Patients with lumbar stenosis more active after prostaglandin E1 derivative treatment
AMSTERDAM — Patients with lumbar spinal stenosis walked further and had less pain after taking a medication that increases vasodilation and inhibits platelet aggregation, according to results of a recently presented level 1 multicenter study.
In their study, H.M. Lee, of Seoul, and investigators at five university hospitals in Korea compared the effects of limaprost, an oral prostaglandin E1 (PGE1) derivative, to the NSAID aceclofenac in patients older than 50 years.
“Limaprost can be a drug of choice for the patient with lumbar spinal stenosis,” Lee said during his presentation at SpineWeek 2012.
After a 2-week washout period, 59 patients were randomized to take the PGE1 drug and 57 patients were randomized to a control group who took the NSAID. Both groups took the medications on the first day, in the second week and in the fourth week of the 8-week study.
“During the 8 weeks of treatment, they were not allowed to take other kinds of medication,” Lee said.
At final follow-up, there were 47 patients in each group.
The study’s primary endpoint was walking 2 km/hour on a treadmill, but Lee noted that for patients who could not walk the minimum distance required, investigators recorded the distance they walked and the time it took them.
At the outset of the study, the average distance patients could walk was 185 meters in the limaprost group and 259 meters in the control group. After 8 weeks, “the distances increased to 340 meters in the limaprost group and 295 meters in the control group,” Lee said.
He said the average 2-month change in walking distance was 154 meters in the limaprost group and 35 meters in the control group — a difference that was significant.
Investigators also recorded Visual Analog Scale and Oswestry Disability Index scores on the first day and at the eighth week of the study, observing significant improvement in the scores from baseline to 8 weeks in both groups. The results, however, showed no statistically significant difference between the groups.
- Lee HM, Kim DJ, Moon SH, et al. The efficacy and feasibility of prostaglandin E1 derivative in patients with lumbar spinal stenosis: A multicenter, double-blinded, randomized comparative study with Aceclofenac. Paper #218. Presented at SpineWeek 2012. May 28-June 1. Amsterdam.
- Disclosure: The research was funded by Dong-a Pharmaceutical Co., Ltd.