veNTIlATIoN - Green Cross Publishing

Coversyl Arginine Plus
Servier Laboratories have announced that Coversyl Arginine
Plus 10mg/2.5mg will be available for prescription in Ireland
from January 2010. Produced in Arklow, Coversyl Arginine Plus
10mg/2.5mg contains 10mg of perindopril arginine and 2.5mg
of indapamide, extending the range and providing more
powerful antihypertensive efficacy.
Coversyl Arginine Plus 10mg/2.5mg provides a high level
of control with 68% of hypertensive patients normalized at 8
weeks. The uptitration to Coversy Arginine Plus 10mg/2.5mg
provides incremental and progressive blood pressure
reductions reaching -23mmHg/15mmHg.
The renal benefits of Coversyl Arginine Plus 10mg/2.5mg
are greater than those for the lower dose Coversyl Arginine
Plus 5mg/1.25mg, with albumin excretion rate reduced by
48%. Further confirmation of renal and cardiac benefits are
demonstrated in the ADVANCE trial of over 11,000 patients with
Type II diabetes, of whom 70% also had hypertension.
Coversyl Arginine Plus 10mg/2.5mg is indicated as
a substitution therapy for the treatment of essential
hypertension in patients already controlled with perindopril
arginine and indapamide given concurrently at the same dose
level.
Coversyl Arginine Plus10mg/2.5mg is
taken once daily and will be available
in pots containing 30 tablets
providing one month of treatment
and will be available on the GMS
scheme.
For full prescribing information
see www.medicines.ie or please
contact Servier Laboratories
Ireland Ltd, Block 2, West Pier
Business Campus, Old Dunleary
road, Dún Laoghaire, Co Dublin or
on (01) 6638110.
Landmark 100th worldwide license for Cervarix
GlaxoSmithKline (GSK) announced in October that the US Food
and Drug Administration (FDA) has approved Cervarix for the
prevention of cervical pre-cancers and cervical cancer related
to human papillomavirus (HPV) types 16 and 18. The vaccine
will be licensed for use in girls and young women (aged 10-25).
This approval makes the US the 100 th country to grant
licensing for Cervarix, following a recent approval in Japan
and previous licenses obtained around the world, including in
the 27 member states of the European Union, Australia, Brazil,
South Korea, Mexico and Taiwan.
“We are extremely proud to know that our cervical cancer
vaccine will soon be available to millions of young women
product news
Flibanserin demonstrates efficacy and
tolerability in pivotal phase III trials in
pre-menopausal women with hypoactive
sexual desire disorder
Data from pooled, pivotal Phase III clinical trials demonstrate
that flibanserin 100 mg taken once daily at bedtime
significantly increased the number of satisfying sexual events
(SSEs) and sexual desire while significantly decreasing the
distress associated with hypoactive sexual desire disorder
(HSDD). Flibanserin is an investigational compound that is
being developed by Boehringer Ingelheim for the treatment of
pre-menopausal women with HSDD.
HSDD is a medical condition characterised by a decrease
in sexual desire associated with marked distress and/or
interpersonal difficulties. Women with HSDD often feel a loss of
intimacy and closeness that they used to enjoy. The condition
can negatively impact a woman´s life and her relationship with
her partner.
The complete flibanserin pivotal trial programme was
presented recently at the 12th Congress of the European
Society for Sexual Medicine in Lyon, France. It included an
analysis of three pivotal Phase III North American trials (DAISy,
VIOLET and DAHLIA) and the pivotal Phase III European data
(ORCHID). In addition results from a pooled analysis of two
pivotal Phase III North American trials (DAISy and VIOLET) and
a pooled analysis of the North American and European data
(DAISy, VIOLET and ORCHID) were presented, assessing the
safety and efficacy of flibanserin 100 mg in pre-menopausal
women suffering with HSDD.
"Despite studies demonstrating that HSDD is a common form
of female sexual dysfunction, there is currently no approved
prescription treatment for pre-menopausal women suffering
from the condition” said Professor Rossella Nappi, director of
the Gynaecological Endocrinology & Menopause Unit at the
Maugeri Foundation, University of Pavia, Italy, and primary
investigator of the European pivotal trial. "Flibanserin is a novel,
non-hormonal compound, that has been investigated as a
treatment for pre-menopausal women with HSDD. Based on
the clinical trial results presented at ESSM it has the potential to
help many women suffering from their lack of sexual desire."
across the US,” said Jean Stéphenne, President and General
Manager, GSK Biologicals. “Alongside our existing access
programmes in Europe, Australia, across emerging markets
and Asia Pacific, this approval marks an important turning
point in our dedicated mission to provide women everywhere
with effective protection against the world’s second-most
common female cancer.”
It is estimated that in 2009, approximately 11,000 women
in the U.S. will be diagnosed with cervical cancer and 4,000
women will die from the disease. Worldwide, these numbers
are estimated at more than 500,000 diagnoses per year and
globally, cervical cancer kills one woman every two minutes.
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