Starting Azilect early delays progression of Parkinson's
This article was originally published in Scrip
Early treatment with Tevaand Lundbeck's Azilect (rasagiline) delays the progression of Parkinson's disease, new data suggest.
Top-line results from the 1,176-patient ADAGIO study showed that early treatment with Azilect was associated with benefits that were not seen in patients started on treatment nine months later. Teva said it intended to submit the results to regulatory authorities in the US and Europe so that the data can be incorporated into the product's label. Azilect is a monoamine oxidase type b inhibitor currently indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease as initial monotherapy and as adjunct therapy to levodopa.
Co-principal investigator Professor Olivier Rascol, of the University Hospital of Toulouse, said that the results support the drug's early use in Parkinson's disease. The other co-principal investigator, Professor Warren Olanow, of the Mount Sinai School of Medicine, New York, said that delaying disease progression was "the most important unmet need in the management of Parkinson's disease".
The study enrolled patients who had had Parkinson's disease for less than 18 months and who did not require medication for the condition at time of enrolment (and were not expected to require any for another nine months). Patients received either Azilect for 72 days (early start) or placebo for 36 days followed by Azilect for 36 days (delayed start). Azilect was given in one of two doses, 1mg/day or 2mg/day.
The difference in the change in total Unified Parkinson's Disease Rating Scale (UPDRS) scores between patients started immediately on Azilect and those in the delayed start group was assessed across three primary endpoints. All of these were met for patients taking the 1mg/day dose: superiority of slope during weeks 12-36 (-0.05, p=0.013), change from baseline to week 72 (-1.7 units, p=0.025) and non-inferiority of slope in weeks 48-72. The 2mg/day dose met two of these (superiority of slope during weeks 12-36 and non-inferiority of slope in weeks 48-72), but failed to demonstrate statistical significance in terms of change from baseline to week 72. Full results of the trial will be presented at the American Neurological Association meeting in late September in Salt Lake City, Utah, Teva said.
Boehringer Ingelheim is also studying whether its Parkinson's disease drug Mirapex (pramipexole), an orally-active dopamine receptor agonist, shows benefits from early use. Mirapex (which is also marketed as Sifrol, Mirapexin and Pexola) has been licensed in the US for the symptomatic treatment of Parkinson's disease since 1997. The 15-month, 535-patient, placebo-controlled PROUD study will compare UPDRS scores after 15 months with early treatment and with treatment delayed by six to nine months. The study will also include a brain imaging arm, which will examine dopamine transporter density in 150 of the patients in the trial. Results of the trial are expected in July 2009.