A little of this, and a little statin, and a little anti-inflammatory like a cox-2 inhibitor, with a little vitamin E and orange juice on the side, and you might have a fighting chance against the cardiovascular boogiemen. Of course one might wonder what you are doing to your liver and kidneys, but one could always get a transplant.
EZETROL(TM), the first of a new class of cholesterol-lowering drugs in 15 years, approved by Health Canada - Studies show significant reductions in cholesterol when added to all statins tested
MONTREAL, June 18 /CNW Telbec/ - EZETROL(TM) (ezetimibe), the first of a
new class of cholesterol-lowering agents since the introduction of statins to
the Canadian market over 15 years ago, has been approved in Canada to reduce
LDL or "bad" cholesterol and total cholesterol in patients with high
cholesterol levels. Ezetimibe, a cholesterol absorption inhibitor, works
uniquely by inhibiting the absorption of cholesterol in the intestine. The
addition of ezetimibe 10 mg/day to ongoing statin monotherapy resulted in an
additional LDL-cholesterol reduction of 25 per cent compared with four per
cent for the addition of placebo(1).
"Adding ezetimibe will improve this greatly despite treatment with
statins," says Dr. George Steiner, Head of the World Health Organization
Collaborating Center for the Study of Atherosclerosis in Diabetes and the
Project Director of the Diabetes Atherosclerosis Intervention Study. "Studies
have demonstrated that combining ezetimibe with a statin inhibits two
important cholesterol pathways: synthesis in the liver and absorption in the
intestine. In clinical trials, this dual inhibition has helped more patients
reach their goal."
In clinical trials, ezetimibe was well tolerated with a side-effect
profile similar to placebo. The drug was discovered by Schering Plough
Corporation and developed in partnership with Merck & Co., Inc. Ezetimibe is
marketed in Canada by Merck Frosst/Schering Pharmaceuticals, a joint venture
between Merck Frosst Canada Ltd. and Schering Canada Inc., part of a worldwide
partnership (except Japan) between the two companies.
"As research and clinical studies continue to underscore the need to
lower cholesterol, ezetimibe offers a new proven treatment option for many
patients and their physicians," says Diana McDougall, Executive Director and
General Manager of Merck Frosst/Schering Pharmaceuticals. "Studies have shown
that alone or in combination with any statin, ezetimibe made a significant
contribution in reducing LDL-cholesterol, a major risk factor for
cardiovascular disease which is the number one killer in Canada."
Additional 25 per cent reduction in LDL-cholesterol achieved within two
weeks
In the "Add-On" study, a multi-centre, placebo-controlled study,
involving patients not meeting their LDL-cholesterol goals despite undergoing
treatment with different statins at all doses(2), the addition of ezetimibe 10
mg/day to ongoing statin monotherapy resulted in an additional LDL-cholesterol
reduction of 25 per cent compared with four per cent for the addition of
placebo(3). The mean LDL-cholesterol level of patients on a constant dose of
statin therapy was reduced from 3.57 mmol/L to 2.64 mmol/L when ezetimibe was
added, compared to a reduction from 3.59 mmol/L to 3.44 mmol/L with the
addition of placebo(4).
Most of the response in LDL-cholesterol reduction was seen within two
weeks of the administration of ezetimibe. Furthermore, the reduction provided
was shown to be consistent in combination with all statins tested, regardless
of the dose.
A further 72 per cent of patients reached goal with addition of
EZETRO(TM) to statin
The study also demonstrated that a further 72 per cent of statin- treated
patients not at goal(5), did reach their target LDL-cholesterol goal when
ezetimibe 10 mg was added to their cholesterol management therapy, compared to
19 per cent of patients who received placebo in addition to a statin.
More significant reductions achieved than with statins alone
Four additional placebo-controlled, co-administration studies were
conducted with ezetimibe and either atorvastatin(6), simvastatin(7),
pravastatin(8) or lovastatin(9) in patients with high cholesterol levels who
had not been previously treated with a statin.
"Studies were conducted in which ezetimibe was co-administered with all
statins on the market at the time. They showed that adding ezetimibe
significantly reduced LDL cholesterol reductions to levels below those seen
with each of the statins alone," said Dr. Steiner. "These studies also showed
that adding ezetimibe to the lowest statin dose provided LDL cholesterol
reductions similar to those seen when the highest dose of the statin was given
by itself. This is important to both physicians and their patients who usually
prefer to use the lowest possible dose of a statin."
In the case of atorvastatin, the reduction in LDL-cholesterol achieved by
the 10 mg dose together with ezetimibe 10 mg was 53 per cent from the original
untreated baseline. This reduction was greater than that achieved with 10 mg,
20 mg, 40 mg and similar to the 80 mg dose of atorvastatin alone.
