The introduction of cyclosporine to immunosuppressive therapy greatly improved the results of organ transplantation. The clinical use of cyclosporine, however, is associated with several serious side effects. Because the drug is primarily eliminated via biliary secretion and thus probably alters bile composition, we investigated the incidence of gallstones in 29 heart transplant recipients receiving immunosuppressive therapy with cyclosporine. Two of three female patients and none of the male patients had gallstones before heart transplantation. After operation, in nine of the 26 male patients cholelithiasis developed during cyclosporine therapy; seven cases of gallstones occurred within the first postoperative year. High cyclosporine blood levels, obesity, and diabetes mellitus in the early postoperative period appeared to be predisposing factors for formation of gallstones. Prevention of biliary calculous disease in heart transplant recipients is especially important because immunosuppressive therapy poses an additional risk on potential complications of cholelithiasis. An immunosuppressive regimen aimed at lower cyclosporine blood levels may help to avoid hepatobiliary complications.

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