PRNewswire (Apr 28, 01:44 PM) SAN FRANCISCO, April 28 /PRNewswire/ -- Results from a large-scale, randomized, double-blind study show MIRAPEX(R) (pramipexole) provides rapid relief in patients with restless legs syndrome (RLS). The results of the study were presented this week at the American Academy of Neurology (AAN) meeting in San Francisco, CA. RLS refers to "unpleasant, deep discomfort, including paresthesias, inside the calves when sitting or lying down, especially just before sleep, producing an irresistible urge to move the legs."(1)
In an analysis of 109 patients randomized to either placebo (n=22) or MIRAPEX (pramipexole) at a daily dose of 0.125 mg (n=21), 0.25 mg (n=22), 0.5 mg (n=22), or 0.75 (n=22), MIRAPEX (pramipexole) showed efficacy over the dose range of 0.125 mg/day to 0.75 mg/day within 3 weeks of therapy. The primary endpoint of the study was the reduction in periodic limb movements during time in bed index (PLMI). Safety and tolerability of MIRAPEX (pramipexole) were favorable in all dose groups tested.
"These findings are most valuable in understanding which drugs are effective in treating RLS, a condition that up to 10% of the general population experiences,"(2) said Dr. Markku Partinen, presenting author of the study results. "In this study, pramipexole demonstrates clearly that it is a promising new therapy for the treatment of restless legs syndrome."
No medication is currently approved by the U.S. Food & Drug Administration for restless legs syndrome. MIRAPEX (pramipexole) is indicated for the treatment of the signs and symptoms of Parkinson's disease. The most commonly reported adverse events in clinical trials of early and late Parkinson's disease were dizziness, dyskinesia, extrapyramidal syndrome, hallucinations, headache, insomnia, somnolence, and nausea.
Boehringer Ingelheim and Pfizer co-promote MIRAPEX (pramipexole) for Parkinson's disease in the US.
Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest US subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim Corporation is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 152 affiliates in 45 countries and more than 34,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2003, Boehringer Ingelheim posted net sales of US $8.37 billion (7.4 billion euro) while spending more than one fifth of net sales in its largest business segment, Prescription Medicines, on research and development.
For more information please visit http://www.boehringer-ingelheim.com/
References:
(1) Dorland's Illustrated Medical Dictionary, 30th edition,
Philadelphia: Saunders, 2003.
(2) Restless Legs Syndrome: A Clinical Study of 55 Patients. Claudio L.
Bassetti; Doris Mauerhofer; Matthias Gugger; Johannes Mathis;
Christian W. Hess. European Neurolog.
Boehringer Ingelheim Pharmaceuticals, Inc.
CONTACT: Sheila Burke, Associate Director of Communications & PublicRelations of Boehringer Ingelheim Pharmaceuticals, Inc., +1-203-798-4715, Fax- +1-203-791-6442
Web site: http://www.boehringer-ingelheim.com/
