Chair highlights press release of AMAG PHARMACEUTICALS Announcement of TOP-LINE Results from the PROLONG TRIAL EVALUATING MAKENA® (hydroxyprogesterone caproate injection)
Chair's highllights on Friday, March 8, 2019 press release:
The PROLONG trial included approximately 1,700 patients. The trial did not demonstrate a statistically significant difference between the treatment and placebo arms for the co-primary endpoints: the incidence of preterm delivery at less than 35 weeks (Makena treated group 11.0% vs. placebo 11.5%, p=.72) and the percentage of patients who met criteria for the pre-specified neonatal morbidity and mortality composite index (Makena treated group 5.4% vs 5.2%, p=.84). The adverse event profile between the two arms was comparable. Nelson DB et al.pdf
In order to provide background on the issue of 17- hydroxyprogesterone caproate, attached are 2 important papers that will give context:
a) A review about progestogens to prevent preterm birth in the Journal of Perinatal Medicine written by Dr. Roberto Romero, Chief of perinatology Research Branch, NICHD/NIH (Article is entitled "blueprint" - see yellow highlight) Journal of Perinatal Medicine A blueprintefor the prevention
b) Paper in AJOG from Southwestern Medical School/ Parkland Hospital, along with the Editorial. This article indicated that when 17-OHPC was introduced in Dallas to prevent recurrence of preterm birth, it did not work. Young D.AJOG.pdf
This is important for you to grasp the implications of the negative results of the PROLONG trial.
As indicated in the press release, I expect your patients and colleagues may ask questions. I hope that the information and attachments help you answer any questions.
Should you have any questions, please do not hesitate to contact me.
Sincerely,
Chaur-Dong Hsu, MD, MPH, FACOG
Chair & Frank P. Iacobell Professor