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50 found after 3 searches:
1. Efficacy and safety of thrombopoietin receptor agonists in children and adults with persistent and chronic immune thrombocytopenia: a meta-analysis.
Expert Opin Pharmacother 2023;24:6. PMID: 37010022 , doi: 10.1080/14656566.2023.2198089, Cited by. Cite
Conclusion: PO-RAs has better efficacy and higher safety in the treatment of ITP. And the overall response rate of avatrombopag in adults was higher than that in eltrombopag and hetrombopag.
2. Safety, tolerance, pharmacokinetic and pharmacodynamic properties of thrombopoietin mimetic peptide for injection in Chinese healthy volunteers: a randomized, placebo-controlled, double-blind study.
Platelets 2022;33:8. PMID: 35549802 , doi: 10.1080/09537104.2022.2073344, Cited by. Cite
Conclusion: TPO-RAs provide ITP patients with well-tolerated, long-term treatment choices.What is new?● The thrombopoietin mimetic peptide for injection is a new TPO-RAs developed by Shandong Quangang Pharmaceutical Co., Ltd. (China).● This study showed that thrombopoietin mimetic peptide is effective at improving PLT after a single subcutaneous injection.● The thrombopoietin mimetic peptide is safe and well-tolerated in Chinese healthy subjects.What is the impact?● This study provides evidence for the further development potential of the thrombopoietin mimetic peptide.
3. A multicentre double-blind, double-dummy, randomised study of recombinant human thrombopoietin versus eltrombopag in the treatment of immune thrombocytopenia in Chinese adult patients.
Br J Haematol 2021;195:5. PMID: 34528239 , doi: 10.1111/bjh.17808, Cited by. Cite
Conclusion: Adverse events were similar in patients given rhTPO and eltrombopag. To conclude, rhTPO is superior to eltrombopag at 25 mg/day in rapidly increasing platelet counts in patients with ITP (ClinicalTrials.gov Identifier: NCT03771378).
Impact/quality: Accompanied by editorial; *
4. Lessons Learned Using Real-World Data to Emulate Randomized Trials: A Case Study of Treatment Effectiveness for Newly Diagnosed Immune Thrombocytopenia.
Clin Pharmacol Ther 2021;110:6. PMID: 34416023 , doi: 10.1002/cpt.2399, Cited by. Cite
Conclusion: We underscore the importance of conducting comprehensive feasibility assessments to identify fit-for-purpose data sources with sufficient sample size, data elements, and follow-up. Beyond technical challenges, we also discuss approaches to increase the credibility of RWE, including systematic incorporation of clinical expertise into study design decisions, and separation between decision makers and the data.
5. Efficacy and Safety of Avatrombopag in Patients with Chronic Immune Thrombocytopenia: A Systematic Literature Review and Network Meta-Analysis.
Adv Ther 2021;38:6. PMID: 33934279 , PubMed Central, doi: 10.1007/s12325-021-01752-4, Cited by. Cite
Conclusion: significantly increased the chance of achieving durable platelet response and reducing the use of concomitant ITP medication vs placebo, and significantly reduced the incidence of any bleeding events compared with placebo, eltrombopag, and romiplostim. The study aims to help guide clinicians managing patients with chronic ITP and insufficient response to previous treatment.
6. A multicenter, randomized phase III trial of hetrombopag: a novel thrombopoietin receptor agonist for the treatment of immune thrombocytopenia.
J Hematol Oncol 2021;14:1. PMID: 33632264 , PubMed Central, doi: 10.1186/s13045-021-01047-9, Cited by. Cite
Conclusion: ag is efficacious and well tolerated with a manageable safety profile. Trial registration Clinical trials.gov NCT03222843 , registered July 19, 2017, retrospectively registered.
7. Efficacy and safety evaluation of avatrombopag in immune thrombocytopenia: analyses of a phase III study and long-term extension.
Platelets 2022;33:2. PMID: 33586606 , doi: 10.1080/09537104.2021.1881952, Cited by. Cite
Conclusion: More than half (57.1%) of patients on chronic corticosteroids reduced or discontinued corticosteroids. In conclusion, avatrombopag enabled most patients with ITP to achieve clinically meaningful and durable platelet count improvements.
