Date of Award

12-2016

Degree Type

Selective Evidence-Based Medicine Review

Degree Name

Master of Science in Health Sciences - Physician Assistant

Department

Physician Assistant Studies

Department Chair

John Cavenagh, MBA, PhD, PA-C

Abstract

OBJECTIVE: The objective of this selective EBM review is to determine whether or not 100mg Flibanserin is effective in increasing the number of sexually satisfying events in women with HSDD.

STUDY DESIGN: Review of three, placebo-controlled trials in which women > 18 years old with HSDD were treated with either 100mg Flibanserin or a Placebo once daily qhs for 24 weeks

DATA SOURCES: Three randomized, placebo-controlled trials found via PubMed searches and published in English peer-reviewed journals between 2011-2014

OUTCOMES MEASURED: Outcomes measured were the number of SSE over 4 weeks and analyzed with Wilcoxon’s rank-sum test.

RESULTS: In DeRogatis et al, 100mg Flibanserin led to increases in the mean (standard error) SSE 1.6 (0.23) vs 0.80 (0.20) and was proven to be statistically significant (p<0.01). AEs led to 6.8% of 100mg Flibanserin subjects vs. 3.4% of Placebo subjects to discontinue the study medication. In Katz et al, 100mg Flibanserin led to increases in the mean (standard deviation) SSE of 2.5(4.6) vs 1.5(4.5) with a p value <0.001. AEs led to 9.76% of Flibanserin subjects vs. 3.47% of subjects on Placebo to discontinue study medications. In Simon et al, 100mg Flibanserin led to increases in in the mean (standard error) SSE 1.0 (0.1) vs. 0.6 (0.1) and was statistically significant with p=0.004. 8.1% of Flibanserin subjects discontinued study medication due to AEs while on 3.1% of Placebo subjects.

CONCLUSIONS: Based on this review, 100mg Flibanserin taken once daily qhs is effective and well tolerated in treating those with HSDD in both pre- and postmenopausal women. The mean number of SSE was statistically significant vs. placebo in all three studies.

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