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Quality of Life Research

, Volume 25, Issue 5, pp 1237–1244 | Cite as

Health-related quality of life in two randomized controlled trials of phentermine/topiramate for obesity: What mediates improvement?

  • Ronette L. KolotkinEmail author
  • Kishore M. Gadde
  • Craig A. Peterson
  • Ross D. Crosby
Article

Abstract

Purpose

Phentermine/topiramate combination therapy resulted in significant weight loss and improvements in cardiometabolic risk factors in patients with obesity/overweight in two published 56-week randomized, placebo-controlled trials (EQUIP and CONQUER). The purpose of the current study was to examine whether phentermine/topiramate is also associated with greater improvements in health-related quality of life (HRQOL) and whether HRQOL improvements are solely attributable to weight reduction.

Methods

Patients in EQUIP (n = 751) had a body mass index (BMI) ≥ 35 with no obesity-related comorbidity. Patients in CONQUER (n = 1623) had a BMI ≥ 27 and ≤ 45 and at least two obesity-related comorbid conditions. HRQOL was assessed with Impact of Weight on Quality of Life-Lite (IWQOL-Lite) and Medical Outcomes Study Short Form (SF-36) (CONQUER only).

Results

Significant improvements in both obesity-specific and physical HRQOL were observed at 56 weeks in both trials (p < .0001). In EQUIP, BMI reduction fully mediated improvements in IWQOL-Lite total score (p < .0001). In CONQUER, both BMI reduction (all p values <.0001) and change in depressive symptoms (all p values <.025) were significant mediators of improved IWQOL-Lite total score and SF-36 Physical Component Summary score. Gender, psychiatric history, and baseline triglycerides moderated these relationships.

Conclusions

Both trials demonstrated that treatment with phentermine/topiramate improved HRQOL compared with placebo. Although reduction in BMI accounted for the majority of improvements in obesity-specific and physical HRQOL, decrease in depressive symptoms was also a significant mediator. Results highlight the predominance of weight reduction as a key factor in improving HRQOL in obesity.

Keywords

Health-related quality of life Phentermine/topiramate Weight loss Mediation analysis Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Short-Form-36 (SF-36) 

Notes

Acknowledgments

Vivus was the sponsor of the two trials (EQUIP and CONQUER) upon which the current study was based.

Compliance with ethical standards

Conflict of interest

Authors R.L.K. and R.D.C. received consulting fees from Vivus, the sponsor of the trials. K.M.G. was the principal investigator for the trial. C.A.P. is an employee of Vivus. R.L.K. received royalties from Duke University for the use of the IWQOL-Lite.

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Copyright information

© Springer International Publishing Switzerland 2015

Authors and Affiliations

  • Ronette L. Kolotkin
    • 1
    • 2
    • 3
    • 4
    Email author
  • Kishore M. Gadde
    • 5
  • Craig A. Peterson
    • 6
  • Ross D. Crosby
    • 7
    • 8
  1. 1.Department of Community and Family MedicineDuke University School of MedicineDurhamUSA
  2. 2.Quality of Life ConsultingDurhamUSA
  3. 3.Department of Health StudiesSogn og Fjordane University CollegeFørdeNorway
  4. 4.Morbid Obesity CentreVestfold Hospital TrustTønsbergNorway
  5. 5.Pennington Biomedical Research CentreBaton RougeUSA
  6. 6.VIVUS, Inc.Mountain ViewUSA
  7. 7.Neuropsychiatric Research InstituteFargoUSA
  8. 8.Department of Psychiatry and Behavioral ScienceUniversity of North Dakota School of Medicine and Health SciencesFargoUSA

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