Segurança do cinacalcete em crianças e adolescentes com distúrbio mineral e ósseo na doença renal crônica: revisão sistemática e metanálise proporcional de série de casos
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Data
2021-09-17
Autores
Zamoner, Soraya Mayumi Sasaoka
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Universidade Estadual Paulista (Unesp)
Resumo
Introdução: A doença mineral e óssea nos pacientes com doença renal crônica na infância pode causar anormalidades no cálcio, fósforo, paratormônio (PTH) e vitamina D e quando não tratada pode resultar em comprometimento do crescimento, deformidades ósseas, fraturas e calcificação vascular. Cinacalcete é um calcimimético amplamente utilizado como terapia na redução nos níveis de PTH na população adulta, tendo entre seus efeitos colaterais a hipocalcemia. A análise da segurança na população pediátrica é questionada devido à escassez de ensaios clínicos randomizados nessa faixa etária. Objetivo: O objetivo desta revisão foi avaliar o aparecimento de hipocalcemia sintomática ou outros eventos adversos (graves ou não graves) com o uso de cinacalcete em crianças e adolescentes com distúrbio mineral e ósseo na doença renal crônica. Critérios de inclusão: Esta revisão considerou ensaios clínicos randomizados (ECR), estudos de caso-controle, séries de casos e coorte, em pacientes de 0 a 18 anos de idade, portadores de doença renal crônica estadio 3 a 5 com distúrbio mineral e ósseo que receberam cinacalcete. Método de busca: os estudos foram obtidos das fontes PUBMED, EMBASE, LILACS, SCOPUS, WEB OF SCIENCE, e COCHRANE sem restrição de idioma. Coleta e análise: foi utilizada ferramenta de extração de dados padrão e foram analisados o aparecimento de hipocalcemia ou outros eventos adversos (graves ou não graves). A análise estatística foi realizada com software R com pacote metafor e os desfechos foram tratados como variáveis dicotômicas. Devido à diferença entre os estudos incluídos, o modelo de efeito aleatório foi utilizado. Foram utilizadas ferramentas do Joanna Briggs Institute para avaliação do risco de viés. Resultados: esta revisão incluiu 9 artigos (4 ECRs e 5 séries de casos). Houve viés de informações demográficas e de características clínicas dos pacientes em cerca de 50% dos estudos. Houve incidência de 0,2% de evento adverso fatal e 16% de eventos adversos graves (p<0,01 e I2= 69%), além de 10,7% de hipocalcemia, totalizando 45,7% de eventos adversos totais. Conclusão: O calcimimético cinacalcete, se utilizado na população pediátrica, deve ter cuidadosa monitorização dos níveis de cálcio sérico e atenção a possíveis eventos adversos, principalmente nas crianças menores de 50 meses. Registro PROSPERO: CRD42019132809
Introduction: Mineral and bone disease in children with chronic kidney disease can cause abnormalities in calcium, phosphorus, parathyroid hormone (PTH), and vitamin D and when left untreated can result in impaired growth, bone deformities, fractures, and vascular calcification. Cinacalcet is a calcimimetic widely used as a therapy to reduce PTH levels in the adult population, with hypocalcemia among its side effects. The analysis of safety in the pediatric population is questioned due to the scarcity of randomized clinical trials in this group. Objective: This review aimed to assess the onset of symptomatic hypocalcemia or other adverse events (serious or non-serious) with the use of cinacalcet in children and adolescents with mineral and bone disorder in chronic kidney disease. Inclusion criteria: This review considered randomized controlled trials (RCT), case-control, case series, and cohort studies, in patients aged 0 to 18 years, with stage 3 to 5 chronic kidney disease with mineral and bone disorder who received cinacalcet. Research methods: studies were obtained from PUBMED, EMBASE, LILACS, SCOPUS, WEB OF SCIENCE, and COCHRANE databases without language restriction. Data collection and analysis: a standard data extraction tool was used and the onset of hypocalcemia or other adverse events (serious or non-serious) were analyzed. Statistical analysis was performed using R software with a metaphor package and outcomes were treated as dichotomous variables. Due to the differences between the included studies, the random effect model was used. Joanna Briggs Institute tools were used to assess the risk of bias. Results: This review included 9 articles (4 RCTs and 5 case series). There was a bias in demographic information and clinical characteristics of patients in about 50% of the studies. There was an incidence of 0.2% of fatal adverse events and 16% of serious adverse events (p<0.01 and I2= 69%), in addition to 10.7% of hypocalcemia, totaling 45.7% of total adverse events. Conclusion: If used in the pediatric population, the calcimimetic cinacalcet should be carefully monitored for serum calcium levels and attention to possible adverse events, especially in children under 50 months.
Introduction: Mineral and bone disease in children with chronic kidney disease can cause abnormalities in calcium, phosphorus, parathyroid hormone (PTH), and vitamin D and when left untreated can result in impaired growth, bone deformities, fractures, and vascular calcification. Cinacalcet is a calcimimetic widely used as a therapy to reduce PTH levels in the adult population, with hypocalcemia among its side effects. The analysis of safety in the pediatric population is questioned due to the scarcity of randomized clinical trials in this group. Objective: This review aimed to assess the onset of symptomatic hypocalcemia or other adverse events (serious or non-serious) with the use of cinacalcet in children and adolescents with mineral and bone disorder in chronic kidney disease. Inclusion criteria: This review considered randomized controlled trials (RCT), case-control, case series, and cohort studies, in patients aged 0 to 18 years, with stage 3 to 5 chronic kidney disease with mineral and bone disorder who received cinacalcet. Research methods: studies were obtained from PUBMED, EMBASE, LILACS, SCOPUS, WEB OF SCIENCE, and COCHRANE databases without language restriction. Data collection and analysis: a standard data extraction tool was used and the onset of hypocalcemia or other adverse events (serious or non-serious) were analyzed. Statistical analysis was performed using R software with a metaphor package and outcomes were treated as dichotomous variables. Due to the differences between the included studies, the random effect model was used. Joanna Briggs Institute tools were used to assess the risk of bias. Results: This review included 9 articles (4 RCTs and 5 case series). There was a bias in demographic information and clinical characteristics of patients in about 50% of the studies. There was an incidence of 0.2% of fatal adverse events and 16% of serious adverse events (p<0.01 and I2= 69%), in addition to 10.7% of hypocalcemia, totaling 45.7% of total adverse events. Conclusion: If used in the pediatric population, the calcimimetic cinacalcet should be carefully monitored for serum calcium levels and attention to possible adverse events, especially in children under 50 months.
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Calcimiméticos, Hiperparatireoidismo, Paratormônio, Doença renal crônica pediátria, Cinacalcete, Calcimimetics, Hyperparathyroidism, Parathormone