Olanzapine in pregnancy and breastfeeding: a review of data from global safety surveillance.

BACKGROUND: Olanzapine use has been reported during pregnancy and breastfeeding, but there are no controlled clinical trials assessing the safety of olanzapine exposure to infants and fetuses. The purpose of this report was to review and analyze prospective post-marketing cases of pregnancy and breastfeeding with olanzapine, in order to guide clinicians and women on the use of olanzapine therapy during pregnancy and/or breastfeeding. METHODS: A worldwide safety database maintained by Eli Lilly and Company was searched for all spontaneous-reported data regarding olanzapine use during pregnancy and/or breastfeeding. Cases reported prior to pregnancy outcome were considered to be prospective, and follow-up was pursued after the delivery date to assess outcome. RESULTS: Outcome data were available for 610 prospectively identified pregnancies during which olanzapine was used. The majority of women had normal births (66%), although premature births were reported in 9.8% and perinatal conditions in 8% of the pregnancies. A total of 102 pregnancies reported olanzapine treatment during breastfeeding. In these infants, the most commonly reported adverse events were somnolence (3.9%), irritability (2%), tremor (2%), and insomnia (2%), although the majority of pregnancies reported no adverse events (82.3%). CONCLUSIONS: The frequency of fetal outcomes in these prospectively identified pregnancies exposed to olanzapine did not differ from rates of outcomes reported in the general population. These data may be useful to help guide clinicians and women decide to continue, or discontinue, olanzapine therapy during pregnancy and/or breastfeeding, but should be considered within the limitations associated with spontaneously reported data. Women should notify their clinicians if they become pregnant or intend to become pregnant while being treated with olanzapine. Because of limited experience in humans, olanzapine should be used in pregnancy only when potential benefit justifies potential risk to the fetus. Olanzapine should only be considered during breastfeeding when the potential benefit justifies the potential risk to the infant.

Edentulism associated with obesity: a study of four national surveys of 16 416 Swedes aged 55–84 years.

OBJECTIVE: To investigate the association between edentulism and obesity in the Swedish population aged 55­84 years over a 22-year period as a result of changes in health and socio-economic factors. MATERIAL AND METHODS: Subjects aged 55­84 years (n = 16 416) were randomly sampled from the Swedish population by Statistics Sweden on four occasions (1980­81, 1988­89, 1996­97 and 2002). Trained interviewers collected information about dental status and anthropometric, demographic, socio-economic, lifestyle and health-related factors. Statistical analyses were based on logistic regression models. RESULTS: Edentulism decreased from 43% to 14% in the age group 55­84 years from 1980 to 2002, and the proportion of subjects with removable dentures decreased from 68% to 33%. In the age group 55­74 years, the proportion of subjects with low education decreased from 60% to 28%, and the proportion of obese subjects (body mass index ≥30 kg/m²) increased from 9% to 15%. In women aged 55­74 years, the association between obesity and edentulism, adjusted for health, lifestyle and socioeconomic factors, was significant in all surveys, and the odds ratio for obesity changed from 1.64 (95% confidence interval 1.18­2.27) in 1980 to 3.17 (95% confidence interval 1.69­6.18) in 2002. In men, the association was weaker and was significant only in the sample that combined all surveys and included individuals aged 55­84 years. CONCLUSION: The study indicated an association between edentulism and obesity, which was most obvious in women aged 55­74 years.

Changes in body composition and its relation to muscle strength in 75-year-old men and women: a 5-year prospective follow-up study of the NORA cohort in Göteborg, Sweden.

