A randomized, double-blind, placebo-controlled pilot study of naltrexone in outpatients with bipolar disorder and alcohol dependence.

BACKGROUND: Alcohol dependence is extremely common in patients with bipolar disorder and is associated with unfavorable outcomes including treatment nonadherence, violence, increased hospitalization, and decreased quality of life. While naltrexone is a standard treatment for alcohol dependence, no controlled trials have examined its use in patients with co-morbid bipolar disorder and alcohol dependence. In this pilot study, the efficacy of naltrexone in reducing alcohol use and on mood symptoms was assessed in bipolar disorder and alcohol dependence. METHODS: Fifty adult outpatients with bipolar I or II disorders and current alcohol dependence with active alcohol use were randomized to 12 weeks of naltrexone (50 mg/d) add-on therapy or placebo. Both groups received manual-driven cognitive behavioral therapy designed for patients with bipolar disorder and substance-use disorders. Drinking days and heavy drinking days, alcohol craving, liver enzymes, and manic and depressed mood symptoms were assessed. RESULTS: The 2 groups were similar in baseline and demographic characteristics. Naltrexone showed trends (p < 0.10) toward a greater decrease in drinking days (binary outcome), alcohol craving, and some liver enzyme levels than placebo. Side effects were similar in the 2 groups. Response to naltrexone was significantly related to medication adherence. CONCLUSIONS: Results suggest the potential value and acceptable tolerability of naltrexone for alcohol dependence in bipolar disorder patients. A larger trial is needed to establish efficacy.

Evaluation of androgenicity, abdominal adiposity, blood pressure and types of ovulatory patterns in a sample of women with menstrual irregularities

Objective: To determine the prevalence of and the relationships between the degree and source of hyperandrogenemia, ovulatory patterns and cardiovascular disease risk indicators (blood pressure, indices or amount of obesity and fat distribution) in women with menstrual irregularities seen at endocrinologists' clinic. Design: A cross-sectional study design. Participants: A sample of 159 women with menstrual irregularities, aged 15-44, seen at endocrinologists' clinic. Main Outcome Measures: androgen levels, body mass index (BMI), waist-hip ratio (WHR), systolic and diastolic blood pressure (SBP & DBP), source of androgens, ovulatory activity. Results: The prevalence of hyperandrogenemia was 54.7% in this study sample. As expected, women with acne or hirsutism had an odds ratio 12.5 (95%CI = 5.2-25.5) times and 36 (95%CI = 12.9-99.5) times more likely to have hyperandrogenemia than those without acne or hirsutism. The main findings of this study were the following: Hyperandrogenemic women were more likely to have oligomenorrheic cycles (OR = 3.8, 95%CI = 1.5-9.9), anovulatory cycles (OR = 6.6, 95%CI = 2.8-15.4), general obesity (BMI $\ge$ 27) (OR = 6.8, 95%CI = 2.2-27.2) and central obesity (WHR $\ge$ 127) (OR = 14.5, 95%CI = 6.1-38.7) than euandrogenemic women. Hyperandrogenemic women with non-suppressible androgens had a higher mean BMI (29.3 $\pm$ 8.9) than those with suppressible androgens (27.9 $\pm$ 7.9); the converse was true for abdominal adiposity (WHR). Hyperandrogenemic women had a 2.4 odds ratio (95%CI = 1.0-6.2) for an elevated SBP and a 2.7 odds ratio (95%CI = 0.8-8.8) for elevated DBP. When age differences were accounted for, this relationship was strengthened and further strengthened when sources of androgens were controlled. When the differences in BMI were controlled, the odds ratio for elevated SBP in hyperandrogenemic women increased to 8.8 (95%CI = 1.1-69.9). When the age, the source of androgens, the amount of obesity and the type of obesity were controlled, hyperandrogenemic women had 13.5 (95%CI = 1.1-158.9) odds ratio for elevated SBP. Conclusions: In this study population, the presence of menstrual irregularities are highly predictive for the presence of elevated androgens. Women with elevated androgens have a high risk for obesity, more specifically for central obesity. The androgenemic status is an independent predictor of blood pressure elevation. It is probable that in the general population, the presence of menstrual irregularities are predictive of hyperandrogenemia. There is a great need for a population study of the prevalence of hyperandrogenemia and for longitudinal studies in hyperandrogenemic women (adrenarche to menopause) to investigate the evolution of these relationships. ^

