Abstract #L12: A Multi-center Crossover Study of MQX-503, a Topical Formulation of Nitroglycerin, in Patients with Raynaud’s phenomenon
Authors:
Christopher P. Denton1, David Fiorentino2, Ariane Herrick3, Sangeeta Sule4, Naomi Rothfield5, Jill Belch6, Lee Shapiro7, Agneta Scheja8, Joseph Shanahan9, Virginia Steen10, Paul Emery11, Lorinda Chung2, Jeffrey Gregory12, Eric Batson12, Thomas Dooley12, Adam Gilbert12, Frederick Dechow12, Frederick M. Wigley4.
Background:
This is the second of 2 randomized controlled trials examining the efficacy of this novel topical nitroglycerin preparation for the management of Raynaud’s phenomenon.
Methods:
The major difference between this trial and the other trial reported at this meeting was the study design. This study was a cross-over study, using the patients as their own controls, whereas abstract #2163 was a concurrent study design. Other differences included slight difference in active study drug dose (0.9% in this study, 1.0% in #2163) and there no requirement to discontinue baseline vasodilator medications in this trial. This study also examined Raynaud’s condition score (RCS) as the primary outcome measure. This trial examined two consecutive 3-week study periods, one with active treatment and one with placebo after a 2 week observation period to ensure eligibility.
Results:
109 subjects were enrolled in the trial and in an ITT analysis and 101 subjects completing the study were evaluated in a per protocol analysis (8 subjects discontinued treatment). There was a significant difference in the mean RCS in those treated with MQX-503 compared to placebo (29.2 vs. 31.7, p=0.008) in the ITT analysis. This difference remained when the scleroderma subject subgroup was analyzed separately. There were no significant differences in adverse events between MQX-503 and placebo.
Editorial Comment:
This is the second phase III study of this novel preparation of nitroglycerin that suggests clinical benefit in patients with primary and secondary Raynaud’s phenomenon. The proposed main advancement of this preparation over currently available preparations is the decreased systemic absorption and this seems to bear out in these 2 clinical trials with no reported increase in systemic side effects (such as headache and lightheadedness). This medication may be a very useful mediation in those patients who have been intolerant to other vasodilators or as an adjunct therapy.
