This article is more than 5 years old. Information may no longer be current.

No ethnic sensitivity observed in combination fluticasone furoate, vilanterol

The combination asthma therapy fluticasone furoate and vilanterol taken at globally recommended doses showed good safety and efficacy in an East Asian population, according to research from a randomized, double blind, multicenter trial.

“The totality of the data from the current analysis, taken together with previously published results in Japanese asthma patients and Japanese healthy subjects, provide confidence that the efficacy and safety of [fluticasone furoate/vilanterol (FF/VI)] is of low ethnic sensitivity and this supports the conclusion that the same clinical doses of FF/VI (100/25 μg [once daily] and 200/25 μg [once daily]) are appropriate for both East Asian and non-East Asian asthma patients,” Annette S. Gross, PhD, of the clinical pharmacology modeling & simulation department at GlaxoSmithKline Research & Development in Sydney, Australia, and colleagues wrote.

Gross and colleagues sought to determine the efficacy and safety profile of globally recommended doses of FF/VI in an East Asian population from both Japan and a combination of Japan and Korea.

Efficacy analysis was obtained from three phase 3 studies, while safety data was analyzed from five clinical studies.

The researchers compared from baseline the results of placebo and twice-daily fluticasone propionate (500 μg) in trough forced expiratory volume in one second (FEV₁) in patients from Japan (n = 148) and outside of Japan (n = 3,066), according to the abstract.

They found patients who took FF/VI 100/25 μg once daily had improved results at week 12 from baseline (Japan least-squares mean change = 0.323 L [0.104-0.542]; Not-Japan least-squares mean change = 0.168 L [0.095-0.241]), whereas patients taking FF/VI 200/25 μg once daily had improved results from baseline at week 24 (Japan least-squares mean change = 0.355 L [0.1152]; Not-Japan = 0.396 L [0.0313]).

The Japan and Korea patients showed a greater percentage of adverse events compared with patients not from Japan and Korea at every treatment dosage (FF/VI 100/25 μg = 79% vs. 57%; FF/VI 200/25 μg = 64% vs. 45%; placebo = 41% vs. 23%), according to the abstract. Gross and colleagues observed no notable adverse events by treatment or class. – by Jeff Craven

Disclosure: Gross and four other researchers are paid employees of and shareholders for GlaxoSmithKline; one other researcher is a paid employee of GlaxoSmithKline. One researcher serves on the speakers bureau for Abbott Japan, Astellas Pharma, AstraZeneca, Boehringer Ingelheim, Eisai, GlaxoSmithKline, Kyorin Pharmaceutical, Merck, Sharp & Dohme, Novartis Pharma and Teijin Pharma.