The European Medicines Agency This information has been echoed in position
statements from a range of organisations, and
specific advice on alternative regimens for
authorisations for all rosiglitazone formulations
individuals currently taking rosiglitazone has
(Avandia® and Avandamet® in the UK). These
been given by the Primary Care Diabetes Society
medicines will stop being available in Europe
(available at: http://bit.ly/doama1).
How this situation may affect the other TZD,
Rosiglitazone, the first thiazolidinedione
pioglitazone, is not known, although some
(TZD) to come to market, has been shrouded
prescribers may believe that there is a possibility
in controversy since its launch in 2000. As a new
of a “class” effect regarding CV risk. However,
class of drug, rosiglitazone (GlaxoSmithKline
it should be noted that evidence to explain the
[GSK], Uxbridge) claimed to reduce peripheral
different CV risk profiles of rosiglitazone and
insulin resistance, leading to a reduction in blood-
pioglitazone, in spite of belonging to the same
glucose concentration. However, 7 years later
drug class, has now emerged (Rosen, 2010). In
Nissen and Wolski (2007) raised concerns about
addition, evidence suggests that pioglitazone
the cardiovascular (CV) safety of rosiglitazone.
either confers no increased CV risk or, in some
recommends suspension of Avandia,
At the American Diabetes Association’s 70th
circumstances, protects against myocardial
Scientific Sessions in Orlando this year there
London. Available at: http://bit. ly/cJiXfU (accessed 06.10.10)
were rumblings of the rosiglitazone licence
It is essential that we avoid a knee-jerk
reaction. We must treat everyone as an individual
Administration. Some 3 months later, at the
and agree, with the person with diabetes, an
recommendations for patients with diabetes. Diabetes Metab
European Association for the Study of Diabetes
appropriate treatment regimen for their needs. 36(Suppl): S4–16
conference in Stockholm, an announcement was
made by the EMA that, following a complete
New global injection recommendations
MaCurdy TE et al (2010) Risk of acute myocardial infarction,
review of the benefit–risk profile of products
On a different note, this September saw the
containing rosiglitazone (Avandia®, Avandamet®
launch of new global injection recommendations
elderly Medicare patients treated with rosiglitazone or pioglitazone.
and Avaglim®) with focus on CV safety, the
for people with diabetes (Frid et al, 2010). These
JAMA304: 411–18
EMA’s Committee for Medicinal Products for
are a result of various meetings within Europe to
Human Use concluded that “the benefits of
use the most up-to-date scientific evidence and
rosiglitazone no longer outweigh its risks and
consensus on best practice in injection technique.
recommended the suspension of the marketing
N Engl J Med356: 2457–71
authorisation of the medicines” (EMA, 2010).
On the same day, GSK released a statement
recommendations and convert them into a UK
rosiglitazone story – lessons learned. N Engl J Med363:
outlining that “patient safety is paramount”,
version. This meeting was facilitated by the FIT
(Forum for Injection Technique) board. As you
l Prescribers are advised not to issue any new or
will see, your own copy of the first UK injection
repeat prescriptions of rosiglitazone-containing
technique recommendations has been included
as a supplement to this edition of JDN.
l Prescribers are advised to review currently
I do hope you will read this document and
treated patients and switch them to suitable
injectable therapy to work optimally, it must
l Pharmacists are advised to refer patients to
be injected using the correct technique, in the
their doctor for advice on their treatment.
correct site, every time. I believe that it is up
l Patients are advised to make an appointment
to us, the healthcare professionals, to ensure
to discuss their treatment and not to stop
we are up to date so we can pass on this
Consultant – Diabetes, NHS Enfield Community
taking rosiglitazone without consulting their
information to people with diabetes who need
Journal of Diabetes Nursing Vol 14 No 9 2010
Acta Odontológica Venezolana - VOLUMEN 46 Nº 3 / 2008 ISSN: 0001-6365 – www.actaodontologica.com P á g i n a | 1 Trabajos Originales: ESTUDIO DE LA SENSIBILIDAD A LOS ANTIMICROBIANOS DE PATÓGENOS PERIODONTALES Recibido para arbitraje: 04/07/2007 Aceptado para publicación: 06/11/2007 • Testa M, Cárdenas IL Cátedra de Microbiología y Parasitología. Facultad
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