8. Efficacy and safety of eltrombopag in Chinese patients with chronic immune thrombocytopenia: stage 2 results from a multicenter phase III study.
Platelets 2022;33:1. PMID: 33251910 , doi: 10.1080/09537104.2020.1847267, Cited by. Cite
Conclusion: The stage 2 results further demonstrated a sustainable long-term efficacy and good tolerability of eltrombopag with a favorable benefit-risk ratio in Chinese chronic ITP patients.Trial registration: Clinicaltrials.gov NCT01762761. Registered 8 January 2013, https://clinicaltrials.gov/ct2/show/NCT01762761.
9. The Cost-effectiveness of Eltrombopag for the Treatment of Immune Thrombocytopenia in the United States.
Clin Ther 2020;42:5. PMID: 32199608 , doi: 10.1016/j.clinthera.2020.02.020, Cited by. Cite
Conclusion: This model was limited by a lack of specific patient-level data and robust data on the duration of secondary therapy, as well as by the fact that utilization values are likely conservative estimates for routine care use.
10. Safety and efficacy of self-administered romiplostim in patients with immune thrombocytopenia: Results of an integrated database of five clinical trials.
Am J Hematol 2020;95:6. PMID: 32129511 , PubMed Central, doi: 10.1002/ajh.25776, Cited by. Cite
Conclusion: Self-administration did not adversely affect safety; duration-adjusted rates for all treatment-emergent adverse events (TEAEs) and bleeding TEAEs were numerically lower with self-administration. Romiplostim self-administration appears effective and well tolerated in eligible patients with ITP.
11. Romiplostim in adult patients with newly diagnosed or persistent immune thrombocytopenia (ITP) for up to 1 year and in those with chronic ITP for more than 1 year: a subgroup analysis of integrated data from completed romiplostim studies.
Br J Haematol 2019;185:3. PMID: 30793285 , PubMed Central, doi: 10.1111/bjh.15803, Cited by. Cite
Conclusion: Independent of ITP duration, rates of serious adverse events and bleeding were lower with romiplostim than placebo/standard of care and thrombotic events occurred at similar rates. In this analysis, romiplostim and placebo/standard of care had similar safety profiles and romiplostim increased platelet counts in patients with either ITP ≤1 year or ITP >1 year, with more treatment-free remission in those with ITP ≤1 year.
12. Systematic literature review of treatments used for adult immune thrombocytopenia in the second-line setting.
Am J Hematol 2019;94:1. PMID: 30264861 , PubMed Central, doi: 10.1002/ajh.25301, Cited by. Cite
Conclusion: This review confirms that for most second-line ITP treatment options, there remains a lack of rigorous evidence derived from RCTs, and for many treatments, there is limited evidence of any kind. The need for additional research to guide treatment choices in this setting and greater use of standardized ITP terminology are highlighted.
13. Phase 3 randomised study of avatrombopag, a novel thrombopoietin receptor agonist for the treatment of chronic immune thrombocytopenia.
Br J Haematol 2018;183:3. PMID: 30191972 , PubMed Central, doi: 10.1111/bjh.15573, Cited by. Cite
Conclusion: The safety profile of avatrombopag was consistent with Phase 2 studies; the most common adverse events were headache and contusion. Overall, avatrombopag was well tolerated and efficacious for the treatment of chronic ITP.
14. [The efficacy and safety of eltrombopag in Chinese patients with chronic immune thrombocytopenia].
