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Budipine Provides Additional Benefit in Patients With Parkinson Disease Receiving a Stable Optimum Dopaminergic Drug Regimen
Horst Przuntek, MD;
Stefan Bittkau, MD;
Harald Bliesath, MD;
Ulrich Büttner, MD;
Gerd Fuchs, MD;
Joachim Glass, MD;
Harald Haller, MD;
Thomas Klockgether, MD;
Peter Kraus, MD;
Lutz Lachenmayer, MD;
Dieter Müller, MD;
Thomas Müller, MD;
Bernhard Rathay, MD;
Jörg Sgonina, PhD;
Volker Steinijans, PhD;
Elemer Teshmar, MD;
Gudrun Ulm, MD;
Dieter Volc, MD
Arch Neurol. 2002;59:803-806.
Background The complex pharmacological profile of the antiparkinsonian drug budipine
influences neurotransmission beyond the dopaminergic system. Previous studies
have demonstrated the therapeutic efficacy of budipine on motor symptoms in
insufficiently treated patients with Parkinson disease.
Objective To demonstrate the efficacy of 20 mg of budipine, 3 times daily, in
addition to a stable, prior, optimum-titrated dopaminergic substitution consisting
of a combination of levodopa and a dopa decarboxylase inhibitor, bromocriptine
mesylate, and optional selegiline hydrochloride in 99 patients with idiopathic
Parkinson disease in a multicenter, double-blind, placebo-controlled trial.
Results Budipine significantly (P<.001) decreased
the Columbia University Rating Scale sum score (median, 15.0; 95% confidence
interval, 11.3-17.0) compared with placebo (median, 4.3; 95% confidence interval,
3.0-7.5) at study end point. Budipine reduced Columbia University Rating Scale
subscores for tremor, rigidity, and akinesia.
Conclusion The additional application of budipine provides further therapeutic
benefit in subjects with Parkinson disease receiving a stable, prior, optimum-titrated
dopaminergic drug regimen because of the hypothetical positive impact of budipine
on altered nondopaminergic neurotransmission in patients with Parkinson disease.
From the Department of Neurology, Ruhr University of Bochum, Bochum,
Germany (Drs Przuntek, Kraus, and T. Müller); Byk Gulden Pharmaceuticals,
Constance, Germany (Drs Bliesath and Steinijans); the Department of Neurology,
Ludwig Maximilian University of Munich, Munich, Germany (Dr Büttner);
Parkinson Clinic, Wolfach (Dr Fuchs); the Department of Neurology, University
of Bonn, Bonn, Germany (Dr Klockgether); the Department of Neurology, Barmbek
General Hospital (Dr Lachenmayer), the Department of Neurosurgery, University
of Hamburg (Dr D. Müller), and Lundbeck GmbH & Co (Dr Sgonina), Hamburg,
Germany; Paracelsus-Elena Clinic, Kassel, Germany (Dr Ulm); and Josephstadt
Neurological Outpatient Clinic, Vienna, Austria (Dr Volc). Drs Bittkau, Glass,
Haller, Rathay, and Teshmar are in private practice in Germany.
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