Planejamento de ensaio clínico randomizado para avaliação da eficácia do uso de alopurinol no acidente vascular encefálico agudo
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Data
2019-02-28
Autores
Araujo, Carolina Fumico Massuda
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Editor
Universidade Estadual Paulista (Unesp)
Resumo
O acidente vascular cerebral (AVC) é uma das mais importantes afecções clínicas atualmente. A Organização Mundial de Saúde (OMS) define o AVC como sendo um comprometimento neurológico focal ou global que subitamente ocorre com sintomas persistindo para além de 24 horas, ou levando à morte, com provável origem vascular. O AVC agudo é responsável por uma carga substancial de morbidade e mortalidade no mundo representando a segunda causa global de anos de vida perdidos por incapacidade e respondendo por cerca de 10% de todas as mortes. No Brasil e nos Estados Unidos, o risco estimado de AVC ao longo da vida foi de 19,1% e 23,7%, respectivamente. A doença pode gerar sequelas e incapacidades resultando em grande impacto econômico e social. O alopurinol é uma droga inibidora da xantina oxidase (XO), a enzima que catalisa a conversão da hipoxantina em xantina e da xantina em ácido úrico a partir da degradação de purinas. Trata-se de medicamento antigo, seguro, disponível amplamente e com custo baixo utilizado principalmente para a prevenção de crises de gota. Além de seus efeitos sobre a redução dos níveis séricos de ácido úrico, sabe-se que o alopurinol também possui efeitos promissores em condições cardiovasculares. Esses efeitos têm o potencial de contribuírem para o tratamento de pacientes com AVC isquêmico agudo. Atualmente, o alopurinol não faz parte do tratamento padrão de pacientes com esse quadro no SUS ou internacionalmente, porém constitui um medicamento promissor a ser melhor estudado. Sabe-se que a condução de ensaios clínicos com medicamentos antigos para descoberta de novas aplicações para as mesmas não é considerada interessante para a indústria farmacêutica, pois após a perda da patente usualmente não há recompensa financeira suficiente para os altos gastos incorridos durante a condução dos ensaios. De tal modo normalmente fica a cargo de universidades e institutos de pesquisa com financiamento público realizar estudos clínicos com medicamentos já aprovados e com longo tempo de uso a fim de descobrir novas aplicações. Inovar com novos usos de medicamentos antigos já conhecidos representa uma oportunidade rara para o sistema público de saúde oferecer mais benefícios à população a um baixo custo. Sendo assim, propomos o presente ensaio clínico randomizado multicêntrico para avaliar a eficácia do alopurinol para prevenção de incapacidades e mortalidade no AVC agudo.
Stroke is one of the most important clinical conditions currently. The World Health Organization (WHO) defines stroke as a focal or global neurological impairment that suddenly occurs with symptoms persisting beyond 24 hours or leading to death with probable vascular origin. Acute stroke accounts for a substantial burden of morbidity and mortality in the world accounting for the second overall cause of Disability-Adjusted Life Year and accounting for about 10% of all deaths. In Brazil and the United States, the estimated lifetime risk of stroke was 19.1% and 23.7%, respectively. The disease can generate sequelae and incapacities resulting in great economic and social impact. Allopurinol is a xanthine oxidase (XO) inhibitor, the enzyme that catalyzes the conversion of hypoxanthine to xanthine and xanthine to uric acid from purine degradation. It is an old, safe, widely available and low cost drug used primarily for the prevention of gout attacks. In addition to its effects on the reduction of serum uric acid levels, it is known that allopurinol also has promising effects under cardiovascular conditions. These effects have the potential to contribute to the treatment of patients with acute stroke. Currently, allopurinol is not part of the standard treatment of patients with this condition in Brazilian Public Health System or internationally, but it is a promising drug to be better studied. It is known that the conduct of clinical trials with old medicines to discover new applications for them is not considered interesting for the pharmaceutical industry, since after the loss of the patent usually there is not enough financial reward for the high expenses incurred during the conduction of the essay. Thus, it is usually the responsibility of publicly funded universities and research institutes to conduct clinical trials of long-term and approved drugs in order to discover new applications. Innovating with new uses of old medicines already known represents a rare opportunity for the public health system to offer more benefits to the population at a lower cost. Therefore, we propose the present multicenter randomized trial to evaluate the efficacy of allopurinol for the prevention of disabilities and mortality in acute stroke.
Stroke is one of the most important clinical conditions currently. The World Health Organization (WHO) defines stroke as a focal or global neurological impairment that suddenly occurs with symptoms persisting beyond 24 hours or leading to death with probable vascular origin. Acute stroke accounts for a substantial burden of morbidity and mortality in the world accounting for the second overall cause of Disability-Adjusted Life Year and accounting for about 10% of all deaths. In Brazil and the United States, the estimated lifetime risk of stroke was 19.1% and 23.7%, respectively. The disease can generate sequelae and incapacities resulting in great economic and social impact. Allopurinol is a xanthine oxidase (XO) inhibitor, the enzyme that catalyzes the conversion of hypoxanthine to xanthine and xanthine to uric acid from purine degradation. It is an old, safe, widely available and low cost drug used primarily for the prevention of gout attacks. In addition to its effects on the reduction of serum uric acid levels, it is known that allopurinol also has promising effects under cardiovascular conditions. These effects have the potential to contribute to the treatment of patients with acute stroke. Currently, allopurinol is not part of the standard treatment of patients with this condition in Brazilian Public Health System or internationally, but it is a promising drug to be better studied. It is known that the conduct of clinical trials with old medicines to discover new applications for them is not considered interesting for the pharmaceutical industry, since after the loss of the patent usually there is not enough financial reward for the high expenses incurred during the conduction of the essay. Thus, it is usually the responsibility of publicly funded universities and research institutes to conduct clinical trials of long-term and approved drugs in order to discover new applications. Innovating with new uses of old medicines already known represents a rare opportunity for the public health system to offer more benefits to the population at a lower cost. Therefore, we propose the present multicenter randomized trial to evaluate the efficacy of allopurinol for the prevention of disabilities and mortality in acute stroke.
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Palavras-chave
allopurinol, stroke, acute stroke, clinical trial, alopurinol, acidente vascular cerebral, AVC agudo, ensaio clínico randomizado