mediarelease

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).

“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 www.merck.com.

Forward Looking Statement

This news release includes “forward-looking statements” 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
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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
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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 (www.sec.gov).

COZAAR^® is a trademark of Merck Sharp &
Dohme Corp., a subsidiary of Merck & Co., Inc.

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