The Cure SMA Membership Surveys: Highlights of Key Demographic and Clinical Characteristics of Individuals with Spinal Muscular Atrophy.

BACKGROUND: Cure SMA maintains the largest patient-reported database for people affected with spinal muscular atrophy (SMA). In 2017, Cure SMA initiated annual surveys with their membership to collect demographic and disease characteristics, healthcare, and burden of disease information from patients and caregivers. OBJECTIVE: To summarize results from two large-scale Cure SMA surveys in 2017 and 2018. METHODS: Cure SMA database members were invited to complete surveys; these were completed by caregivers for living or deceased individuals with SMA and/or affected adults. RESULTS: In 2017, 726 surveys were completed for 695 individuals with SMA; in 2018, 796 surveys were completed for 760 individuals with SMA. Data from both survey years are available for 313 affected individuals. Age at symptom onset, distribution of SMN2 gene copy number, and representation of each SMA type in the surveys were consistent with that expected in the SMA population. In the 2018 survey, the average age at diagnosis was 5.2 months for SMA type I and the reported mean age at death for this subgroup was 27.8 months. Between survey years, there was consistency in responses for factors that should not change within individuals over time (e.g., reported age at diagnosis). CONCLUSIONS: Results from the Cure SMA surveys advance the understanding of SMA and facilitate advocacy efforts and healthcare services planning. Longitudinal surveys are important for evaluating the impact of effective treatments on changing phenotypes, and burden of disease and care in individuals with SMA.

Prescriber Compliance With Liver Monitoring Guidelines for Pazopanib in the Postapproval Setting: Results From a Distributed Research Network.

OBJECTIVES: Pazopanib received US Food and Drug Administration approval in 2009 for advanced renal cell carcinoma. During clinical development, liver chemistry abnormalities and adverse hepatic events were observed, leading to a boxed warning for hepatotoxicity and detailed label prescriber guidelines for liver monitoring. As part of postapproval regulatory commitments, a cohort study was conducted to assess prescriber compliance with liver monitoring guidelines. METHODS: Over a 4-year period, a distributed network approach was used across 3 databases: US Veterans Affairs Healthcare System, a US outpatient oncology community practice database, and the Dutch PHARMO Database Network. Measures of prescriber compliance were designed using the original pazopanib label guidelines for liver monitoring. RESULTS: Results from the VA (n = 288) and oncology databases (n = 283) indicate that prescriber liver chemistry monitoring was less than 100%: 73% to 74% compliance with baseline testing and 37% to 39% compliance with testing every 4 weeks. Compliance was highest near drug initiation and decreased over time. Among patients who should have had weekly testing, the compliance was 56% in both databases. The more serious elevations examined, including combinations of liver enzyme elevations meeting the laboratory definition of Hy's law were infrequent but always led to appropriate discontinuation of pazopanib. Only 4 patients were identified for analysis in the Dutch database; none had recorded baseline testing. CONCLUSIONS: In this population-based study, prescriber compliance was reasonable near pazopanib initiation but low during subsequent weeks of treatment. This study provides information from real-world community practice settings and offers feedback to regulators on the effectiveness of label monitoring guidelines.

Cumulative Burden of Glucocorticoid-related Adverse Events in Patients with Systemic Lupus Erythematosus: Findings from a 12-year Longitudinal Study.

