Increased arterial stiffness as measured by aortic pulse wave velocity ( aPWV ) predicts cardiovascular events and mortality and is elevated in patients with COPD ( chronic obstructive pulmonary disease ).
Prior investigation suggests that a long-acting beta-agonist ( LABA ) / inhaled corticosteroid ( ICS ) lowers aPWV in patients with baseline aPWV greater than or equal to 11 m/s.
A study has compared the effect of the ICS/LABA Fluticasone furoate / Vilanterol ( FF/VI; USA: Breo Ellipta; Europa: Relvar Ellipta ), 100/25 mcg, delivered via the Ellipta dry powder inhaler, with Tiotropium bromide ( Spiriva ), 18 mcg, on aPWV.
This multicenter, randomized, blinded, double-dummy, parallel-group, 12-week study compared Fluticasone furoate / Vilanterol and Tiotropium, both administered once daily.
The primary end point was aPWV change from baseline at 12 weeks. Safety end points included adverse events, vital signs, and clinical laboratory tests.
Two hundred fifty-seven patients with COPD and aPWV greater than or equal to 11 m/s were randomized; 87% had prior cardiovascular events and/or risk. T
he mean difference in aPWV between Fluticasone furoate / Vilanterol and Tiotropium at week 12 was not significant ( P = 0.484 ).
Because the study did not contain a placebo arm, a post hoc analysis was performed to show that both treatments lowered aPWV by an approximate difference of 1 m/s compared with baseline.
The proportion of patients reporting adverse reactions was similar with Fluticasone furoate and Vilanterol ( 24% ) and Tiotropium ( 18% ).
There were no changes in clinical concern for vital signs or clinical laboratory tests.
In conclusion, no differences on aPWV were observed between Fluticasone furoate / Vilanterol and Tiotropium. However, further studies with a placebo arm are required to establish definitively whether long-acting bronchodilators lower aPWV.
Both treatments have demonstrated an acceptable tolerability profile. ( Xagena )
Pepin JL et al, Chest 2014;146:1521-1530