PMID- 26341755
OWN - NLM
STAT- MEDLINE
DCOM- 20160114
LR  - 20161125
IS  - 1432-0584 (Electronic)
IS  - 0939-5555 (Linking)
VI  - 94
IP  - 12
DP  - 2015 Dec
TI  - Efficacy and safety of the thrombopoietin receptor agonist romiplostim in 
      patients aged >/= 65 years with immune thrombocytopenia.
PG  - 1973-80
LID - 10.1007/s00277-015-2485-x [doi]
AB  - Thrombopoietin receptor agonists increase platelet counts and reduce bleeding 
      risk in patients with immune thrombocytopenia (ITP). Studies have reported that 
      these agents may represent a risk factor for thromboembolic events, especially in 
      the elderly, who are at increased risk for such complications relative to younger 
      patients. In this retrospective analysis, efficacy and safety data for 
      romiplostim in patients with ITP aged >/=65 years versus those aged <65 years are 
      described. Data from 3 studies (N = 159; 24.5% >/= 65 years of age) were analyzed 
      for efficacy. Data from 13 studies (N = 1037; 28.4% >/= 65 years of age) were 
      analyzed for adverse events (AEs). Relative risk (RR) ratios with 95% CIs were 
      calculated for duration-adjusted incidences of AEs for romiplostim versus 
      placebo/standard of care (SOC) in patients >/= 65 and <65 years. Slightly higher 
      platelet response rates were seen among romiplostim-treated patients >/= 65 versus 
      <65 years. In the safety analyses, 65 (6.3%) received placebo/SOC, 69 (6.7%) 
      received placebo/SOC and then romiplostim, and 903 (87.1%) received romiplostim 
      only. Duration-adjusted AE rates were similar for romiplostim versus placebo/SOC 
      in older and younger patients. 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.
FAU - Michel, Marc
AU  - Michel M
AD  - Henri Mondor University Hospital, Creteil, France. marc.michel@hmn.aphp.fr.
AD  - Department of Internal Medicine, Hopital Henri Mondor, 51 Avenue du Mal de Lattre 
      de Tassigny, 94 000, Creteil, France. marc.michel@hmn.aphp.fr.
FAU - Wasser, Jeffrey
AU  - Wasser J
AD  - University of Connecticut School of Medicine, Farmington, CT, USA.
FAU - Godeau, Bertrand
AU  - Godeau B
AD  - Henri Mondor University Hospital, Creteil, France.
FAU - Aledort, Louis
AU  - Aledort L
AD  - Mount Sinai School of Medicine, New York, NY, USA.
FAU - Cooper, Nichola
AU  - Cooper N
AD  - Catherine Lewis Centre, Hammersmith Hospital, London, UK.
FAU - Tomiyama, Yoshiaki
AU  - Tomiyama Y
AD  - Osaka University Hospital, Osaka, Japan.
FAU - Khellaf, Mehdi
AU  - Khellaf M
AD  - Henri Mondor University Hospital, Creteil, France.
FAU - Wang, Xuena
AU  - Wang X
AD  - Amgen Inc., Thousand Oaks, CA, USA.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150904
PL  - Germany
TA  - Ann Hematol
JT  - Annals of hematology
JID - 9107334
RN  - 0 (Receptors, Fc)
RN  - 0 (Receptors, Thrombopoietin)
RN  - 0 (Recombinant Fusion Proteins)
RN  - 143641-95-6 (MPL protein, human)
RN  - 9014-42-0 (Thrombopoietin)
RN  - GN5XU2DXKV (romiplostim)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Female
MH  - Hemorrhage/chemically induced/epidemiology
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Purpura, Thrombocytopenic, Idiopathic/*drug therapy/epidemiology
MH  - Receptors, Fc/*administration & dosage
MH  - Receptors, Thrombopoietin/*agonists
MH  - Recombinant Fusion Proteins/*administration & dosage/adverse effects
MH  - Risk Factors
MH  - Thrombopoietin/*administration & dosage/adverse effects
OTO - NOTNLM
OT  - Efficacy
OT  - Geriatric
OT  - Immune thrombocytopenia
OT  - Romiplostim
OT  - Safety
OT  - Thrombopoietin receptor agonist
EDAT- 2015/09/06 06:00
MHDA- 2016/01/15 06:00
CRDT- 2015/09/06 06:00
PHST- 2015/04/21 00:00 [received]
PHST- 2015/08/17 00:00 [accepted]
PHST- 2015/09/06 06:00 [entrez]
PHST- 2015/09/06 06:00 [pubmed]
PHST- 2016/01/15 06:00 [medline]
AID - 10.1007/s00277-015-2485-x [pii]
AID - 10.1007/s00277-015-2485-x [doi]
PST - ppublish
SO  - Ann Hematol. 2015 Dec;94(12):1973-80. doi: 10.1007/s00277-015-2485-x. Epub 2015 
      Sep 4.