Relvar’s Safety Profile
Common adverse events
|Common adverse events|
|Headache (very common)||Upper respiratory tract infections|
|Nasopharyngitis (very common)||Influenza|
|Candidiasis of mouth and throat||Cough|
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. 4*
*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). 4
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
- In two replicate 12-month studies in a total of 3,255 COPD patients with an exacerbation in the previous year, pneumonia occurred in 6.3% of patients receiving Relvar, compared with 3.3% of patients receiving Vilanterol only 8**
- There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk among ICS products 1
*Usual care was defined as physician’s free choice of COPD maintenance therapy 7
**Relvar Ellipta 92/22 mcg OD vs vilanterol (VI) 22 mcg OD (3%) 8
Risk factors for pneumonia in patients with COPD include: 1
- Current smoking
- Older age
- Low body mass index (BMI)
- Severe COPD
Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations. 1
Patients with COPD should be offered influenza and pneumococcal vaccinations. 9
The pneumonia that may occur with Relvar should be managed according to existing local protocols for management of pneumonia.
- Relvar™ Ellipta™ 92/22 mcg Summary of Product Characteristics. GlaxoSmithKline; 2016
- Relvar™ Ellipta™ 184/22 mcg Summary of Product Characteristics. GlaxoSmithKline; 2016
- Seretide Accuhaler Summary of Product Characteristics. GlaxoSmithKline; 2015.
- 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 disase. 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).