CASTLEFORD, England, September 21, 2010 /PRNewswire/ -- Teva UK Limited today announced the results of its real-life observational study, published in the September issue of the Journal of Asthma and Clinical Immunology. Using data from the General Practice Research Database (GPRD), the study demonstrated that patients treated with QVAR(R) either as initial therapy or with an increase (step up) in dose, had an equal or better chance of achieving asthma control than those patients who were treated with fluticasone propionate. Moreover, patients in the QVAR(R) population achieved asthma control, as defined by the study, at lower doses of drug versus those in the fluticasone population.

Rigorously conducted, retrospective observational studies are important because they reflect patients' and physicians' real life experiences with medication, said David Price, Primary Care Respiratory Society Professor of Primary Care Respiratory Medicine, University of Aberdeen Centre of Academic Care and lead investigator of the study. Overall, more than 80% of the patients in the study achieved the primary measure of asthma control, reinforcing the view that use of ICSs as monotherapy can provide effective asthma control.

According to Dr. Price, this study is especially noteworthy as long-term trials comparing ICSs, particularly in real-world populations (as represented by the GPRD database), have not been conducted. Although generally it is presumed that benefits seen in randomised clinical trials (RCTs) can be applied to a wider population, evidence points to the fact that an intervention is often missed in RCTs due to the strict patient selection criteria, said Dr. Price. Specifically for asthma studies, real-world factors like smoking, patient compliance and inhaler technique are important, considering the gap in asthma control achieved through RCTs and asthma control achieved in studies conducted in less selective, more real-world-representative settings.

In this study comparing asthma-related outcomes, patients treated with QVAR(R) consistently achieved better outcomes compared with fluticasone users. In both groups, QVAR(R) patients were prescribed significantly less drug (P less than or equal to 0.001) and were able to achieve equal (in the case of the step-up patients) or superior (for patients initiated on QVAR(R)) asthma control compared to fluticasone users. In addition, all QVAR(R) patients were significantly less likely (P less than or equal to 0.001 for initiation population and P=0.006 for step-up population) to require additional or change to therapy in order to achieve asthma control, compared to patients treated with fluticasone.

These results support the consideration of particle size, formulation and site of action as important criteria for determining real-life effectiveness of an ICS agent in asthma patients. QVAR(R)'s overall performance against fluticasone in this study suggests a clinically meaningful difference in asthma outcomes depending on choice of ICS agent.

Notes to Editors

About the Study

The objective of this retrospective, observational study was to compare asthma-related outcomes over 1 year as recorded in a primary care database for patients aged 5-60 years receiving a first prescription (initiation population) or dose increase (step-up population) of hydrofluoroalkane HFA-beclometasone (QVAR(R) or fluticasone (HFA or CFC formulation) delivered by metered-dose inhaler (MDI)). Patients in both the initiation and step-up groups were selected using a matched cohort analysis that matched patients based on baseline disease severity, therapy, and demographic characteristics. Co-primary outcomes were asthma control (a composite measure comprising no unplanned visit or hospitalisation for asthma, oral corticosteroids, or antibiotics for lower respiratory infection) and exacerbation rate.

About GPRD

The General Practice Research Database (GPRD) is a large, well-maintained database, administered as a not-for-profit by the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency that contains deidentified longitudinal medical records from approximately 500 primary care practices in the UK. Patient records in the GPRD total 13 million; and active records number 3.6 million, equivalent to 5.5% of the UK population. The demographic characteristics of patients included in the GPRD are considered broadly representative.

The GPRD is the largest and most comprehensive source of data of its kind and is used worldwide for research by the pharmaceutical industry, clinical research organisations, regulators, government departments and leading academic institutions. GPRD is considered the gold standard of research databases.

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Qvar(R) Aerosol , Autohaler(R) and Easi-Breathe(R) Prescribing Information:

Presentation: Qvar(R) 50 and 100 Autohaler(R) Inhaler, Qvar(R) 50 and 100 Easi-Breathe(R) Inhaler. Qvar(R) 50 and 100 Aerosol Inhaler. Each actuation of Qvar Inhalers contains beclometasone dipropionate 50 mcg or 100 mcg ex-valve. Qvar contains beclometasone dipropionate in solution in propellant HFA-134a resulting in an extrafine aerosol. Indications: Prophylactic management of mild, moderate or severe asthma. Dosage: The dose should be adjusted to individual patient needs. Adults, elderly, and children over 12 years: Starting and maintenance dose: Mild asthma: 100 to 200 mcg daily in two divided doses. Moderate asthma: 200 to 400 mcg daily in two divided doses. Severe asthma: 400 to 800 mcg daily in two divided doses. Transferring patients from CFC beclometasone inhalers and budesonide: Patients with well-controlled asthma: prescribe Qvar at about half current dose. Patients with poorly controlled asthma: switch from CFC-BDP or budesonide to Qvar at the same mcg for mcg dose up to 800 mcg daily. Transferring patients from Fluticasone: Transfer patients at the same mcg for mcg dose up to 800 mcg daily. Children under 12 years: Not recommended. Contra-indications: Hypersensitivity to beclometasone dipropionate or any other ingredients. Special warnings and precautions: Use regularly. When symptoms are controlled, maintenance therapy should be reduced to the minimum effective dose. Not indicated for the immediate relief of asthma attacks or management of status asthmaticus. Advise patients to seek medical attention for review of their maintenance therapy if their asthma seems to be worsening. Patients receiving systemic steroids for long periods and/or at high doses should have stable asthma before transfer to inhaled steroids. Withdrawal of systemic steroids should be gradual. Patients should carry a steroid warning card and have adrenocortical function monitored regularly. Monitor height of children regularly. Prolonged treatment with high doses of inhaled corticosteroids, particularly higher than recommended doses, may result in clinically significant adrenal suppression. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery. Caution in patients with active or latent pulmonary tuberculosis. Interactions: None known. Pregnancy and lactation: Should only be used if the benefits outweigh the potential risks to foetus or neonate. Side-effects: Occasional incidence of hoarseness and/or rare occurrence of oral candidiasis (throat and mouth) may occur. Paradoxical bronchospasm with wheezing may occur. Systemic effects may occur with inhaled steroids, particularly at high doses for prolonged periods. These include: adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma. Hypersensitivity reactions and angioedema. Consult the Summary of Product Characteristics (SmPC) in relation to other side-effects. Overdosage: Acute overdose is unlikely to cause problems. Suppression of HPA function following inhalation of large amounts of the drug over a short period. Excessive doses taken over a prolonged period can produce a degree of atrophy of the adrenal cortex in addition to HPA suppression. In this event treat patient as steroid-dependent and transfer to a suitable maintenance dose of a systemic steroid such as prednisolone. Once the condition is stabilised, the patient should restart Qvar as described in the SmPC. Further information: AeroChamber Plus(R) and AeroChamber(R) devices are compatible with Qvar(R) Aerosol Inhalers. Basic NHS Price: Per 200 dose unit: Qvar(R) 50 Aerosol: 7.87 pounds Sterling, Qvar(R) 100 Aerosol: 17.21 pounds, Qvar(R) 50 Autohaler(R): 7.87 pounds, Qvar(R) 100 Autohaler(R): 17.21 pounds, Qvar(R) 50 Easi-Breathe(R): 7.74 pounds, Qvar(R) 100 Easi-Breathe(R): 16.95 pounds. Legal category: POM. Marketing Authorisation Holder: Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, BN22 9AG, United Kingdom for Product licence number: Qvar(R) 50 Aerosol: PL 00289/1371. Qvar(R) 100 Aerosol: PL 00289/1372. Qvar(R) 50 Autohaler(R): PL 00289/1373. Qvar(R) 100 Autohaler(R): PL 00289/1374. Qvar(R) 50 Easi-Breathe(R): PL 00289/1375. Qvar(R) 100 Easi-Breathe(R): PL 00289/1376

Date of Revision: July 2010

PI code QV/10/050

About Teva UK Limited

Teva UK Limited is one of the UK's top ten pharmaceutical manufacturers, with a presence in the generics, branded respiratory and hospitals markets. It has the widest range of any UK generic pharmaceutical company and markets solid and liquid dose, injectable and respiratory medicines to healthcare professionals. The company is part of Teva Pharmaceutical Industries Ltd which has nearly 40,000 employees based in 60 countries around the world.

About Teva Pharmaceutical Industries Ltd

Teva Pharmaceutical Industries Ltd. , headquartered in Israel, is among the top 15 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative pharmaceuticals and active pharmaceutical ingredients. Over 80 percent of Teva's sales are in North America and Western Europe.

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Ref. CPE/10/013

SOURCE: Teva UK Limited

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