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Spain:Cannabis-Based Spray Shows Positive Impact on Overactive Bladder

Bruce Sylvester

Doctors Guide

Tuesday 03 Oct 2006

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Cannabis-Based Spray Shows Positive Impact on Overactive Bladder
Symptoms of Multiple Sclerosis: Presented at ECTRIMS

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.

[Presentation title: Randomised Controlled Study Of Cannabis-Based
Medicine (Sativex) In Patients Suffering From Multiple Sclerosis
Associated Detrusor Overactivity. Abstract P411]
http://www.docguide.com/news/content.nsf/news/852571020057CCF6852571FC004CB0F7

 

 

 

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