Abstract:

To investigate clinical characteristics and related factors of telbivudine-associated rhabdomyolysis (RM), we searched domestic and foreign medical literature databases as well as Beijing Adverse Drug Reaction Monitoring Database. Cases of telbivudine-associated RM were collected. General information of patients and information of medications were extracted. Onset of adverse drug reactions (ADRs), clinical manifestations, treatments and outcomes were investigated and analyzed. After reviewing226 literatures and 71 reports, a total of 22 RM cases were collected. All the cases were male patients with an average age of (34.5±11.2) years, and all these patients had chronic hepatitis B and received telbivudine 600 mg/day. The occurrence time of RM varied. One case occurred within 5 months (4.5%), 11 cases occurred within 6 to 10 months (50.0%), 8 cases occurred within 11 to 15 months (31.8%), and 3 cases occurred after 15 months (13.6%). Clinical manifestations were mostly nausea, vomiting, palpitations, weakness and edema of the lower extremities. After the telbivudine treatment was discontinued and symptomatic treatments were provided, 12 patients were clinically improved, 4 patients were physically impaired, 2 patients showed unknow results, and 4 deaths were reported. However, age (P = 0.61), duration of medication (P = 0.54) and CK value (P = 0.07) were not statisticallyassociated with death. Clinicians are advised to monitor clinical manifestations in patients receiving telbivudine. Monitoring on serum creatinine level is suggested if necessary. Telbivudine should be promptly discontinued, and symptomatic treatment should be given when ADRs occur.

Key words: Telbivudine, Rhabdomyolysis, Clinical characteristics