Poster Presentation Australian Diabetes Society and the Australian Diabetes Educators Association Annual Scientific Meeting 2014

Real World Clinical Use of Vildagliptin with or without Metformin in a Large Multiethnic Population with Type 2 Diabetes Mellitus: GUARD Study (#314)

Reynaldo Rosales 1 , Elizabeth Abou Jaoude 2 , Monira Al-Arouj 3 , Asher Fawwad 4 , Abbas Orabi 5 , Parag Shah 6 , Shelley DiTommaso 7 , Julius A Vaz 8 , Zafar A Latif 9
  1. St. Luke’s Medical Center, Quezon City, Philippines
  2. Middle East Institute of Health, Bsalim, Lebanon
  3. Dasman Diabetes Institute, Dasman, Kuwait
  4. Baqai Institute of Diabetology & Endocrinology, Baqai Medical University, Karachi, Pakistan
  5. Zagazig University, Zagazig-Sharkia, Egypt
  6. Gujarat Endocrine Centre, Ahmedabad, India
  7. Novartis Pharma AG, Basel, Switzerland
  8. Novartis Healthcare Pvt. Ltd., Hyderabad, India
  9. Ibrahim Memorial Diabetes Centre, BIRDEM Hospital, Dhaka, Bangladesh

GUARD was a multinational, prospective, non-interventional study evaluating the clinical effectiveness, safety and tolerability of vildagliptin or vildagliptin + metformin as part of routine care for 24 weeks in adult patients with type 2 diabetes mellitus (T2DM) (drug-naive or treated with an oral antidiabetic [OAD] agent). Patients were enrolled from countries in Asia, the Middle East, Central America and Africa. Primary endpoint: change in HbA1c from baseline until Week 24; secondary assessments: proportion of patients reaching HbA1c ≤7.0%; change in body weight and BMI from baseline; and safety (including hypoglycaemic events).

Of 19,331 patients analysed (mean baseline age 48.8 years, weight 78.1 kg, BMI 28.3 kg/m2, and HbA1c 8.40%), 3,511 received vildagliptin (the majority monotherapy, a small proportion [n=73] received other OADs) and 15,820 received vildagliptin + metformin. At study end, mean HbA1c was reduced significantly from baseline by –1.27% overall (vildagliptin: –1.17%; vildagliptin + metformin: –1.29%, p<0.0001). Overall, 43.6% of patients reached the HbA1c ≤7.0% (vildagliptin: 47.2%; vildagliptin + metformin: 42.8%). Weight and BMI changes from baseline were –1.1 kg and –0.4 kg/m2 with vildagliptin and –1.5 kg and –0.5 kg/m2 with vildagliptin + metformin, respectively (p<0.0001 for weight and BMI). Treatment with vildagliptin was generally well tolerated. Adverse events (AEs) were reported in 699 (3.6%) patients overall (vildagliptin: 143 [4.1%]; vildagliptin + metformin: 556 [3.5%]). Most frequently reported AEs were hypoglycaemia, nausea and diarrhoea, occurring similarly in both vildagliptin treatment groups. Serious AEs occurred in 22 patients (0.1%) overall, of which 4 were suspected as being related to the medication of interest. No cases of pancreatitis or pancreatic cancer were reported.

In this real world study, vildagliptin +/- metformin provided statistically significant and clinically relevant glycaemic control with weight control and was well tolerated in a large multiethnic patient population with T2DM.

Funded by Novartis Pharma AG (including medical writing assistance)