ASH News Daily 2012 - Monday, December 10, 2012 - (Page A-3)
Monday, December 10, 2012
MYELOPROLIFERATIVE DISORDERS
Vera Veritas: Identifying Hematocrit Targets in P Vera
BY MARC J. KAHN, MD, MBA
T
he abnormal increased production
of red blood cells associated
with polycythemia vera (PV)
leads to an increased risk of thromboembolism
and cardiovascular events.
Although expert opinion suggests
that patients with PV should have
their hematocrit values maintained
at levels less than 45 percent in order
to decrease the risk of cardiovascular
events and thromboembolism, this
recommendation has not been previously
tested in a prospective fashion.
Analysis of at least two large studies
of PV patients, PVSG-1 and ECLAP,
suggested that there was no difference
in major thrombosis when the
hematocrit was kept in the 40 to 50
percent range. Yesterday, during
the Plenary session, Tiziano Barbui,
MD, from Bergamo, Italy, presented
the first randomized study to date
comparing hematocrit values in PV
patients. Dr. Barbui is professor of
hematology and scientific director of
the Research Foundation at Ospedali
Riuniti de Bergamo. He had previously
served as head of the Department
of Hematology in Bergamo.
Further, as former president of the
Italian Society of Hematology and
leader of the GIMEMA group on myeloproliferative
disorders, Dr. Barbui’s
research interests have recently
focused on the optimization of PV
and essential thrombocythemia care
and therapy.
The session was introduced by
Claire Harrison, DM, from Guy’s
Hospital, London. She reminded us
of an observational study published
in 1978 that correlated a hematocrit
over 45 percent with increased cardiovascular
events in patients with
PV. Dr. Harrison also reminded us
that this study, which appeared in
the Lancet, was coincidentally published
by investigators
from her
current institution. Dr. Harrison
introduced the session with the notion
that despite the advent of JAK2
inhibitors for the treatment of PV, the
fundamental question regarding the
role of venisection and target hematocrit
remains unanswered.
Dr. Barbui and his co-investigators
presented the results of a large-scale
randomized trial involving 21 Italian
hematologic centers and included 365
patients. The patients were randomized
into two groups. Patients randomly
assigned to arm A had their
hematocrits maintained at less than
45 percent; patients assigned to arm
B had a more permissive approach,
maintaining hematocrits of 45 to 50
percent. Patients in both arms were
equally treated with antiplatelet
drugs or warfarin. Patients in arm A
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had median hematocrit values of 44
percent, whereas those randomized
to arm B had median values of 48 percent.
Hematocrit values were maintained
by either phlebotomy, cytoreductive
therapy, or a combination of
both. Target hemoglobin values were
reached at six months. Interestingly,
the white count was also significantly
lower in the group targeted to a lower
hematocrit, suggesting the increased
use of cytoreductive therapy in that
group. The primary endpoint, total
cardiovascular events, was four-fold
higher in the group with hematocrit
values in the 45 to 50 percent range.
Additionally, major thrombotic
events were significantly decreased
in the group with a lower hematocrit.
There was no difference in the two
groups regarding evolution to myelofibrosis,
evolution of myelodysplasia,
or incidence of leukemia. Dr. Barbui
was quick to assert that these data are
relevant for patients with an intrinsic
marrow process and should not be
generalized to patients with secondary
polycythemia due to congenital
heart disease or pulmonary disease.
Supporting the clinical importance
ASH NEWS DAILY
Page A–3
®
of Dr. Barbui’s work, the results of
this study were just published in the
New England Journal of Medicine simultaneously
with the ASH presentation.
Dr. Barbui and his colleagues
have shown the truth in the treatment
of PV and truth is beauty. Namely, a
target hematocrit value of less than
45 percent is significantly associated
with prevention of cardiovascular
deaths and major thrombotic complications
in patients with PV.
Dr. Kahn indicated no relevant conflicts
of interest.
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