Ambulatory blood pressure and physical activity in heart failure

Background. Ambulatory blood pressure (ABP) measurement is a means of monitoring cardiac function in a noninvasive way, but little is known about ABP in heart failure (HF) patients. Blood pressure (BP) declines during sleep as protection from consistent BP load, a phenomenon termed "dipping." The aims of this study were (1) to compare BP dipping and physical activity between two groups of HF patients with different functional statuses and (2) to determine whether the strength of the association between ambulatory BP and PA is different between these two different functional statuses of HF. ^ Methods. This observational study used repeated measures of ABP and PA over a 24-hour period to investigate the profiles of BP and PA in community-based individuals with HF. ABP was measured every 30 minutes by using a SpaceLabs 90207, and a Basic Motionlogger actigraph was used to measure PA minute by minute. Fifty-six participants completed both BP and physical activity for a 24-hour monitoring period. Functional status was based on New York Heart Association (NYHA) ratings. There were 27 patients with no limitation of PA (NYHA class I HF) and 29 with some limitation of PA but no discomfort at rest (NYHA class II or III HF). The sample consisted of 26 men and 30 women, aged 45 to 91 years (66.96 ± 12.35). ^ Results. Patients with NYHA class I HF had significantly greater dipping percent than those with NYHA class II/III HF after controlling their left ventricular ejection fraction (LVEF). In a mixed model analysis (PROC MIXED, SAS Institute, v 9.1), PA was significantly related to ambulatory systolic and diastolic BP and mean arterial pressure. The strength of the association between PA and ABP readings was not significantly different for the two groups of patients. ^ Conclusions. These preliminary findings demonstrate differences between NYHA class I and class II/III of HF in BP dipping status and ABP but not PA. Longitudinal research is recommended to improve understanding of the influence of disease progression on changes in 24-hour physical activity and BP profiles of this patient population. ^ Key Words. Ambulatory Blood Pressure; Blood Pressure Dipping; Heart Failure; Physical Activity. ^

A geographic analysis of liver cancer mortality and alcohol dependence or abuse in Texas and the U.S., 1980--2003

Background. Liver cancer mortality continues to be a significant factor in deaths worldwide and in the U.S., yet there remains a lack of studies on how mortality burden is impacted by racial groups or by heavy alcohol use. This study evaluated the geographic distribution of liver cancer mortality across population groups in Texas and the U.S. over a 24-year period, as well as determining whether alcohol dependence or abuse correlates with mortality rates. ^ Methods. The Spatial Scan Statistic was used to identify regions of excess liver cancer mortality in Texas counties and the U.S. from 1980 to 2003. The statistic was conducted with a spatial cluster size of 50% of the population at risk, and all analyses used publicly available data. Alcohol abuse data by state and ethnicity were extracted from SAMHSA datasets for the study period 2000–2004. ^ Results. The results of the geographic analysis of liver cancer mortality in both Texas and the U.S. indicate that there were four and seven regions, respectively, that were identified as having statistically significant excess mortality rates with elevated relative risks ranging from 1.38–2.07 and 1.05–1.623 (p = 0.001), respectively. ^ Conclusion. This study revealed seven regions of excess mortality of liver cancer mortality across the U.S. and four regions of excess mortality in Texas between 1980–2003, as well as demonstrated a correlation between elevated liver cancer mortality rates and reporting of alcohol dependence among Hispanics and Other populations. ^

Illicit drug use, alcohol use and nicotine dependence as predictors of antiretroviral adherence in a sample of HIV positive smokers

Objective. Predictors of non-adherence to antiretroviral medications in a population of low-income, multiethnic, HIV-positive smokers were investigated. ^ Methods. A secondary analysis was conducted using baseline data collected from 326 patients currently prescribed antiretrovirals enrolled in a randomized clinical trial assessing smoking outcomes. Variables evaluated included demographics, stress, depression, nicotine dependence, illicit drug use and alcohol use. ^ Results. The average age of participants was 45.9 years (SD=7.6). The majority of participants were male (72.1%), Black (76.7%), reported sexual contact as the method of HIV exposure (heterosexual (43%) and MSM (27%)) and were antiretroviral adherent (60.4%). Results from unadjusted analyses indicated depression (OR=1.02; 95% CI=1.00-1.04), illicit drug use (OR=2.39; 95% CI=1.51-3.79) and alcohol consumption (OR=2.86; 95% CI=1.79-4.57) were associated with non-adherence. Multivariate analyses indicated nicotine dependence (OR=1.13; 95% CI=1.02-1.25), illicit drug use (OR=2.10; 95% CI=1.27-3.49) and alcohol use (OR=2.50; 95% CI=1.52-4.12) were associated with nonadherence. ^ Conclusions. Illicit drug use, alcohol use and nicotine dependence are formidable barriers to antiretroviral adherence in this population. Future research is needed to assess how to address these variables in the context of improving antiretroviral adherence for individuals living with HIV/AIDS.^

