Deaths of MCI Patients using Galantamine hydrobromide Powder

A total of 13 patients on galantamine hydrobromide powder (n=1026) at and one patient on placebo (n=1022) died in two 2-year randomized placebo-controlled trials in patients with mild cognitive impairment (MCI). The deaths were caused by various factors that would be expected in an elderly population; about half of the galantamine deaths tended to be caused by vascular issues (myocardial infarction, stroke, and sudden death).

While there was a substantial difference in mortality between the galantamine- and placebo-treated groups in these two trials, the findings are inconsistent with other galantamine studies. The death rate in the placebo-treated patients in these two MCI studies was significantly lower than the amount in placebo-treated patients in hearings of galantamine in Alzheimer’s disease or other dementias (0.7 per 1000 person-years compared to 22-61 per 1000 person-years, respectively). Although the mortality rate in galantamine-treated MCI patients was lower than in galantamine-treated Alzheimer’s disease and other dementia trials (10.2 per 1000 person-years vs. 23-31 per 1000 person-years, respectively), the relative difference was much smaller.

When the mortality rates from Alzheimer’s disease and other dementia trials were combined (n=6000), the placebo group had a numerical advantage over the galantamine group. Furthermore, no patients in the placebo community died after 6 months in the MCI hearings, particularly in this population.

Mild cognitive dysfunction manifests as isolated memory impairment that is greater than normal for their age and education but does not meet existing Alzheimer’s disease diagnosis criteria.

Toxicology in a Nonclinical Setting
Carcinogenesis, Mutagenesis, and Fertility Impairment
Carcinogenesis is the process of being cancerous.

A rise in endometrial adenocarcinomas was observed at 10 mg/kg/day (4 times the MRHD of 24 mg/day on an mg/m2 basis or six times on a plasma exposure [AUC] basis) and 30 mg/kg/day (12 times the MRHD on an mg/m2 basis or 19 times on an AUC basis) in a 24 months oral carcinogenicity study in rats. Females at 2.5 mg/kg/day (equivalent to the MRHD on an mg/m2 basis or two times on an AUC basis) and males at the maximum dose measured of 30 mg/kg/day (12 times the MRHD on an mg/m2 and AUC basis) showed no rise in neoplastic changes.

In a 6 month carcinogenicity study in transgenic mice at oral doses up to 20 mg/kg/day and a 24 months carcinogenicity study in mice at oral doses up to 10 mg/kg/day, galantamine was not carcinogenic (equivalent to the MRHD on a plasma AUC basis).

Mutagenesis is a term used to describe the process of Galantamine tested negative in a battery of in vitro and in vivo genotoxicity tests (bacterial reverse mutation, mouse lymphoma TK, and chromosomal aberration in mammalian cells).

Infertility is a condition in which a person’s ability to reproduce is impaired

Rats provided up to 16 mg/kg/day (7 times the MRHD on an mg/m2 basis) for 14 days before mating in females and 60 days before mating in males showed no signs of infertility. For more information, you can check this page.