Rosiglitazone: the prescribing dilemma continues
From an editorial perspective it has been of considerable
between the two TZDs. Although new prescribing already
interest to observe the Pandora’s Box phenomenon that
may have shifted in the light of these recent reports, such
has followed the now much publicised meta-analysis
a switch in existing usage takes the issue that one step
paper1 in respect of rosiglitazone and possible increased
further. A round-robin peer consensus enquiry suggests
risk of myocardial infarction. Sensation-seeking head-
that not everyone is yet ready to take this step, but in the
lines have appeared within the popular press (‘Is
true spirit of open debate we feel that it is important to
Avandia the next Vioxx?’),2 whilst medical journals have
publish Bob Ryder’s paper and will be interested to learn
provided prominent coverage in news sections (‘Study
of readers’ views on his recommendation.
links diabetes drug to heart deaths’).3 The intensity ofinterest has largely obscured any easy interpretation of
the issue, particularly as the debate is far from concluded
The whole episode will surely go down as a milestone in
with uncertainties of actual risk still to be established.4
the way we introduce new drugs for diabetes. Issues con-
Some prominent editorial leaders have attempted to
cerning the adequacy of trial data provided for regula-
maintain a measure of commonsense, arguing the need
tory purposes and its relevance to the wider population
for a ‘calmer and more considered approach’5 and cau-
post licensing have rightly been highlighted. Certainly,
tioning against ‘overreaction’,6 whilst our own commis-
emphasising the ongoing need for careful surveillance
sioned commentary favoured ‘a pragmatic approach’.7
of drug outcomes post marketing launch, both from further controlled studies as well as observation from
open clinical practice, is essential. New treatments for
Certainly, many questions remain unanswered, but it is
diabetes are still much needed but perhaps the learning
salutory to note how the use of relative changes in effect
message from this experience is that new therapies,
(so favoured in drug trials when positive and in subse-
however welcome in principle, must be embraced with
quent drug marketing) can work to disadvantage in this
objective circumspection10 and a considered commit-
negative context, when in reality the much smaller
ment to our patients’ best interests. Ryder’s reminder of
dimension of absolute change may be more meaningful.
‘primum non nocere’ is appropriate.
Current outstanding key questions are whether thereported adverse effects with rosiglitazone, if proven, are
drug specific or whether they might be a drug class effect
with implications for the other current alternative thia-zolidinedione (TZD), pioglitazone. So far the FDA has
advised caution for both drugs, but this primarily rests
1. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of
on an increased heart failure risk known to be common
myocardial infarction and death from cardiovascular
to both.8 The real immediate question from patients and
causes. N Engl J Med 2007; 356: 2457–2471.
prescribers alike is ‘what to do?’: what are the real risks
2. Thottam J. Is Avandia the next Vioxx? Time 2007: 21 May.
with TZDs?; do the potential risks merit withdrawal of
3. Tanne JH. Study links diabetes drug to heart deaths. BMJ
TZD prescribing?; and, if so, what are the alternative
2007; 334: 1073.
therapeutic options? Not forgetting the importance of
4. Diamond GA, Bax L, Kaul S. Uncertain effects of rosiglita-
continued lifestyle attention, the tried and tested tradi-
zone on the risk for myocardial infarction and cardio-
tional therapies of metformin and second generation
sulphonylureas still serve well in the oral treatment of
VL (scheduled 16 October 2007: 147(8)).
type 2 diabetes, whilst the new DPP4 inhibitors, yet to be
5. Editorial. Rosiglitazone: seeking a balanced perspective.
fully evaluated in clinical practice, are another consider-
Lancet 2007; 369: 1834.
ation in the available drug armamentarium.
6. Hirsch IB. TZDs: Where do we go from here? Diabetes, obe-
We believe guidelines on drug prescribing are impor-
sity and cardiovascular news. American Diabetes
tant in supporting good clinical practice9 but recognise
the need to revise recommendations in the light of new
7. Drummond R, Fisher M. Fractures, heart failure and fears
evidence. To determine definitive guidance on TZD
of myocardial ischaemia: has the record stuck for rosiglita-
prescribing just at this moment in time is very difficult,
zone and the thiazolidinediones? Pract Diabetes Int 2007; 24:
and professional bodies such as the Association of British
8. Singh H, Loke YK, Furberg CD. Thiazolidinediones and
Clinical Diabetologists will now no doubt wait until there
heart failure. Diabetes Care 2007; 30: 2148–2153.
is greater clarity. In the meantime, individual opinion will
9. Higgs ER, Krentz AJ, on behalf of the Association of British
be held and championed such as by Bob Ryder, who has
Clinical Diabetologists. ABCD position statement on glita-
marshalled his arguments (see Personal Comment on
zones. Pract Diabetes Int 2004; 21: 293–295.
page xxx) promoting a prescribing switch from rosiglita-
10. Nathan DM. Finding new treatments for diabetes – How
zone to pioglitazone on the basis of reported differences
many, how fast . how good? N Engl J Med 2007; 356: 437–440. Pract Diab Int October 2007 Vol. 24 No. 8Copyright 2007 John Wiley & Sons
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VARICELA CONGÉNITA Y NEONATAL Dr. Julio Moreno Hernando Unitat de Neonatología. Servicio de Pediatría. Septiembre,1998. INTRODUCCION La varicela es una enfermedad exantemática frecuente en la infancia (antes de los 10 años el 85% han pasado la infección) , pero la varicela que ocurre en el período gestacional su incidencia es escasa ( 0.1-0-7 por mil embarazos). Entre 80-95% d