Sandoz salmeterol/fluticasone propionate combination product showed superiority at 12 months over its reference product in persistence to treatment
- New study shows that rate of patient persistence using Sandoz salmeterol/fluticasone propionate combination product is twice as high as for the reference product.
- Study highlights importance of improving treatment "persistence" over time for long-term respiratory diseases.
- Analysis, published in leading medical journal, is largest European Real-World Evidence study ever conducted in asthma and COPD.
New data just published in a leading medical journal shows for the first time that the rate of treatment persistence for patients using the innovative Sandoz respiratory inhaler with combined salmeterol and fluticasone ropionate is more than twice as high as for the reference product.
Persistence to treatment is defined as the duration of time from initiation to iscontinuation of treatment . Dr. Bruce Bender, the lead author on the paper, said: "COPD and asthma are long term diseases requiring long-term, persistent adherence to therapy. While adherence abandon their asthma treatment suggests that persistence to treatment may be more relevant for longer-term outcomes."
Poor persistence to treatment rates are likely to result in poor outcomes including disease exacerbations, reduced quality of life, hospitalization, increased mortality, increased burden on the healthcare system and high economic costs ,,. Relatively few studies have investigated persistence in patients taking inhaled therapies, but those that have report sub-optimal rates in these patients ,,.
The results are reported in the latest edition of the leading Journal of Allergy and Clinical Immunology: In Practice. The comparative analysis study is the largest European Real-World Evidence (RWE) study ever conducted in asthma and COPD (chronic obstructive pulmonary disease).
The study, entitled "Comparative analysis of persistence to treatment among patients with asthma or COPD receiving Sandoz combination therapy in an innovative device or the reference product with combined salmeterol / fluticasone propionate", concluded that patients using the Sandoz device showed a persistence rate of 22.9%, compared to 10.5% for those using the reference product device.
"These results fully validate our decision at Sandoz to develop our inhaler device in close collaboration with patients, incorporating their feedback", said Dr. Spencer Jones, Sandoz Head of Global Medical Affairs, Respiratory. "This approach, which results in the device being effectively designed to give direct feedback to users, is the key to success in treating chronic conditions."
He added: "What the data also highlight is the need for even more research to better understand patient persistence behaviors and to develop strategies to address what are still unacceptably low overall levels."
The study was designed to retrospectively analyze persistence rates between the two devices, using dispensing data from a large German pharmacy database. While retrospective database analyses have some limitations, the strengths of this data include the fact that 11,744 patients were included in a matched pair analysis, controlled for gender, age and month of treatment initiation (to limit seasonal effects).
All patients were first time users of salmeterol/fluticasone propionate and persistence to treat was analyzed for a 12- month period.
About the medicinal product
The innovative Sandoz respiratory inhaler offers the proven combination of salmeterol (a long-acting inhaled ß2-agonist) and fluticasone propionate (an inhaled corticosteroid) in an innovative device. Safety, efficacy and equivalence have been proven in multiple clinical trials.
It was developed at Aeropharm GmbH in Rudolstadt, Germany, Sandoz's global respiratory Center of Excellence. Sandoz collaborated with UK-based Vectura Group plc, a respiratory product development company, in the design and development of the product. The innovative and intuitive-to-use inhaler was invented at Vectura and its design was awarded the Red Dot Product Design award in 2011, an internationally recognized quality seal awarded by the Design Zentrum Nordrhein Westfalen in Essen, Germany.
In order to improve patient experience with inhalation devices, Sandoz and Vectura collaborated closely with patients during the development process. The device includes multiple feedback mechanisms such as visual control features, which help reassure the patient about dosing and a simple lever arm to load the dose.
The respective medicinal product has been launched to date in approximately 30 countries, in Europe and elsewhere.
# # #
 Bender BG, Vecino RAH, McGrath K, Jones S. Comparative analysis of persistence to treatment among patients with asthma or COPD receiving AirFluSal® Forspiro® or Seretide® Diskus® salmeterol/fluticasone proportionate combination therapy. J Allergy Clin Immunol Pract 2016;4:884-9.
 Cramer JA, Bradley-Kennedy C, Scalera A. Treatment persistence and compliance with medications for chronic obstructive pulmonary disease. Can. Respir. J 2007; 14(1):25-29.
 Bender BG. Advancing the science of adherence measurement: implications for the clinician. J Allergy Clin. Immunol. Pract. 2013; 1(1): 92-3.
 Antoniu SA. Adherence to inhaled therapy in COPD: effects on survival and exacerbations. Expert Rev Pharmacoecon. Outcomes Res. 2010; 10(2):115-7.
 Hasford J, Uricher J, Tauscher M, Bramlage P, Virchow JC. Persistence with asthma treatment is low in Germany especially for controller medication-a population based study of 483 051 patients. Allergy 2010; 65:347-354.
 Penning-van Beest F et al. three-year dispensing patterns with long-acting inhaled drugs in COPD: a database analysis. Respir Med. 2011; 105(2):259-65.
 Barnes CB, Ulrik CS. Asthma and adherence to inhaled corticosteroids: current status and future perspectives. Respir. Care 2015; 60(3):455-468.
Lek, a Sandoz company, is one of the key pillars of the second-largest generic pharmaceutical company globally. Its role within Sandoz is to act as: a leading global development center for technologically demanding products and technologies; a key global manufacturing center for active pharmaceutical ingredients and medicines; a competence center for the development of vertically integrated products; a Sandoz competence center in the field of development and manufacturing of biosimilar active ingredients and products; a supply center for the markets of Central and Eastern Europe (CEE), South East Europe (SEE) and the Commonwealth of Independent States (CIS), and is responsible for marketing and sales of Sandoz products on the Slovenian market. For further information, please visit www.lek.si.
Sandoz, a Novartis company, is a global leader in generic pharmaceuticals and biosimilars, driving sustainable access to high-quality healthcare. Sandoz supplies a broad range of affordable, primarily off-patent products to patients and customers around the globe. The Sandoz portfolio comprises approximately 1,100 molecules, which accounted for 2015 sales of USD 9.2 billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area. The company holds leading global positions in biosimilars as well as in generic anti-infectives, ophthalmics and transplantation medicines.
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2015, the Group achieved net sales of USD 49.4 billion, while R&D throughout the Group amounted to approximately USD 8.9 billion (USD 8.7 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 118,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit www.novartis.com.
This press release contains statements and conclusions based on projections of Lek’s future business operations. These estimates are derived from the best information currently available. In case these forecasts prove unreliable, the actual results could prove different from those projected.
For additional information contact:
Novartis Media Relations
Central media line: +41 61 324 2200