WEIGHT- AND HEALTH-RELATED QUALITY OF LIFE (WRQOL AND HRQOL) WITH CANAGLIFLOZIN (CANA) VERSUS SITAGLIPTIN (SITA) IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS (T2DM) ON BACKGROUND METFORMIN

Author(s)

Traina SB*1, Ho KF2 1Janssen Global Services, LLC, Raritan, NJ, USA, 2STAT-TU Inc., Toronto, ON, Canada

OBJECTIVES: CANA is a sodium glucose co-transporter 2 inhibitor developed for the treatment of T2DM.  In a Phase 3 multi-national, randomised, double-blind, placebo- and active-controlled study, CANA improved glycaemia and reduced body weight and systolic blood pressure compared with placebo and SITA in subjects with T2DM on background metformin.  Herein we report post-hoc analyses of the HRQoL and WRQoL data.   METHODS: WRQoL and HRQoL were measured using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) and the 36-item Short Form (SF-36) at baseline, Week 26, and Week 52; with both instruments, higher scores indicate better quality of life.  Data were analysed for CANA 100 (n=368) and 300 mg (n=367), and SITA 100 mg (n=366).  Least-squares mean changes were evaluated using ANCOVA models; gender, anti-hyperglycaemic adjustment, baseline score, and treatment as covariates.   RESULTS: Improvements from baseline to Weeks 26 and 52 were detected for WRQoL total, physical function, and self-esteem scores in the CANA (both doses) and SITA groups (95% CI excludes zero), and for the other WRQoL domains, there was either improvement or no difference.  A comparison of CANA 300 mg versus SITA at Week 26 suggests a difference in physical function (p=0.0374).  Improvements from baseline to Weeks 26 and 52 were also detected for HRQoL general health scores in the CANA (both doses) and SITA groups (95% CI excludes zero), and for other domains, there was either improvement or no difference.  Other HRQoL results suggest possible differences in bodily pain (Week 26, CANA 100 mg vs. SITA, p=0.0518) and the mental component summary score (Week 52, CANA 300 mg vs. SITA, p=0.0908).   CONCLUSIONS: CANA and SITA were associated with improvements in WRQoL and HRQoL over 1 year in dual therapy.  Results suggest that CANA is associated with a greater positive impact on patients versus SITA.

Conference/Value in Health Info

2013-11, ISPOR Europe 2013, The Convention Centre Dublin

Value in Health, Vol. 16, No. 7 (November 2013)

Code

PDB95

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Diabetes/Endocrine/Metabolic Disorders

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