Impact of Canagliflozin Treatment on Health-Related Quality of Life among People with Type 2 Diabetes Mellitus: A Pooled Analysis of Patient-Reported Outcomes from Randomized Controlled Trials

Abstract

Background: Evidence from patient-reported outcomes in clinical trials may explain health-related behaviors observed in the real world.

Objective: The purpose of this analysis was to evaluate the effect of treatment with canagliflozin, a sodium glucose co-transporter 2 inhibitor, compared with placebo or sitagliptin on health-related quality-of-life outcomes in participants with type 2 diabetes mellitus from the clinical development program.

Methods: Patient-reported outcomes data from four randomized controlled trials of canagliflozin (n = 2536) were pooled and analyzed to evaluate participants' interest in continuing study medication; satisfaction with weight; and physical, mental, and emotional health after 26-52 weeks of treatment with canagliflozin vs. placebo or sitagliptin.

Results: Upon trial completion, participants treated with canagliflozin were more likely to express interest in continuing study medication than participants treated with placebo or sitagliptin [odds ratio (95% confidence interval) of 1.54 (1.19-1.99); p = 0.001]. Those treated with canagliflozin were also more likely to be satisfied with their weight and report favorable outcomes (score improvement or maintenance of good scores) related to physical and emotional health.

Conclusions: The results of this pooled analysis suggest that people with type 2 diabetes mellitus treated with canagliflozin generally had positive experiences with treatment and improvements in health-related quality of life. Future research is needed to determine if these improvements result in improved type 2 diabetes mellitus management and treatment adherence. CLINICALTRIALS.

Gov identifiers: NCT01106625, NCT01106677, NCT01137812, NCT02025907.

Conflict of interest statement

Funding

This analysis was supported by Janssen Scientific Affairs, LLC and Janssen Global Services, LLC, using data from studies funded by Janssen Research & Development, LLC. Canagliflozin has been developed by Janssen Research & Development, LLC, in collaboration with Mitsubishi Tanabe Pharma Corporation.

Conflict of interest

Jennifer Cai is a full-time employee of Janssen Scientific Affairs, LLC. Linda M. Delahanty is a consultant for Janssen Global Services, LLC. Sydney Akapame and April Slee are full-time employees of Axio Research, and they received payment from Janssen for statistical support of the analyses reported in this manuscript. Shana Traina is a full-time employee of Janssen Global Services, LLC.

Ethics approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Consent to participate

Informed consent was obtained from all individual participants for the studies on which these analyses are based.

Figures

Fig. 1

Proportion of participants with favorable outcomes of patient-reported outcome measures at week 26.aCHES-Q Current Health Satisfaction Questionnaire, CI confidence interval, IWQoL-Lite Impact of Weight on Quality of Life-Lite, MCS mental component summary score, OR odds ratio, PCS physical component summary score, SF-36 Short Form-36. aFavorable outcomes are defined as maintaining high baseline scores through the follow-up period or improvement at follow-up for participants with lower baseline scores (refer to Table 1 for more details)

Fig. 2

Change from baseline in patient-reported outcomes related to (a) weight and (b) physical and mental/emotional satisfaction. CHES-Q Current Health Satisfaction Questionnaire, CI confidence interval, IWQoL-Lite Impact of Weight on Quality of Life-Lite, LSM least squares mean, MCS mental component summary score, PCS physical component summary score, SF-36 Short Form-36