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Objective Antipsychotics may increase serum prolactin, which has particularly been observed with risperidone. Further, hyperprolactinemia has been linked to osteoporosis-related fractures. Therefore, we investigated fracture risk in a nationwide cohort exposed to antipsychotics. Methods Swedish registers were used to identify adults with two consecutive dispensations of risperidone (n = 38 211), other atypical antipsychotics not including paliperidone (n = 60 691), or typical antipsychotics (n = 17 445) within three months between 2006 and 2013. An osteoporosis-related fracture was defined as a non-open hip/femur fracture in primary analyses. Cox regression was used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs). Results Risperidone users were on average older (mean age of 68, 44, and 63 years for risperidone, other atypical antipsychotics, and typical antipsychotics respectively). Compared with other atypical antipsychotics, there was no association between risperidone and osteoporosis-related fractures in the overall (HR = 1.04, CI: 0.91-1.19) or age-stratified analyses. A significantly increased risk of typical antipsychotics (HR = 1.24, CI: 1.07-1.45) compared with other atypical antipsychotics remained for ages >45 years. Conclusion Risperidone does not appear to be associated with an increased risk of osteoporosis-related fracture compared with other atypical antipsychotic agents as a group. For typical antipsychotics, a moderately elevated risk of hip fractures was noted compared with other atypical antipsychotics, possibly because of residual confounding.

The aim of this study was to investigate the risk of falls and fractures among older adults receiving atypical antipsychotics.An emulation analysis of a previously published study was performed using the US Truven MarketScan Medicare Supplemental database (MDCR). In addition, modified analyses were implemented to evaluate alternative confounding control strategies that (1) included all covariates used to fit propensity score models in outcome models and (2) required patients to have a mental health condition diagnosis and a health care visit within 90 days prior to the index date.The MDCR emulation analyses yielded similar results as the previous study. For the previous study and our emulation analysis, the results were: nonvertebral osteoporotic fractures (odds ratio [OR], 1.51; 95% confidence interval [CI], 1.41-1.60; and OR, 1.49; 95% CI, 1.37-1.63, respectively), hip fractures (OR, 1.67; 95% CI, 1.53-1.81; and OR, 1.59; 95% CI, 1.43-1.77, respectively), any fracture (OR, 1.29; 95% CI, 1.24-1.34; and OR, 1.32; 95% CI, 1.23-1.41, respectively), and falls (OR, 1.54; 95% CI, 1.47-1.61; and OR, 1.45; 95% CI, 1.11-1.89, respectively). However, in modified analyses, no associations were significant. The primary change that resulted in the attenuation of associations was the requirement for patients to have a mental health condition diagnosis and a health care visit prior to the index date.Our MDCR emulation analysis yielded similar results as a previous study; however, in modified analyses, the associations between fractures and falls and atypical antipsychotics were no longer significant. The contrast of results between the emulation and modified analyses may be due to the analytic approach used to compare patients (and potential confounding by indication). Further research is warranted to evaluate these associations.

A recently published analysis of population-based claims data from Ontario, Canada reported higher risks of acute kidney injury (AKI) and related outcomes among older adults who were new users of atypical antipsychotics (AAPs) compared with unexposed patients. In light of these findings, the objective of the current study was to further investigate the risks of AKI and related outcomes among older adults receiving AAPs. A replication of the previously published analysis was performed using the US Truven MarketScan Medicare Supplemental database (MDCR) among patients aged 65 years and older. Compared with non-users of AAPs, the study compared the risk of AKI and related outcomes with users of AAPs (quetiapine, risperidone, olanzapine, aripiprazole, or paliperidone) using a 1-to-1 propensity score matched analysis. In addition, we performed adapted analyses that: (1) included all covariates used to fit propensity score models in outcome models; and (2) required patients to have a diagnosis of schizophrenia, bipolar disorder, or major depression and a healthcare visit within 90 days prior to the index date. AKI effect estimates [as odds ratios (ORs) with 95% confidence intervals (CIs)] were significantly elevated in our MDCR replication analyses (OR 1.45, 95% CI 1.32–1.60); however, in adapted analyses, associations were not significant (OR 0.91, 95% CI 0.78–1.07)). In analyses of AKI and related outcomes, results were mostly consistent between the previously published and the MDCR replication analyses. The primary change that attenuated associations in adapted analyses was the requirement for patients to have a mental health condition and a healthcare visit prior to the index date. The MDCR analysis yielded similar results when the methodology of the previously published analysis was replicated, but, in adapted analyses, we did not find significantly higher risks of AKI and related outcomes. The contrast of results between our replication and adapted analyses may be due to the analytic approach used to compare patients (and potential confounding by indication). Further research is warranted to evaluate these associations, while also examining methods to account for differences in older adults who do and do not use these medications.