Zhonghua Xue Ye Xue Za Zhi 2018;39:1. PMID: 29551030 , PubMed Central, doi: 10.3760/cma.j.issn.0253-2727.2018.01.007, Cited by. Cite
Conclusion: 目的: 观察艾曲泊帕治疗成人慢性原发免疫性血小板减少症(ITP)的疗效及安全性。 方法: 2013年1月29日至2014年5月16日,纳入35例慢性ITP患者进行随机、双盲、安慰剂对照临床研究,以25 mg/d为起始剂量给予艾曲泊帕(17例)或安慰剂(18例),疗程为6周。 结果: 35例慢性ITP患者中男6例、女29例,中位年龄42(22~66)岁。艾曲泊帕组退组1例,其余患者均完成治疗。艾曲泊帕组在治疗开始2周内PLT≥30×10(9)/L的患者百分比高于安慰剂组[64.71%(11/17)对27.78%(5/18),P=0.031]。治疗第6周,艾曲泊帕组PLT≥50×10(9)/L、PLT≥30×10(9)/L患者百分比均高于安慰剂组[64.71%(11/17)对11.11%(2/18),P=0.001;76.47%(13/17)对38.89%(7/18),P=0.028]。艾曲泊帕组6周治疗期内至少1次PLT≥50×10(9)/L、50%时间PLT≥50×10(9)/L的患者百分比均高于安慰剂组[94.11%(16/17)对33.33%(6/18),P<0.001;70.59%(12/17)对11.11%(2/18),P<0.001]。安慰剂组8例(44.44%)患者治疗期间增加合并用药,艾曲泊帕组无增加合并用药病例(P=0.002)。治疗第6周WHO出血分级比较:艾曲泊帕组16例均为0级(退组1例未评估),安慰剂组0、1级分别为14、4例,两组差异无统计学意义(P=0.066)。与艾曲泊帕可能相关的不良事件包括转氨酶增高3例、胆红素增高5例、血小板升高相关脑梗死1例。 结论: 艾曲泊帕治疗成人慢性ITP起效时间较快且具有良好的安全性。.
15. Multicentre, randomised phase III study of the efficacy and safety of eltrombopag in Chinese patients with chronic immune thrombocytopenia.
Br J Haematol 2017;176:1. PMID: 27734464 , doi: 10.1111/bjh.14380, Cited by. Cite
Conclusion: Tolerability, pharmacokinetics, and pharmacokinetics/pharmacodynamics were similar to previous findings in East Asian patients. In conclusion, in Chinese patients with chronic ITP, eltrombopag 25 mg once daily, elevated platelet counts to a safe range and reduced bleeding.
16. Romiplostim in children with immune thrombocytopenia: a phase 3, randomised, double-blind, placebo-controlled study.
Lancet 2016;388:10039. PMID: 27103127 , doi: 10.1016/S0140-6736(16)00279-8, Cited by. Cite
Conclusion: In children with chronic immune thrombocytopenia, romiplostim induced a high rate of platelet response with no new safety signals. Ongoing romiplostim studies will provide further information as to long-term efficacy, safety, and remission in children with immune thrombocytopenia.
Impact/quality: Accompanied by editorial; *
17. A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Effect of Romiplostim on Health-Related Quality of Life in Children with Primary Immune Thrombocytopenia and Associated Burden in Their Parents.
Pediatr Blood Cancer 2016;63:7. PMID: 27037553 , PubMed Central, doi: 10.1002/pbc.25984, Cited by. Cite
Conclusion: The treatment with romiplostim may be associated with improved HRQoL in children with primary ITP and reduced burden to their parents.
18. Eltrombopag for the treatment of children with persistent and chronic immune thrombocytopenia (PETIT): a randomised, multicentre, placebo-controlled study.
Lancet Haematol 2015;2:8. PMID: 26688484 , doi: 10.1016/S2352-3026(15)00114-3, Cited by. Cite
Conclusion: Our results showed that eltrombopag could be used to increase platelet counts and reduce clinically significant bleeding in children with persistent or chronic immune thrombocytopenia. Prevalence of increased liver laboratory values was similar to that seen in adults.
19. Efficacy and safety of the thrombopoietin receptor agonist romiplostim in patients aged ≥ 65 years with immune thrombocytopenia.