OBJECTIVE: The aim of this population-based study is to examine the adverse events (AE) associated with longitudinal systemic glucocorticoid (GC) use among an ethnic Chinese systemic lupus erythematosus (SLE) cohort. METHODS: Our study subjects were patients with newly diagnosed SLE aged 18 and older who received at least 1 prescription of systemic GC between 2001 and 2012 from Taiwan's National Health Insurance Research Database (NHIRD). The earliest prescription date of systemic GC for each subject was defined as the index date. For each subject, we calculated the average prednisolone-equivalent dose and the medication possession ratio (MPR) of GC use every 90 days for each patient after the index date. Patients with a diagnosis of AE (defined by the International Classification of Diseases-9-Clinical Modification diagnosis code) during the followup were also identified from the NHIRD. Generalized estimating equations adjusted for propensity score were applied to examine the association between longitudinal GC use and risks of prespecified AE (musculoskeletal, gastrointestinal, ophthalmologic, infectious, cardiovascular, neuropsychiatric, metabolic, and dermatologic diseases). RESULTS: We identified 11,288 patients with SLE (mean followup: 6.28 yrs). Higher doses and higher MPR of GC were associated with increased risk of osteonecrosis [adjusted OR (aOR) 2.87-9.09]. Similar results were found regarding the risk of osteoporosis (aOR 1.71-3.67), bacterial infection (aOR 2.12-3.89), Cushingoid syndrome (aOR 6.51-62.03), and sleep disorder (aOR 1.42-3.59). CONCLUSION: To our knowledge, this is the first study to show that the dose and intensity of longitudinal use of GC were both associated with risk of AE among a nationwide Asian SLE cohort.

Occurrence of hepatotoxicity with pazopanib and other anti-VEGF treatments for renal cell carcinoma: an observational study utilizing a distributed database network.

PURPOSE: To quantify the hepatic safety of pazopanib and comparator anti-vascular endothelial growth factor (VEGF) therapies in clinical practice among renal cell carcinoma (RCC) patients. METHODS: A population-based cohort study of new anti-VEGF users was conducted in two US healthcare databases, Department of Veterans Affairs (VA) and an oncology practice network (Altos), and the PHARMO Database Network in The Netherlands. A common protocol was used to collect liver chemistry (LC) data from anti-VEGF initiation through 4 years of follow-up. In the VA population, suspected drug-induced liver injury (DILI) outcomes were investigated via chart review, with adjudication by hepatologists. RESULTS: In Altos and VA, respectively, the total RCC patients were: pazopanib (156, 243), bevacizumab (122, 99), sorafenib (82, 249) and sunitinib (285, 751). PHARMO contained too few patients to be included. Few cases of alanine aminotransferase (ALT) ≥8× the upper limit of normal were seen across the anti-VEGF cohorts; incidence rates (per 100 person-years) ranged from 0 (sunitinib) to 8.2 (pazopanib) in Altos and from 0 (bevacizumab and sorafenib) to 2.1 (pazopanib) among VA patients. No cases of Hy's law identified by combination LC elevations were seen in patients treated with pazopanib or bevacizumab; one case was observed in those treated with sorafenib, and two cases were found among sunitinib users. One case of adjudicated DILI was observed in a sunitinib-treated patient; none were found among patients treated with pazopanib, bevacizumab or sorafenib. CONCLUSIONS: Severe liver injury occurred infrequently during exposure to pazopanib and other anti-VEGF therapies in a population-based setting.

Racial ethnic differences in type 2 diabetes treatment patterns and glycaemic control in the Boston Area Community Health Survey.

OBJECTIVES: Numerous studies continue to report poorer glycaemic control, and a higher incidence of diabetes-related complications among African-Americans and Hispanic-Americans as compared with non-Hispanic Caucasians with type 2 diabetes. We examined racial/ethnic differences in receipt of hypoglycaemic medications and glycaemic control in a highly insured Massachusetts community sample of individuals with type 2 diabetes. SETTING: Community-based sample from Boston, Massachusetts, USA. PARTICIPANTS: 682 patients with physician-diagnosed diabetes from the third wave of the Boston Area Community Health Survey (2010-2012). The study included approximately equal proportions of African-Americans, Hispanics and Caucasians. METHODS: We examined racial/ethnic disparities in diabetes treatment by comparing proportions of individuals on mutually exclusive diabetes treatment regimens across racial/ethnic subgroups. Using multivariable linear and logistic regression, we also examined associations between race/ethnicity and glycaemic control in the overall population, and within treatment regimens, adjusting for age, gender, income, education, health insurance, health literacy, disease duration, diet and physical activity. RESULTS: Among those treated (82%), the most commonly prescribed antidiabetic regimens were biguanides only (31%), insulin only (23%), and biguanides and insulin (16%). No overall racial/ethnic differences in treatment or glycaemic control (per cent difference for African-Americans: 6.18, 95% CI -1.00 to 13.88; for Hispanic-Americans: 1.01, 95% CI -10.42 to 12.75) were observed. Within regimens, we did not observe poorer glycaemic control for African-Americans prescribed biguanides only, insulin only or biguanides combined with insulin/sulfonylureas. However, African-Americans prescribed miscellaneous regimens had higher risk of poorer glycaemic control (per cent difference=23.37, 95% CI 7.25 to 43.33). There were no associations between glycaemic levels and Hispanic ethnicity overall, or within treatment regimens. CONCLUSIONS: Findings suggest a lack of racial/ethnic disparities in diabetes treatment patterns and glycaemic control in this highly insured Massachusetts study population. Future studies are needed to understand impacts of increasing insurance coverage on racial/ethnic disparities in treatment patterns and related outcomes.

