(Ξένη δημοσίευση)-ΑΝΑΚΟΙΝΩΣΗ ΤΥΠΟΥ- BW-Higher Dose of Merck’s COZAAR® (losartan potassium tablets) Signifi...
![Logo]()
src="http://mms.businesswire.com/bwapps/mediaserver/ViewMedia?mgid=57257&vid=2">
Nov. 17, 2009 13:00 UTC
Higher Dose of Merck’s
COZAARΒ® (losartan potassium tablets) Significantly
Reduced Deaths and Hospitalizations Due to Heart Failure In Investigational
Study
Results from HEAAL Study Presented as Late-Breaker
at American Heart Association Scientific Sessions 2009
ORLANDO, Fla.--(BUSINESS WIRE)-- In
an investigational study, Merck & Co., Inc.'s medicine COZAAR (losartan
potassium tablets) 150 mg, administered once daily, significantly reduced the
risk of all-cause death or hospitalization due to heart failure compared to its
lower 50 mg once daily dose. The Merck & Co Inc.-sponsored study compared
the safety and efficacy of two doses of COZAAR in patients with chronic heart
failure and reduced cardiac function (left ventricular ejection fraction) who
were intolerant of angiotensin-converting enzyme (ACE) inhibitors. The results
of the study, called HEAAL -- Heart failure Endpoint evaluation of the
A-II-Antagonist Losartan -- were presented by researchers during a late breaking
clinical trial session at the American Heart Association (AHA) Scientific
Sessions 2009.
COZAAR is not approved for use, for any indication, at the 150 mg dose used
in the HEAAL study. The treatment is an angiotensin II antagonist (AIIA),
cardiovascular medicine approved in many countries in the European Union for the
treatment of:
- Essential hypertension in adults and in
children and adolescents 6 - 16 years of age at doses of 50 mg to 100 mg once
daily.
- Renal disease in patients with hypertension and
type 2 diabetes mellitus with proteinuria ≥ 0.5 g/day as part of an
antihypertensive treatment.
- Chronic heart failure (in patients ≥ 60 years),
when treatment with ACE inhibitors is not considered suitable due to
incompatibility, especially cough, or contraindication at doses of 12.5 mg to 50
mg once daily. Patients with heart failure who have been stabilised with an ACE
inhibitor should not be switched to losartan. The patients should have a left
ventricular ejection fraction ≤ 40% and should be clinically stable and on an
established treatment regimen for chronic heart failure.
- Reduction in the risk of stroke in hypertensive
patients with left ventricular hypertrophy documented by ECG at doses of 50 mg
to 100 mg once daily. (The data do not support the use of losartan for this
indication in black patients).
β€HEAAL is the first study to examine and document the value of a higher dose
of an angiotensin II antagonist in patients with heart failure," said lead study
investigator Marvin A. Konstam, M.D., Chief Physician Executive, the
Cardiovascular Center, Tufts Medical Center, and Professor of Medicine, Tufts
University School of Medicine.
"HEAAL is another important study in a long-line of large outcomes studies
that Merck has sponsored and conducted to help the medical community to better
understand the role of our cardiovascular medicines in improving cardiovascular
outcomes," said Francis Plat, M.D., Vice President and clinical therapeutic area
head for Atherosclerosis and Cardiovascular, Merck Research Laboratories. "Like
SOLV-D, 4S, LIFE and RENAAL, this study, too, advances our understanding of the
role that pharmaceutical innovations can have and answers an important
outstanding question as only a clinical outcomes trial can."
About the HEAAL Study
Study results demonstrated losartan administered in a 150 mg once daily dose,
when compared with 50 mg per day, significantly reduced the risk of the primary
composite endpoint (all cause death or hospitalization for heart failure) in
patients with reduced left ventricular ejection fraction (LVEF); and reduced ACE
inhibitor intolerance (p=0.027).
The multicenter, prospective, randomized, double-blind, event-driven clinical
trial enrolled 3,834 patients with symptomatic congestive heart failure
intolerant of ACE inhibitor treatment at 255 sites in 30 countries. Patients
were randomized to two losartan treatment arms: 150 mg once daily (n=1,921) and
50 mg once daily (n=1,913). Among these patients, 3,723 completed endpoint
follow-up with a median follow-up time of 4.7 years. Prior to randomization,
patients not already receiving an AIIA were titrated onto losartan from 12.5 mg
daily to 25 mg daily over two weeks. For patients already receiving an AIIA,
their prescription was discontinued, and investigators had the option of
initiating open-label losartan 25 mg daily for one week or directly randomizing
the patient.
The primary composite endpoint of the HEAAL study was all cause death or
hospitalization for heart failure and the secondary composite endpoint was all
cause death or cardiovascular hospitalization. Secondary symptom assessments,
including an increase in left-ventricular ejection fraction (LVEF) function and
changes in New York Heart Association (NYHA) classification, also were
completed.
Patients in the 150 mg treatment group had a significantly lower risk of
hospitalization due to heart failure or cardiovascular hospitalization compared
to patients in the 50 mg treatment group. 450 patients in the 150 mg treatment
group (6.0 per 100 patient-years of follow-up) were hospitalized for heart
failure during the course of the study compared to 503 patients in the 50 mg
treatment group (7.0 per 100 patient-years of follow-up) (p=0.025). Renal
impairment, hyperkalameia (p<0.001), ,hypotension (p=0.002) and angioedema
(p=0.03) as defined by the investigator were more common in the COZAAR 150 mg
group than in the 50 mg treatment arm. Renal impairment was the adverse event
which most commonly lead to drug discontinuation in the two groups (0.65 and
0.49 per 100 patient years respectively) but the number (and rate) of individual
or total discontinuations were similar for the two treatment groups.