Ann Hematol 2015;94:12. PMID: 26341755 , doi: 10.1007/s00277-015-2485-x, Cited by. Cite
Conclusion: The risks for grade ≥ 3 bleeding (RR 1.92; 95% CI, 0.47-7.95) and thromboembolic events (RR 3.85; 95% CI, 0.53-27.96) were numerically but not significantly higher for romiplostim versus placebo/SOC in patients ≥ 65 years. Romiplostim is effective and, with the exception of nonsignificant trends showing increased risks of grade ≥ 3 bleeding and thromboembolic events (a trend observed in other studies), generally well tolerated in older patients with ITP.
20. Case study of remission in adults with immune thrombocytopenia following cessation of treatment with the thrombopoietin mimetic romiplostim.
Hematology 2016;21:4. PMID: 26251926 , doi: 10.1179/1607845415Y.0000000041, Cited by. Cite
Conclusion: In adults, immune thrombocytopenia (ITP), characterized by platelet counts <100 × 10(9)/l, is typically chronic, with remission reported infrequently ≥3 years post-diagnosis. The thrombopoietin mimetic romiplostim increases platelet counts and reduces use of concomitant ITP medications in chronic ITP. While often perceived as a long-term treatment, dose-adjustment rules allow romiplostim to be discontinued when hemostatic platelet counts are reached, as reported in Amgen trials.
21. Eltrombopag for children with chronic immune thrombocytopenia (PETIT2): a randomised, multicentre, placebo-controlled trial.
Lancet 2015;386:10004. PMID: 26231455 , doi: 10.1016/S0140-6736(15)61107-2, Cited by. Cite
Conclusion: Eltrombopag, which produced a sustained platelet response in 40% of patients with chronic immune thrombocytopenia, is a suitable therapeutic option for children with chronic symptomatic immune thrombocytopenia. We identified no new safety concerns and few patients discontinued treatment because of adverse events.
Impact/quality: Accompanied by editorial; *
22. Integrated analysis of long-term safety in patients with chronic immune thrombocytopaenia (ITP) treated with the thrombopoietin (TPO) receptor agonist romiplostim.
Int J Hematol 2015;102:3. PMID: 26201709 , doi: 10.1007/s12185-015-1837-6, Cited by. Cite
Conclusion: Three patients developed neutralizing antibodies to romiplostim, but not to endogenous TPO. This integrated analysis of the safety profile of romiplostim in patients with ITP is consistent with previously reported studies; no new safety concerns emerged.
23. Evaluation of bone marrow reticulin in patients with chronic immune thrombocytopenia treated with eltrombopag: Data from the EXTEND study.
Am J Hematol 2015;90:7. PMID: 25801698 , doi: 10.1002/ajh.24011, Cited by. Cite
Conclusion: After withdrawing from the study, the biopsy of 1 patient reverted to normal. There were no other pathologic changes identified among on-treatment specimens, and no pattern of abnormal reticulin deposition associated with eltrombopag treatment was evident.
24. Lack of clinically significant pharmacokinetic interaction between the thrombopoietin receptor agonist eltrombopag and hepatitis C virus protease inhibitors boceprevir and telaprevir.
Antimicrob Agents Chemother 2014;58:11. PMID: 25155600 , PubMed Central, doi: 10.1128/AAC.03091-14, Cited by. Cite
Conclusion: There were no severe or serious adverse events. Dose adjustment is not required when eltrombopag is coadministered with boceprevir or telaprevir given the lack of clinically significant pharmacokinetic interaction.
25. A randomized trial of avatrombopag, an investigational thrombopoietin-receptor agonist, in persistent and chronic immune thrombocytopenia.
Blood 2014;123:25. PMID: 24802775 , doi: 10.1182/blood-2013-07-514398, Cited by. Cite
Conclusion: Avatrombopag was active and generally well tolerated, with PC response rates and AE incidence comparable with other TPO-RAs. These studies were registered at www.clinicaltrials.gov as #NCT00441090 and #NCT00625443.
26. Efficacy of eltrombopag in management of bleeding symptoms associated with chronic immune thrombocytopenia.
Blood Coagul Fibrinolysis 2013;24:3. PMID: 23492914 , doi: 10.1097/MBC.0b013e32835fac99, Cited by. Cite
Conclusion: The odds of clinically significant bleeding in RAISE were 65% lower (P<0.001). In conclusion, analysis of prospective data from five clinical studies demonstrates that eltrombopag significantly reduces bleeding in adult patients with chronic ITP.
