Dental procedures in 24 patients with chronic immune thrombocytopenia in prospective clinical studies of eltrombopag

Abstract

Primary immune thrombocytopenia (ITP) is an autoimmune disease characterized by chronically low peripheral blood platelet counts. Eltrombopag is an oral, non-peptide, thrombopoietin-receptor agonist that increases platelet production. This report examines peri-procedural platelet counts and bleeding complications among chronic ITP patients requiring dental procedures while participating in clinical studies with eltrombopag. A total of 494 patients participated in five clinical studies of eltrombopag in chronic ITP. Information about dental procedures was collected prospectively in four studies and retrospectively in one study. Twenty-four patients (22 eltrombopag, 2 placebo) underwent 32 dental procedures (dental cleaning, tooth repair, artificial crown, dental prosthesis, tooth extraction, dental or wisdom teeth extraction, dental root extraction, and endodontic procedures, among others) during study treatment or up to 10 days later. Supplemental ITP therapy (e.g., corticosteroids, platelet transfusions) was given before the dental procedure to increase platelet counts in three eltrombopag-treated patients and both placebo-treated patients. The mean pre-procedure platelet count ± standard deviation for all procedures in the overall population of patients, eltrombopag group, and placebo group prior to undergoing dental procedures was 96 000 ± 81 069/µl,103 517 ± 81 522/µl, and 23 333 ± 9291/µl, respectively. Two patients in each group had platelet counts below 30 000/µl before the procedure. No patient who had a dental procedure experienced a bleeding adverse event. Among patients with chronic ITP who required a dental procedure during clinical studies of eltrombopag, supplemental ITP treatment was required for both patients who received placebo but was not required for most patients who received eltrombopag. No bleeding complications were reported. These data imply that patients with chronic ITP who receive eltrombopag and experience increases in platelet counts fulfill current pre-procedural platelet count recommendations to undergo invasive dental procedures, and may have a lower risk of bleeding complications and a reduced need for supplemental ITP treatment.

Thrombopoetin receptor agonist therapy in thrombocytopenia: ITP and beyond

“…The earlier use of eltrombopag in the treatment paradigm is important for several reasons: prevention of side effects associated with therapies often used before the availability of THPO agonists, avoiding inconvenience for patients with regard to day case admission for IVIg, avoiding unnecessary exposure to blood products and reduced immunosuppression. Beyond using eltrombopag in severe, chronic and/or refractory ITP, there is growing awareness of its role in temporarily boosting the platelet count prior to surgery or other intervention, such as dental procedures (Tarantino et al , , ; Zaja et al , ). Our bridging group had a higher baseline platelet count than that of the severe ITP group, but demonstrated a higher CR rate to that already published (Zaja et al , ).…”

World Workshop on Oral Medicine VII: Platelet count and platelet transfusion for invasive dental procedures in thrombocytopenic patients: A systematic review

“…In two studies, not all patients with haematological malignancy were thrombocytopenic at time of extraction (Overholser, Peterson, Bergman, & Williams, 1982;Raut, Huryn, Hwang, & Zlotolow, 2001); however, for all other studies, we only included thrombocytopenic patients with platelet count < 100,000 at time of extraction. Two studies did not include the exact number of teeth extracted (Raut et al, 2001;Tarantino, Fogarty, Shah, & Brainsky, 2015). No bleeding complications were reported among the ITP patients, and 11 patients (5.5%) with thrombocytopenia related to haematological malignancy or disease had bleeding (7 minor and 4 moderate bleeding episodes) ( Table 2 presents details of platelet transfusions and bleeding episodes.…”

“…An even lower threshold (platelet count < 30,000/μl) was allowed for scaling and root planing (Morimoto, Niwa, Imai, & Kirita, 2004). In two studies, the decision on platelet transfusion threshold was based on the attending specialist judgement (Raut et al, 2001;Tarantino et al, 2015).…”

Dental extraction is probably safe for patients with thrombocytopenia: the standard of care is a guide for clinical decision making related to platelet transfusion

“…1 Another 2015 study of 24 patients with immune thrombocytopenia showed no bleeding complications as long as severely thrombocytopenic patients were given supplemental platelet transfusion preoperatively. 2 The most relevant article has been chosen for critical appraisal. The 2013 Mayo Clinic study explicitly addresses safety and complications of tooth extraction in thrombocytopenic patients without a focus on a particular disease.…”