[Results of the open multicenter prospective study of safety and tolerability of rivastigmine (exelon) in different titration regimes in mild and moderate Alzheimer's disease].
Treatment with cholinesterase inhibitors can cause tolerability-related problems in many patients. To facilitate the titration process, rivastigmine, a novel form of the drug (solution), has been elaborated. An objective of the study was to compare efficacy, safety and tolerability of rivastigmine (exelon) used in conventional capsules and/or solution and to assess adherence to this drug in patients with mild and moderate Alzheimer's disease. A prospective uncontrolled multicenter study included 207 patients: 126 (60,8%) received rivastigmine capsules and 81 (39,2%) - a solution and capsules with flexible doses of titration regime. In the latter group, the mean dose of rivastigmine was 8,5+/-1,1 mg daily to the end of titration period that was significantly differed from the daily dose used for capsules 4,8+/-1,9 mg (p<0,01). The treatment resulted in the significant improvement of the state of cognitive functions on the MMSE (from 18,5+/-3,8 to 21,9+/-4,3 scores), reduction of intensity of psychotic disturbances and positive changes in evaluation of satisfaction with the therapy given by caregivers of these patients (p<0,001). Due to statistically significant correlations (r=0,48; p=0,017) between MMSE scores and the final dose of rivastigmine, it is necessary to achieve the maximum tolerable dose level. Six patients receiving capsules were withdrawn from the study whereas all patients receiving the solution and capsules completed the study. The flexible titration regime and using the solution of rivastigmine allow to achieve better tolerability and higher dose of the drug to the end of titration period.
Litvinenko
I V
IV
Sakharovskaia
A A
AA
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000188:drug therapy* / Q000523:psychology; D002800:Cholinesterase Inhibitors / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D048448:Phenylcarbamates / Q000008:administration & dosage*; D011446:Prospective Studies; D011594:Psychometrics / Q000379:methods; D000068836:Rivastigmine; D012720:Severity of Illness Index; D017186:Titrimetry; D016896:Treatment Outcome
D002800:Cholinesterase Inhibitors; D048448:Phenylcarbamates; D000068836:Rivastigmine