Approximately one half of patients who undergo antiviral therapy for chronic hepatitis C virus (HCV) genotype 1 infection do not respond to treatment. African Americans (AAs) are less responsive to treatment than Caucasian Americans (CAs), but the reasons for this disparity are largely unknown. Recent studies suggest that serum lipids may be associated with treatment response. The aims of this study were to evaluate baseline and changes in serum lipids during therapy, determine whether serum lipids are associated with virological response, and assess whether these measures explain the racial difference in efficacy. The study participants were from Virahep-C, a prospective study of treatment-naïve patients with genotype 1 HCV infection who received peginterferon (PEG-IN) alfa-2a plus ribavirin therapy for up to 48 weeks. Fasting serum lipids were analyzed at baseline and during and after therapy in 160 AAs and 170 CAs. A relative risk (RR) model was employed to evaluate characteristics associated with sustained virological response (SVR). Antiviral therapy was associated with changes in serum lipids during and after antiviral therapy, with the changes differing by race and the amount of PEG-IFN taken. Baseline lipid measures independently associated with higher rates of SVR were lower triglyceride and higher low-density lipoprotein cholesterol, with an interaction between high-density lipoprotein cholesterol (HDLc) and gender. Lipid measures did not contribute significantly to an explanation of the racial difference in SVR.Serum lipids are associated with SVR, although these paramaters did not explain the racial difference in treatment response. The results of this study are compatible with proposed biological mechanisms of HCV entry, replication, and secretion, and may underscore new potential therapeutic targets for HCV eradication.

The objective of this study was to examine the association between caffeine usage in U.S. adolescents and the frequency that feeling tired in the morning and having difficulty sleeping is reported. In this study we found that feeling tired in the morning and having difficulty sleeping was experienced more commonly in those adolescents that have a high intake of caffeine.

Justificación y objetivo: Streptococcus pneumoniae es globalmente la primera causa de muertes inmunoprevenibles en niños menores de 5 años. Métodos: entre 2007 y 2009 se realizó una vigilancia prospectiva con base poblacional en niños de 28 días a 36 meses en San José, Costa Rica. Se determinaron la incidencia de la enfermedad neumocócica invasora y de neumonía confirmada clínicamente y por radiografía, la distribución de serotipos y la sensibilidad a los antibióticos. Resultados: participaron 8801 sujetos (mediana de edad: 13,0 meses). En 25 niños se detectó enfermedad neumocócica invasora mediante aislamiento en cultivos (22) o mediante reacción de polimerasa en cadena y un cuadro clínico compatible con enfermedad neumocócica invasora (3) En los casos diagnosticados únicamente por cultivo, la tasa de incidencia de enfermedad neumocócica invasora en niños de 28 días a 36 meses de edad fue de 33,7/100 000 por año para los años 1 y 2 combinados. Al considerar los casos adicionales diagnosticados por reacción de polimerasa en cadena, la incidencia aumentó a 46,0/100 000. El serotipo más frecuente fue el 14 (28,6%), seguido por los serotipos 3, 4, 6A, 19A y 22F. 42,9% de los aislamientos eran insensibles a la penicilina y al cotrimoxazol. La incidencia de neumonía confirmada clínicamente y de neumonía confirmada por radiografía fue de 1968/100 000 y 551/100 000, respectivamente. Conclusión: la incidencia de enfermedad neumocócica invasora y neumonía en niños de San José es considerable. Estos datos epidemiológicos sirven como línea de base para evaluar la efectividad de nuevas vacunas antineumocócicas conjugadas. Background and aim: Streptococcus pneumoniae is globally the leading cause of vaccine-preventable death in children below 5 years of age. Methods: Between 2007 and 2009, a prospective, population-based surveillance was conducted in children aged 28 days to 36 months in San José, Costa Rica. Incidence of invasive pneumococcal disease as well as clinically- and chest X ray-confirmed pneumonia were determined, as well as serotype distribution and antibiotic susceptibility. Results: 8801 subjects were enrolled (median age: 14.5 months). Invasive pneumococcal disease was detected in 25 children by isolation from cultures (22)or by PCR and a clinical picture consistent with invasive pneumococcal disease (3). For culture-positive only cases in children aged 28 days to

