by Ray Sahelian, M.D.
January 25 2016
Pramipexole, a compound from Boehringer Ingelheim research, is approved in the U.S. for the treatment of the signs and symptoms of idiopathic Parkinson's disease. An application has been submitted to the Food and Drug Administration (FDA) for pramipexole for the treatment of moderate to severe primary RLS. Pramipexole is supported by nearly a decade of real-world experience in the treatment of Parkinson's disease, and approximately 10 million prescriptions for pramipexole have been written in the U.S. since its launch in 1997.
Clin Interv Aging. 2012. Role and clinical utility of
pramipexole extended release in the treatment of early Parkinson's disease. The
aim of this article is to provide a short review of the most relevant
pharmacological and clinical data on pramipexole extended release (ER) as well
as to address the clinical utility and potential advantages of a once-daily
formulation especially in the treatment of early Parkinson's disease (PD).
Pramipexole is widely established as a symptomatic treatment in early as well as
advanced PD. The development of an ER formulation, with stable pramipexole
plasma concentration over 24 hours, now offers a bioequivalent once-daily
alternative. Double-blind randomized controlled trials in early and advanced PD,
have established noninferiority of pramipexole ER compared with immediate
release as well as superiority of both formulations over placebo. The overnight
switch from the standard to the once-daily formulation was shown to be
successful in >80% of patients without requiring any dose adjustments. Potential
benefits of the prolonged-release design, which have not yet been formally
demonstrated in the pivotal trial program, include improved compliance and a
potential for better symptomatic control, particularly in patients with early
disease that can be managed with monotherapy.
Pramipexole side effect
Pramipexole may cause patients to fall asleep without any warning, even while doing normal daily activities such as driving. Another side effect of pramipexole is hallucinations. Sometimes patients may feel dizzy, sweaty or nauseated upon standing up. The most common pramipexole side effects in clinical trials for RLS are nausea, headache, and tiredness. The most commonly reported pramipexole side events in early and late Parkinson's disease in clinical trials are dizziness, involuntary movement, hallucinations, headache, difficulty falling asleep, sleepiness, and nausea. Patients and caregivers should be informed that impulse control disorders / compulsive behaviors may occur while taking medicines, including pramipexole, to treat Parkinson's disease.
Clin Neuropsychol. 2015. Neuropsychological findings in a
case of punding before and after cessation of pramipexole. Clinical
neuropsychologists are well trained to recognize neurological and psychiatric
conditions that impact behavior, but tend to have less familiarity with
iatrogenic consequences of various pharmacological treatments. One such
consequence is the development of an impulse control disorder (ICD), which can
result from treatment with dopamine agonists. Knowledge of ICDs is important
because they can mimic obsessive-compulsive disorder, mania, or the behavioral
variant of frontotemporal dementia. The current case examines a patient who
developed punding, which is a type of ICD characterized by repetitive behavior,
as a result of treatment with pramipexole.
Pramipexole for RLS
According to a study published in the journal Neurology, pramipexole significantly improved RLS symptoms in patients with moderate to severe restless legs syndrome (RLS) versus those on placebo. Therapeutic effects were evident within 1 week of initiating treatment. Primary efficacy endpoints were measured by patient ratings of symptom severity using the International RLS Study Group Rating Scale (IRLS), and clinician ratings of improvement on the Clinical Global Impressions- Improvement Scale (CGI-I). Secondary endpoints for the study included the Patient Global Impression (PGI) responder rate, visual analogue scale (VAS) ratings of sleep, quality of life as measured by the Johns Hopkins Restless Legs Syndrome Qualify of Life (RLS-QOL) questionnaire, and safety.