The primary efficacy measures for this study were the SIB and CIBIC-plus.At 24 weeks of treatment, statistically significant treatment differences were observed between the 10 mg/day dose of donepezil and placebo on both the SIB and CIBIC-plus.
The CIBIC-plus used in donepezil hydrochloride tablets trials was a semi-structured instrument that was intended to examine four major areas of patient function: General, Cognitive, Behavioral, and Activities of Daily Living. In a secondary analysis, a subgroup of individuals with the … Most common adverse reactions in clinical studies of donepezil hydrochloride tablets are nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and anorexia (
However, to reduce the likelihood of cholinergic effects, the 10 mg/day treatment was started following an initial 7-day treatment with 5 mg/day doses.Figure 1 illustrates the time course for the change from baseline in ADAS-cog scores for all three dose groups over the 30 weeks of the study. DSM IV, ICD 10). The inhibition of acetylcholinesterase (AChE) in red blood cells by donepezil hydrochloride has been shown to correlate to changes in ADAS-cog, a sensitive scale that examines selected aspects of cognition. Inducers of CYP 3A (e.g., phenytoin, carbamazepine, dexamethasone, rifampin, and phenobarbital) could increase the rate of elimination of donepezil hydrochloride tablets.Formal pharmacokinetic studies demonstrated that the metabolism of donepezil hydrochloride tablets is not significantly affected by concurrent administration of digoxin or cimetidine.Drug displacement studies have been performed in vitro between this highly bound drug (96%) and other drugs such as furosemide, digoxin, and warfarin. Approximately 77% of patients were women, and 23% were men. The ADCS-ADL-severe is a subset of 19 items, including ratings of the patient’s ability to eat, dress, bathe, use the telephone, get around (or travel), and perform other activities of daily living; it has been validated for the assessment of patients with moderate to severe dementia. Time-course of the Change from Baseline in ADAS-cog Score for Patients Completing 24 Weeks of Treatment.Figure 2 illustrates the cumulative percentages of patients from each of the three treatment groups who had attained the measure of improvement in ADAS-cog score shown on the X axis. Following administration of The mean age of patients participating in donepezil hydrochloride tablets trials was 73 years with a range of 50 to 94. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. Therapy with donepezil should only be started if a caregiver is available who will regularly monitor drug intake for the patient. Controlled and uncontrolled trials in the United States included approximately 900 patients. Cumulative Percentage of Patients Completing 24 Weeks of Double-blind Treatment with Specified Changes from Baseline ADAS-cog Scores. Updated In a study in healthy volunteers, ketoconazole increased mean donepezil concentrations by about 30%. After 6 months of treatment, the mean difference in the ADCS-ADL-severe change scores for donepezil hydrochloride tablets treated patients compared to patients on placebo was 1.8 points. Maintenance treatment can be continued for as long as a therapeutic benefit for the patient exists. Patient Information leaflet. Increasing muscle weakness is a possibility and may result in death if respiratory muscles are involved. Time-course of the Change from Baseline in SIB Score for Patients Completing 24 Weeks of Treatment.Figure 12 illustrates the cumulative percentages of patients from each of the two treatment groups who attained the measure of improvement in SIB score shown on the X-axis.

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