PDB17 Using a Novel, Graphical Method to Analyze Complex Treatment Patterns For Patients With Acromegaly

Abstract

of 0.34 mg/kg/week; and showed a median height of 110.0cms (-2.5 SDS (Tanner)) at baseline. Likewise, girls reached a median height of 117.1cms ) at the end of the first year and 122.5cms ) at the end of the second year; which represents an improvement of over 20% growth compared to girls with TS without GH therapy. CONCLUSIONS: Due to an earlier initiation of treatment in Colombian girls compared to global reported data (at 9.7 years), GH achieved at the end of first year height increments of 8.6cm for the Colombian cohort vsersus 7.2cm in global cohort. OBJECTIVES:The ADA/EASD Consensus Panel recommends an individualized treatment approach for patients with type 2 diabetes (T2DM) based on efficacy, safety, tolerability, and ease of use. A challenge in the management of T2DM is to maximize glycemic control while minimizing side effects, such as weight gain and hypoglycemia. A clinically relevant composite endpoint of HbA1cϽ7%, no weight gain, and no hypoglycemia may be useful for evaluation of diabetes treatments. The objective is to estimate the Number Needed to Treat (NNT), using this composite endpoint, across all seven RCTs in T2DM patients in the liraglutide clinical trial program. METHODS: The findings of a recently conducted meta-analysis (Zinman et al. 2012) from seven trials (Nϭ4625) at week 26 in the liraglutide clinical trial program were used to calculate the NNT to achieve the composite endpoint of HbA1cϽ7%, no weight gain and no hypoglycemia for liraglutide vs. comparator therapies and placebo. Logistic regression on the intent-to-treat population using the last observation carried forward was used. The NNT was calculated as 1/Absolute Risk Reduction (ARR), with ARR being the difference in the percentage of patients achieving the composite endpoint with liraglutide vs. the comparator therapy or placebo. RESULTS: The calculated NNT values for liraglutide 1.2 mg ranged from 3.8 (vs. rosiglitazone) to 4.8 (vs. sitagliptin) and from 2.9 (vs. rosiglitazone) to 6.7 (vs. exenatide) for liraglutide 1.8 mg. The NNT across all comparators for liraglutide 1.2 mg was 3.8 vs. rosiglitazone, 4.2 vs. glimepiride, 4.2 vs. placebo and 4.8 vs. sitagliptin. For liraglutide 1.8 mg the NNT was 2.9 vs. rosiglitazone, 3.1 vs. glimepiride, 3.1 vs. placebo, 3.4 vs. sitagliptin, 4.0 vs. insulin glargine and 6.7 vs. exenatide. CONCLUSIONS: Across the seven phase 3 trials in the liraglutide clinical trial program, the calculated NNT suggests that liraglutide provides clinically meaningful benefits in T2DM.