ly gastrointestinal and tended to be less frequent with the 16 mg/day recommended initial maintenance dose.Table 2: The Most Frequent Adverse Events in the Placebo-Controlled Trial With Dose Escalation Every 4 Weeks Occurring in at Least 5% of Patients Receiving Galantamine Hydrobromide and at Least Twice the Rate on Placebo. Galantamine Hydrobromide Galantamine Hydrobromide
Placebo 16 mg/day 24 mg/day
Adverse Event
N=286
N=279
N=273
Nausea
5%
13%
17%
Vomiting
1%
6%
10%
Diarrhea
6%
12%
6%
Anorexia
3%
7%
9%
Weight decrease
1%
5%
5%
Table 3: The most common adverse events (adverse events occurring with an incidence of at least 2% with galantamine hydrobromide treatment and in which the incidence was greater than with placebo treatment) are listed in Table 3 for four placebo-controlled trials for patients treated with 16 or 24 mg/day of galantamine hydrobromide.Table 3: Adverse Events Reported in at Least 2% of Patients With Alzheimer’s Disease Administered Galantamine Hydrobromide and at a Frequency Greater Than With Placebo Body System Placebo Galantamine Hydrobromide*
Adverse Event (N=801) (N=1040)
*
Adverse events in patients treated with 16 or 24 mg/day of galantamine hydrobromide in four placebo-controlled trials are included.
Body as a whole - general disorders
Fatigue
3%
5%
Syncope
1%
2%
Central & peripheral
nervous system disorders
Dizziness
6%
9%
Headache
5%
8%
Tremor
2%
3%
Gastrointestinal system disorders
Nausea
9%
24%
Vomiting
4%
13%
Diarrhea
7%
9%
Abdominal pain
4%
5%
Dyspepsia
2%
5%
Heart rate and rhythm disorders
Bradycardia
1%
2%
Metabolic and nutritional disorders
Weight decrease
2%
7%
Psychiatric disorders
Anorexia
3%
9%
Depression
5%
7%
Insomnia
4%
5%
Somnolence
3%
4%
Red blood cell disorders
Anemia
2%
3%
Respiratory system disorders
Rhinitis
3%
4%
Urinary system disorders
Urinary tract infection
7%
8%
Hematuria
2%
3%
Adverse events occurring with an incidence of at least 2% in placebo-treated patients that was either equal to or greater than with galantamine hydrobromide treatment were constipation, agitation, confusion, anxiety, hallucination, injury, back pain, peripheral edema, asthenia, chest pain, urinary incontinence, upper respiratory tract infection, bronchitis, coughing, hypertension, fall, and purpura.
There were no important differences in adverse event rates related to dose or sex. There were too few non-Caucasian patients to assess the effects of race on adverse event rates.
No clinically relevant abnormalities in laboratory values were observed.
Other Adverse Events Observed During Clinical Trials
Galantamine hydrobromide tablets were administered to 3055 patients with Alzheimer's d |
