vildagliptin add-on to metformin in real-world settings in Egypt - results from the GUARD study.
abstract: OBJECTIVE
  The GUARD study evaluated the effectiveness, safety, and tolerability of vildagliptin treatment with or without metformin in patients with type 2 diabetes mellitus (T2DM) in real-life settings. Here we present the results of the GUARD study for the patient subset from Egypt.
  
  
  METHODS
  This was a 24 ± 6 weeks, prospective, non-interventional study that enrolled adult patients with T2DM receiving vildagliptin or vildagliptin + metformin combination therapy as per local prescribing information.
  
  
  METHODS
  The primary effectiveness endpoint was change in HbA1c levels from baseline to week 24 ± 6 endpoint. Safety was assessed by reporting of adverse events and serious adverse events (SAEs).
  
  
  RESULTS
  Of 2786 patients enrolled from Egypt, 655 received vildagliptin and 2131 received vildagliptin + metformin. Overall, at baseline, mean (± standard deviation [SD]) age was 49.5 ± 9.49 years, BMI was 31.5 ± 4.85 kg/m2, HbA1c was 8.4 ± 0.86%, and duration of T2DM was 2.3 ± 3.78 years. At week 24, significant reductions in mean (±SD) HbA1c were observed in the vildagliptin (-1.47 ± 0.79%) and vildagliptin + metformin (-1.62 ± 0.82%) groups (both p < 0.0001) from baseline HbA1c of 8.1% and 8.4%, respectively. At week 24, 67.5% patients in the vildagliptin group and 60.5% in the vildagliptin + metformin group achieved HbA1c ≤7.0%. Treatment with vildagliptin (± metformin) was well tolerated, with a low incidence of hypoglycemia in both groups (vildagliptin, 0.5%; vildagliptin + metformin, 0.6%). No SAEs or deaths were reported in the vildagliptin group; however, 0.2% of patients experienced SAEs and one death (accidental death) was reported in the vildagliptin + metformin group.
  
  
  CONCLUSIONS
  In a real-world setting, vildagliptin, with or without metformin, resulted in significant reductions in HbA1c and was well tolerated in patients with T2DM from Egypt. Limitations of the study include non-randomization and the open-label, observational nature of the study.
authors.affiliation: a Ain Shams Faculty of Medicine , Cairo , Egypt.
authors.forename: Salah
authors.initials: S
authors.lastname: Shelbaya
authors.affiliation: b Novartis Pharma SAE, Amiria , Cairo , Egypt.
authors.forename: Sameh
authors.initials: S
authors.lastname: Rakha
mesh_terms: D000218:Adamantane / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000328:Adult; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D016903:Drug Monitoring; D004359:Drug Therapy, Combination; D004534:Egypt / Q000453:epidemiology; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced / Q000517:prevention & control; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008687:Metformin / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D009570:Nitriles / Q000008:administration & dosage / Q000009:adverse effects; D011446:Prospective Studies; D011759:Pyrrolidines / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D000077597:Vildagliptin
chemical_list: D000218:Adamantane; D054873:Dipeptidyl-Peptidase IV Inhibitors; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D009570:Nitriles; D011759:Pyrrolidines; D000077597:Vildagliptin
keywords: Dipeptidyl peptidase-4 inhibitor; oral antidiabetes drugs; real-world; type 2 diabetes mellitus; vildagliptin