Background
Health care costs are growing faster than the rest of the global economy, according to the World Health Organization (WHO). Countries’ health expenditures include paying for general medicine, diagnostic procedures, hospitalizations and surgeries, as well as medications and prescribed treatment. Primary biliary cholangitis (PBC) is a rare autoimmune liver disease and the first line available treatment is ursodeoxycholic acid (UDCA), however, direct and indirect treatment costs are expensive. Main aim of this trial was to assess if the therapeutic efficacy of UDCA manufactured by the university hospital is equivalent to that of standard UDCA and treatment cost reduction in patients with PBC.
Methods
It is a prospective, interventional, randomized, and crossover study in patients diagnosed with PBC. UDCA 300 mg tablets and capsules were developed and manufactured by the university hospital. Thirty patients under treatment with standard UDCA, in stable doses were randomized in sequence A and B, 15 patients in each arm. The groups were treated for 12 weeks and after, the UDCA formulation was changed, following for another 12 weeks of continuous therapy (tablets and capsules / capsules and tablets). Laboratory tests were performed at time T0 (beginning of treatment), T1 (at the 12 week-therapy, before the crossing-over) and T2 (end of treatment). The evaluation was done by comparing the hepatic parameters ALP, GGT, ALT, AST and total bilirubin, also considering the adverse events. The comparison of costs was based on price of the manufactured UDCA and standard UDCA price of the hospital.
Results
Hospital reduced 66.1% the PBC treatment costs using manufactured UDCA. There were no differences in the biochemical parameters between sequence (A and B) and tablets or capsules of UDCA formulations applied in the treatment of PBC.
Conclusions
The study showed that there was no significant difference between manufactured UDCA (capsule and tablet) and standard UDCA. Hospital reduced the PBC treatment costs using the manufactured UDCA by the university hospital.
Trial registration
ClinicalTrials.gov:
NCT03489889
retrospectively registered on January 12th, 2018; Ethics Committee approved the study (ID: 1.790.088) on October 25th, 2016.
Dedico esta dissertação às pessoas mais importantes da minha vida: Aos meus pais por serem meu alicerce, exemplos de vida e que não existem palavras que expressem meu amor e minha gratidão por vocês.Ao meu irmão Cleber, por me ensinar que não devemos desistir de nossos sonhos e que a paciência, persistência e resiliência é um treinamento diário para o sucesso.Ao meu irmão Ricardo (in memorian), que apesar de sua partida repentina, ter mostrado sua humildade e simplicidade de ver a vida durante esta jornada conosco.Aos meus avós paternos (in memorian), pela honra de terem me escolhido como neta nesta vida e que o amor deles sempre será incondicional. E, ao meu companheiro Leandro Nunes dos Santos, que acreditou em mim em todos os momentos e não deixou que eu desistisse no meio do caminho.
AGRADECIMENTOSMais uma etapa se completa. Nada na vida é por acaso! A cada pessoa que conhecemos, tem um propósito e, neste momento, é imprescindível o agradecimento à todos os que me rodeiam e que contribuíram com o meu crescimento pessoal, acadêmico e profissional.Primeiramente, agradeço à Profª Drª Suzane Kioko Ono, por simplesmente ser uma das pessoas mais importantes nesta caminhada de Hospital das Clínicas da
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