Progesterone Changes VEGF and BDNF Expression and Promotes Neurogenesis After Ischemic Stroke
Who the fuck is going to answer that question and write up a stroke protocol?http://www.mdlinx.com/internal-medicine/medical-news-article/2014/12/15/traumatic-brain-injury/5803762/?
Progesterone
has been associated with robust positive effects in animal models of
traumatic brain injury (TBI) and with clinical benefits in two phase 2
randomized, controlled trials. Authors investigated the efficacy and
safety of progesterone in a large, prospective, phase 3 randomized
clinical trial. Primary and secondary efficacy analyses showed no
clinical benefit of progesterone in patients with severe TBI. These data
stand in contrast to the robust preclinical data and results of early
single–center trials that provided the impetus to initiate phase 3
trials.
Methods
- Authors conducted a multinational placebo–controlled trial, in which 1195 patients, 16 to 70 years of age, with severe TBI (Glasgow Coma Scale score, <=8 [on a scale of 3 to 15, with lower scores indicating a reduced level of consciousness] and at least one reactive pupil) were randomly assigned to receive progesterone or placebo.
- Dosing began within 8 hours after injury and continued for 120 hours.
- The primary efficacy end point was the Glasgow Outcome Scale score at 6 months after the injury. The Extended Glasgow Outcome Scale may be widely used and accepted but it still has no objective measurement except for the death answer.
Results
- Proportional–odds analysis with covariate adjustment showed no treatment effect of progesterone as compared with placebo (odds ratio, 0.96; confidence interval, 0.77 to 1.18).
- The proportion of patients with a favorable outcome on the Glasgow Outcome Scale (good recovery or moderate disability) was 50.4% with progesterone, as compared with 50.5% with placebo.
- Mortality was similar in the two groups.
- No relevant safety differences were noted between progesterone and placebo.
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