GlaxoSmithKline PLC GSK data from PIII STABILITY study of darapladib (5442D)
March 31 2014 - 2:00AM
UK Regulatory
TIDMGSK
RNS Number : 5442D
GlaxoSmithKline PLC
30 March 2014
Issued: 30 March 2014, London UK - LSE Announcement
GSK presents data from Phase III STABILITY study of darapladib
in patients with chronic coronary heart disease
GlaxoSmithKline plc (LSE/NYSE: GSK) today presented datafrom the
pivotal Phase III STABILITY study of darapladib at the American
College of Cardiology 63(rd) Annual Scientific Session in
Washington, DC. The data have also been published in the New
England Journal of Medicine. Darapladib is not approved for use
anywhere in the world.
This global, double-blind, event-driven trial randomized 15,828
patients with chronic coronary heart disease (CHD) to receive 160mg
of darapladib or placebo once daily on a background of standard of
care. The primary endpoint was time to first occurrence of any
major adverse cardiovascular event (MACE) comprising cardiovascular
death, myocardial infarction (MI) and stroke. Secondary endpoints
included major coronary events (MCE) comprising CHD death, MI or
urgent coronary revascularisation for myocardial ischemia; total
coronary events comprising CHD death, MI, hospitalisation for
unstable angina or any coronary revascularisation procedure; the
individual components of MACE; and all-cause mortality.
No difference was seen in the treatment groups in the time to
first occurrence of MACE. During 3.7 years median follow-up, the
primary endpoint of MACE occurred in 9.7% of patients in the
darapladib group and 10.4% of patients in the placebo group; hazard
ratio (HR) 0.94, 95% confidence interval (0.85 - 1.03), p=0.199.
HRs for individual components were cardiovascular death 0.96 (0.83
- 1.11), MI 0.89 (0.77 - 1.03) and stroke 1.01 (0.81 - 1.27).
Among the secondary endpoints, major coronary events occurred in
9.3% of patients taking darapladib versus 10.3% in the placebo
group; HR 0.90 (0.82 - 1.00), p=0.045 (nominal significance).
Similar effects were observed for the composite of total coronary
events, which occurred in 14.9% of patients on darapladib versus
16.1% on placebo; HR 0.91 (0.84, 0.98), p=0.019 (nominal
significance). There was no difference in all-cause mortality which
occurred in 7.3% of patients in both groups.
The safety profile was well-characterised in this large outcome
study. The frequency of serious adverse events was 43% in the
darapladib group and 44% in the placebo group. Adverse events
leading to study drug discontinuation occurred in 20% of patients
on darapladib and 14% on placebo.
Dr Harvey White, MD, Director of Coronary Care Unit, Green Lane
Cardiovascular Unit, Auckland City Hospital, Auckland, New Zealand,
and the co-chair of the STABILTY study, commented:
"In the STABILITY study, the lack of effect on stroke was
disappointing but not unexpected given the emerging epidemiology
data. While the study didn't meet its primary endpoint, the effects
of darapladib on the reduction of coronary events are of potential
interest. These findings take us a step further towards defining
which patients may benefit from treatment with darapladib."
Dr Murray Stewart, Senior Vice President, Metabolic Pathways
Cardiovascular Therapy Area, added:
"STABILITY was a robust, large-scale cardiovascular outcomes
study of a novel mechanism with the goal of providing incremental
benefit above a high level of standard of care. Given the unmet
medical need, the results of the STABILITY study are important in
understanding how this mechanism may impact the lives of patients
with heart disease. We await the results of the second study,
SOLID-TIMI 52, to better understand the findings."
About darapladib and atherosclerosis
Darapladib is a selective and orally active inhibitor of
Lp-PLA(2) (lipoprotein-associated phospholipase A2) currently being
investigated as a potential agent for the reduction of
cardiovascular events in patients with coronary heart disease.
Lp-PLA(2) is an enzyme that is found in blood and in
atherosclerotic plaques. Atherosclerosis is characterised by the
build-up of plaques of fat, cholesterol and other substances within
the walls of arteries and is, in part, an inflammatory disease.
When these plaques rupture they can block vital blood vessels,
causing acute coronary syndromes (heart attacks) and strokes.
Elevated Lp-PLA(2) activity has been implicated in the development
and progression of atherosclerosis.
About STABILITY trial design and the Phase III programme
STABILITY (STtabilisation of Atherosclerotic plaque By
Initiation of darapLadIb TherapY) is the first of two Phase III
studies with darapladib. It was a randomised, placebo-controlled,
double-blind event-driven study in adults with chronic coronary
heart disease. Patients were randomised to receive either 160mg
darapladib or placebo in addition to standard of care. Standard of
care could include a statin, aspirin and blood pressure
medications. The study enrolled more than 15,000 patients across 39
countries and continued until 1,500 major adverse cardiovascular
events had occurred. The study design of STABILITY was published in
the October 2010 edition of the American Heart Journal (H. White et
al).
The second Phase III study, SOLID-TIMI 52 will evaluate the
effects of darapladib in patients with acute coronary syndrome. The
trial has enrolled over 13,000 patients across 36 countries.
SOLID-TIMI 52 is ongoing and remains blinded. Results are expected
in the second quarter of 2014. The study design of SOLID-TIMI 52
was published in the October 2011 edition of the American Heart
Journal (M.L. O'Donoghue et al).
V A Whyte
Company Secretary
30 March 2014
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