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Health-related quality of life in Brazilian patients with cutaneous leishmaniasis using EQ-5D

by Janaína de Pina Carvalho, Sarah Nascimento Silva, Tália Santana Machado de Assis, Endi Lanza Galvão, Mayra Soares Moreira, Mônica Viegas Andrade, Kenya Valéria Micaela de Souza Noronha, Gláucia Cota

Cutaneous leishmaniasis (CL) is a neglected infectious disease with a global distribution and a known health-related quality of life (HRQoL) impact. However, no utility-based HRQoL assessments for CL patients are available. The aim of this study was to quantitatively assess the health-related quality of life among patients with CL attending a Brazilian reference center. A retrospective interview-based longitudinal study was conducted using the EQ-5D-3L/VAS to assess the current health status during active disease, and retrospectively before the onset of disease symptoms. In addition, socioeconomic data were collected via a standardized questionnaire, and sociodemographic and clinical data were collected directly from medical records. A total of 143 patients with a mean age of 52 (±17) years were included, 73% of whom were men. The mean utility score before the onset of CL symptoms was 0.858. Comparison of responses related to health status before and after disease onset revealed significant losses (p 

Safety profile of miltefosine in the treatment of cutaneous leishmaniasis

by Laís Raquel Ribeiro, Sarah Nascimento Silva, Mell Ferreira Saliba, Janaína de Pina Carvalho, Gláucia Cota

Cutaneous leishmaniasis (CL) is a neglected tropical disease that poses a significant public health challenge in Brazil and worldwide. Miltefosine, the only orally administered drug available for CL, was recently incorporated into Brazil’s treatment protocols following recommendations by the World Health Organization (WHO) and revisions by national health authorities. While this represents an important advancement, miltefosine is associated with frequent gastrointestinal side effects and potential teratogenic risks, necessitating careful patient eligibility assessments and close clinical monitoring throughout treatment. Furthermore, the absence of national effectiveness data underscores the need for careful monitoring during large-scale implementation. This study, part of a broader implementation monitoring process, seeks to estimate the frequency, intensity, and seriousness of adverse events (AEs) associated with miltefosine. It also aims to identify factors linked to treatment discontinuation during the pilot phase of miltefosine distribution in the state of Minas Gerais, Brazil. Descriptive analyses were performed to present measures of central tendency and dispersion for the variables. Additionally, a multivariate analysis was conducted to explore relationships between explanatory variables and outcomes of interest. Between 2021 and 2023, 77.1% of patients treated with miltefosine experienced at least one AE. The rate of serious AEs related to treatment was 1.3%. Gastrointestinal symptoms were the most commonly reported AEs, followed by musculoskeletal manifestations. The most frequent laboratory alteration observed was an increase in serum creatinine, which was significantly associated with hypertension, age, and mucosal involvement of leishmaniasis. No pregnancies were recorded during the implementation period. Early treatment discontinuation rate occurred in 11.8% of cases, with discontinuation associated with age and baseline serum creatinine alterations. Half of the patients required temporary treatment interruptions or irregular dosing, extending the treatment duration beyond the planned 28 days. This pharmacovigilance model provides valuable insights, representing an approach potentially applicable to other neglected disease control programs, especially when introducing new treatment technologies.
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