[e-farmacos] Mas de Coxib

["Madurga, Mariano" <mmadurga@agemed.es>]

Estimadas y estimados amigos,

El pasado 25 de enero, se ha publicado en The Lancet un estudio de caso-control anidado con una base de datos de California, dirigido por David
Graham de la FDA, en el que se estima que entre 80.000 y 140.000 casos
mortales cardiovasculares se pueden asociar al uso de rofecoxib durante los
anhos que estuvo comercializado.

Tambien se incluye un Editorial de Maxwell en el que se revisa la situacion.

La informacion en: 
http://www.thelancet.com/journal

Risk of acute myocardial infarction and sudden cardiac death in patients
treated with cyclo-oxygenase 2 selective and non-selective non-steroidal
anti-inflammatory drugs: nested case-control study  

David J Graham, David Campen, Rita Hui, Michele Spence, Craig Cheetham,
Gerald Levy, Stanford Shoor, Wayne A Ray 


Summary 

Background Controversy has surrounded the question about whether high-dose
rofecoxib increases or naproxen decreases the risk of serious coronary heart
disease. We sought to establish if risk was enhanced with rofecoxib at
either high or standard doses compared with remote non-steroidal
anti-inflammatory drug (NSAID) use or celecoxib use, because celecoxib was
the most common alternative to rofecoxib. 

Methods We used data from Kaiser Permanente in California to assemble a
cohort of all patients age 18-84 years treated with a NSAID between Jan 1,
1999, and Dec 31, 2001, within which we did a nested case-control study.
Cases of serious coronary heart disease (acute myocardial infarction and
sudden cardiac death) were risk-set matched with four controls for age, sex,
and health plan region. Current exposure to cyclo-oxygenase 2 selective and
non-selective NSAIDs was compared with remote exposure to any NSAID, and
rofecoxib was compared with celecoxib. 

Findings During 2 302 029 person-years of follow-up, 8143 cases of serious
coronary heart disease occurred, of which 2210 (27·1%) were fatal.
Multivariate adjusted odds ratios versus celecoxib were: for rofecoxib (all
doses), 1·59 (95% CI 1·10-2·32, p=0·015); for rofecoxib 25 mg/day or less,
1·47 (0·99-2·17, p=0·054); and for rofecoxib greater than 25 mg/day, 3·58
(1·27-10·11, p=0·016). For naproxen versus remote NSAID use the adjusted
odds ratio was 1·14 (1·00-1·30, p=0·05). 

Interpretation Rofecoxib use increases the risk of serious coronary heart
disease compared with celecoxib use. Naproxen use does not protect against
serious coronary heart disease. 

Un abrazo,

Mariano Madurga
Agencia Espanhola de Medicamentos y Productos Sanitarios
www.agemed.es