Additional important information about COZAAR (losartan potassium
tablets)
When used in pregnancy during the second or third trimesters, drugs that act
directly on the renin-angiotensin system can cause injury and even death to the
developing fetus. When pregnancy is detected, losartan should be discontinued as
soon as possible.
Losartan is contraindicated in patients who are hypersensitive to any
component of these products. All patients receiving thiazides should be observed
for clinical signs of fluid or electrolyte imbalance, including hypokalemia.
In patients who are volume-depleted, symptomatic hypotension may occur after
initiation of therapy. This condition should be corrected prior to
administration of the drug, or a 25 mg dosage should be used. As with other
drugs that block angiotensin II or its effects, concomitant use of
potassium-sparing diuretics, potassium supplements, or salt substitutes
containing potassium may lead to increases in serum potassium.
In clinical trials for hypertension, the most common adverse events with an
incidence greater or equal to two percent of patients treated with losartan
(n=1,075) and occurring more commonly than placebo (n=334) included upper
respiratory infection (8 percent vs. 7 percent respectively), dizziness (3
percent vs. 2 percent respectively), nasal congestion (2 percent vs. 1 percent
respectively), and back pain (2 percent vs. 1 percent respectively).
Dosing and administration
In patients with hypertension, the usual starting dose is 50 mg once daily.
The maximum daily dose is 100 mg. If the antihypertensive effect measured at
trough using once-a-day dosing is inadequate, a twice-a-day regimen at the same
total daily dose or an increase in dose may give a more satisfactory response.
In patients with heart failure, the usual initial dose is 12.5 mg once daily.
The dose should generally be titrated at weekly intervals (i.e. 12.5 mg daily,
25 mg daily, 50 mg daily) to the usual maintenance dose of 50 mg once daily, as
tolerated by the patient.
For reduction in the risk of stroke in hypertensive patients with left
ventricular hypertrophy documented by ECG, the usual starting dose is 50 mg once
daily. A low dose of hydrochlorothiazide should be added and/or the dose of
losartan should be increased to 100 mg once daily based on blood pressure
response.
In patients who are volume-depleted, symptomatic hypotension may occur after
initiation of the therapy. This condition should be corrected prior to
administration of the drug, or a dosage of losartan 25 mg should be used. In
patients with a history of hepatic impairment, a starting dose of 25 mg should
be used. In hypertensive patients with left ventricular hypertrophy, treatment
should be initiated with 50 mg once daily.
About Merck
Today's Merck is working to help the world be well. Through our medicines,
vaccines, biologic therapies, and consumer and animal products, we work with
customers and operate in more than 140 countries to deliver innovative health
solutions. We also demonstrate our commitment to increasing access to healthcare
through far-reaching programs that donate and deliver our products to the people
who need them. Merck. Be Well. For more information, visit
href="http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.merck.com&esheet=6098781&lan=en_US&anchor=www.merck.com&index=1&md5=9debacea93bf465a9d3b11df30a3c66b">www.merck.com.
Forward Looking Statement
This news release includes β€forward-looking statementsβ€ within the meaning of
the safe harbor provisions of the United States Private Securities Litigation
Reform Act of 1995. Such statements may include, but are not limited to,
statements about the benefits of the proposed merger between Merck and
Schering-Plough, including future financial and operating results, the combined
company’s plans, objectives, expectations and intentions and other statements
that are not historical facts. Such statements are based upon the current
beliefs and expectations of Merck’s and Schering-Plough’s management and are
subject to significant risks and uncertainties. Actual results may differ from
those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ
from those set forth in the forward-looking statements: the possibility that the
expected synergies from the merger of Merck and Schering-Plough will not be
realized, or will not be realized within the expected time period, due to, among
other things, the impact of pharmaceutical industry regulation and pending
legislation that could affect the pharmaceutical industry; the risk that the
businesses will not be integrated successfully; disruption from the merger
making it more difficult to maintain business and operational relationships;
Merck’s ability to accurately predict future market conditions; dependence on
the effectiveness of Merck’s patents and other protections for innovative
products; the risk of new and changing regulation and health policies in the
U.S. and internationally and the exposure to litigation and/or regulatory
actions.
Merck undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or otherwise.
Additional factors that could cause results to differ materially from those
described in the forward-looking statements can be found in Merck’s 2008 Annual
Report on Form 10-K, Schering-Plough’s Quarterly Report on Form 10-Q for the
quarterly period ended Sept. 30, 2009, the proxy statement filed by Merck on
June 25, 2009 and each company’s other filings with the Securities and Exchange
Commission (SEC) available at the SEC’s Internet site (
href="http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.sec.gov&esheet=6098781&lan=en_US&anchor=www.sec.gov&index=2&md5=8821fa38986f2237024f770c5e999f34">www.sec.gov).
COZAARΒ® is a trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc.
![]()
src="http://cts.businesswire.com/ct/CT?id=bwnews&sty=20091117005195r1&sid=cHJybEBhbmEuZ3I%3D&distro=email/>Contacts
Merck & Co., Inc. Media: Noreen Verbrugge,
+1-908-423-6301 or Investor: Carol Ferguson, +1-908-423-4465
Source: Merck & Co., Inc.
![]()
title="Business Wire is the leading source for full-text breaking news and press releases, multimedia and regulatory filings for companies and groups throughout the world"
border=0 alt="Powered by Business Wire"
src="http://home.businesswire.com/images/Powered-by-Business-Wire.gif">
href="http://www.businesswire.com">
View this news release online at:
href="http://www.businesswire.com/news/home/20091117005195/en">http://www.businesswire.com/news/home/20091117005195/en
More details on the subscriber's page of APE-MPE | Subscription request form
|