Pramipexole and rasagiline combo first line treatment for parkinsons

Written By : MD Editorial Team |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2022-04-13T09:45:01+05:30 | Updated On 13 April 2022 12:27 PM IST

Parkinson's disease (PD) is a brain disorder that leads to shaking, stiffness, and difficulty with walking, balance, and coordination. Parkinson's symptoms usually begin gradually and get worse over time.

Levodopa is considered to be the most effective treatment for PD, but long-term use is associated with increased risk for motor complications, such as dyskinesia. Dopamine agonists such as pramipexole have been linked in previous research to excessive daytime sleepiness and impulse control disorders.

An experimental drug that combines fixed doses of extended-release (ER) formulations of existing medications can significantly reduce symptoms in patients with untreated early-stage PD, new research suggests. The findings were presented at the American Academy of Neurology (AAN) 2022 Annual Meeting.

Researchers used P2B001, developed by Pharma Two B, is a combination of 0.6 mg of pramipexole and 0.75 mg of rasagiline. The drugs work by dual mechanisms, which investigators suspected to have synergistic effects. Tracing the results from an earlier trial, researches launched a phase 3, 12-week, international, randomized, double-blind trial to study the efficacy, safety, and tolerability of P2B001 compared with its individual components and with a calibration arm of pramipexole ER in 519 patients with early PD. Participants received P2B001, 0.6 mg of pramipexole ER, 0.75 mg of rasagiline ER, or pramipexole ER titrated to an optimal dose for each patient (1.5 to 4.5 mg).

Results showed that the

• Adjusted mean change from baseline in total Unified Parkinson's Disease Rating Scale (UPDRS) score was -2.66 points for P2B001 vs pramipexole (P = .0018) and -3.30 points for P2B001 vs rasagiline (P = .0001).

• There was no significant difference in UPDRS scores between P2B001 and pramipexole ER, but patients who received P2B001 reported significantly less daytime sleepiness.

• The adjusted mean change from baseline in Epworth Sleepiness Scale score for P2B001 vs pramipexole ER was -2.66 points (P < .0001).

• In addition, fewer dopaminergic adverse events were reported with the combination drug vs pramipexole ER (44.7% vs 66.2%), including somnolence (14.7% vs. 31.1%) and orthostatic hypotension (2.7% vs 12.2%).

Researchers concluded that "As a first-line treatment, P2B001 could offer an effective option instead of levodopa, It could be really good for patients because it would delay the introduction of levodopa and allow levodopa to be used in lower doses when the time comes and hopefully reduce the risk of complications"

Reference: https://movementdisorders.onlinelibrary.wiley.com/doi/epdf/10.1002/mds.26941

parkinsonsP2B001experimental drugLevodopamotor complicationsdyskinesiapramipexolerasagilineAmerican Academy of Neurology

Source : American Academy of Neurology

MD Editorial Team

Medical Dialogues consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers. Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751