How to deal with military prescriptions - Pharmaceutical Press

The Pharmaceutical Journal 349
Landmark drugs
Since anaemia is an independent risk
factor for poorer prognosis in CKD patients,
and small studies showed that correction of
anaemia resulted in partial regression of left
ventricular hypertrophy, it was hoped that Hb
normalisation would bring cardiovascular and
survival benefits in CKD.
Interest in ESAs spread well beyond renal
disease because oncologists began to use them
to combat anaemia in cancer patients
undergoing chemotherapy, and liver disease
specialists found them helpful in offsetting the
anaemia associated with interferon and
ribavirin treatment for hepatitis C. In the
sports world, some elite athletes were tempted
into illegal use of ESAs to boost their
performance by using the drug to mimic the
RBC-stimulating effects of altitude training.
Raising Hb — when to stop?
Within the renal world, researchers responded
to the need for evidence of the effects of Hb
normalisation on cardiovascular morbidity
and mortality by setting up Correction of
Hemogloblin and Outcomes in Renal
Insufficiency (CHOIR) — an open-label trial
of 1,432 CKD patients to test the effects of
epoetin alfa to achieve an Hb level of 13.5g/dl.
Rather unexpectedly, more patients who
achieved the high level had composite events
(death, admission to hospital for heart failure,
myocardial infarction, stroke) than those at a
lower target of 11.3g/dl (P=0.03). 7
A second study that investigated the effects
of epoetin beta to achieve Hb levels of 13.0 to
15.0g/dl in 603 CKD patients proved equally
disappointing. Complete correction of
anaemia over a three-year period failed to
affect the likelihood of a first cardiovascular
event compared with achieving a lower level of
10.5–11.5g/dl. 8
Still determined to prove the value of ESAs
on more than just anaemia, a third study, this
time with 4,038 patients with type 2 diabetes,
CKD and anaemia, compared the effects of
boosting haemoglobin levels to approximately
13g/dl with darbepoetin alfa with those of
maintaining a lower level of 9g/dl. 9 No effect
was seen on death or cardiovascular events,
but fatal or non-fatal strokes were nearly twice
as frequent when Hb was maintained at the
higher level (P