27. Long-term treatment with romiplostim in patients with chronic immune thrombocytopenia: safety and efficacy.
Br J Haematol 2013;161:3. PMID: 23432528 , doi: 10.1111/bjh.12260, Cited by. Cite
Conclusion: There was a low rate of bleeding and infrequent need for rescue treatments. In conclusion, this study demonstrated that romiplostim was safe and well-tolerated over 614 patient-years of exposure in ITP patients, and that efficacy was maintained with stable dosing for up to 5 years of continuous treatment.
28. Repeated short-term use of eltrombopag in patients with chronic immune thrombocytopenia (ITP).
Br J Haematol 2013;160:4. PMID: 23278590 , doi: 10.1111/bjh.12169, Cited by. Cite
Conclusion: 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.
29. Evaluation of bleeding-related episodes in patients with immune thrombocytopenia (ITP) receiving romiplostim or medical standard of care.
Int J Hematol 2012;96:1. PMID: 22562409 , doi: 10.1007/s12185-012-1088-8, Cited by. Cite
Conclusion: Bleeding-related hospitalizations were rare in both groups. Thus, romiplostim treatment provided greater reductions in all BREs, as well as BREs involving Ig rescue medications, than did SOC.
30. Health-related quality of life in nonsplenectomized immune thrombocytopenia patients receiving romiplostim or medical standard of care.
Am J Hematol 2012;87:5. PMID: 22460421 , doi: 10.1002/ajh.23163, Cited by. Cite
Conclusion: Overall, treatment of ITP was associated with improvement in HRQOL. Patients receiving romiplostim had greater HRQOL improvements than those receiving SOC, but the magnitude ofthe difference is of uncertain clinical benefit.
31. A lower starting dose of eltrombopag is efficacious in Japanese patients with previously treated chronic immune thrombocytopenia.
J Thromb Haemost 2012;10:5. PMID: 22409309 , doi: 10.1111/j.1538-7836.2012.04695.x, Cited by. Cite
Conclusion: Eltrombopag was generally well tolerated; one patient experienced a transient ischemic attack on day 9. Eltrombopag (12.5-50 mg) is effective for the management of Japanese patients with chronic ITP (NCT00540423).
32. Romiplostim dose response in patients with immune thrombocytopenia.
J Clin Pharmacol 2012;52:10. PMID: 22167563 , doi: 10.1177/0091270011420843, Cited by. Cite
Conclusion: Visual and numerical predictive checks suggested accurate prediction of platelet time course and durable response rate in ITP patients. Model-based simulations confirmed the effectiveness of dose reduction to prevent platelet counts >400 × 10(9)/L.
33. Romiplostim for the treatment of chronic immune thrombocytopenia in adult Japanese patients: a double-blind, randomized Phase III clinical trial.
Int J Hematol 2011;94:1. PMID: 21706145 , doi: 10.1007/s12185-011-0886-8, Cited by. Cite
Conclusion: Adverse events that occurred more frequently (>10%) in romiplostim-treated patients included nasopharyngitis, headache, peripheral edema, back pain, and extremity pain. In conclusion, romiplostim significantly increased and maintained platelet counts and was well tolerated in Japanese patients with ITP.
34. A randomized, double-blind study of romiplostim to determine its safety and efficacy in children with immune thrombocytopenia.
Blood 2011;118:1. PMID: 21502541 , doi: 10.1182/blood-2010-10-313908, Cited by. Cite
Conclusion: In this short-term study, romiplostim increased platelet counts in 88% of children with ITP and was well-tolerated and apparently safe. The trial was registered with http://www.clinicaltrials.gov as NCT00515203.
