Proven Efficacy With Mulpleta in Two Clinical Trials
The efficacy of Mulpleta was established in two randomized, double-blind, placebo-controlled trials (L-PLUS 1, L-PLUS 2)1,2
†Patients undergoing laparotomy, thoracotomy, open-heart surgery, craniotomy, or organ resection were excluded. Patients with a history of splenectomy, partial splenic embolization, or thrombosis and those with Child-Pugh class C liver disease, absence of hepatopetal blood flow, or a prothrombotic condition other than chronic liver disease were not allowed to participate.
‡Randomization was stratified by liver ablation/coagulation or other procedures and the platelet count at screening/baseline.
- L-PLUS 1: Proportion of patients who required no platelet transfusion§ prior to the primary invasive procedure
- L-PLUS 2: Proportion of patients who required no platelet transfusion§ prior to the primary invasive procedure and no rescue therapy¶ for bleeding from randomization through 7 days after the primary invasive procedure
§Platelet transfusion was required if the platelet count was <50,000/μL.
¶Rescue therapy: Platelet preparations; other blood preparations, including red blood cells and plasma; volume expanders.
Procedures performed after treatment with Mulpleta1
In patients treated with Mulpleta, 95% of procedures were performed within the scheduled period.2
The majority of patients avoided platelet transfusion1
A significantly greater proportion of patients treated with Mulpleta avoided platelet transfusion vs placebo
The majority of patients achieved platelet count ≥50,000/μL1
A significantly greater proportion of patients treated with Mulpleta reached a platelet count of ≥50,000/μL and had a minimum increase of 20,000/μL from baseline vs placebo
- Mean (SD) maximum platelet count in patients treated with Mulpleta without platelet transfusion and patients who received placebo with platelet transfusion:
- L-PLUS 1: 90,200/μL (22,100/μL) with Mulpleta (n=38) and 52,800/μL (10,800/μL) with placebo (n=41)
- L-PLUS 2: 86,900/μL (27,200/μL) with Mulpleta (n=74) and 49,300/μL (13,900/μL) with placebo (n=73)
Patients maintained platelet count ≥50,000/μL1,2
Duration of platelet count ≥50,000/μL was longer with Mulpleta* vs placebo†
- In patients treated with Mulpleta without platelet transfusion, mean (SD) time to reach maximum platelet count was 13.4 (3.8) days in L-PLUS 1 (n=38) and 12.4 (4.7) days in L-PLUS 2 (n=74)2