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Novartis AG (NVS)' Onbrez Beats Boehringer Ingelheim Corporation/Pfizer Inc. (PFE)'s Spiriva for COPD Quality of Life  
10/3/2011 8:07:26 AM

Frimley, UK, 3 OCTOBER 2011 – a study published on October 1 2011 in the European Respiratory Journal shows that once-daily Onbrez® Breezhaler®? (indacaterol) was as effective as tiotropium in improving lung function in patients with chronic obstructive pulmonary disease (COPD), whilst providing significantly greater clinical benefit in terms of reduced shortness of breath, lower use of reliever medication and improved capacity for day-to-day activities1.

INTENSITY is the first, blinded, head-to-head study whose primary aim was to compare indacaterol with tiotropium, an established treatment for COPD. A total of 1,598 patients with moderate-to-severe COPD were enrolled in the study and they received once daily treatment with either 150mcg indacaterol or 18mcg tiotropium.

Professor Paul Jones, Professor of Respiratory Medicine, St Georges Hospital, Tooting, commented: “The INTENSITY study compared a more recently licensed drug, indacaterol, with a well-established and very effective therapy, tiotropium. The study shows that indacaterol was significantly more effective than tiotropium in improving the patients' health-related quality of life. Patients who received indacaterol in routine practice are also more likely to experience an improvement in their wellbeing and symptoms, particularly shortness of breath, than with tiotropium. This represents a significant advance in the management of COPD – a chronic disease that has a large effect on the daily life of nearly every person with the condition.”

The study met its primary endpoint by demonstrating non-inferiority of indacaterol to tiotropium after 12 weeks in terms of lung function measured by forced expiratory volume of breath in one second (FEV1)1.

Significantly greater clinical benefits (secondary endpoints) related to patient outcomes compared with tiotropium were seen: improvements in shortness of breath (total scores of 2.01 vs 1.43 in transition dyspnoea index, p<0.001); a higher proportion of days without reliever medication (46.1% vs 41.4%, p=0.004) and improved quality-of-life (mean change of -5.1 vs -3.0 in St George’s Respiratory Questionnaire, p<0.001)1.

The INTENSITY study found that both treatments were well-tolerated, with similar incidence of adverse events reported (39.7% versus 37.2% of patients using indacaterol and tiotropium respectively). The most common adverse event in this study was COPD worsening, cough and nasopharyngitis1.

Dr Jerome Kerrane, GP, Layton Medical Centre, Blackpool commented: "Shortness of breath is the hallmark symptom of COPD and is the reason that most patients seek medical attention. As lung function deteriorates, shortness of breath becomes more intrusive and starts to affect activities of daily living and impact on quality of life. Patients may notice that they are unable to walk at the same speed as other people of a similar age, and may experience difficulties in performing activities such as carrying shopping bags or mowing the lawn. As shortness of breath is the most disabling symptom for COPD patients, the results of the INTENSITY study are relevant as they suggest that indacaterol may provide more symptomatic benefit than tiotropium. It therefore extends our therapeutic options for patients with COPD."

COPD affects an estimated 3.7 million people in the UK and is projected to be the third leading cause of death worldwide by 20202,3. It is a progressive, life-threatening lung disease that interferes with normal breathing and causes high levels of disability and incapacity that disrupt working, family and social life2,4. The most common symptoms are shortness of breath, abnormal sputum and a chronic cough. Day-to-day activities, such as walking up a short flight of stairs or carrying a suitcase, can become very difficult as the condition gradually worsens4. Although often considered a disease of the elderly, 50% of patients are estimated to be under the age of 65 and are likely to be at the peak of their earning power and family responsibilities5. The primary cause of COPD is exposure to tobacco smoke; it is not curable, but treatment can relieve the symptoms of the disease4.

- Spiriva® and HandiHaler® are registered trademarks of Boehringer Ingelheim Pharma GmbH & Co. KG.

About Onbrez Breezhaler (indacaterol)

Onbrez Breezhaler (indacaterol maleate) is an effective and well-tolerated once-daily long-acting beta2 agonist (LABA) for the treatment of chronic obstructive pulmonary disease (COPD) in people who remain short of breath despite short-acting treatments; it is marketed by Novartis Pharmaceuticals UK Ltd (Novartis)6.

The recommended dose of Onbrez Breezhaler is one 150mcg capsule once a day, administered using the Breezhaler device6.

Indacaterol is packaged in a transparent capsule, which makes a spinning noise inside the Breezhaler device as patients inhale correctly. This means that patients can feel confident that they have taken their medication correctly. In an open label study of patient preference for single dose dry-power inhalers, significantly more patients preferred the Onbrez Breezhaler over the Spiriva HandiHaler in terms of comfort, simplicity and confidence in use7.

In clinical trials, indacaterol has been shown to be well-tolerated with most side effects being mild to moderate in nature and becoming less frequent as treatment continued. There are currently approximately 16,000 patients participating in a wide range of clinical trials involving indacaterol; the future results of these trials will provide a fuller understanding of its efficacy and safety.

For further information on indacaterol and COPD, and a comprehensive bank of online CPD resources produced in collaboration with leading clinical experts visit www.Gladstoneuk.com an online network of medical resources and treatment information for healthcare professionals, developed by Novartis UK.

About Novartis

Novartis provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, consumer health products, preventive vaccines and diagnostic tools. Novartis is the only company with leading positions in these areas. In 2010, the Group’s continuing operations achieved net sales of USD 50.6 billion, while approximately USD 9.1 billion (USD 8.1 billion excluding impairment and amortization charges) was invested in R&D throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 121,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.co.uk

References

1. Buhl R, et al. Blinded 12-Week Comparison of Once-daily Indacaterol and Tiotropium in COPD. ERJ 2011, 38: 797–803.

2. British Lung Foundation, 2007. Invisible Lives Chronic Obstructive Pulmonary Disease (COPD): Finding the Missing Millions. Available at: http://www.lunguk.org/. Accessed September 2011.

3. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease. Updated 2010.

4. WHO. Factsheet No 315: Chronic obstructive pulmonary disease (COPD). Available at: www.who.int/mediacentre/factsheets/fs315/en/index.html. Accessed September 2011.

5. Fletcher MJ et al. COPD Uncovered: An International survey on the impact of chronic obstructive pulmonary disease (COPD) on a working age population. BMC Public Health 2011, 11:612.

6. Onbrez Breezhaler, Summary of Product Characteristics, last updated July 2010.

7. Chapman KR et al. Int J Chron Obstruct Pulmon Dis. 2011;6:353-363.

Read more: http://www.pharmiweb.com/pressreleases/pressrel.asp?ROW_ID=48039#ixzz1ZjAaAQfj


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