Drug monitoring study (phase IV) of xantinolnicotinate (Complamin) in general practice.
For 30 years, xantinolnicotinate has been on the market for the treatment of impaired brain function, i.e., organic brain syndromes of various etiologies. Controlled double-blind phase-III clinical trials have shown that xantinol-nicotinate is an effective drug in the treatment of dementia. Nevertheless, it is also important to assess xantinolnicotinate under routine treatment conditions in order to learn what type of patient is preferably treated, which ADRs can be observed how often, and whether the efficacy claimed by phase III studies can still be seen under routine treatment conditions. Theoretically, the more complex treatment situation in routine practice could lead to major changes in the selection of patients, the type and frequency of ADRs, or efficacy. The treatment of 10,134 patients was monitored in a treatment observation study. Results show that target illnesses are not cases of 'pure dementia', but more complex cases, in which multimorbidity plays an important role, so that the older term 'cerebrovascular insufficiency' seems more appropriate to describe this group of patients. Another interesting group is made up of younger patients suffering from a variety of psycho-organic syndromes. The assessment of therapeutic efficacy, e.g., with the SCAG, shows highly significant improvements during treatment, which are well comparable to those reported in controlled studies. The success of treatment was most expressed in the target symptoms "dizziness", "fatigue", "disturbance of concentration", "affective disorders", and "disturbance of vigilance and vitality". In 87% of these cases, no adverse drug reactions were reported.(ABSTRACT TRUNCATED AT 250 WORDS)
Department of Psychiatry, University of Düsseldorf, Germany.
E
E
Lehmann
L
L
van der Crone
R
R
Grobe-Einsler
M
M
Linden
D000368:Aged; D002561:Cerebrovascular Disorders / Q000188:drug therapy*; D003704:Dementia / Q000188:drug therapy*; D006801:Humans; D014971:Xanthinol Niacinate / Q000009:adverse effects / Q000627:therapeutic use*
D014971:Xanthinol Niacinate