[A study of the tolerability and effectiveness of nicardipine retard in cognitive deterioration of vascular origin].

INTRODUCTION

Nicardipine is a calcium antagonist which in previous trials has been shown to be effective in the prevention of stroke and the treatment of its sequelae, such as cognitive deterioration of vascular origin. We consider a phase IV study at primary care level to analyze the tolerability and efficacy of a retarded action formulation of 40 mg nicardipine.

PATIENTS AND

METHODS

In this open, prospective, multicentric trial 6,375 patients took part, of whom 5,593 were evaluated (87.7%). All were diagnosed as having vascular-type dementia (Hachinski > 6) and were given treatment with nicardipine retard (40 mg/day/6 months). The patients were assessed on the Montorio (daily activity) and SPMSQ (cognitive function) scales at the first visit and after one, three and six months, together with a record of side effects.

RESULTS

Only 0.9% of the patients recruited abandoned the study for problems of tolerability of the drug. The average improvement seen on Montorio's test was statistically significant from the first month, and reached 9% after six months. The 65.5% of the patients who started the study in seriously deteriorated condition showed improvement after six months. For the SPMSQ test, the average improvement was also statistically significant from the first visit and over 40% after six months. There was improvement in 64.4% of the patients who were severely deteriorated at the start of the study.

CONCLUSION

Nicardipine retard is a drug which is safe and effective when used for the treatment of mental deterioration of vascular origin.