Combination therapy of bezafibrate and ursodeoxycholic acid in primary biliary cirrhosis: a preliminary study

Nakai, S.; Masaki, Tsutomu; Kurokohchi, Kazutaka; Deguchi, Akihiro; Nishioka, Mikio

doi:10.1016/s0002-9270(99)00726-1

Cited by 35 publications

(52 citation statements)

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“…Most importantly, the negative consequences of bezafibrate discontinuation were corrected after restarting the combined treatment in all cases. These results are in accordance with those reported over the last decade in studies that included small number of patients or treated them for a shorter period of time (12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24). The current study adds some remarkable results on the effects of bezafibrate combined with UDCA in PBC, since it has been performed in the largest series of patients (24 cases completed the 12 months of treatment).…”

Section: Discussionsupporting

confidence: 92%

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Bezafibrate normalizes alkaline phosphatase in primary biliary cirrhosis patients with incomplete response to ursodeoxycholic acid

Lens

Leoz

Nazal

et al. 2013

Liver International

101

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Section: Discussionsupporting

confidence: 92%

“…In the last decade, some appealing data regarding the favourable effects of fibrates, mostly combined with UDCA have been reported (12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24). However, the studies have only been done in a small number of patients, low UDCA doses or short duration of treatment.…”

Section: Introductionmentioning

confidence: 99%

Bezafibrate normalizes alkaline phosphatase in primary biliary cirrhosis patients with incomplete response to ursodeoxycholic acid

Lens

Leoz

Nazal

et al. 2013

Liver International

101

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“…Fibrate, one of the promising medicines, increases the excretion of phospholipid into the bile via peroxisome proliferator-activated receptor a, leading to the formation of micelle that protects cells from the toxicity of hydrophobic bile acid. Preliminary results 61 and a succeeding trial demonstrated the efficacy of fibrate in terms of the biochemical response and improvement of fibrotic markers. 62 Meta-analysis could not demonstrate the efficacy of colchicine, 63 methotrexate, 64 penicillamine, 65 azathioprine, 66 or cyclosporine 67 so far, which should be re-checked by the subgroup analysis as described above.…”

Section: Re-evaluation Of the Complemental Therapies And Clinical Trialsmentioning

confidence: 98%

Treatment of Primary Biliary Cirrhosis: A new challenge?

Fukushima

Ueno

Shimosegawa

2010

Hepatology Research

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Primary biliary cirrhosis (PBC) is characterized by unknown etiologies, anti-mitochondrial antibodies, injury of the biliary duct and the lack of a definite remedy. The etiologies of PBC have been well-discussed, including microorganisms and xenobiotics as the triggers for initiating the disease, and an abnormality of immune-tolerance. Recently, several animal models of PBC have been developed that may lead to the development of new therapies. Here, we reviewed the articles that address the etiology of PBC and the therapy for this disease for the confirmation of our current positions and future directions.

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“…(15) The beneficial effect of BF in PBC patients prior to cirrhosis was first reported by Iwasaki et al in 1999. (16) After several pilot studies, (17)(18)(19)(20)(21) prospective randomized controlled studies demonstrated that short-term combination therapy with UDCA and BF was effective, in biochemical terms, against PBC that is refractory to UDCA monotherapy. (22,23) In this clinical scenario, BF has been used in Japan as a second-line treatment for more than a decade; and in Western countries, the efficacy of BF against PBC has also been recognized.…”

Section: Study Groupmentioning

confidence: 99%

Bezafibrate Improves GLOBE and UK‐PBC Scores and Long‐Term Outcomes in Patients With Primary Biliary Cholangitis

et al. 2019

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In Japan, bezafibrate (BF) is a second‐line agent for primary biliary cholangitis (PBC) that is refractory to ursodeoxycholic acid (UDCA) treatment. From a retrospective cohort (n = 873) from the Japan PBC Study Group, we enrolled 118 patients who had received UDCA monotherapy for at least 1 year followed by combination therapy with UDCA+BF for at least 1 year. GLOBE and UK‐PBC scores after UDCA monotherapy (i.e., immediately before UDCA+BF combination therapy) were compared with those after 1 year of UDCA+BF combination therapy. The real outcomes of enrolled patients estimated by Kaplan–Meier analysis were compared with the predicted outcomes calculated using GLOBE and UK‐PBC scores. In addition, the hazard ratio of BF treatment was calculated using propensity score analysis. The mean GLOBE score before the combination therapy was 0.504 ± 0.080, which improved significantly to 0.115 ± 0.085 (P < 0.0001) after 1 year of combination therapy. The real liver transplant‐free survival of enrolled patients was significantly better than that predicted by GLOBE score before introducing BF. Combination therapy did not significantly improve the real rates of liver transplantation or liver‐related death compared with those predicted by UK‐PBC risk score before introducing BF, but the predicted risk was significantly reduced by the addition of BF (P < 0.0001). Cox regression analysis with inverse probability of treatment weighting showed that the addition of BF significantly reduced the hazard of liver transplant or liver‐related death in patients who, after 1 year of UDCA monotherapy, had normal serum bilirubin (adjusted hazard ratio 0.09, 95% confidence interval 0.01‐0.60, P = 0.013). Conclusion: Addition of BF to UDCA monotherapy improves not only GLOBE and UK‐PBC scores but also the long‐term prognosis of PBC patients, especially those with early‐stage PBC.

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Combination therapy of bezafibrate and ursodeoxycholic acid in primary biliary cirrhosis: a preliminary study

Cited by 35 publications

References 0 publications

Bezafibrate normalizes alkaline phosphatase in primary biliary cirrhosis patients with incomplete response to ursodeoxycholic acid

Bezafibrate normalizes alkaline phosphatase in primary biliary cirrhosis patients with incomplete response to ursodeoxycholic acid

Treatment of Primary Biliary Cirrhosis: A new challenge?

Bezafibrate Improves GLOBE and UK‐PBC Scores and Long‐Term Outcomes in Patients With Primary Biliary Cholangitis

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