Update on Pramipexole

I have mentioned pramipexole before. In the United States it is approved for the treatment of the signs and symptoms of idiopathic Parkinson’s disease.

I’m always on the look out for medicines that can be part of a package of healthcare, and we need to learn both the pros and cons of new medicines. This looks to be a medicine that can be incorporated into Integrated Medicine. And before you ask, I have no links at all with the manufacturer, Boehringer Ingelheim.

There have been a number of interesting papers presented at the 10th International Congress of Parkinson’s Disease and Movement Disorders in Kyoto, Japan this week.

New data presented have shown that people taking pramipexole (Mirapexin®/ Sifrol®) can experience significant improvements in a broad range of symptoms associated with Restless Legs Syndrome (RLS). 

In all studies presented at the meeting, people taking pramipexole reported clinically meaningful improvements in both their night and day-time symptoms, as measured on the International Restless Legs Scale (IRLS). The IRLS measures several aspects of the condition, ranging from discomfort, the need to move around, relief by moving around and then more specific RLS symptoms such as sleep disturbance, day-time tiredness, mood disorder, as well as addressing overall severity, weekly frequency, daily severity, and impact on daily activities.

One of the big problems in the treatment of RLS is that people who have it frequently have other problems as well, such as hypertension, arthritis, gastroesophageal reflux disease, depression, anxiety, and diabetes. So it is essential that the physical component of treatment should not cause any deterioration in associated illnesses. One of the papers presented in Kyoto indicated that pramipexole could be used in people with RLS who are also taking an array of other medicines. That claim is going to have to be checked by the FDA, but the data look very encouraging.

Still, when using medications, there’s no such thing as a free lunch: The most commonly reported adverse reactions in clinical trials for RLS were nausea, headache, and tiredness.

In people with Parkinson’s disease, pramipexole may cause them to fall asleep without any warning, even while doing normal daily activities such as driving. This is obviously very serious, and before the medicine gets an RLS indication in the USA, the FDA will really check this out in great detail. When taking pramipexole hallucinations have been known to occur and sometimes patients may feel dizzy, sweaty or nauseated upon standing up. In Parkinson’s disease, there is also a warning that as with many other medicines used to treat it, including pramipexole may be associated with impulse control disorders/compulsive behaviors.

So we need to keep an eye on safety, but so far the data is very encouraging, and we may soon have something else to add to an integrated treatment program for people with RLS.

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Here’s a P.S. On November 10th, 2006, pramipexole was approved for use in RLS by the FDA. Here’s the announcement:

Ingelheim/Germany, 10 November 2006 – Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has approved pramipexole, a non-ergot dopamine agonist, for the treatment of moderate to severe primary Restless Legs Syndrome (RLS).1 This is an important milestone for pramipexole (Mirapexin® / Sifrol® / Mirapex®), which was already approved throughout the European Union in April 2006 for this second indication.