Zyprexa (Page 6 of 14)

5.6 Weight Gain

Potential consequences of weight gain should be considered prior to starting olanzapine. Patients receiving olanzapine should receive regular monitoring of weight [see Patient Counseling Information (17.6)].

Olanzapine Monotherapy in Adults — In an analysis of 13 placebo-controlled olanzapine monotherapy studies, olanzapine-treated patients gained an average of 2.6 kg (5.7 lb) compared to an average 0.3 kg (0.6 lb) weight loss in placebo-treated patients with a median exposure of 6 weeks; 22.2% of olanzapine-treated patients gained at least 7% of their baseline weight, compared to 3% of placebo-treated patients, with a median exposure to event of 8 weeks; 4.2% of olanzapine-treated patients gained at least 15% of their baseline weight, compared to 0.3% of placebo-treated patients, with a median exposure to event of 12 weeks. Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories. Discontinuation due to weight gain occurred in 0.2% of olanzapine-treated patients and in 0% of placebo-treated patients.

In long-term studies (at least 48 weeks), the mean weight gain was 5.6 kg (12.3 lb) (median exposure of 573 days, N=2021). The percentages of patients who gained at least 7%, 15%, or 25% of their baseline body weight with long-term exposure were 64%, 32%, and 12%, respectively. Discontinuation due to weight gain occurred in 0.4% of olanzapine-treated patients following at least 48 weeks of exposure.

Table 6 includes data on adult weight gain with olanzapine pooled from 86 clinical trials. The data in each column represent data for those patients who completed treatment periods of the durations specified.

Table 6: Weight Gain with Olanzapine Use in Adults
Amount Gainedkg (lb) 6 Weeks(N=7465)(%) 6 Months(N=4162)(%) 12 Months(N=1345)(%) 24 Months(N=474)(%) 36 Months(N=147)(%)
≤0 26.2 24.3 20.8 23.2 17.0
0 to ≤5 (0-11 lb) 57.0 36.0 26.0 23.4 25.2
>5 to ≤10 (11-22 lb) 14.9 24.6 24.2 24.1 18.4
>10 to ≤15 (22-33 lb) 1.8 10.9 14.9 11.4 17.0
>15 to ≤20 (33-44 lb) 0.1 3.1 8.6 9.3 11.6
>20 to ≤25 (44-55 lb) 0 0.9 3.3 5.1 4.1
>25 to ≤30 (55-66 lb) 0 0.2 1.4 2.3 4.8
>30 (>66 lb) 0 0.1 0.8 1.2 2

Olanzapine Monotherapy in Adolescents — The safety and efficacy of olanzapine have not been established in patients under the age of 13 years. Mean increase in weight in adolescents was greater than in adults. In 4 placebo-controlled trials, discontinuation due to weight gain occurred in 1% of olanzapine-treated patients, compared to 0% of placebo-treated patients.

Table 7: Weight Gain with Olanzapine Use in Adolescents from 4 Placebo-Controlled Trials
Olanzapine-treated patients Placebo-treated patients
Mean change in body weight from baseline (median exposure = 3 weeks) 4.6 kg (10.1 lb) 0.3 kg (0.7 lb)
Percentage of patients who gained at least 7% of baseline body weight 40.6% 9.8%
(median exposure to 7% = 4 weeks) (median exposure to 7% = 8 weeks)
Percentage of patients who gained at least 15% of baseline body weight 7.1% 2.7%
(median exposure to 15% = 19 weeks) (median exposure to 15% = 8 weeks)

In long-term studies (at least 24 weeks), the mean weight gain was 11.2 kg (24.6 lb); (median exposure of 201 days, N=179). The percentages of adolescents who gained at least 7%, 15%, or 25% of their baseline body weight with long-term exposure were 89%, 55%, and 29%, respectively. Among adolescent patients, mean weight gain by baseline BMI category was 11.5 kg (25.3 lb), 12.1 kg (26.6 lb), and 12.7 kg (27.9 lb), respectively, for normal (N=106), overweight (N=26) and obese (N=17). Discontinuation due to weight gain occurred in 2.2% of olanzapine-treated patients following at least 24 weeks of exposure.

Table 8 shows data on adolescent weight gain with olanzapine pooled from 6 clinical trials. The data in each column represent data for those patients who completed treatment periods of the durations specified. Little clinical trial data is available on weight gain in adolescents with olanzapine beyond 6 months of treatment.

Table 8: Weight Gain with Olanzapine Use in Adolescents
Amount Gainedkg (lb) 6 Weeks(N=243)(%) 6 Months(N=191)(%)
≤0 2.9 2.1
0 to ≤5 (0-11 lb) 47.3 24.6
>5 to ≤10 (11-22 lb) 42.4 26.7
>10 to ≤15 (22-33 lb) 5.8 22.0
>15 to ≤20 (33-44 lb) 0.8 12.6
>20 to ≤25 (44-55 lb) 0.8 9.4
>25 to ≤30 (55-66 lb) 0 2.1
>30 to ≤35 (66-77 lb) 0 0
>35 to ≤40 (77-88 lb) 0 0
>40 (>88 lb) 0 0.5

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.