Relvar’s Safety Profile
Relvar 92/22 mcg and 184/22 mcg in asthma and Relvar 92/22 mcg in COPD are generally well tolerated 12
Common adverse events
In a Phase III safety population for Relvar comprising 7,034 patients with asthma and 6,237 patients with COPD, the common adverse events were as shown in the following table: 12
Common adverse events | |
Headache (very common) | Upper respiratory tract infections |
Nasopharyngitis (very common) | Influenza |
Pneumonia | Oropharyngeal pain |
Bronchitis | Pharyngitis |
Candidiasis of mouth and throat | Cough |
Sinusitis | Abdominal pain |
Rhinitis | Back pain |
Dysphonia | Pyrexia |
Arthralgia | |
Fractures | |
Muscle spasms |
Relvar vs Seretide
Comparison in asthma
In a 24-week study, Relvar 92/22 mcg OD, had similar rates of adverse events and serious adverse events vs Seretide 250/50 mcg BD. 34*
*A 24-week randomized, double-blind, double-dummy, parallel group, multicentre study to assess efficacy and safety of Relvar Ellipta 92/22 mcg OD vs Seretide 250/50 mcg BD (n=806). 34
Comparison in COPD
In a 12-week study, Relvar 92/22 mcg OD, displayed a similar rate of adverse events vs Seretide 500/50 mcg BD. 5
*A 12-week study comparing Relvar Ellipta 92/22 mcg OD to Seretide 500/50 mcg BD in patients with moderate to very severe COPD (n=528). 5
References
- Relvar Summary of Product Characteristics, GlaxoSmithKline
- RelvarSummary of Product Characteristics, GlaxoSmithKline
- Seretide Diskus Summary of Product Characteristics, GlaxoSmithKline
- Woodcock A et al. Efficacy and safety of fluticasone furoate/vilanterol compared with fluticasone propionate/salmeterol combination in adult and adolescent patients with persistent asthma: a randomized trial. Chest. 2013; 144(4): 1222-1229.
- Agusti A et al. A comparison of the efficacy and safety of once-daily fluticasone furoate/vilanterol with twice-daily fluticasone propionate/salmeterol in moderate to very severe COPD. Eur Respir J. 2014; 42(3): 763-772.
- Kew KM et al. Inhaled steroids and risk of pneumonia for chronic obstructive pulmonary disease. Cochrane Data Syst Rev. 2014; Issue 3. Art. No.: CD010115.DOI:10.1002/14651858.CD010115.pub2.
- Vestbo J et al. Effectiveness of Fluticasone Furoate-Vilanterol in COPD in Clinical Practice. NEJM 2016. DOI: 10.1056/NEJMoa1608033.
- Dransfield MT et al. Once-daily inhaled fluticasone furoate and vilanterol versus vilanterol only for prevention of exacerbations of COPD: two replicate double-blind, parallel-group, randomized controlled trials. Lancet Resp Med. 2013; 1(3): 210-223.
- Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease (Updated 2017). http://goldcopd.org/gold-2017-global-strategy-diagnosis-management-prevention-copd/(Accessed 16/11/2016).