Ursodeoxycholic acid therapy for primary biliary cirrhosis. A 10-year British single-centre population-based audit of efficacy and survival

Abstract

SummaryThe effect of ursodeoxycholic acid treatment on survival in primary biliary cirrhosis was studied in 40 patients with symptomatic disease. Two patients developed early exacerbation of symptoms and stopped therapy in days; they are both alive 4 and 41/2 years later. The other 38 patients have continued on treatment for up to 10 years. Results were compared with 12 other similar cases previously seen but not given specific therapy. Kaplan-Meier analysis showed that ursodeoxycholic acid treatment was associated with better survival (p <0.05) after the first two years of therapy. Predictors of favourable outcome included histological stage I disease. In 26 patients with primary biliary cirrhosis stage II, III or IV, therapy showed a trend to improved survival, but this was still significantly worse than the general population. Prognosis was not different between these different advanced stages. Symptoms improved in 28 out of 40 patients on ursodeoxycholic acid, but 50% had a recurrence by two years.

Hypergastrinaemia with long‐term omeprazole treatment

“…However, there is a continuous concentration-dependent response for the effect of gastrin, both for stimulation of function 2,3 and growth. 4,5 Therefore it is arti®cial to de®ne hypergastrinaemia into severe and not severe forms. The reason why some patients with H. pylori infection develop higher gastrin values than other patients during treatment with proton pump inhibitors, is probably due to a H. pylori induced atrophic gastritis affecting the oxyntic mucosa and thus reducing gastric acidity.…”

“…This is the dose that was used in the only UK study, where UDCA 750 mg daily (equivalent to 13 mg/kg/day) de®nitely prolonged transplant-free survival. 4 The case for adjusting the dose for body weight is not convincing. The bile acids are not distributed throughout the body but are recirculated between the gut, liver and biliary system in the enterohepatic circulation.…”

“…If the beneficial effects of UDCA relate directly to the proportional enrichment of the bile acid pool with UDCA, then 750 mg daily is the appropriate dose. This is the dose that was used in the only UK study, where UDCA 750 mg daily (equivalent to 13 mg/kg/day) definitely prolonged transplant‐free survival 4 . The case for adjusting the dose for body weight is not convincing.…”

O tratamento contínuo superior a cinco anos com ácido ursodesoxicólico gera benefícios na taxa de mortalidade e na taxa de transplantes em colangite biliar primária: revisão sistemática da literatura e metanálise

“…Entre os dois estudos com menor tamanho amostral, o ECR de Papatheodoridis et al, 2002(Papatheodoridis et al, 2002 não observou efeitos em longo prazo do tratamento com AUDC, e o estudo prospectivo controlado de Bateson e Gedling, 1998 (Bateson & Gedling, 1998), mostrou tendência de melhor sobrevida em pacientes com estágios histológicos II, III ou IV tratados com AUDC, em comparação com nenhuma intervenção.…”

Evidence-based clinical practice guidelines for liver cirrhosis 2015

“…Some studies supported its beneficial effect on prognosis [86,[88][89][90], whereas others, including a Cochrane database systemic review, did not support it [91][92][93][94]. Good biochemical response to UDCA is related to good prognosis [95] and poor response is related to disease progression [96] and HCC development [97].…”