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November 1998, Week 1


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"Donna L. Kurkul" <[log in to unmask]>
Reply To:
Tue, 3 Nov 1998 20:30:07 -0500
text/plain (128 lines)

RE: your request. Here are some URLS that may provide you answers. I
would have mailed you the pages, but I didn't know if you're e-mail
package permits you to view web pages directly. The search was performed
in Alta Vista, and I used its language translator for the Italian and
German pages.

(1)From this page:, it looks like the
study II will continue into late 1999.

August 16,1998
       Pharmaceuticals Division
       Press Information
       Increased chances for survival of patients with chronic heart
       International study demonstrates a new option for treatment with
       the drug bisoprolol
August 24,1998
    Pharmaceuticals Department
    Press Information

    Increased chances for survival of patients with chronic heart
failure International study demonstrates a new option for treatment with
the drug bisoprolol. The mortality rate of cardiac failure patients
(myocardial  insufficiency) can be reduced by one third
if the beta-blocker bisoprolol is taken in addition to the standard
therapy. This was the result of a large-scale international study which
was presented this weekend by Professor Henri Dargie, Glasgow, Great
Britain during the European Congress of Cardiologists in Vienna. He
stressed the significantly increased survival rate in patients suffering
from heart disease.

    Bisoprolol was developed by Merck KGaA, Darmstadt, Germany and is a
leading world-wide product in its class. It will be filed for
registration for the therapy of heart insufficiency this year. After
receiving registration by the regulatory agencies, bisoprolol will be
available for this new indication.  Moreover bisoprolol will be
available in much lower doses compared to the doses which are currently
used for the treatment of high blood pressure (hypertension) and
coronary artery desease (angina pectoris).

    The intermediate results which were published as early as March
1998, showed such a positive effect with the treated patients, that the
study was concluded earlier than anticipated. It could not be justified
to continue the study until the end of 1999. The results of the study
that have now been completely evaluated for the first time, support this
decision. There was such a convincing difference in the amount of deaths
between both groups that continuation of the study was not ethically
justified with regard to the patients who did not receive bisoprolol.
After the study was stopped, the patients who had only received the
standard therapy and a placebo, were given bisoprolol as soon as
possible, in order to profit from its convincing effects.

    The decisive question of this presented study was: Can the mortality
rate of cardiac failure patients be reduced when treated with the
beta-blocker bisoprolol?  CIBIS II (Cardiac  Insufficiency Bisoprolol
Study), which started in November 1995 included 2,647 cardiac failure
patients. The participants were divided in two groups. Both groups
received the current standard therapy during the complete course of the
study. One of the groups was additionally treated with the beta-blocker
bisoprolol, the other one with a  placebo. The results now presented
show a much lower mortality rate in the same period of time for the
group given bisoprolol than for the group that was treated with a

    The decrease of mortality could be proven for all patients treated
with bisoprolol, regardless of the cause of their myocardial
insufficiency. Especially impressive  was the fact that within the
bisoprolol group, the number of sudden deaths due to heart failure,
which follows serious rhythm disorders of the heart and can lead to
death within minutes, could be reduced by 45 per cent. Significantly
fewer patients in the bisoprolol group had to be hospitalized due to a
massive deterioration of their
myocardial insufficiency. Bisoprolol thus helps patients achieve an
improved quality of life and at the same time helps reduce healthcare
costs by diminishing the number of hospitalizations.

    Despite all available therapeutic options, about 50 per cent of the
patients die within 5 years after cardiac insufficiency has been
diagnosed. In Germany 57,000 patients die due to cardiac insufficiency
every year; in the US the number of deaths is even higher at 225,000.

    For many years, beta-blockers have been successfully given to treat
hypertension and
angina pectoris. Beta-blockers were regarded as unsuitable for treating
cardiac insufficiency. What makes the results of the CIBIS II trial
especially important to modern medicine, is the fact that the study
shows an improved patient survival chance. The results clearly prove
that the therapy of cardiac insufficiency can be an additional
indication for the application of beta-blockers like bisoprolol. For
more information visit the internet at:

Here are other possibilities, if you had not already seen them:
Schädlich PK, Paschen B, Brecht JG. "Economic Evaluation of the Cardiac
Insufficiency Bisoprolol Study for the Federal Republic of Germany."
PharmacoEconomics 1998; 13: 147-155.

Heart cycle: Heart insufficiency CIBIS II (Cardiac Insufficiency
Bisoprolol Study)

Bisoprololo: interesting result in the therapy of the cardiac lack of

P.S. Glad to have an e-mail address for you. There are lots of things to
talk about....another time.

Donna L. Kurkul, M.L.S. Information Specialist, Author & Consultant
*Contributing Editor*, Medicine On The Net, COR Healthcare Resources,
Santa Barbara, California USA    Visit us at

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Home tel. 413-586-4845 or 584-1219 / 6 Frallo Drive, Hadley, MA 01035