ts, each different in terms of depth and structure. As such, results from a CIBIC-plus reflect clinical experience from the trial or trials in which it was used and can not be compared directly with the results of CIBIC plus eva luations from other clinical trials. The CIBIC-plus used in the trials was a semi-structured instrument based on a comprehensive eva luation at baseline and subsequent time-points of 4 major areas of patient function: general, cognitive, behavioral and activities of daily living. It represents the assessment of a skilled clinician based on his/her observation at an interview with the patient, in combination with information supplied by a caregiver familiar with the behavior of the patient over the interval rated. The CIBIC-plus is scored as a seven point categorical rating, ranging from a score of 1, indicating "markedly improved", to a score of 4, indicating "no change" to a score of 7, indicating "marked worsening". The CIBIC-plus has not been systematically compared directly to assessments not using information from caregivers (CIBIC) or other global methods.
The efficacy of galantamine hydrobromide extended-release capsules was studied in a randomized, double-blind, placebo-controlled trial which was 6 months in duration, and had an initial 4-week dose-escalation phase. In this trial, patients were assigned to one of 3 treatment groups: galantamine hydrobromide extended-release capsules in a flexible dose of 16 to 24 mg once daily; galantamine hydrobromide tablets in a flexible dose of 8 to 12 mg twice daily; and placebo. The primary efficacy measures in this study were the ADAS-cog and CIBIC-plus. On the protocol-specified primary efficacy analysis at Month 6, a statistically significant improvement favoring galantamine hydrobromide extended-release capsules over placebo was seen for the ADAS-cog, but not for the CIBIC-plus. Galantamine hydrobromide extended-release capsules showed a statistically significant improvement when compared with placebo on the Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale, a measure of function, and a secondary efficacy measure in this study. The effects of both galantamine hydrobromide extended-release capsules and galantamine hydrobromide tablets on the ADAS-cog, CIBIC-plus, and ADCS-ADL were similar in this study.
INDICATIONS AND USAGE
Galantamine hydrobromide extended-release capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type.
CONTRAINDICATIONS
Galantamine hydrobromide extended-release capsules are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation.
WARNINGS
Anesthesia
Galantamine, as a cholinesterase inhibitor, is likely to exaggerate the neuromuscular blocking effects of succinylcholine-type and similar neuromuscular blocking agents during anesthesia.
Cardiovascular Conditions
Because of their pharmacological action, cholinesterase inhibitors have vagotonic effects on the sinoatrial and atrioventricular nodes, leading to bradycardia and AV block. These actions may be particularly important to patients with supraventricular cardiac conduction disorders or to patients taking other drugs concomitantly that significantly slow heart rate. Postmarketing surveillance of marketed anticholinesterase inhibitors has shown, however, |