Reproductive history and progression of lower urinary tract symptoms in women: results from a population-based cohort study.

OBJECTIVE: To examine whether reproductive history and related conditions are associated with the development and persistence of lower urinary tract symptoms (LUTS) other than urinary incontinence in a racially and/or ethnically diverse population-based sample of women. MATERIALS AND METHODS: The Boston Area Community Health Survey enrolled 3201 women aged 30-79 years of black, Hispanic, or white race and/or ethnicity. Baseline and 5-year follow-up interviews were completed by 2534 women (conditional response rate, 83.4%). The association between reproductive history factors and population-weighted estimates of LUTS progression and persistence was tested using multivariable logistic regression models. RESULTS: Between baseline and 5-year follow-up, 23.9% women had LUTS progression. In age-adjusted models, women who had delivered ≥2 childbirths had higher odds of LUTS progression, but the association was completely accounted for by vaginal child delivery (eg, 2 vaginal childbirths vs none, multivariable-adjusted odds ratio = 2.21; 95% CI, 1.46-3.35; P <.001). No increased odds of LUTS progression were found for women with only 1 vaginal delivery or who only had cesarean section(s). Uterine prolapse was associated with higher odds of LUTS progression (multivariable-adjusted odds ratio = 3.05; 95% CI, 1.43-6.50; P = .004). Gestational diabetes was associated with approximately twice the odds of LUTS progression, but only among younger women (interaction P = .003). CONCLUSION: In this cohort study, ≥2 vaginal child deliveries, uterine prolapse, and among younger women, gestational diabetes were robust predictors of LUTS progression. Clinicians should assess the presence of bothersome urinary frequency, urgency, and voiding symptoms among women who have had multiple vaginal childbirths or gestational diabetes.

Has Massachusetts health care reform worked for the working poor? Results from an analysis of opportunity.

PURPOSE: Health care reform was introduced in Massachusetts (MA) in 2006 and serves as a model for what was subsequently introduced nationally as the Patient Protection and Affordable Care Act. The Boston Area Community Health survey collected data before (2002-2005) and after (2006-2010) introduction of the MA health insurance mandate, providing a unique opportunity to assess its effects in a large, epidemiologic cohort. METHODS: We report on the apparent effects of the mandate on the same participants over time, focusing specifically on the vulnerable working poor (WP). We evaluated differences in subpopulations of interest at pre- and post-reform periods to explore whether MA health care reform resulted in an overall gain in insurance coverage. RESULTS: MA health care reform was associated with net gains in health insurance coverage overall and among the subgroups studied. Our findings suggest that despite being targeted by health care reform legislation, the WP in MA continue to report lower rates of insurance coverage compared with both the nonworking poor and the not poor. CONCLUSIONS: MA health care reform legislation, including the expansion of Medicaid, resulted in substantial overall gains in coverage. Disparities in insurance coverage persist among some subgroups following health care reform implementation in MA. These results have important implications for health services researchers and policy makers, particularly in light of the ongoing implementation of the Patient Protection and Affordable Care Act.

