MADRID, SPAIN -- October 3, 2006 -- Treatment with cannabis-based Sativex has a positive and sometimes significant impact on the symptoms of overactive bladder in multiple sclerosis (MS) patients, researchers reported here at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
Sativex is an investigational cannabis-based treatment for pain and symptoms of multiple sclerosis. GW Pharmaceuticals, based in Salisbury, United Kingdom, filed a regulatory submission for the drug in the United Kingdom, Spain, Denmark and the Netherlands for symptomatic relief of spasticity in patient with MS.
"We found both a trend toward improvement in incontinence, the primary endpoint of the study, and statistically significant improvements in a number of related secondary endpoints," said investigator Cris S. Constantinescu, MD, PhD, professor of neurology, University of Nottingham, Nottingham, U.K.
Bladder problems are a common feature of MS, with up to 80% of patients reporting voiding dysfunction, the authors noted in their poster, which was presented on September 29th.
In their 10-week, double-blind, randomised, placebo-controlled trial, Dr. Constantinescu and colleagues evaluated 135 patients with MS who reported detrusor overactivity who were treated with either Sativex or placebo.
The primary endpoint of the study was reduction number of daily episodes of urgency incontinence. Secondary endpoints included incidence of nocturia and urgency, overall bladder condition measured on an 11-point numerical rating scale, daytime frequency, quality of life, patient's global impression of change (PGIC) and volume voided.
The decrease in incontinence episode frequency per day favoured the Sativex-treated group but was not statistically significant (-1.08, P = .57), the investigators reported.
Results also showed statistical significance in favour of Sativex for 10 of the 11 secondary/tertiary endpoints, with 4 out of 7 secondary endpoints. These included: reduction in nocturia episodes (-0.28, P = .010); highly statistically significant improvement in patients' opinion of bladder symptom severity (-1.16 points, P = .001); reduction in the number of voids per day (-0.85, P = .007) and PGIC scores, where 83.6% of subjects receiving Sativex compared with 58.2% receiving placebo said that the status of their bladder condition had improved (odds ratio 2.56, P = .005).
Findings for number of urgency episodes in Sativex-treated subjects fell just short of statistical significance (-0.76, P = .071).
For tertiary endpoints, the investigators reported that the number of daytime voids was statistically significant in favour of Sativex (-0.57, P = .044). There was also a trend in favour of Savitex for improvement in quality of life but this did not reach statistical significance, the researchers noted.
The study was supported by GW Pharmaceuticals.