No abstract

In this Danish‐Norwegian randomized double‐blind parallel‐group multicentre study, we compared the therapeutic response of slow‐release Madopar HBS® to standard Madopar® in 134 de novo patients with idiopathic Parkinson's disease during a 5‐year period. The drugs were dosed according to the individual need of the patients. The Webster, NUDS, UPDRS and Hoehn & Yahr scales were used for evaluation of symptoms. Addition of a morning dose of standard Madopar 62.5 mg was allowed after 6 months. Bromocriptine could be administered but not Selegiline. Sixty‐five patients got Madopar HBS and 69 standard Madopar. Surprisingly, no differences were found as to the mean daily levodopa dose, the mean number of daily doses or the use of and doses of bromocriptine. Unexpectedly, we found a trend towards a more frequent use of a morning dose of standard Madopar in the group treated with the standard formulation. No differences were observed in the occurrence of motor fluctuations or dyskinesia, the incidence of which was relatively low. Sustained‐release Madopar (HBS) thus proved to be as effective as standard Madopar in the long‐term treatment of de novo parkinsonian patients, but the drug showed no advantage in postponing or reducing the long‐term levodopa treatment problems.

objective: Tesofensine (TE) is a norepinephrine, dopamine, and serotonin reuptake inhibitor. We conducted a meta-analysis of TE's effect on body weight in trials investigating its potential for treatment of Parkinson's or Alzheimer's disease. Methods and Procedures: Four randomized, double-blind, multicenter trials compared TE (n = 740) and placebo (n = 228), two in each disease. Patients received oral TE or placebo once daily for 14 weeks without any weight loss program. Results were adjusted for baseline values, age, and study. Results: In the placebo group, 14% were obese and 21% were in the TE group. In the total cohort, weight change after 14 weeks was +0.5, −0.5, −0.9, −1.8, −2.8% in the placebo, 0.125, 0.25, 0.5 and 1.0 mg in the TE groups, respectively (P = 0.015 for dose effect). In the obese subgroup, weight changes were −0.2, −1.7, −1.6, −1.5, −3.7%, and 2.1, 8.2, 14.1, 20.9, 32.1% of the obese patients achieved ≥5% weight loss (P < 0.001 for 0.25, 0.5, and 1.0 mg vs. placebo for both end points). Changes in heart rate were −0.4, 2.1, 4.2, 6.0, and 6.8 bpm after 14 weeks (TE vs. placebo: P < 0.001 from 0.25 mg), but no effect on blood pressure was observed. Discussion: TE produced a placebo-subtracted weight loss of ~4% for >14 weeks without any diet and lifestyle therapy, which is similar to that of sibutramine, but with no effect on blood pressure. On the basis of these results, TE is now being developed for obesity management.

The spine and hip BMD reduction of 6%-8% is similar to that found in a comparable population-based study performed in another area in Norway. Among the disease-related variables tested for, only the use of prednisolone was independently associated with BMD reduction. However, the BMD reduction measured in this study indicates that disease-related mechanisms are involved.

The antiepileptic properties of carbamazepine (Tegretol) and clonazepam (Rivotril) were compared in a double-blind randomized study comprising 36 patients with newly diagnosed, untreated psychomotor epilepsy (partial seizures with complex symptomatology). No significant differences were found between the two drugs during the 6 months of treatment. Measurements of concentrations in plasma confirmed that the patients exceeded the accepted lower limit for therapeutic range of the drugs.