Population-based patterns of prescription androgen use, 1976-2008.

PURPOSE: Prescription testosterone (T) has limited approved medical indications and is a controlled substance in Canada. Utilization studies in other Westernized countries have revealed sharp increases in T use in recent years. We examined medical use of androgens, including T, over a ≥30-year period among adult (18+) men in a population-based study set in a Canadian juridisdiction of universal health care. METHODS: Analyses were based on data from electronic records of dispensed prescriptions during 1976-2008 in Saskatchewan, Canada. All formulations of androgens listed in the provincial formulary (oral and injectable) were included. We examined demographics of users, androgen types used, switching patterns, and trends in the annual rate of use over time. RESULTS: There were 11 521 androgen users who were followed for an average of 11.8 years. Overall, 11 types of androgens were used, and there were 86 812 dispensing events. The mean age at first use was 56.4 years (median: 58). Men had 7.5 prescription dispensing events on average (median: 2). The most commonly used formulations were methyl-T (36.2% of users) followed by T-enanthate (32.5%), T-cypionate (22.3%), and T-undecanoate (20.0%). Most users (82%) did not switch among androgen types. The annual rate of use varied substantially over time, with a marked increase observed from 1994 to 1999 and a decrease from 2000 to 2008. CONCLUSIONS: Androgen users were largely middle aged and had relatively few dispensings. We hypothesize that observed secular trends in androgen use may align with drug treatment pattern changes for erectile dysfunction, including the advent of phosphodiesterase type 5 inhibitors.

Treatment status and risk factors for incidence and persistence of urinary incontinence in women.

INTRODUCTION AND HYPOTHESIS: The objective of this analysis was to describe urinary incontinence (UI) incidence and persistence over 5 years in association with treatment status, sociodemographic, medical, and lifestyle factors, in a racially/ethnically diverse population-based female sample. METHODS: The Boston Area Community Health Survey enrolled 3,201 women aged 30-79 years of black, Hispanic, and white race/ethnicity. Five-year follow-up was completed by 2,534 women (conditional response rate 83.4 %), allowing population-weighted estimates of UI incidence and persistence rates. Predictors of UI were determined using multivariate logistic regression models. RESULTS: Incidence of UI at least monthly was 14.1 % and weekly 8.9 %. Waist circumference at baseline and increasing waist circumference over 5-year follow-up were the most robust predictors of UI incidence in multivariate models (P ≤ 0.01). Among 475 women with UI at baseline, persistence was associated with depression symptoms [monthly UI, odds ratio (OR) = 2.39, 95 % confidence interval (CI) 1.14-5.02] and alcohol consumption (weekly UI, OR = 3.51, 95 % CI 1.11-11.1). Among women with weekly UI at baseline, 41.7 % continued to report weekly UI at follow-up, 14.1 % reported monthly UI, and 44.2 % had complete remission. Persistence of UI was not significantly higher (58.2 % vs. 48.0 %, chi-square P = 0.3) among untreated women. Surgical or drug treatment for UI had little impact on estimates for other risk factors or for overall population rates of persistence or remission. CONCLUSIONS: Women with higher gains in waist circumference over time were more likely to develop UI, but waist circumference was not predictive of UI persistence. UI treatments did not affect associations for other risk factors. Additional research on the role of alcohol intake in UI persistence is warranted.

Treatment status and progression or regression of lower urinary tract symptoms in a general adult population sample.

