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UDCA/BF therapy effective in lowering ALP serum levels in patients with primary biliary cirrhosis

Combination therapy of bezafibrate and ursodeoxycholic acid was more effective in lowering alkaline phosphatase levels vs. monotherapy with ursodeoxycholic acid among a cohort of patients with primary biliary cirrhosis, according to study data.

“We performed a prospective, multicenter, randomized controlled study to compare the combined therapy using [bezafibrate] and [ursodeoxycholic acid] monotherapy to elucidate the long-term prognosis, efficacy and safety,” the researchers wrote.

Patients with primary biliary cirrhosis (PBC) were dosed with ursodeoxycholic acid (UDCA) for at least 24 weeks. Patients with alkaline phosphatase (ALP) levels above 350 IU/l at the end of treatment were allocated to different treatment groups that included UDCA alone at 600 or 900 mg per day (n=14) or UDCA with bezafibrate (BF; n=13) at 400 mg per day. The median treatment period was 107 months in the UDCA group and a median of 110 months for the UDCA and BF group. The primary end point was the ALP serum levels after treatment, as well as the severity of PBC and the transplant-free survival of PBC, according to the research.

Overall, ALP levels and PBC severity were lower in the UDCA and BF group compared with the UDCA alone group 8 years after baseline (P < .05 for both). No patients were lost to follow-up and none underwent transplantation. Three patients in the UDCA and BF group died due to hepatocellular carcinoma, pancreatic cancer and an unknown cause, compared with no patients dying in the UDCA alone group. The mortality rates between the two treatment groups were not significantly different, according to the research.

No adverse events or discontinuations were observed in the UDCA alone group. However, two patients in the UCDA and BF group reduced doses of BF due to renal dysfunction. These patients’ renal function improved slightly after a reduction in BF, but not UDCA. One of these patients discontinued treatment at 41 months.   

“Long-term combination therapy using BF and UDCA significantly improved serum ALP levels and the Mayo risk score compared with UDCA monotherapy,” the researchers wrote. “This combined therapy may cause notable adverse events such as renal dysfunction and a resultant dose reduction or discontinuation of BF treatment.” – by Melinda Stevens

Disclosure: The researchers report no relevant financial disclosures.