Table 3—

Cardiovascular(CV) events and all-cause mortality in randomised controlled trials of inhaled corticosteroids in chronic obstructive pulmonary disease

Study [Ref.]InterventionTotal participantsParticipants
MICV deathOverall mortality
Aaron 15#Salmeterol/fluticasone combination145106
Salmeterol xinafoate148216
Placebo156214
Burge 16Fluticasone propionate37681032
Placebo37591236
Calverley 17Salmeterol/fluticasone combination358302
Salmeterol xinafoate372203
Fluticasone propionate374113
Placebo361137
Calverley 19Formoterol/budesonide254NANA5
Formoterol255NANA13
Budesonide257NANA6
Placebo256NANA5
Calverley 18¶,+Salmeterol/fluticasone combination15462860193
Salmeterol xinafoate15423645205
Fluticasone propionate15523061246
Placebo15442871231
Ferguson 20Salmeterol/fluticasone combination394226
Salmeterol xinafoate388313
FLTA3025 21Fluticasone propionate434100
Placebo206100
Hanania 26Salmeterol/fluticasone combination178000
Salmeterol xinafoate177000
Fluticasone propionate183100
Placebo185000
Kardos 27Salmeterol/fluticasone combination507317
Salmeterol xinafoate487239
Lung Health Study 29Triamcinolone559NA615
Placebo557NA219
Lofdahl 28Budesonide634928
Placebo64314110
Mahler 30Salmeterol/fluticasone combination165000
Salmeterol xinafoate160000
Fluticasone propionate168000
Placebo181003
Paggiaro 31Fluticasone propionate142100
Placebo139102
Rennard 32Budesonide/formoterol9885NA9
Formeterol4952NA2
Placebo4811NA4
SCO100250 22Salmeterol/fluticasone combination394204
Salmeterol xinafoate403106
SCO100470 24Salmeterol/fluticasone combination518003
Salmeterol xinafoate532123
SCO40041 23Salmeterol/fluticasone combination92505
Salmeterol xinafoate94017
SFCT01/SCO30002 25Fluticasone propionate131100
Placebo125000
Szafranski 33Formoterol/budesonide208NANA6
Formoterol201NANA6
Budesonide198NANA5
Placebo205NANA9
Tashkin 34Budesonide/formoterol845117
Formoterol284111
Budesonide275112
Placebo300001
van der Valk 35Fluticasone propionate123014
Placebo121000
Vestbo 36Budesonide145234
Placebo145205
Wouters 37Salmeterol/fluticasone combination189002
Salmeterol xinafoate184124
  • Data are presented as n. MI: myocardial infarction; NA: not available. #: reported as serious adverse event of MI or acute arrhythmia; : CV adverse event data extracted from manufacturers clinical trials register; +; CV mortality data extracted from regulatory agencies as unavailable in publications.