Drug May Cut Parkinson's Disease Disability
Downtime Shorter When Taking Rasagiline With Levodopa, Says Study
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Participants were 687 Parkinson's patients in Israel, Argentina, and Europe. All were taking levodopa. Participants were randomly assigned to take rasagiline, a placebo, or entacapone along with levodopa for 18 weeks.
Rasagiline and Comtan both reduced "off-time" by about the same amount -- 1.18 hours for rasagiline and 1.2 hours for entacapone. The drugs also boosted "on-time" periods, when motor function was clearly better.
Both drugs also had similar rates of side effects. Half of the patients -- 343 people -- reported "adverse events," says the study, calling 41 cases serious (12 with rasagiline, 12 with Comtan, and 17 with the placebo).
Adverse events included drops in blood pressure when changing position, fainting, constipation, diarrhea, dry mouth, nausea, vomiting, and swelling of the legs and ankles. Some patients also had abnormal dreams, anxiety, confusion, depression, dizziness, abnormal muscle movements, hallucinations, and sleep problems.
Age didn't make adverse events more likely. Neither did taking the drugs with dopamine agonists.
A total of 88 patients quit the study early. Most left because they withdrew their consent, says the study. The rasagiline group had the fewest dropouts.
Of the 34 people who quit the study because of adverse events, seven had taken rasagiline, compared to 16 and 11 for Comtan and the placebo, respectively.
The study was conducted by researchers including Olivier Rascol, a professor in the clinical pharmacology department at University Hospital in Toulouse, France.
Rasagiline is taken as a single oral daily dose and is easier to use for both patients and clinicians than most other therapies, says Carl Clarke of the neurology department at England's University of Birmingham.
"As such, this drug is likely to find favor with both neurologists and geriatricians as a useful addition to Parkinson's disease therapeutics," writes Clarke in an editorial for The Lancet.
Still, Clarke says the 18-week study was a bit short for studying a chronic disease. A year-long study would have been better, but it would have been unethical to leave patients on a placebo for that long, he writes.
Clarke also says rasagiline still needs a head-to-head comparison with another drug -- Tasmar, a drug similar to Comtan.
The study and editorial appear in The Lancet's March 12 edition.