Long-Term Treatment with Extended-Release Carbidopa– Levodopa (IPX066) in Early and Advanced Parkinson’s Disease: A 9-Month Open-Label Extension Trial

Background and Objective IPX066 is a multiparticulate extended-release formulation of carbidopa–levodopa, designed to produce prolonged therapeutic levodopa plasma concentrations. This 9-month open-label extension study assessed its long-term safety and clinical utility in early and advanced Parkinson’s disease (PD). Methods Participants were enrolled from two phase III IPX066 studies and one open-label phase II study. Early PD patients were titrated to an appropriate dosing regimen while advanced patients started with regimens established in the antecedent studies. Adjustment was allowed throughout the extension. Clinical utility measures included the Unified Parkinson’s Disease Rating Scale (UPDRS) and Patient Global Impression (PGI) ratings. Results Among 268 early PD patients, 53.4 % reported adverse events (AEs) and 1.1 % (three patients) discontinued due to AEs; the most frequent AEs were nausea (5.6 %) and insomnia (5.6 %). Among 349 advanced patients, 60.2 % reported AEs and 3.7 % (13 patients) discontinued due to AEs; the most frequent AEs were dyskinesia (6.9 %) and fall (6.6 %). At month 9 (or early termination), 78.3 % of early patients were taking IPX066 three times daily (median: 720 mg/day) and 87.7 % of advanced patients were taking IPX066 three or four times daily (median: 1450 mg/day). Adjusting for 70 % bioavailability relative to immediate-release (IR) carbidopa–levodopa, the median dosages correspond to *500 and *1015 mg/day of IR levodopa in early and advanced PD, respectively. Based on the plasma profiles previously observed in PD patients, the IPX066 regimens in the extension can be estimated to provide a levodopa Cmax (maximum plasma drug concentration) similar to or lower than that provided by IR regimens during the antecedent trials. UPDRS and PGI findings showed sustained treatment effects throughout the extension. Conclusion During 9 months of extended use, IPX066 exhibited a safety/tolerability profile consistent with dopaminergic PD therapy

Long-term treatment with extended-release carbidopa-levodopa (IPX066) in early and advanced Parkinson's Disease : a 9-month open-label extension trial

Background and Objective IPX066 is a multiparticulate extended-release formulation of carbidopa–levodopa, designed to produce prolonged therapeutic levodopa plasma concentrations. This 9-month open-label extension study assessed its long-term safety and clinical utility in early and advanced Parkinson’s disease (PD). Methods Participants were enrolled from two phase III IPX066 studies and one open-label phase II study. Early PD patients were titrated to an appropriate dosing regimen while advanced patients started with regimens established in the antecedent studies. Adjustment was allowed throughout the extension. Clinical utility measures included the Unified Parkinson’s Disease Rating Scale (UPDRS) and Patient Global Impression (PGI) ratings. Results Among 268 early PD patients, 53.4 % reported adverse events (AEs) and 1.1 % (three patients) discontinued due to AEs; the most frequent AEs were nausea (5.6 %) and insomnia (5.6 %). Among 349 advanced patients, 60.2 % reported AEs and 3.7 % (13 patients) discontinued due to AEs; the most frequent AEs were dyskinesia (6.9 %) and fall (6.6 %). At month 9 (or early termination), 78.3 % of early patients were taking IPX066 three times daily (median: 720 mg/day) and 87.7 % of advanced patients were taking IPX066 three or four times daily (median: 1450 mg/day). Adjusting for 70 % bioavailability relative to immediate-release (IR) carbidopa–levodopa, the median dosages correspond to *500 and *1015 mg/day of IR levodopa in early and advanced PD, respectively. Based on the plasma profiles previously observed in PD patients, the IPX066 regimens in the extension can be estimated to provide a levodopa Cmax (maximum plasma drug concentration) similar to or lower than that provided by IR regimens during the antecedent trials. UPDRS and PGI findings showed sustained treatment effects throughout the extension. Conclusion During 9 months of extended use, IPX066 exhibited a safety/tolerability profile consistent with dopaminergic PD therapy

Orientação farmacêutica para DST: uma proposta de sistematização STD management in community pharmacies: an organizing proposal

As DST se constituem num grave problema de saúde pública. Diante da baixa notificação de casos, a OMS estima que 70% dos portadores de DST no Brasil não busquem tratamento em unidades de saúde. Em todo o mundo a farmácia comunitária é um importante local de busca por atendimento primário de saúde e os farmacêuticos são numerosos e se constituem nos profissionais de saúde mais acessíveis para o público em geral. A dificuldade de acesso a serviços de saúde, a falta de orientação para o uso racional de medicamentos ao usuário e a automedicação são uma realidade no Brasil, onde se convive, de um lado, com a falta de acesso de grande parcela da população a medicamentos essenciais, e de outro, com o uso abusivo e irracional pelos segmentos que têm poder de compra. As farmácias devem, portanto, ser consideradas locais de intervenção para o estabelecimento de parcerias no sentido de divulgar e disseminar práticas educativas quando se pensa em campanhas educativas e prevenção de doenças como as DST. Propõe-se, então, uma sistematização da orientação farmacêutica com relação às DST, na tentativa de concretizar um melhor atendimento aos possíveis portadores que procuram a resolução de seu problema de saúde na farmácia e contribuir para o enfraquecimento da cadeia de transmissão dessas doenças.<br>Sexually transmitted diseases (STD) are a major public health issue. According to estimates of the WHO, 70% of those infected by STDs in Brazil do not seek treatment in health units due to the reduced notification of cases. Community pharmacies around the world are an important site where people seek primary health services. In addition, there are a great number of pharmacists, making them the most accessible health care professional for the general public. Difficult access to health services, lack of guidance in the rational use of drugs, and self-medication are a reality in Brazil. On one hand a great majority of the population does not have access to essential drugs, while on the other there is an irrational and abusive use of drugs by those who have the financial means. Pharmacies, therefore, should be viewed as establishments were partnerships could be made to better promote and disseminate information related to prevention and educational campaigns on diseases such as STD. Thus, systematization of pharmaceutical guidance for STD is suggested in an attempt to provide better services for those possibly infected and who seek a solution in pharmacies, as well as to interrupt the spread of these diseases

The Effects of Catholic Schooling on Civic Participation

The promotion of adult civic engagement is one of the primary goals of public schools. And the putatively negative effects of private schooling on civic engagement provide one of the most fundamental motivations for publicly provided schooling. In this study, I examine the comparative effects of Catholic and public high schools on adult voter participation and volunteering in the United States. I find that students who attended Catholic high schools are actually more likely to vote, though not volunteer, as adults. These estimated effects are robust to conditioning on a rich set of individual, family and community traits. I also present two-stage least squares estimates, which provide suggestive evidence that these results are not due to selection biases. Copyright Springer Science + Business Media, Inc. 2005public, private, education, civic, externality,