IMPERIAL scientists studying different blood pressure
treatments and the effects of additional cholesterol lowering, have
stopped part of their European trial earlier than expected because
results collected already show a significant benefit to patients on
one of its treatments.
Professor Peter Server |
It found that among 10,297 patients with hypertension and
cholesterol levels lower than currently recommended for treatment,
those given the cholesterol-lowering drug atorvastatin suffered
significantly fewer heart attacks and strokes compared to those
receiving the placebo treatment.
The International Steering Committee of the independent
Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) have stopped the
relevant part of the trial and informed fellow investigators, their
patients and the regulatory authorities about the newly emerged
results.
The rest of the trial, which compares different blood pressure
treatment strategies, will continue unchanged.
"The trial shows that patients with high blood pressure but low
cholesterol benefit clearly from tak ing a statin. It is too early
to quantify the precise size of the effect, but we expect to see a
reduction in heart attacks of about one third among those taking a
statin," say ASCOT study co-chairmen Professor Peter Sever, faculty
of medicine, and Björn Dahlöf from the Sahlgrenska
University Hospital, Östra, Sweden.
"However the ASCOT trial still continues and we wish to make it
clear to all our patients that this new information does not mean
they should stop the tablets they are taking. It is vital that all
patients on the trial carry on with their treatment regimens," they
add.
Members of ASCOT's Data Safety Monitoring Board, who work
independently of the trial investigators and are the only
researchers permitted to look at the results of the five-year old
trial while it is ongoing, reported their findings to the ASCOT
International Steering Committee on 2 September 2002.
They described a highly significant reduction in the number of
heart attacks and a significant reduction in strokes experienced by
those patients receiving atorvastatin compared to placebo.
As the size of the benefit exceeded the stopping rules for this
part of the trial, the Data Safety Monitoring Board's
recommendations to close this section of the study were accepted by
the ASCOT Steering Committee. This part of the study was formally
closed on 1 October 2002 but data collection relating to it is
expected to continue until the end of December 2002.