PURPOSE: We report progression and regression of lower urinary tract symptoms in a population based cohort by race/ethnicity, gender, age and lower urinary tract symptom medication use. MATERIALS AND METHODS: The BACH (Boston Area Community Health) Survey enrolled 5,502 participants 30 to 79 years old of black, Hispanic or white race/ethnicity. The 5-year followup interviews were completed by 1,610 men and 2,534 women for a conditional response rate of 80%. Population weighted estimates of lower urinary tract symptoms severity were assessed using the AUASI (American Urological Association symptom index) and analyzed using multivariate models. RESULTS: Symptom progression (increase in AUASI score of 3 or more points) was reported by 21% to 33% of participants and regression (decrease 3 or greater) by 30% to 44% of participants, most commonly women and Hispanic participants. Age and higher body mass index were associated with progression (p <0.01), but not with regression. Lower urinary tract symptom medication use at baseline only was associated with improved symptoms scores 5 years later (multivariate adjusted OR 3.10, 95% CI 1.28-7.51, compared to nonusers), whereas using medication at baseline and followup was associated with similar rates of progression and regression as observed among participants not using lower urinary tract symptom medication at either point. CONCLUSIONS: Lower urinary tract symptoms persisted at followup for approximately half of the population experiencing symptoms at baseline, including many men and women using lower urinary tract symptom medications. However, overall lower urinary tract symptom medication use and surgical treatment appeared beneficial for symptom control at 5-year followup. Age and body mass index were associated with symptom worsening, and Hispanic ethnicity was associated with greater symptom fluctuation. Clinicians should consider the higher likelihood of lower urinary tract symptom progression for older or heavier patients, and monitor responsiveness to lower urinary tract symptom medication.

Common prescription medication use and erectile dysfunction: results from the Boston Area Community Health (BACH) survey.

OBJECTIVE: To investigate the association of erectile dysfunction (ED) with commonly used medications including antihypertensive treatment (AHT), psychoactive medication and pain and anti-inflammatory medication. SUBJECTS AND METHODS: The Boston Area Community Health (BACH) survey used a multistage stratified design to recruit a random sample of 2301 men aged 30-79 years. ED was assessed using the five-item International Index of Erectile Function (IIEF-5). Prescription medications, captured using a combination of drug inventory and self-report with a prompt by indication, included in this analysis comprised AHT, psychoactive medication, and pain and anti-inflammatory medication. Logistic regression was used to estimate the odds ratios (ORs) of the association of medication use with ED and to adjust for potential confounders including age, comorbid conditions and sociodemographic and lifestyle factors. RESULTS: Multivariable analyses showed benzodiazepines (adjusted OR = 2.34, 95% confidence interval [CI]: 1.03, 5.31) and tricyclic antidepressants (adjusted OR = 3.35, 95% CI: 1.09, 10.27) were associated with ED, while no association was observed for serotonin reuptake inhibitors/serotonin-norepinephrine reuptake inhibitors and atypical antipsychotics. The use of AHT, whether in monotherapy or in conjunction with other AHTs, and pain or anti-inflammatory medications were not associated with ED after accounting for confounding factors. CONCLUSIONS: Results of the BACH survey suggest adverse effects of some psychoactive medications (benzodiazepines and tricyclic antidepressants). No evidence of an association of AHT or pain and anti-inflammatory medication with ED was observed.

Prevalence and overlap of childhood and adult physical, sexual, and emotional abuse: a descriptive analysis of results from the Boston Area Community Health (BACH) survey.

Abuse is associated with a wide variety of health problems, yet comprehensive population-based data are scant. Existing literature focuses on a single type of abuse, population, or lifestage. Using a racially/ethnically diverse community-based sample, we document the prevalence of physical, emotional, and sexual abuse by lifestage and gender, assess variation in abuse by sociodemographics; establish overlap of abuses; and examine childhood abuse relationships with abuse in adulthood. Prevalence of abuse ranges from 15% to 27%; women report more adulthood emotional abuse and lifetime sexual abuse than men; reports of abuse can vary by race/ethnicity and poverty status, particularly in women; there is overlap between types of abuse; and a history of childhood abuse is associated with a greater risk of abuse as an adult.

Association of lower urinary tract symptoms and the metabolic syndrome: results from the Boston area community health survey.

