Monsanto, American Home Drugs Cut Death Rate in Heart Failure
Bloomberg News
November 11, 1998, 2:55 p.m. ET
Monsanto, American Home Drugs Cut Death Rate in Heart Failure
Dallas, Nov. 11 (Bloomberg) -- Drugs sold by Monsanto Co.
and American Home Products Corp. can extend the lives of patients
suffering from heart failure, according to two new studies.
The studies add to positive news for patients with the
debilitating and life-shortening condition, in which a weak heart
can't properly pump blood. Yesterday, a study showed that Astra
AB's Toprol-XL drug could also slash the death rate in heart
failure patients when given on top of standard care.
The new studies, released at a meeting of the American Heart
Association in Dallas, may also lead to greater use of the drugs,
which are already approved and used for other types of heart
patients.
''We were delighted'' with the results, said Bertram Pitt, a
researcher from the University of Michigan who led the company-
sponsored study of Searle's Aldactone drug. ''This is going to
have a major public health benefit.''
In the Searle study, Pitt and his colleagues found that
Aldactone, also known as spironolactone, could reduce the risk of
death by 27 percent.
The study is another boost to Monsanto's Searle drug unit,
which yesterday reported strong results for its Celebrex drug in
treating patients with rheumatoid arthritis. Shares of St. Louis-
based Monsanto, a leading agriculture biotechnology company with
a growing drug business, fell 3/16 to 39.
Aldactone, which works by draining fluids from the body, has
been available for more than three decades, mainly as a treatment
for high blood pressure. The new results, however, could spark
greater use of the drug. Previously, most doctors thought a drug
such as Aldactone couldn't be added to the standard therapy known
as ACE inhibitors, Pitt said.
Study Ended Early
In September, Searle announced that it had ended the so-
called RALES study of more than 1,600 patients more than a year
early because of the drug's benefits. Ending the study means all
patients have the option to receive the drug and no one is on
placebo.
The trial involved researchers in 15 countries who studied
the effects of the drug versus a placebo on top of the care
generally given to heart failure patients. Searle is still
considering whether to seek U.S. Food and Drug Administration
approval of a new claim for the drug, a spokesman said.
Since the drug is already commercially available, however,
doctors can prescribe it to patients even without formal approval
of a new claim for the drug.
Meanwhile, researchers in the so-called CIBIS-II study found
similar benefits for American Home's bisoprolol, with the drug
reducing the overall risk of death in the 2,647-patient study by
32 percent. Bisoprolol, sold by American Home as Ziac, is a
member of a class of drugs known as beta blockers.
Currently, SmithKline Beecham Plc's Coreg is the only beta
blocker drug approved by the FDA for treatment of heart failure.
Beta blocker drugs, which work by muting the effects of stress
hormones in the body and can decrease the force of the heart's
contractions, have long been used for a variety of heart
patients. Only recently, however, have doctors begun to
understand their potential benefits for patients suffering from
heart failure.
Meanwhile, researchers have high hopes for devices developed
by a host of companies including Baxter International Inc. and
Guidant Corp. that could help improve patients' quality of life.
--Kristin Jensen in Dallas through the Washington newsroom (202)
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