Safety and efficacy of sitaxsentan 50 and 100 mg in patients with pulmonary arterial hypertension

Objective: To assess safety and efficacy of sitaxsentan 50 and 100 mg in patients with pulmonary arterial hypertension (PAH). Background: Sitaxsentan is a highly selective endothelin-A receptor antagonist that was recently withdrawn by the manufacturer because of a pattern of idiosyncratic liver injury. Methods: Before sitaxsentan withdrawal, this 18-week double-blind, placebo-controlled study randomized patients with PAH to receive placebo or sitaxsentan 50 or 100 mg once daily. The primary efficacy endpoint was change from baseline in 6-min walk distance (6MWD) at week 18. Changes in World Health Organization (WHO) functional class and time to clinical worsening (TTCW) were secondary endpoints. The primary efficacy analysis was powered for sitaxsentan 100 mg versus placebo. Results: Of 98 randomized patients, 61% were WHO functional class II at baseline. Improvement from baseline to week 18 in 6MWD occurred with sitaxsentan 100 but not 50 mg; a strong placebo effect was observed. At week 18, WHO functional class was improved or maintained in more patients receiving sitaxsentan 100 mg than placebo (P = 0.038); 0% versus 12% of patients deteriorated, respectively. TTCW was not significantly different for 100-mg sitaxsentan patients than placebo (P = 0.090). Adverse events (AEs) occurring more frequently with sitaxsentan (50 or 100 mg) included headache, peripheral edema, dizziness, nausea, extremity pain, and fatigue; most AEs were of mild or moderate severity. Conclusion: Sitaxsentan 100 mg improved functional class but not 6MWD in PAH patients who were mostly WHO functional class II at baseline. No patient receiving sitaxsentan 100 mg experienced clinical worsening; sitaxsentan was well tolerated. (C) 2011 Elsevier Ltd. All rights reserved.

Prevalência de lesões por fricção em pacientes hospitalizados com câncer

Esse estudo objetivou identificar a prevalência de lesões por fricção (LF) em pacientes hospitalizados com câncer e avaliar os fatores demográficos e clínicos associados ao seu desenvolvimento. Estudo epidemiológico, de corte transversal, realizado no Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira. Todos os pacientes adultos, internados entre 10 e 18 de abril de 2010, foram avaliados por meio de entrevista e exame físico. Utilizou-se o teste Qui-Quadrado para comparação das variáveis demográficas e clínicas entre pacientes com e sem LF. Foram avaliados 157 pacientes: cinco apresentaram nove LF, acarretando prevalência de 3,3%. Quanto às variáveis demográficas, houve diferença estatisticamente significativa somente para o número de filhos (p=0,027). Clinicamente, pacientes com LF apresentaram menores escores na escala de Karnofsky (p=0,031) e na Escala de Braden (p=0,026), além de comportamento pouco colaborativo (p=0,042). Esse estudo contribui para um melhor conhecimento acerca das LF em pacientes com câncer.