WEIGHT SATISFACTION AND AMOUNT OF WEIGHT CHANGE- EVIDENCE FROM A PHASE 3 TRIAL OF CANAGLIFLOZIN (CANA) VS. PLACEBO (PBO)
Author(s)
Traina SB1, Slee A2, Neslusan C1
1Janssen Global Services, LLC, Raritan, NJ, USA, 2Axio, Seattle, WA, USA
Presentation Documents
OBJECTIVES: Weight satisfaction (WS) has been shown to be associated with positive health behaviors important for optimal management of type 2 diabetes mellitus (T2DM). In a previously reported study of CANA vs. PBO in triple therapy with metformin and sulfonylurea in addition to background diet and exercise, CANA was associated with significant reduction in body weight vs. PBO at 26 weeks, with an absolute mean weight loss of up to -2.52 kg (SE = 0.29). The objective of this analysis was to explore the direction and strength of the relationship between weight change and change in WS using data from this trial. METHODS: The Current Health Satisfaction Questionnaire was administered at baseline and over time to capture agreement with a statement about WS. Subjects were re-classified into 2 categories at baseline, satisfied or dissatisfied/neutral, based upon responses to a 7-point Likert-style scale. Differences in least square (LS) mean change in weight by changes in WS after 26 weeks were compared regardless of treatment using ANCOVA models and adjusted for selected baseline covariates (i.e., weight, age, and gender). Logistic regression, adjusted for the same covariates, was used to generate odds ratios (OR) for changes in WS associated with weight change. RESULTS: Of the subjects in the study (n = 386), 75.6% were dissatisfied/neutral with their body weight at baseline. Subjects with improved WS lost more weight on average than those with no WS improvement (difference in LS means = -1.52 kg [95% CI: -2.68, -0.36]). Weight loss of 3kg was associated with a 54% greater chance of an improvement in WS from dissatisfied/neutral to satisfied (OR = 1.54; 95% CI: 1.15, 2.05). CONCLUSIONS: These results suggest that an amount of weight loss in the range achieved by subjects taking CANA is noticeable and important to people living with T2DM.
Conference/Value in Health Info
2014-05, ISPOR 2014, Palais des Congres de Montreal
Value in Health, Vol. 17, No. 3 (May 2014)
Code
PDB100
Topic
Patient-Centered Research
Topic Subcategory
Stated Preference & Patient Satisfaction
Disease
Diabetes/Endocrine/Metabolic Disorders