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2 agonists
a Drug
Safety Research Unit, Bursledon Hall, Blundell Lane, Southampton, SO31 1AA, UK, b School of Medicine Faculty of Medicine, Health
and Biological Sciences, University of Southampton,
Southampton, SO16 7PX
Correspondence to: Dr R M Martin.
Received 28 November 1997; Returned to authors 3 February 1998; Revised version received 6 March 1998; Accepted for publication 30 March 1998
BACKGROUND
The long
term safety of 
agonists, particularly in patients with heart
disease, has not been fully established.
METHODSThis study
accessed the results of three cohort studies involving: 12 294
patients receiving at least one prescription for nedocromil between
November 1986 and September 1988; 15 407 patients prescribed
salmeterol between December 1990 and May 1991; and 8098 patients
prescribed bambuterol between February 1993 and December 1995. Details
of all dispensed prescriptions for these drugs prescribed by general
practitioners in England soon after their launch were provided in
confidence by the Prescription Pricing Authority. Questionnaires were
sent to the prescriber asking for details of events occurring after the
first prescription (prescription event monitoring). Rates and relative
risks of non-fatal cardiac failure and ischaemic heart disease were
calculated, comparing bambuterol and salmeterol with the reference drug nedocromil.
RESULTSThe age and
sex adjusted relative risk of non-fatal cardiac failure associated with
bambuterol was 3.41 (95% confidence limits (CL) 1.99 to 5.86) when
compared with nedocromil. When salmeterol was compared with nedocromil
the adjusted relative risk of non-fatal cardiac failure was 1.10 (95%
CL 0.63 to 1.91). The adjusted relative risk of non-fatal ischaemic
heart disease was 1.23 (95% CL 0.73 to 2.08) and 1.07 (95% CL 0.69 to
1.66) for bambuterol and salmeterol, compared with nedocromil,
respectively. However, in the first month of exposure the adjusted
relative risk of non-fatal ischaemic heart disease was 3.95 (95% CL
1.38 to 11.31) when bambuterol was compared with nedocromil.
CONCLUSIONSCaution
should be exercised when prescribing long acting oral agonists to
patients at risk of cardiac failure. More definitive evidence would
come from prospective randomised trials.
agonists, prescription event monitoring, cardiac
failure
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