27 October 2016 | Influencers | By BioSpectrum Bureau
"Prevalence of COPD in Asia is similar to Western countries'
Prof. Norbert Berend, Head of Respiratory Research, The George Institute for Global Health
GlaxoSmithKline and biopharmaceutical company, Innoviva, have concluded Salford Lung Study (SLS), a Phase IIIb multi-centre, open label randomised controlled trial designed to evaluate the effectiveness and safety of GSK's drug, Relvar Ellipta, in patients with chronic obstructive pulmonary disease (COPD), compared with their usual care administered in an everyday clinical practice setting.
Prof. Norbert Berend, Head of Respiratory Research, The George Institute for Global Health and former President of the Thoracic Society of Australia and New Zealand and the Asian Pacific Society of Respirology, has a strong research background in asthma and COPD. In an interview with BioSpectrum, he shares his views on the prevalence of COPD in Asia and the effective ways to control and manage the disease.
Asia is still lacking in COPD management. There is little awareness among patients to effectively manage the disease or even consult specialists. How do you think the burden of COPD can be handled in Asia?
Despite many risk factors like high smoking rates, exposure to biomass smoke and air pollution, the prevalence of COPD in Asia is similar to Western countries. However, the effectiveness of policies to reduce these risks is in question. What is required is a greater effort for primary prevention and then allocation of appropriate resources to treat the condition with both pharmacological and non-pharmacological interventions. The latter include vaccination against influenza and pneumococcal infections and pulmonary rehabilitation which is virtually non-existent in many countries. Given the substantial socio-economic burden of the disease, it is also important for healthcare providers to make advanced treatment options widely available and accessible for patients in both private and public health-care systems.
According to a study done in 2010 by the Canadian Lung Association along with medical experts from Canadian Thoracic Society, titled "Awareness of risk factors among persons at risk for lung cancer, chronic obstructive pulmonary disease and sleep apnea: A Canadian population-based study", the awareness level of COPD in western countries is as low as 17 percent and far worse in Asia. What role can pharmaceutical companies play to increase the awareness of the disease?
Pharmaceutical companies should team with national and international respiratory societies to develop patient education platforms. In addition, there should be more effective patient advocacy groups which can, again, team with pharmaceutical companies to develop better patient education programs and lobby governments for greater allocation of the resources to treat this condition.
Kindly shed light on the SLS study. What difference can Relvar Ellipta make in the existing COPD management process?
In essence, the study shows that Relvar Ellipta, used in patients diagnosed to have COPD in general practice, with a lot of symptoms and exacerbations can deliver an 8.4 percent reduction in exacerbations compared with patients in the usual care group, with only 7 patients needed to be treated to save one exacerbation.
The Salford Lung Study (SLS) is an open label randomised controlled trial (RCT), with very broad inclusion criteria, that aims to guide COPD treatment choices by generating unique effectiveness and safety data in a patient population intended to represent that seen in everyday clinical practice.
The study is sponsored by GSK, and designed and made operational in collaboration with multiple stakeholders - North West e-Health, The University of Manchester, NHS Salford and healthcare providers in Salford including GPs, nurses and community pharmacists.
It is the first pragmatic, randomised controlled trial to be initiated prior to the medicine being licensed, as an important complement to RCTs in order to establish the value of a medication in an everyday clinical setting and will offer a different type of evidence of the risk/benefit profile of FF/VI in a wider COPD population.
The study compares the effectiveness and safety of Relvar Ellipta (FF/VI) versus usual care, using electronic medical record (EMR) system, which links GP practices and hospitals, enabling data on study endpoints and patient safety to be collected continuously and remotely with minimal intervention or intrusion into patients' everyday lives. It has provided important information for clinicians, healthcare providers, payers and patients on the effectiveness and the true value of the medicine.
It provides physicians with an advanced treatment option delivered via the Ellipta inhaler to meet the needs of patients with asthma and COPD.
What are the effective ways of managing COPD at an early level? How can this be implemented in Asia given the wide demographics?
The essential goal of effective COPD management is to improve a patient's quality of life by preserving an optimal lung function, improving their symptoms, and treating and preventing the recurrence of exacerbations to reduce mortality. In addition health education and adjunct therapy can also play an important role in improving patient's ability to cope with illness, including support for smoking cessation.
The single most important intervention is smoking cessation as part of both primary and secondary prevention. It is the only intervention shown to reduce the rate of decline of lung function.
In addition, patient's present with symptoms late in the course of the disease. In many cases 50 percent of lung function has already been lost when patients first present with disease symptoms. Symptoms are often sub-optimally treated and ongoing symptoms are associated with exacerbations and hospitalisations. Every effort should be made to achieve best possible lung function using combination of long-acting bronchodilators. The recognition that a patient exacerbates frequently should be a taken as a signal for rapid decline of lung function and high mortality and needs to be treated with medicines that have been shown to be effective in reducing exacerbations. When patients have a lot of symptoms as well as frequent exacerbations, inhaled corticosteroids in addition to combination bronchodilators i.e. triple therapy should be considered.
What should be the priority of pharmaceutical companies and clinicians when it comes to managing the right intervention for COPD patients?
COPD patients have disabling symptoms and exacerbations which result in a poor quality of life. Diagnosing the features of COPD which contribute most to the poor quality of life enables clinicians to select the most appropriate treatment for the patient.
We are fortunate that in contrast to the situation in the past we now have highly effective bronchodilators and inhaled corticosteroids that are able to be used once daily with easy to use inhalers. Hence, clinicians and pharma companies should ensure that these advanced treatment options are easily available in both private and public health care systems to truly meet patient's needs. Clinicians should also not neglect non-pharmacological treatment like flu and pneumococcal vaccination and pulmonary rehabilitation or at least regular exercise.