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Repeated short-term use of eltrombopag in patients with chronic immune thrombocytopenia (ITP).

Abstract：

:Eltrombopag is a thrombopoietin-receptor agonist that stimulates platelet production and increases platelet counts in patients with chronic immune thrombocytopenia (ITP). This open-label, single-arm study evaluated consistency of response and safety following repeated intermittent dosing of eltrombopag 50 mg daily over 3 cycles (1 cycle = up to 6 weeks on therapy followed by up to 4 weeks off therapy). The primary endpoint was proportion of patients with a response (platelet count ≥50 × 10(9) /l and ≥2× baseline) in Cycle 1 who subsequently responded in Cycle 2 or 3. Fifty-two of 65 evaluable patients (80%) responded in Cycle 1; these responding patients comprised the primary analysis population. Of these, 45/52 (87%) responded in Cycle 2 or 3 [95% confidence interval (CI), 74-94%] and 34/48 (71%; 95% CI, 56-83%) responded in both Cycles 2 and 3. Time to response was consistent, with >50% of responders responding by Day 8 in each cycle. Bleeding rates relative to baseline decreased by approximately 50% during each treatment cycle. The frequency or severity of adverse events, most commonly headache, did not increase over successive cycles. If a chronic ITP patient not requiring consistent therapy responds to short-term eltrombopag, then subsequent courses of eltrombopag, as needed, are likely to be safe and effective.

journal_name

Br J Haematol

journal_title

British journal of haematology

authors

Bussel JB,Saleh MN,Vasey SY,Mayer B,Arning M,Stone NL

doi

10.1111/bjh.12169

subject

Has Abstract

pub_date

2013-02-01 00:00:00

pages

538-46

issue

4

eissn

0007-1048

issn

1365-2141

journal_volume

160

pub_type

杂志文章,多中心研究,随机对照试验

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