In EQUIP, the proportions of patients achieving a meaningful change in weight-related quality of life were 30% with placebo, 37% with the lower phentermine/topiramate dose, and 49% with the higher dose.
In CONQUER, meaningful improvement on IWQOL-Lite occurred in 36% of the placebo patients, compared with 52% of each of the two doses of phentermine/topiramate. Similar results in CONQUER were seen with the SF-36, for which meaningful improvement was defined as an increase of 2.5 or more points. Those percentages were 36% for placebo, 55% for the lower dose, and 53% for the higher dose, she reported.
Not surprisingly, improvement in quality of life was directly related to amount of weight lost. In EQUIP, those losing less than 5% of their body weight had a mean change of 5 points on the IWQOL-Lite at 56 weeks, compared with 17 points for those who lost 10% or more of their body weight. Similar results were seen on the IWQOL-Lite in CONQUER (from 6 vs. 18 points, respectively), and on the SF-36 in CONQUER (2 vs. 6 points).
"Quality of life is an important health outcome in its own right, representing the ultimate goal of all health interventions," Dr. Kolotkin said, quoting Dr. Richard Rubin (Diabetes Metab. Res. Rev. 1999;15:205-18). And, she added, "Improved HRQOL has been shown to improve diabetes self-management, which is likely, in turn, to slow disease progression."
Separately, Miriam M. Rueger, R.N., a certified diabetes educator at the University of Alabama at Birmingham, and her associates presented data showing sustained weight loss among the CONQUER patients in a 52-week extension trial (SEQUEL).
In the double-blind, placebo-controlled extension study of subjects who completed 56 weeks of treatment in CONQUER and enrolled in SEQUEL, the original randomization was maintained in a total of 675 patients for an additional 52 weeks, with 227 continuing to receive placebo, 153 the lower phentermine/topiramate dose, and 295 the higher dose. In the ITT-LOCF analysis at 108 weeks, significantly greater weight loss was achieved with both the lower and higher drug doses, compared with placebo (9% and 11%, respectively, compared with 2%). The proportions of those achieving a body weight loss of 10% or more were 54% and 50% for the higher and lower doses, respectively, vs. just 12% with placebo, said Ms. Rueger.
The proportion of patients who discontinued the study because of adverse events was low and did not differ between groups, ranging from 3% with placebo to 5% with the lower drug dose, they said.
All studies were funded by Vivus. Dr. Kolotkin and Ms. Rueger reported having no further disclosures.