Impact/quality: Accompanied by editorial; *
35. Romiplostim in children with chronic refractory ITP: randomized placebo controlled study.
Ann Hematol 2011;90:11. PMID: 21318572 , doi: 10.1007/s00277-011-1172-9, Cited by. Cite
Conclusion: Ten patients on romiplostim (83.3%) maintained the efficacy endpoint (PC > 50,000). Romiplostim was well-tolerated and efficient in treating the children with chronic refractory ITP with no unexpected AEs.
36. Romiplostim or standard of care in patients with immune thrombocytopenia.
N Engl J Med 2010;363:20. PMID: 21067381 , doi: 10.1056/NEJMoa1002625, Cited by. Cite
Conclusion: Patients treated with romiplostim had a higher rate of a platelet response, lower incidence of treatment failure and splenectomy, less bleeding and fewer blood transfusions, and a higher quality of life than patients treated with the standard of care. ( ClinicalTrials.gov number, NCT00415532.).
Impact/quality: Accompanied by editorial; *
37. Eltrombopag (75 mg) does not induce photosensitivity: results of a clinical pharmacology trial.
Photodermatol Photoimmunol Photomed 2010;26:5. PMID: 20831698 , doi: 10.1111/j.1600-0781.2010.00538.x, Cited by. Cite
Conclusion: Repeat dosing of eltrombopag 75 mg q.i.d. for 6 days in healthy men and women did not induce photosensitivity at any wavelength tested (UVA, ultraviolet B) in this study. Eltrombopag is well tolerated and does not induce photosensitivity.
38. Eltrombopag for management of chronic immune thrombocytopenia (RAISE): a 6-month, randomised, phase 3 study.
Lancet 2011;377:9763. PMID: 20739054 , doi: 10.1016/S0140-6736(10)60959-2, Cited by. Cite
Conclusion: Eltrombopag is effective for management of chronic immune thrombocytopenia, and could be particularly beneficial for patients who have not responded to splenectomy or previous treatment. These benefits should be balanced with the potential risks associated with eltrombopag treatment.
Impact/quality: Accompanied by editorial; editorial; *
39. Population pharmacokinetics of eltrombopag in healthy subjects and patients with chronic idiopathic thrombocytopenic purpura.
J Clin Pharmacol 2011;51:6. PMID: 20663993 , doi: 10.1177/0091270010375427, Cited by. Cite
Conclusion: There was also a dose effect, with CL/F and Vc/F estimated to be respectively 68% and 55% higher for doses 20 mg or less. In conclusion, East Asian race had the largest impact on eltrombopag exposure with a lower initial dose being recommended.
40. Romiplostim for the treatment of chronic immune (idiopathic) thrombocytopenic purpura.
Oncology (Williston Park) 2009;23:8. PMID: 19711585 , Cited by. Cite
Conclusion: The FDA approved romiplostim for use among certain patients with chronic ITP. This approval included a Risk Evaluation and Mitigation Strategy to ensure that the benefits of the drug outweigh its risks.
Impact/quality: Accompanied by editorial; editorial; *
41. Evaluation of bone marrow reticulin formation in chronic immune thrombocytopenia patients treated with romiplostim.
Blood 2009;114:18. PMID: 19671919 , doi: 10.1182/blood-2009-05-224766, Cited by. Cite
Conclusion: This report suggests that romiplostim produces reversible, dose-dependent bone marrow changes in rats and produces modest increases in bone marrow reticulin in some ITP patients that decrease when therapy is discontinued. These studies were registered at www.clinicaltrials.gov as #NCT00102323, #NCT00102336, #NCT00861224, and #NCT00116688.
Impact/quality: Accompanied by editorial; *
42. Effects of food and antacids on the pharmacokinetics of eltrombopag in healthy adult subjects: two single-dose, open-label, randomized-sequence, crossover studies.
Clin Ther 2009;31:4. PMID: 19446149 , doi: 10.1016/j.clinthera.2009.04.010, Cited by. Cite
Conclusion: Concomitant administration of eltrombopag with high-calcium food or an antacid containing aluminum and magnesium was associated with significantly reduced systemic exposure, whereas low-calcium meals were not. A single dose of eltrombopag was generally well tolerated in these healthy volunteers.