To determine if social support (SS) is associated with clinical outcomes during antiviral therapy for chronic hepatitis C virus (HCV).Data from 394 patients who participated in the prospective, longitudinal VIRAHEP-C study were examined. VIRAHEP-C enrolled 401 adults with HCV to evaluate factors associated with antiviral treatment response. Perceived SS was measured using the Medical Outcome Study Social Support Survey (MOS-SSS) at baseline and treatment week 24. Scores were calculated as a continuous variable ranging from 0% to 100% with higher scores indicating greater support. Two SS variables were created: (1) baseline SS (BL-SS) and (2) change in SS from baseline to treatment week 24 (CH-SS). The primary endpoint was sustained virological response (SVR) six months post-treatment. Intermediate outcomes included: symptom-reporting; virological response at treatment week 24; medication adherence; neuropsychiatric adverse events; and dose reductions and premature medication discontinuation. The relative risk of each outcome was estimated using modified Poisson regression models or linear mixed models.BL-SS was relatively high (mean=79%). Overall, SS declined from baseline to treatment week 24 (median change: -1.3%; p.01). Neither BL-SS nor CH-SS was associated with SVR. However, BL-SS was associated with multiple symptoms (fatigue, headache, irritability, aches/pains) during treatment, even after adjusting for baseline depression, which was significantly associated with symptom-reporting.SS was not directly associated with efficacy measures, such as SVR. However, baseline SS predicted an increase in symptomatology over the course of antiviral therapy. Baseline depression was also significantly associated with symptom-reporting.

Background & Aims The recommended therapy for chronic hepatitis C, pegylated interferon and ribavirin for 24 or 48 weeks, has many known adverse side effects. The aim of this study was to evaluate the impact of antiviral therapy on male sexual health. Methods As part of the Study of Viral Resistance to Antiviral Therapy of Chronic Hepatitis C (Virahep-C), 260 men treated with pegylated interferon alfa-2a and ribavirin completed self-administered questionnaires concerning sexual desire, sexual function, including erectile and ejaculatory function, and sexual satisfaction before, during, and after treatment. Results Before therapy, 37% of men reported at least some degree of impairment in sexual desire and 44% reported dissatisfaction with their sexual life, while 26% reported impairment in erectile and 22% in ejaculatory function. During therapy, significant declines were observed in all components of sexual health compared with pretreatment. At the end of therapy (24 or 48 weeks), an estimated 38%–48% of men reported that overall sexual function was worse than before treatment. African American patients reported less impairment in sexual desire and satisfaction than Caucasian American patients during therapy. By 24 weeks after treatment, sexual desire and satisfaction improved and were comparable to baseline levels. However, among men who received 48 weeks of therapy, the estimated percentage of men reporting posttreatment erectile or ejaculatory problems remained higher than baseline, although persistent erectile impairment was limited to Caucasian American patients. Conclusions Sexual impairment is common among men with chronic hepatitis C undergoing therapy with pegylated interferon and ribavirin and should be considered as a potential side effect of antiviral therapy.

Combination therapy for chronic hepatitis C is associated with depression, which may lead to worse treatment outcomes. The objectives of this study were to determine the association between patient characteristics and depression before and during treatment and to evaluate the relationship between depression and treatment outcomes.Prospective data from the Viral Resistance to Antiviral Therapy of Chronic Hepatitis C (Virahep-C) study were analyzed (191 African Americans, 203 Caucasians). Depression was defined as a score of23 on the Center for Epidemiologic Studies Depression (CES-D) scale. Scores were taken before treatment, at weeks 4, 12, and 24 of treatment, and 24 weeks after treatment ended. Baseline social support was measured using the Medical Outcomes Study (MOS) Social Support Survey. Associations between baseline patient characteristics and incident depression were assessed with discrete-time Cox proportional hazards models.At baseline, 47 (12%) participants had CES-D scores 23. Univariable analyses indicated that several patient characteristics were associated with baseline depression, including lower social support (P0.0001). On treatment, these patients were more likely to have psychiatric adverse events (AEs) or start new antidepressants (45 vs. 28%, P=0.02) and to have had early treatment discontinuation (38 vs.13%, P0.0001); however, sustained virological response (SVR) rates were similar (38 vs. 40%, P=0.79) to those of participants without baseline depression. The incidence of new-onset depression was 26% by 24 weeks. One-third of patients were started on antidepressants, and no patients attempted suicide. Multivariable analyses indicated that new-onset depression was significantly associated with younger age (P=0.04), lower social support (P0.001), and "feeling depressed, sad, or blue" (P=0.008). Patients who developed depression during treatment were more likely to have a psychiatric AE or begin antidepressants (44 vs. 23%, P0.001) but had lower rates of treatment discontinuation (6 vs. 15%, P=0.02) and comparable rates of SVR compared with patients without depression (47 vs. 38%, P=0.16). There were no differences in the frequency of pretreatment or new-onset depression between African-American and Caucasian participants in this study.In this large prospective analysis, baseline and new-onset depression were associated with patient characteristics and treatment outcomes; however, SVR rates did not differ between depressed and nondepressed patients. The relationship of lower baseline social support with depressive symptoms warrants further investigation.