Oral receptor safely treats thrombocytopenia in patients with chronic liver disease

SAN FRANCISCO — In the L-PLUS-1 clinical trial, researchers in Japan found S-888711, also known as lusutrombopag, to be effective for the treatment of thrombocytopenia in patients with chronic liver disease, according to a Late Breaker at The Liver Meeting 2015.

Namiki Izumi, MD, PhD, of the Musashino Red Cross Hospital, Tokyo, Japan, and colleagues randomly assigned 96 patients with thrombocytopenia and chronic liver disease scheduled to undergo elective invasive procedures to receive either placebo (n = 48) or 3 mg of S-888711 (lusutrombopag [LUSU], Shionogi Inc.; n = 48) once daily for up to 1 week.

All patients had a platelet count less than 50,000/µL. The primary endpoint was the number of patients who did not require preoperative platelet transfusion after therapy.

The number of patients who did not require preoperative platelet transfusion was greater in the LUSU group (n = 38) compared with the placebo group (n = 6; P < .0001). Also, the number of responders was greater in the LUSU-treated group (n = 37) compared with placebo (n = 3; P < .0001).

Patients in the LUSU-treated group had a greater median number of days without having to undergo platelet transfusion due to platelet count being more than 50,000 µL (22.1 days) compared with the placebo group (3.3 days; P < .0001).

Adverse events were common among both groups; 93.8% in the LUSU group and 100% in the placebo group. The most common adverse events in both groups were postoperative fever (LUSU: 39.6%, placebo: 56.3%), procedural pain (48.5%, 41.7%), procedural hypertension (41.7%, 37.5%) and higher aspartate aminotransferase levels (22.9%, 31.3%).

“No patients died or discontinued due to an [adverse event],” the researchers wrote.

Increased alanine aminotransferase levels were more common in the placebo group (20.8%), as well a greater incidence of bleeding-related adverse events compared with the LUSU-treated group (27.1% vs. 14.6%).

The researchers concluded: “LUSU was an efficacious and well-tolerated alternative to platelet transfusion in thrombocytopenic patients with CLD… A global phase 3 study [known as L-PLUS-2] is ongoing.” – by Melinda Stevens

Reference:

Izumi N, et al. Abstract LB-30. Presented at: The Liver Meeting; Nov. 13-17, 2015; San Francisco.

Disclosures: Izumi reports speaking and teaching for MSD Co., Beyer Co., Daiichi Sankyo Co., Gilead Sciences and Shionogi Co. Please see the abstract for a full list of all other authors’ relevant financial disclosures.