43. Eltrombopag.
Drugs 2009;69:5. PMID: 19368418 , doi: 10.2165/00003495-200969050-00005, Cited by. Cite
Conclusion: Eltrombopag therapy for 6 weeks also significantly decreased the incidence of WHO-defined bleeding compared with placebo. Eltrombopag was generally well tolerated in clinical trials, with an adverse events profile that did not differ significantly from that with placebo.
44. Effect of eltrombopag on platelet counts and bleeding during treatment of chronic idiopathic thrombocytopenic purpura: a randomised, double-blind, placebo-controlled trial.
Lancet 2009;373:9664. PMID: 19231632 , doi: 10.1016/S0140-6736(09)60402-5, Cited by. Cite
Conclusion: Eltrombopag is an effective treatment for managment of thrombocytopenia in chronic ITP.
Impact/quality: Accompanied by editorial; *
45. Evaluating clinically meaningful change on the ITP-PAQ: preliminary estimates of minimal important differences.
Curr Med Res Opin 2009;25:2. PMID: 19192982 , doi: 10.1185/03007990802634119, Cited by. Cite
Conclusion: These MID estimates will serve as a useful tool to researchers and clinicians using the ITP-PAQ, providing guidance for interpretation of baseline scores as well as changes in ITP-PAQ scores over time. Additional work should be done to finalize these initial estimates using more appropriate anchors that correlate more highly with the ITP-PAQ scales.
46. Improved quality of life for romiplostim-treated patients with chronic immune thrombocytopenic purpura: results from two randomized, placebo-controlled trials.
Br J Haematol 2009;144:3. PMID: 19016720 , doi: 10.1111/j.1365-2141.2008.07464.x, Cited by. Cite
Conclusion: Data pooled from the two trials, adjusted for splenectomy status, showed significant improvement for romiplostim-treated patients in six scales; Symptoms, Bother, Activity, Fear, Social Activity and Women's Reproductive Health. These results suggest that adult patients with chronic ITP have improved HRQoL following romiplostim therapy.
47. Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial.
Lancet 2008;371:9610. PMID: 18242413 , doi: 10.1016/S0140-6736(08)60203-2, Cited by. Cite
Conclusion: Romiplostim was well tolerated, and increased and maintained platelet counts in splenectomised and non-splenectomised patients with ITP. Many patients were able to reduce or discontinue other ITP medications. Stimulation of platelet production by romiplostim may provide a new therapeutic option for patients with ITP.
Impact/quality: Accompanied by editorial; * Governmental/foundation support *
48. Eltrombopag for the treatment of chronic idiopathic thrombocytopenic purpura.
N Engl J Med 2007;357:22. PMID: 18046028 , doi: 10.1056/NEJMoa073275, Cited by. Cite
Conclusion: Eltrombopag increased platelet counts in a dose-dependent manner in patients with relapsed or refractory ITP. (ClinicalTrials.gov number, NCT00102739.)
Impact/quality: Accompanied by editorial; *
49. Pharmacodynamics and pharmacokinetics of AMG 531, a thrombopoiesis-stimulating peptibody, in healthy Japanese subjects: a randomized, placebo-controlled study.
J Clin Pharmacol 2007;47:12. PMID: 17925591 , doi: 10.1177/0091270007306563, Cited by. Cite
Conclusion: Four of 8 subjects receiving 1 microg/kg and 7 of 8 receiving 2 microg/kg had platelet count increases > or =1.5-fold over baseline, an effect similar to that seen in non-Japanese subjects. Serum AMG 531 concentrations were below the lower limit of quantification in all but 2 subjects receiving 2 microg/kg.
50. AMG 531, a thrombopoiesis-stimulating protein, for chronic ITP.
N Engl J Med 2006;355:16. PMID: 17050891 , doi: 10.1056/NEJMoa054626, Cited by. Cite
Conclusion: AMG 531 caused no major adverse events and increased platelet counts in patients with ITP. (ClinicalTrials.gov number, NCT00111475 [ClinicalTrials.gov].).
Impact/quality: Accompanied by editorial; *
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