Blood pressure and dietary factors in Mexican-Americans of Starr County, Texas

This study examined the cross-sectional associations between blood pressure, hypertension and dietary factors among 580 Mexican-American adults residing in Starr County, Texas. The data were collected as part of Gallbladder Disease Study between April, 1985 and December, 1986.^ Dietary intake was assessed for the month previous to the interview by means of a 38 food item quantified frequency questionnaire representing foods and mixed dishes commonly consumed in the community. From the dietary information intake of calcium, cholesterol, total kilocalories, and percent of kilocalories contributed by total fat, saturated fat, monounsaturated fatty acids, polyunsaturated fatty acids, protein, carbohydrates were calculated. The effect of other factors associated with blood pressure, such as age, body mass index, body fat distribution, smoking, and drinking were controlled.^ Age was the most important predictor of both systolic and diastolic blood pressure and hypertension. For both males and females, systolic and diastolic blood pressure levels were consistently positively associated with body mass index but were not associated with waist hip ratio. However, a strong positive relationship between hypertension and waist hip ratio but not body mass index was observed.^ After controlling for age and body mass index it was noted that for males there were no significant associations between the dietary variables and systolic blood pressure. For diastolic blood pressure there were significant associations with percent fat, percent monounsaturated fatty acids, percent protein and percent carbohydrates.^ For females, there were significant associations between systolic blood pressure and percent protein, percent carbohydrates and cholesterol. There were no significant associations between dietary variables and diastolic blood pressure.^ After controlling for age and waist hip ratio significant associations between hypertension and percent fat, percent saturated fat, percent monounsaturated fatty acids, percent carbohydrate and percent protein were observed in males. Significant associations between hypertension and percent polyunsaturated fatty acids and percent protein were noted in females. ^

The effect of life events on blood pressure and body mass index in children

In Conroe, Texas, 492 students ages 5 to 15 participated in a screening examination for cardiovascular risk factor study. Among 492 students, 141 elementary and junior high students participated in the present sub-study to investigate the effect of the number of recent life events on blood pressure and on body mass index. Using the elementary and junior high school Coddington scales, life events occurring in the past 12 months were measured for students ages 9 to 14 years, no significant differences in life events were observed by age and sex. The number of life events was not related to blood pressure but was positively correlated to body mass index in children and adolescents. ^

Low birthweight and the risk of developing subsequent high blood pressure and/or dyslipidemia in childhood

The association between birthweight and blood pressure (BP), and birthweight and serum lipid concentrations at age 7 through 11 years was examined in 1446 black and white children. The prevalence ratio (with 95% confidence interval) for being in the race-, sex- and age-specific upper decile of diastolic BP in children born with low birthweight (LBW, $<$2500 grams) versus children with birthweight $\geq$2500 grams was for black boys, 2.66 (1.24-5.70). In the other race-sex groups for diastolic BP, and in all race-sex groups for systolic BP this ratio did not differ from one. Among white boys with LBW, but not in the other race-sex groups, higher than expected percentages of subjects were in the highest decile group of triglyceride concentrations (0.01 $<$ p $<$ 0.05). The prevalence ratio was 2.42 (1.19-4.91). When prematures were excluded only more than expected white girls with LBW were in the highest decile group of triglyceride concentrations. The prevalence ratio was 3.23 (1.16-9.00). Prevalence ratios for triglyceride concentrations in black boys and girls, and for LDL/HDL-C ratio, cholesterol and VLDL-C concentrations in all race-sex groups were not different from one in analyses including and in those excluding prematures. Mean triglyceride concentrations stratified by tertiles of Quetelet Index, race and sex showed a strongly positive association between triglyceride concentrations and Quetelet Index, and in the upper tertile of the Quetelet Index an association between LBW and raised triglyceride concentrations. Multiple linear regression analyses showed that after adjusting for sex, race and age present Quetelet Index (p $<$ 0.001) is a much stronger predictor of systolic and diastolic BP, and also of LDL-C/HDL-C ratio and triglyceride concentrations in this age group than birthweight (p $>$ 0.05). Thus, an association between LBW and subsequent risk for elevated BP was confirmed for diastolic BP in black boys, but not for the other race-sex groups, and not for systolic BP in any group. This is the first study finding an association between LBW and elevated triglyceride concentrations in boys (white and black) and girls (white). A follow-up study to assess whether the findings can be confirmed at adult age is recommended. ^