OBJECTIVE: The purpose of this study was to explore the association between body composition in the elderly and subsequent changes in muscle strength during aging. METHODS: This was a longitudinal study with a 5-y follow-up. Eighty-seven men (n = 38) and women (n = 49) from a random sample of 75-y-old subjects in the Göteborg part of the Nordic Research on Aging study who were investigated at ages 75 and 80 y and were free from any major diseases at baseline were included. Body composition was estimated from bioelectrical impedance. The maximal isometric strengths of handgrip, arm flexion, and knee extension were measured on the side of the dominant hand while a subject was in a sitting position in an adjustable dynamometer chair. RESULTS: Fat-free mass decreased significantly (P < 0.001) in both sexes, but more in men. Percentage of body fat increased only in men (P < 0.05). Body height decreased in both sexes, but more in women (P < 0.001). Declines in muscle strengths were evident for all muscle groups in both sexes but more prominent in men. It was observed that body composition status at baseline, measured as fat-free mass and fat-free mass index, was a statistically significant predictor for decline in muscle strength, particularly in the extremities. CONCLUSION: Fat-free mass at age 75 y was associated with lower 5-y decline in muscle strength. This finding underscores the potential importance of fat-free mass for maintaining functional ability during aging.

Obesity in 70-year-old subjects as a risk factor for 15-year coronary heart disease incidence.

OBJECTIVE: To investigate the role of obesity in general and waist circumference (WC) and BMI in particular as risk factors for 15-year incidence of coronary heart disease (CHD) in the elderly. RESEARCH METHODS AND PROCEDURES: This prospective study was based on 1597 (737 males and 860 females) 70-year-olds free from CHD and participants of three birth cohorts examined in 1971 to 1972 (Cohort I), 1976 to 1977 (Cohort II), and 1981 to 1982 (Cohort III) at Göteborg, Sweden. Fifteen-year incidence of CHD (fatal and nonfatal) was ascertained from follow-up examinations and registers. Relative risk (RR) for first ever CHD in reference to the lowest quartiles of WC and BMI was calculated from Cox regression. RESULTS: In males, RRs for CHD in the highest WC and BMI quartiles were 1.36 [95% confidence interval (CI) 1.00 to 1.85] and 1.42 (95% CI 1.04 to 1.92), respectively, after adjustment for cohorts, smoking habits, diabetes, systolic blood pressure, and total cholesterol. In men, the risk associated with WC was independent of BMI. Neither WC nor BMI was related to CHD risk in females. After exclusion of first 5-year all-cause deaths, the adjusted RRs in the highest WC and BMI quartiles in males were 1.47 (95% CI 1.06 to 2.04) and 1.42 (1.04 to 1.92), respectively. In females, a significantly higher RR of 1.41 (95% CI 1.02 to 1.94) was observed in the second BMI quartile only after such exclusions. DISCUSSION: WC, an indicator of both central and general obesity, appears to be a stronger predictor of CHD than BMI in elderly males, but in females, obesity was not a risk factor for CHD.

Waist circumference, body mass index, and risk for stroke in older people: a 15 year longitudinal population study of 70- year-olds.

OBJECTIVES: To investigate waist circumference (WC) and body mass index (BMI) at age 70 as risk factors for stroke. DESIGN: Cohort study of 70-year-olds with 15-year follow-up. SETTING: Geriatric Medicine Department, Göteborg University, Sweden. PARTICIPANTS: Two thousand two hundred eighty-seven (1,045 men; 1,242 women) 70-year-olds examined between 1971 and 1981 in Göteborg, Sweden. MEASUREMENTS: Cox regression model was used to calculate relative risk (RR) and 95% confidence interval (CI) for first-ever stroke (fatal and nonfatal) in reference to the lowest quartiles of WC and BMI. Tests for trend were performed fitting WC and BMI in their original continuous form. RESULTS: In men and women, RRs for stroke, in the highest WC quartile were 1.65 (95% CI = 1.08-2.51) and 1.31 (95% CI = 0.88-1.92), respectively, after adjustment for cohorts, smoking habit, coronary heart disease (CHD), diabetes mellitus, total cholesterol (TC), systolic blood pressure (SBP), and height at age 70. In men, RR for stroke in the highest BMI quartile (> or=28 kg/m2) was 1.68 (95% CI = 1.12-2.53) after adjustment for cohorts, smoking habits, CHD, diabetes mellitus, TC, and SBP at age 70. In women, adjusted RRs for stroke across the BMI quartiles were not significantly different. In men, population attributable fractions of stroke were 24.8% and 25.2% for the highest quartiles of WC and BMI, respectively. CONCLUSIONS: High WC (> or =99 cm) and BMI (> or =28 kg/m2) are risks for stroke in older men but not in older women.