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Dear friends:
My basic question is that if there is really an "ethnic differences"
between us, Asians, Caucasians, Africans on metabolism of some
medicines, especially
anti-cancer drugs. I believe it's the individual differences that count
more than the "ethnic differences" do. .Not much human evidence I found.
What do you think ?
Genshin TEI, RPh.
tei-ge.at.mc.pref.osaka.jp
tei.at.yo.rim.or.jp (Home)
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Genshin:
A recent example of labeling that recommends different dosing for
ethnicities is rosuvastatin; however, there are examples drug
labeling that
note differences in exposure but do not require changes in dosing .
Ethnic differences probably represent variable distribution of
variants in
P450 enzymes, UGTs and transport systems such as OATP. Distribution of
variants among ethnicities are fairly well described for CYP2C9,
CYP2C19 and
CYP2D6 but much less for UGTs and transporters. Once we understand those
distributions better than terms like ethnic differences may disappear.
Carol Collins
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Dear Genshin,
We have done 20+ ethnic Japanese/Caucasian PK and/or PD comparisons
on many drugs in our clinic in Hawaii. In general, variation
between individuals is greater than variation between ethnic groups.
However, we have seen some compounds with significant inter-ethnic PK
and PD differences that we've not been able to explain by isolating
subsets such as fast and slow metabolizing phenotypes.
Arlin Blood
Radiant Research | Honolulu
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Dear,
Please note the following on ethinic differences:
--
On June 23, 2005, FDA approved BiDil, a drug for the treatment of
heart failure for black patients.
FDA Approves BiDil Heart Failure Drug for Black Patients
The Food and Drug Administration (FDA) approved BiDil (bye-DILL), a
drug for the treatment of heart failure in self-identified black
patients, representing a step toward the promise of personalized
medicine.
Heart failure is a condition in which the heart is weakened and does
not pump enough blood. It can be caused by a variety of damage to the
heart, including heart attacks, high blood pressure, and infections.
The approval of BiDil was based in part on the results of the African-
American Heart Failure Trial (A-HeFT). The study, which involved
1,050 self-identified black patients with severe heart failure who
had already been treated with the best available therapy, was
conducted because two previous trials in the general population of
severe heart failure patients found no benefit, but suggested a
benefit of BiDil in black patients. Patients on BiDil experienced a
43% reduction in death and a 39% decrease in hospitalization for
heart failure compared to placebo, and a decrease of their symptoms
of heart failure.
"Today's approval of a drug to treat severe heart failure in self-
identified black population is a striking example of how a treatment
can benefit some patients even if it does not help all patients,"
said Dr. Robert Temple, FDA Associate Director of Medical Policy.
"The information presented to the FDA clearly showed that blacks
suffering from heart failure will now have an additional safe and
effective option for treating their condition. In the future, we hope
to discover characteristics that identify people of any race who
might be helped by Bidil."
BiDil is a combination of two older drugs, neither approved for heart
failure--hydralazine and isosorbide dinitrate.
As an anti-hypertensive agent, hydralazine relaxes the arteries, and
decreases the work of the heart. The anti-anginal agent, isosorbide
dinitrate, relaxes the veins as well as the arteries. Isosorbide
seems to work by releasing nitric oxide at the blood vessel wall, but
its effect usually wears off after half a day. Hydralazine may
prevent this loss of effect. But how the two drugs work together is
not fully known.
Some common side effects with the use of BiDil are headache and
dizziness.
BiDil is marketed by NitroMed, Inc. of Lexington, MA.
Best regards,
Kees Bol
Kees Bol, PhD
Director Clinical Research
Kinesis Holding
Consultants in Drug Development
Lage Mosten 29
4822 NK Breda
The Netherlands
tel: +31 (0) 76 54 80 621
gsm: +31 (0) 65 31 26 153
fax: +31 (0) 76 54 21 777
kees.bol.aaa.kinesis-pharma.com
www.kinesis-pharma.com
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