[e-drug] NEJM this week: Clinical trials ethics (cont'd)

[Valeria Frighi <valeria.frighi@dtu.ox.ac.uk>]

E-drug: NEJM this week: Clinical trials ethics (cont'd)
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I agree only to some extent. ACE inhibition dramatically improves
both the renal and cardiovascular prognosis of nephropathic diabetic
patients. However, some patients do not tolerate ACE inhibitors
because of cough, a not infrequent side effect. It is important for
the clinician confronted with such patients to be able to use other
drugs which achieve the same biological effect, ie angiotensin II
blockade, and improve surrogate measures of renal function (ie
proteinuria, dobling of creatinine). Angiotensin Receptor
Antagonists have not been around long enough to know whether
they will improve clinical outcome as ACE inhibitors have been
shown to do but they seem extremely promising. Personally,
although my first choice is an ACE inhibitor, I use ARIs extensively
as second line drugs either when an ACE is not tolerated or even as
a useful adjunct in cases of resistant hypertension. Most clinicians
are well aware of financial issues in drug prescribing and I don't
think many of us would forego well tested, effective and relatively
cheap drugs like ACE inhibitors to jump easily to new, expensive
drugs unless there was a good clinical reason for doing so.
Personally, I was delighted by this week's articles in NEJM as they
extend hope for difficult diabetic patients. Moreover, for those of
you who are not too familiar with the diabetic world, these studies
come from some of the best scientists and clinicians in the area of
diabetic nephropathy and hypertension. Ironically, they were the
very researchers who pioneered the use of ACE inhibitors over 20
years ago.

Valeria

Dr. Valeria Frighi
Diabetes Trials Unit
Radcliffe Infirmary
Woodstock Road
Oxford OX2 6HE, UK
tel +44-1865-228422
fax +44-1865-224584
e-mail: valeria.frighi@dtu.ox.ac.uk

[A minor comment only: the NEJM editorial did not question past
scientific accomplishments of the researchers involved, but the
blurring of borders between scientific design of trials and
commercial marketing strategies. Keeping in mind recent editorial
decisions of the major medical journals, I think NEJM has a couple
of very good points there. HH]


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