title: Effects of vildagliptin as add-on treatment in patients with type 2 diabetes mellitus: insights from long-term clinical studies in Japan.
abstract: BACKGROUND
  Vildagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, is wildly used to treat type 2 diabetes mellitus (T2DM) with mono- or combination-therapy. We review two previously published open-label studies to extract insights on the long-term efficacy and safety of vildagliptin.
  
  
  METHODS
  Two studies were conducted in Japan to assess the efficacy and safety of vildagliptin as an add-on to other oral antidiabetes drugs (OADs) for 52 weeks. These studies were performed under the similar protocol in Japanese patients with T2DM who were inadequately controlled with OAD monotherapy [excluding other dipeptidyl peptidase-4 (DPP-4) inhibitors].
  
  
  RESULTS
  Addition of vildagliptin (50 mg twice daily) to other OAD monotherapy [sulfonylurea (SU), metformin, thiazolidinedione, alpha-glucosidase inhibitor and glinide] reduced glycated hemoglobin (HbA1c) levels by -0.64 %,-0.75 %,-0.92 %,-0.94 % and - 0.64 %, respectively, over 52 weeks of treatment. Overall, the incidence of hypoglycemia was low and was slightly higher in the add-on to SU treatment group compared with the other groups. The incidences of adverse events were comparable among the treatment groups, and vildagliptin was well-tolerated as add-on therapy to other OADs.
  
  
  CONCLUSIONS
  The evidence from the two studies indicates that vildagliptin as an add-on therapy to other OADs is a clinically reasonable option for Japanese patients with T2DM who respond inadequately to other OAD monotherapy.
authors.affiliation: The Department of Diabetology, Endocrinology, Metabolism and Rheumatology, Tokyo Medical University, 6-7-1, Nishi-Shinjuku, Shinjuku-ku, Tokyo 160-0023 Japan.
authors.forename: Masato
authors.initials: M
authors.lastname: Odawara
authors.affiliation: Medical Division, Novartis Pharm K.K, Toranomon Hills Mori Tower, 23-1, Toranomon 1-chome, Minato-ku, 105-6333 Tokyo Japan.
authors.forename: Rieko
authors.initials: R
authors.lastname: Sagara
keywords: Combination therapy; Dipeptidyl peptidase-4 inhibitor; Long-term administration; Oral antidiabetes drugs; Vildagliptin