标题：Effects of the European restrictive actions concerning nimesulide prescription: a simulation study on hepatopathies and gastrointestinal bleedings in Italy
摘要：Summary. In 2002 and 2007 the European Medicines Agency (EMA) examined the signals of a
greater risk of hepatopathies related to nimesulide use. In 2007 restrictive actions were adopted in
Europe. Moreover, EMA initiated a new referral in February 2010. The objective of this paper is
to evaluate the effects of the 2007 regulatory measures concerning nimesulide and to estimate the
potential effect of further actions. Specifically, we carried out a simulation on the expected number
of hospitalisations for hepatopathies and upper gastrointestinal bleedings (UGIBs) in Italy before
and after the regulatory measures (2006 vs. 2009), taking into account the shifting of nimesulide
prescriptions on other non steroidal anti-inflammatory drugs (NSAIDs). The expected figures of
hospitalisation for hepatopathies and UGIBs for all NSAIDs were calculated on the basis of risk
estimates reported in two epidemiological studies. The result of the simulation suggests that the implementation
of the restrictive actions might prevent 79 events of liver injuries, but might increase
UGIBs by 859 events. The simulation helped to clarify the effects on hepatopathies and UGIBs as
a consequence of nimesulide restriction of use. Analogous simulations might be conducted when
assuming regulatory actions.
关键词：Key words: nimesulide, adverse drug reaction, hepatotoxicity, upper gastrointestinal bleeding.
