New GPRD Analysis Shows QVAR(R) (beclometasone dipropionate HFA) Delivers Equal or Better Asthma Control with Less Drug than Fluticasone
By Teva Uk Limited, PRNEMonday, September 20, 2010
Real World Observational Study Suggests that QVAR(R) Particle Size, Formulation and Site of Action May Be Linked to Effective Asthma Control
CASTLEFORD, England, September 21, 2010 - Teva UK Limited (Nasdaq: TEVA) 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.
For media enquiries, telephone the Teva UK Limited Communications team on
+44-(0)-1977-628500, or email media.enquiries@tevauk.com.
For full Summary of Product Characteristics, please see website:
www.tevauk.com.
Adverse events should be reported. Reporting forms and information can be
found at www.yellowcard.gov.uk. Adverse events should also be reported
to Teva UK Limited
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
(NASDAQ: TEVA) which has nearly 40,000 employees based in 60 countries around
the world.
About Teva Pharmaceutical Industries Ltd
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.
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current beliefs and expectations of management. Such statements are based on
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Ref. CPE/10/013
For media enquiries, telephone the Teva Communications team on +44-01977-628500, or email media.enquiries at tevauk.com
Tags: Castleford, England, September 21, Teva Uk Limited, United Kingdom