Pijnstiller geeft duidelijk verhoogde kans op een hartaanval.*
Volgens een onderzoek uit Nieuw Zeeland blijkt dat de veel bij artritis gebruikte pijnstiller Celebrex de kans op een hartaanval doet verdubbelen. Nadat vorig jaar al een vergelijkbaar product (Vioxx) uit de handel was genomen vanwege hartproblemen werd nu gekeken naar dit product. Vier trials met ruim vier duizend personen en nog eens een analyse van zes studies gaven gemiddeld een extra risico van meer dan 200%. Bij Vioxx was dit extra risico 224%. Het hoofd van het onderzoek Prof. Richard Baesley wacht nu af wat de gevolgen zullen zijn; of de overheden zullen ingrijpen of dat net als bij Vioxx het medicijn van de markt gehaald zal worden.
Celecoxib
Increases Risk Of Heart Attack, New Study Finds
A study published in the March issue
of the Journal of the Royal Society of Medicine, has found celecoxib
increases the risk of a heart attack by over two-fold.
Celecoxib is the most commonly used COX-2 inhibitor drug in the treatment of
arthritis and acute pain. It is manufactured by Pfizer and marketed under
the brand name Celebrex.
“Our evidence shows an increased risk of heart
attack in patients taking celecoxib,” said
Professor Richard Beasley of New Zealand's Medical Research Institute.
“Drug regulatory authorities need to urgently re-examine the assessment of
the drug in light of these findings.”
Cyclooxygenase-2 (COX-2) inhibitor drugs are popular analgesics as they have
fewer gastrointestinal side effects than traditional NSAIDs like ibuprofen
and diclofenac. However, the extent to which use of COX-2 inhibitors
increase the risk of cardiovascular events has been the subject of
considerable debate in the last two years.
Rofecoxib, also a COX-2 inhibitor drug, was manufactured by drug company
Merck under the name Vioxx but voluntarily withdrawn worldwide following
evidence linking it to an increase in the risk of heart attacks and stroke.
Professor Beasley undertook a systematic review and meta-analysis of
randomized double-blind clinical trials of celecoxib of at least six weeks'
duration and which presented data on serious cardiovascular events.
Specifically, the researchers examined whether the increased risk of
cardiovascular events with rofecoxib was also present with celecoxib and
thus represented a class effect of COX-2 inhibitors.
Four placebo-controlled trials with 4422 patients were included in the
primary meta-analysis comparing celecoxib with placebo. The findings show
the use of celecoxib was associated with a 2.26-fold increased risk of
myocardial infarction when compared to a placebo.
The second meta-analysis included a total of six studies of 12,780 patients
and demonstrated a 1.88-fold increased risk of myocardial infarction when
celecoxib was compared with all comparator treatment groups including
ibuprofen, paracetomol and diclofenac.
“These findings are critical as the risk is similar in magnitude to the
2.24-fold increased risk of heart attack with Vioxx as reported in a comparable meta-analysis,”
said Professor Beasley.
“Given the popularity of celecoxib in the treatment of arthritis, drug
regulators must undertake an up-to-date risk assessment based on the
findings presented here.”
Currently, the European Medicines Agency's advice is COX-2 inhibitors should
not be used in patients with heart disease or stroke and doctors should use
the lowest effective dose of the COX-2 medicine for the shortest possible
duration of treatment.
“It will be interesting to see if the drug regulators tighten restrictions
and whether celecoxib is now withdrawn as occurred with Vioxx,” Professor
Beasley said.
JRSM Editor, Kamran Abbasi, said controversy had raged for almost two years
about the safety of this class of drug.
“The early warnings on Vioxx went unheeded. We can only hope that
clinicians and regulatory authorities around the world will not make the
same mistake twice. This is another lesson that wonder drugs often come with
a sting in the tail,” Dr Abbasi said.
In contrast to the increased risk of myocardial infarction, this study did
not identify a corresponding increased risk of cerebrovascular events.
‘Risk of cardiovascular events and celecoxib: a systematic review and
meta-analysis' by B Caldwell, S Aldington, M Weatherall, P Shirtcliffe and R
Beasley is published in the March issue (Vol. 99) of the Journal of the
Royal Society of Medicine.
JRSM is the flagship journal of the Royal Society of Medicine. It has been
published continuously since 1809. Its Editor is Dr Kamran Abbasi.
Founded in 1805, the Royal Society of Medicine is an independent
organisation that promotes the exchange of knowledge, information and ideas
in medical science and continued improvement in human health. http://www.rsm.ac.uk
(Maart
2006)