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MLT_GIB/OTH/0007/17m
Date of preparation: March 2018

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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

Pneumonia risk

Like other ICS-containing medicines, there is an increased risk of pneumonia for COPD patients treated with Relvar. 12

  • Pneumonia risk data and management

    The incidence of pneumonia is similar to that seen with other ICS/LABA combinations 1246 and was not statistically different to that seen with usual care. 7*

    • 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: 9

    • 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.9

    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.

References

  1. Relvar Summary of Product Characteristics, GlaxoSmithKline 
  2. RelvarSummary of Product Characteristics, GlaxoSmithKline
  3. Seretide Diskus Summary of Product Characteristics, GlaxoSmithKline
  4. 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.
  5. 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.
  6. 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.
  7. Vestbo J et al. Effectiveness of Fluticasone Furoate-Vilanterol in COPD in Clinical Practice. NEJM 2016. DOI: 10.1056/NEJMoa1608033.
  8. 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.
  9. 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).

Relvar and Ellipta are registered trademarks of the GlaxoSmithKline Group of Companies