PURPOSE: In this study we investigated the relationship between lower urinary tract symptoms as defined by the American Urological Association symptom index and the metabolic syndrome, and determined the relationship between individual symptoms comprising the American Urological Association symptom index and the metabolic syndrome. MATERIALS AND METHODS: The Boston Area Community Health Survey used a 2-stage cluster design to recruit a random sample of 2,301 men 30 to 79 years old. Analyses were conducted on 1,899 men who provided blood samples. Urological symptoms comprising the American Urological Association symptom index were included in the analysis. The metabolic syndrome was defined using a modification of the Adult Treatment Panel III guidelines. The association between lower urinary tract symptoms and the metabolic syndrome was assessed using odds ratios and 95% confidence intervals estimated using logistic regression models. RESULTS: Increased odds of the metabolic syndrome were observed in men with mild to severe symptoms (American Urological Association symptom index 2 to 35) compared to those with an American Urological Association symptom index score of 0 or 1 (multivariate OR 1.68, 95% CI 1.21-2.35). A statistically significant association was observed between the metabolic syndrome and a voiding symptom score of 5 or greater (multivariate adjusted OR 1.73, 95% CI 1.06-2.80) but not for a storage symptom score of 4 or greater (multivariate adjusted OR 0.94, 95% CI 0.66-1.33). Increased odds of the metabolic syndrome were observed even with mild symptoms, primarily for incomplete emptying, intermittency and nocturia. These associations were observed primarily in younger men (younger than 60 years) and were null in older men (60 years old or older). CONCLUSIONS: The observed association between urological symptoms and the metabolic syndrome provides further evidence of common underlying factors between lower urinary tract symptoms and chronic conditions outside the urinary tract.

Contributors to self-reported health in a racially and ethnically diverse population: focus on Hispanics.

PURPOSE: To understand if Hispanics report health differently than other racial and ethnic groups after controlling for demographics and risk factors for poor health. METHODS: The sample (N = 5502) included 3201 women, 1767 black, 1859 white, and 1876 Hispanic subjects from the Boston Area Community Health Survey, a population-based survey of English- and Spanish-speaking residents of Boston, Massachusetts, United States, aged 30-79 years in 2002-2005. Multiple logistic regression models were used to examine the association between race/ethnicity (including interview language for Hispanics) and fair/poor self-reported health (F/P SRH) adjusting for gender, age, socioeconomic status, depression, nativity, and comorbidities. RESULTS: Compared with whites, Hispanics interviewed in Spanish were seven times as likely to report F/P SRH (odds ratio, 7.7; 95% confidence interval, 4.9-12.2) after adjusting for potential confounders and those interviewed in English were twice as likely. In analyses stratified by depression and nativity, we observed stronger associations with Hispanic ethnicity in immigrants and nondepressed individuals interviewed in Spanish. CONCLUSIONS: Increased odds of F/P SRH persisted in the Hispanic group even when accounting for interview language and controlling for socioeconomic status, age, depression, and nativity, with interview language mitigating the association. These findings have methodological implications for epidemiologists using SRH across diverse populations.

Characteristics of persons with overactive bladder of presumed neurologic origin: results from the Boston Area Community Health (BACH) survey.

AIMS: To compare the descriptive epidemiology of overactive bladder (OAB) of presumed neurologic origin (NOAB) to OAB of non-neurologic origin (N-NOAB). METHODS: Five thousand five hundred three community-dwelling persons aged 30-79 were interviewed regarding urologic symptoms (2002-2005). NOAB was defined as symptoms of urgency and/or urgency incontinence among those with a self-reported history of healthcare provider diagnosed stroke (N = 98), multiple sclerosis (N = 21), or Parkinson's disease (N = 7). N-NOAB was defined identically but occurring among those not reporting neurologic disease (ND). Prevalence estimates were weighted to reflect sampling design; chi-square, Fisher's exact, or t-tests were used to test differences. Urologic symptom interference was assessed using the Epstein scale, while the impact of urinary incontinence (UI) on health-related quality-of-life (HRQOL) was measured using a modification of the Incontinence Impact Questionnaire-7. RESULTS: Forty-five (31.0%) of 125 persons with ND and 994 (16.7%) of 5378 persons without ND reported OAB symptoms. The overall prevalence of NOAB and N-NOAB was 0.6% and 16.4%, respectively. Persons with NOAB had higher (worse) mean American Urologic Association Symptom Index scores (13.0 vs. 10.0, P = 0.09) compared to those with N-NOAB, and were significantly more likely to have diabetes, high blood pressure, cardiac disease, and fair/poor self-reported health (all P < 0.05). Mean symptom interference and UI HRQOL scores were significantly higher (worse) in the NOAB group compared to persons with N-NOAB (all P < 0.05). CONCLUSIONS: Persons with NOAB appeared to have a greater burden of urologic illness with respect to symptom interference and HRQOL compared to persons with N-NOAB.

