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.