Similar statistically significant reductions were achieved with the
addition of ezetimibe 10 mg to all doses of simvastatin, pravastatin and
lovastatin. With simvastatin, for example, patients receiving the 10 mg dose
together with ezetimibe 10 mg recorded a 46 per cent LDL-cholesterol
reduction. This reduction was greater than that achieved with 10 mg, 20 mg, 40
mg and similar to the 80 mg dose of simvastatin alone.
Additional benefits in cholesterol management
In general, there were incremental benefits in HDL or "good" cholesterol
levels and triglycerides with ezetemibe-statin therapy than with statins
alone.
For example, the combination of ezetimibe and atorvastatin reduced
triglycerides by 33 per cent compared to 24 per cent for atorvastatin alone.
With simvastatin the reduction of triglycerides was 29 per cent compared to 20
per cent for simvastatin alone. HDL-cholesterol was improved by seven per cent
with the co-administration of ezetimibe and atorvastatin versus four per cent
for atorvastatin alone and by nine per cent when combined with simvastatin
versus seven per cent for simvastatin alone.
Results achieved without compromising tolerability
Clinical studies involving more than 4,700 patients demonstrated that
ezetimibe, administered alone or with a statin, was generally well tolerated.
The overall incidence of adverse events reported with ezetimibe was similar to
that reported with placebo, and the discontinuation rate due to adverse events
was also similar for ezetimibe and placebo.
Unique and complementary mechanism of action provides additional
cholesterol reduction
Ezetimibe is a once a day 10 mg dose tablet, that can be taken alone, or
with any statin, with or without food. Its unique mechanism of action lowers
LDL?cholesterol by inhibiting dietary and biliary cholesterol absorption in
the intestine. Taken with a statin, which inhibits cholesterol synthesis in
the liver, ezetimibe ensures complementary cholesterol reduction.
Currently available in eight countries, including Germany and the United
States, ezetimibe was approved by Health Canada as adjunctive therapy to diet
for the reduction of elevated total cholesterol, LDL-cholesterol,
apolipoprotein B and triglycerides and the increase of HDL-cholesterol in
patients with primary hypercholesterolemia.
About Merck Frosst/Schering Pharmaceuticals
Merck Frosst/Schering Pharmaceuticals (MFSP) is a joint venture between
Merck Frosst Canada Ltd. and Schering Canada Inc., which was established in
December 2001 as part of a worldwide partnership (except Japan) between the
two companies. MFSP was formed to develop and market new prescription
medicines for the management of cholesterol. A result of the alliance of
equals, ezetimibe is the first of a new class of cholesterol-lowering agents
to be made available in Canada.
(TM) Trademark used under license.
B-Roll Satellite Coordinates for Wednesday June 18, 2003 at 13:00 - 14:00
ET: ANIK E2, C-Band, Transponder 6B, Audio 6.2 and 6.8, Downlink
Frequency 3940 Vertical.
_____________________________
(1) Gagné C, Bays HE, Weiss, SR, Mata P, et al. Efficacy and Safety of
Ezetimibe Added to Ongoing Statin Therapy for Treatment of Patients
with Primary Hypercholesterolemia, Am J Cardiol 2002;90:1084-1091.
(2) Various doses of atorvastatin, simvastatin, pravastatin, lovastatin
and fluvastatin. (3) Gagné C, Bays HE, Weiss, SR, Mata P, et al.
Efficacy and Safety of
Ezetimibe Added to Ongoing Statin Therapy for Treatment of Patients
with Primary Hypercholesterolemia, Am J Cardiol 2002;90:1084-1091.
(4) Throughout the document, US Units, mg/dL, have been converted to
Standard International (i.e. Canadian) Units, mmol/L using 38.7 as
the conversion factor. (5) Fodor, J., et al., Recommendations
for the Management and Treatment
of Dyslipidemia, Report of the Working Group on Hypercholesterolemia
and Other Dyslipidemias, CMAJ 2000; 162(10): 1441-7. (6)
Ballantyne, C., et al., Effect of Ezetimibe Coadministered with
Atorvastatin in 628 Patients with Primary Hypercholesterolemia,
Circulation 2003; 107:2409-2415. (7) Davidson MH, McGarry T,
Bettis R et al. Ezetimibe Coadministered with
Simvastatin in Patients with Primary Hypercholesterolemia, J Am Coll
Cardiol 2002;40:2125-34i. (8) Melani L, et al., Efficacy and
Safety of Ezetimibe Co-Administered
with Pravastatin in Patients with Primary Hypercholesterolemia: A
Prospective, Randomized, Double-Blind Trial, European Heart Journal
2003; 24: 717-728. (9) Kerzner B, Corbelli J, Sharp S et al.
Efficacy and Safety of
Ezetimibe Coadministered with Lovastatin in Primary
Hypercholesterolemia, Am J Cardiol 2003;91:418-424. |