Associations of commonly used medications with urinary incontinence in a community based sample.

PURPOSE: We examined the association between the use of medications and the prevalence of urinary incontinence in gender specific analyses of a community based, representative sample. MATERIALS AND METHODS: A population based epidemiological study was conducted of 5,503 men and women 30 to 79 years old residing in Boston, Massachusetts (baseline data collected from 2002 to 2005). Urological symptoms were ascertained in a 2-hour, in person interview. Urinary incontinence was defined as urine leakage occurring weekly or more often during the last year. Medications used in the last month were considered current use. Associations of 20+ medications and prevalent urinary incontinence were examined using multivariate logistic regression (ORs and 95% CIs) with adjustments for known urinary incontinence risk factors. RESULTS: The prevalence of urinary incontinence in the analysis sample was 9.0% in women and 4.6% in men. For women the prevalence was highest among users of certain antihistamines (28.4%) and angiotensin II receptor blockers (22.9%). For men the prevalence was highest among angiotensin II receptor blocker (22.2%) and loop diuretic (19.1%) users. After final multivariate adjustment there were significant positive associations for certain antihistamines, beta receptor agonists, angiotensin II receptor blockers and estrogens with urinary incontinence in women (all ORs greater than 1.7), and a borderline significant association for anticonvulsants (OR 1.75; 95% CI 1.00, 3.07). Among men only anticonvulsants were associated with urinary incontinence after final adjustments (OR 2.50; 95% CI 1.24, 5.03), although angiotensin II receptor blockers showed an adjusted association of borderline significance (OR 2.21; 95% CI 0.96, 5.10). CONCLUSIONS: Although a cross-sectional analysis cannot determine causality, our analysis suggests certain medications should be further examined in longitudinal analyses of risk to determine their influence on urological symptoms.

Commonly used antihypertensives and lower urinary tract symptoms: results from the Boston Area Community Health (BACH) Survey.

UNLABELLED: Study Type - Prevalence (inception cohort) Level of Evidence 1b What's known on the subject? and What does the study add? Certain antihypertensives, particularly diuretics and calcium channel blockers, are known to be associated with increased risk of LUTS including nocturia, but little is known about gender-specific effects. This is the first epidemiological study, to our knowledge, to compare the prevalence of several urological symptoms (storage, voiding and nocturia) among male and female users of a wide variety of common antihypertensives using a community-based sample. OBJECTIVE: To examine differences in the prevalence of lower urinary tract symptom (LUTS) among users of five common AHT classes compared with non-users, adjusted for LUTS risk factors in a large, representative sample. SUBJECTS AND METHODS: Data were from the Boston Area Community Health Survey, a population-based study of community-dwelling male and female (30-79 years) residents of Boston, MA, USA for whom prescription drug information was collected between 2002 and 2005. The urological symptoms of storage, voiding, and nocturia were assessed using interviewer-administered questionnaires and the American Urological Association Symptom Index. This analysis was conducted among 1865 participants with an AHT indication. Associations of angiotensin-converting enzyme inhibitors, beta blockers, calcium channel blockers (CCBs) and loop and thiazide diuretics with the three groups of LUTS were estimated using odds ratios (ORs) and 95% confidence intervals (CIs) from multivariate logistic regression (referent group: untreated hypertension). Overlap in use was accounted for using monotherapy and combination therapy exposure categories. RESULTS: Among women, monotherapy with CCBs was associated with increased prevalence of nocturia (OR = 2.65, 95% CI: 1.04-6.74) and voiding symptoms (OR = 3.84, 95% CI: 1.24-11.87); these results were confined to women aged <55 years. Among men of all ages, positive associations were observed for thiazides and voiding symptoms (monotherapy OR = 2.90, 95% CI: 1.17-7.19), and loop diuretics and nocturia (combination therapy OR = 2.55, 95% CI: 1.26-5.14). CONCLUSION: Results are consistent with the hypothesis that certain AHTs may aggravate LUTS. The presence of new or worsening LUTS among AHT users suggests medications should be reviewed and a change in AHT class considered.

