QVAR Versus Fluticasone in a Real-World Study Highlights the Importance of Inhaled Corticosteroid (ICS) Choice in Achieving Asthma Control
Study reveals that patients treated with QVAR had a similar or better chance of achieving asthma control at lower prescribed doses than with fluticasone
HORSHAM, Pa., Sept. 8 /PRNewswire/ -- Teva Pharmaceutical
Industries Ltd. (NASDAQ:TEVA) today announced the publication of
results from a real-life observational study of the General
Practice Research Database (GPRD), which revealed that asthma
patients treated with QVAR® (beclomethasone dipropionate HFA),
either as initial therapy or with an increase (step up) in dose,
had a similar or better chance of achieving asthma control as
patients who were treated with fluticasone propionate
(Flovent®). Asthma control was achieved in the QVAR population
at lower doses of drug versus those in the Flovent population.
These results were published in the September issue of the Journal
of Allergy and Clinical Immunology (JACI) and are available at
www.jacionline.org/inpress.
"The results of Teva's most recent study using the GPRD database
reinforce the effectiveness of ICS monotherapy in achieving asthma
control for most patients who either initiate ICS therapy or who
are already on an ICS and need a step up in dose," said Paul
Dorinsky, MD, Vice President, Teva Global Respiratory Research and
Development. "In fact, over 85% of the study patients achieved the
primary measure of asthma control as defined by the study. The GPRD
findings are timely given the recent FDA guidance advocating
limited use of products containing long-acting beta-agonists
(LABAs), including LABA-plus-ICS combination products, while
recommending more aggressive treatment with monotherapy ICS agents.
We are also encouraged that patients in the initiation population
of the study treated with QVAR achieved better asthma control at
lower prescribed doses of drug, as a key goal of asthma management
is to use the lowest dose needed to achieve overall asthma control
and prevent exacerbations. In the step up population, patients
receiving QVAR had a similar chance of achieving asthma control at
lower prescribed doses than with Flovent. In both populations, the
rate of exacerbations was not significantly different between the
QVAR and Flovent patient groups."
Historically, the choice of ICS has been driven by a number of
criteria, including cost and convenience. Less emphasis has been
placed on therapeutic index, as no randomized controlled trials
have consistently demonstrated clinically meaningful differences in
outcomes among available ICS options. The present study using the
GPRD database is a rigorously conducted, real-world observational
study that compared the clinical effectiveness of QVAR and
Flovent®, two ICS agents that have different formulations and
product attributes. This highlights the importance and potential
value/relevance of real-world, retrospective studies in evaluating
therapeutic options within a class of drugs.
"Retrospective studies like the GPRD study provide real-life
evidence that indicates there may be clinically meaningful
differences in asthma outcomes, depending on which ICS agent is
used," said David Price, Primary Care Respiratory Society professor
of primary care respiratory medicine, University of Aberdeen Center
of Academic Care and lead investigator of the study. "QVAR's
smaller particle size combined with its delivery system allows it
to be distributed throughout the entire lung, where it reaches and
treats the inflammation in the large and small airways associated
with asthma. The benefits demonstrated by QVAR in this study may be
associated with the product's ability to treat both the large and
small airways."
As governments, patients and physicians continue their search
for medicines that are efficacious, safe and cost-effective, the
GPRD findings have important implications as to how QVAR and
Flovent® could be implemented in clinical practice moving
forward.
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-beclomethasone
(QVAR®) 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
hospitalization 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 organizations, regulators, government
departments and leading academic institutions.
About Asthma
Asthma is a chronic (long-term) disease of inflammation of both
the large and small airways of the lung, characterized by symptoms
of wheezing and coughing. Asthma causes recurring periods of
wheezing (a whistling sound when you breathe), chest tightness,
shortness of breath and coughing that often occurs at night or
early in the morning. Without appropriate treatment, asthma
symptoms may become more severe and result in an asthma attack,
which can lead to hospitalization and even death.
About QVAR®
QVAR® is indicated in the maintenance treatment of asthma as
prophylactic therapy in patients 5 years of age or older. QVAR®
is also indicated for asthma patients who require systemic
corticosteroid administration, where adding QVAR® may reduce or
eliminate the need for systemic corticosteroids.
Important Safety Information QVAR® does not replace fast-acting (rescue) inhalers for sudden symptoms.
If you are switching from an oral corticosteroid to QVAR®,
follow your doctor's instructions to avoid health risks when you
stop using oral corticosteroids.
Inhaled corticosteroids may cause a reduction in growth rate.
The long-term effect on final adult growth is unknown.
In clinical studies, common side effects included headache and
pharyngitis.
Do not stop taking QVAR® abruptly without talking to your doctor. QVAR® is a registered trademark of IVAX LLC, a member of the TEVA Group.
For full Prescribing Information, please click here: http://www.qvar.com/Document/PrescribingInformation.pdf.
About Teva
Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) , 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.
Teva's Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995:This release contains forward-looking
statements, which express the current beliefs and expectations of
management. Such statements are based on management's current
beliefs and expectations and involve a number of known and unknown
risks and uncertainties that could cause our future results,
performance or achievements to differ significantly from the
results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to: our
ability to successfully develop and commercialize additional
pharmaceutical products, the introduction of competing generic
equivalents, the extent to which we may obtain U.S. market
exclusivity for certain of our new generic products and regulatory
changes that may prevent us from utilizing exclusivity periods,
potential liability for sales of generic products prior to a final
resolution of outstanding patent litigation, including that
relating to the generic versions of Neurontin®, Lotrel®,
Protonix® and Yaz®, the extent to which any manufacturing
or quality control problems damage our reputation for high quality
production, the effects of competition on sales of our innovative
products, especially Copaxone® (including potential generic and
oral competition for Copaxone®), the impact of continuing
consolidation of our distributors and customers, our ability to
identify, consummate and successfully integrate acquisitions
(including the acquisition of ratiopharm), interruptions in our
supply chain or problems with our information technology systems
that adversely affect our complex manufacturing processes, intense
competition in our specialty pharmaceutical businesses, any
failures to comply with the complex Medicare and Medicaid reporting
and payment obligations, our exposure to currency fluctuations and
restrictions as well as credit risks, the effects of reforms in
healthcare regulation, adverse effects of political or economical
instability, major hostilities or acts of terrorism on our
significant worldwide operations, increased government scrutiny in
both the U.S. and Europe of our agreements with brand companies,
dependence on the effectiveness of our patents and other
protections for innovative products, our ability to achieve
expected results through our innovative R&D efforts, the
difficulty of predicting U.S. Food and Drug Administration,
European Medicines Agency and other regulatory authority approvals,
uncertainties surrounding the legislative and regulatory pathway
for the registration and approval of biotechnology-based products,
potentially significant impairments of intangible assets and
goodwill, potential increases in tax liabilities resulting from
challenges to our intercompany arrangements, our potential exposure
to product liability claims to the extent not covered by insurance,
the termination or expiration of governmental programs or tax
benefits, current economic conditions, any failure to retain key
personnel or to attract additional executive and managerial talent,
environmental risks and other factors that are discussed in this
report and in our other filings with the U.S. Securities and
Exchange Commission ("SEC").
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Source: Teva Respiratory, a subsidiary of Teva Pharmaceutical Industries Ltd.
CONTACT: Denise Bradley, +1-215-591-8974, denise.bradley@tevausa.com
Posted: September 2010
