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)

Clinical aspects of nimodipine.

This overview describes the result of the clinical development program in organic brain syndrome (impaired brain function in old age), where efficacy was proven in 11 double-blind, placebo-controlled studies. Another study within this development program showed nimodipine not only to be superior to placebo but also to hydergine. Furthermore, in a placebo-controlled clinical trial, nimodipine caused further improvement in performance compared to regular mental exercise at home. Due to the results in the organic brain syndrome program, registration was granted in 23 countries worldwide for this indication. In one clinical trial in the dementia development program, patients with dementia were carefully allocated either to primary degenerative dementia (PDD) or multi-infarct dementia (MID) stratum; nimodipine was shown to be superior to placebo independent of the etiology. Other clinical trials conducted in this indication supported the evidence for efficacy and showed that nimodipine-treated patients performed better than placebo patients. The safety profile of the drug is well established and substantiated by extensive postmarketing surveillance. In general, nimodipine was well tolerated, showing few adverse events. Finally, topics for future research are covered such as developing new instruments to assess more severe patients, expanding the patient collective to secondary dementias such as AIDS and Parkinson dementia, implementation of cost/utility elements in the development program, and the issue of nimodipine's potential role in the prevention of disease.

Efficacy of xantinolnicotinate in patients with dementia.

Activation of cerebral metabolism and improvement of microcirculation by influencing rheological parameters are claimed to be the underlying pharmacological principles responsible for the efficacy of xantinolnicotinate. This dual mechanism of action led the authors to perform a double-blind, randomized, placebo-controlled study in patients with mild to moderate dementia (DSM III), characterized by a score of 40-90 on the Sandoz Clinical Geriatric Scale (SCAG), with a separate randomization for patients with Multi-Infarct Dementia (MID) and Senile Dementia of Alzheimer Type (SDAT). It was calculated that 150 patients would have to be recruited for each group. Allocation to the respective group (MID or SDAT) was based on the Hachinski Ischemic Score and computer tomogram. Preceded by a 2-week placebo run-in period, a 12-week treatment period followed with either 3 x 1 g xantinolnicotinate (Complamin) or placebo. Prior to the study, the physician's rating of the global therapeutic effect from the clinical global impression (CGI) was designated as the primary criterion of efficacy. Secondary efficacy criteria were SCAG, the BGP nursing rating, and, as psychometric variables, tests from the Nuremberg Psychogeriatric Inventory (NAI). The improvement compared to placebo was statistically significant for the CGI in both treatment groups (p less than 0.0001) and hence independent of etiology. Concerning the nurses' rating (BGP), apart from a marginally statistically significant difference for the factor "need of help" in the SDAT group, no remarkable changes were registered during treatment. However, in the SCAG the differences between verum and placebo were significant (MID p less than 0.0002; SDAT p less than 0.0001).(ABSTRACT TRUNCATED AT 250 WORDS)

[Chemotherapy for Hodgkin's disease during pregnancy--a case report]. / Zytostatika-Therapie bei Morbus Hodgkin in der Schwangerschaft. Ein kasuistischer Beitrag.

Based on a case report of a 19-year-old woman with Hodgkin's disease in pregnancy and on several casuistic communications and comparative studies from the literature the problems of cytostatic therapy in pregnancy are discussed. The following conclusions may be drawn: Cytostatic therapy in varying combination seems not to be associated with a damage to the fetus, even when applied in the first trimester of pregnancy. Fetal disturbances occurred almost exclusively under a combination chemotherapy and radiation therapy. In the case observed by us a combination chemotherapy with adriblastin, vincristine and prednisone was successfully applied from the 28th week of pregnancy on. The child showed no disturbances apart from a slight degree of intrauterine growth retardation which must also be seen in connection with a severe anemia of the mother or her nicotine abuse.