Non steroidal anti-inflammatory drug use and levels of oestrogens and androgens in men.

OBJECTIVE: Studies suggest that regular use of nonsteroidal anti-inflammatory drugs (NSAIDs) may lower oestrogen levels in women. However, no large, population-based studies have assessed NSAID/hormone associations in men. Our objective was to examine the association between use of prescription and over-the-counter NSAIDs, and levels of oestrogens and androgens in men. DESIGN: The Boston Area Community Health Survey, an observational survey with initial data collection in 2002-2005. PATIENTS: A total of 1766 men who provided a blood sample and data on recent analgesic use. MEASUREMENTS: Adjusted geometric mean levels of androgens, oestrogens, SHBG, LH and FSH for each category of NSAID use and the per cent difference in hormone levels for users vs nonusers. RESULTS: There was no significant association between prescription/over-the-counter NSAID use and any hormone examined after adjustment for potential confounders. For example, geometric mean testosterone levels were 13·8, 13·6 and 14·2 nM in nonusers, prescription users and over-the-counter NSAID users, respectively; the corresponding levels for estradiol were 80·3, 70·4 and 79·9 pM. In stratified analyses, however, prescription NSAID use was associated with lower testosterone, estradiol and estrone levels in obese men and lower testosterone and dehydroepiandrosterone sulphate levels in inactive men. CONCLUSIONS: While overall these data do not provide strong support for an association between NSAID use and hormone levels in men, prescription NSAIDs may decrease levels of certain oestrogens and androgens in obese and inactive men.

Low dietary or supplemental zinc is associated with depression symptoms among women, but not men, in a population-based epidemiological survey.

BACKGROUND: Prior studies indicate that the biochemical alterations of depressive episodes result in decreased serum zinc concentrations. Given these findings, it is plausible that consistently low dietary zinc intakes contribute to depressive symptoms, yet epidemiological data are lacking. The authors tested the hypothesis that low zinc intake is associated with depressive symptoms using cross-sectional data from the population-based Boston Area Community Health survey (2002-2005). METHODS: Dietary and supplement use data were collected by validated food frequency questionnaire. Current depressive symptoms were assessed by the abridged validated Center for Epidemiologic Studies Depression scale and analyzed using multivariate logistic regression, adjusting for sociodemographic, health and lifestyle characteristics. RESULTS: Results showed an interaction (P=0.03) with gender, whereby zinc was associated with depressive symptoms in women (N=2163), but not men (N=1545). Women with low dietary or supplemental zinc intake were more likely to have depressive symptoms (e.g., dietary zinc quartile 1 vs. 4, OR=1.76, 95% CI: 1.26, 2.45; P-trend=0.004; supplemental zinc P-trend=0.03). Associations were stronger among women using antidepressant medications (e.g., total zinc OR=4.75, 95% CI: 1.98, 11.4; P-trend=0.0005). LIMITATIONS: The cross-sectional, observational nature of the study leaves uncertain whether the observed associations represent actual causal relationships between zinc intake and depressive symptoms. CONCLUSIONS: These findings suggest: (1) gender-specific pathophysiological mechanisms of depression, (2) inadequate dietary zinc intake contributes to depressive symptoms in women, and (3) supplemental zinc is a beneficial adjunct to antidepressant therapy in women. Additional research on both men and women is needed to verify these novel findings. If confirmed by other studies, the potential importance of adequate zinc intake is underscored by the recognized limitations of pharmacotherapy for depression.