SAFETY AND EFFICACY DURING LONG-TERM TREATMENT WITH MOCLOBEMIDE

Safety aspects [adverse events, blood pressure and heart rate, weight, and laboratory tests (liver parameters, hemoglobin, leukocytes)] of l ong-term treatment in 1,120 patients are discussed. Adverse events dur ing this long-term treatment were also compared with those of a subgro up of these patients who, before long-term treatment, were treated on a short-term basis (n = 706). Efficacy [Hamilton Depression Rating Sca le (HAM-D), Clinical Global Impression of Efficacy (CGI), and occurren ce of relapses and recurrences] in a homogeneous sample of 485 patient s is also discussed. The adverse events most frequently observed durin g long-term treatment were insomnia, headache, and dizziness. Insomnia and headache were also most often occurring in the compared sample of patients with short-term treatment, whereas dizziness during this tre atment period ranked at the fifth position. Supine and standing mean b lood pressure did not consistently change during long-term treatment, the most prominent increases in comparison with baseline were seen in the period > 1 year of treatment (6.3 mm Hg supine/7.2 mm Hg standing) . Comparison of blood pressure values in the hypertensive range at bas eline and during long-term treatment revealed no statistical differenc e (McNemar test p = 0.07829). Mean heart rate slightly decreased durin g long-term treatment (by a maximum of 6.3 beats/min supine, 8.2 beats /min standing. Mean weight did not change between baseline and treatme nt end point. There were 23 patients with a weight loss of 10 kg or mo re and 16 patients with a weight gain of 10 kg or more. For none of th e laboratory parameters tested was there a statistical significance re garding shifts from normal to pathological values. HAM-D mean total sc ores in the above-mentioned subgroup of patients decreased from 25.05 points at baseline (n = 485) to 7.88 points after 1 year of treatment (n = 139). Seventy-five patients who had favorably responded to treatm ent (total responders n = 300) relapsed during the first 6 months of t reatment. During the second half-year of treatment the recurrence rate was 14.8%, and during the third 6 months the recurrence rate was 12.2 %. CGI in the same subsample of patients in whom HAMD was evaluated (n = 485) compared with those patients who did not drop out during the s hort-term period up to 44 days and entered long-term treatment (n = 40 1) showed that the percentage of the ratings ''no change/worse'' was h igher in the sample that also included patients who withdrew from trea tment during the short-term period. Comparison of the total of patient s with long-term treatment (n = 1,120) and the previously mentioned su bgroup with long-term treatment (n = 401) showed that in the larger sa mple, ratings of ''very good'' were more frequent and that the percent age of ratings ''no change or worse'' was lower. From the present resu lts it may be concluded that moclobemide is safe during long-term trea tment and that efficacy-according to mean HAM-D total scores and CGI o f efficacy tested in selected samples-seems even to improve during lon g-term treatment. The relapse and recurrence rates were comparable to those published for other antidepressants.