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Senior Citizen Health & Medicine
Statin Users Risk Heart Attack by Dropping Drugs or
Taking Low Doses
Projects 5-7,000 Americans yearly suffer unnecessary heart attacks
December 8, 2006 - Thousands of statin users
primarily older people - worldwide are suffering preventable heart
attacks, simply because they are not complying with their treatment or
they are taking too low a dose, according to new research published
online yesterday in European Heart Journal. These life-saving drugs,
used to lower cholesterol levels in people at risk of coronary heart
disease (CHD), can only be optimally effective if patients use them
properly and many are not.
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That is the conclusion by the research team, who
followed the prescription records of nearly 60,000 patients in the
Netherlands for up to 14 years.
Dr Fernie Penning-van Beest and colleagues from the
PHARMO Institute, the Utrecht Institute of Pharmaceutical Sciences and
the Academic Hospital in Amsterdam, analyzed 548,084 prescriptions of
statin treatment issued over the first two years of treatment in 59,094
new users in the period January 1991-December 2004, and followed the
patients until their first hospital admission for heart attack, death,
or the end of the study in December 2004.
The aim was to see how effective robust statin
treatment was for primary and secondary CHD in the real world as
opposed to in clinical trials. Their results enabled them to calculate
the absolute number of avoidable heart attacks that occurred because
patients had stopped taking their drugs or were not taking them
consistently. They were also able to compare the preventive effects of
different doses and types of statins.
Patients were divided into two groups those at
high risk of heart attack and those at intermediate or low risk, with
over a fifth of patients (12,762) considered high risk.
They found more than half of all patients (31,557)
stopped taking statins within two years and only just over a third
(20,883) were persistent users on a high or intermediate dose.
Among persistent users, hospital admission for
heart attacks fell by nearly a third (30%) compared to non-persistent
users, in both primary and secondary prevention groups.
In the primary prevention group, admission was down
from 0.52 per 100 patient years among non-persistent users to 0.42 per
100 patient years in persistent users. In the secondary prevention group
it was down from 0.86 to 0.62.
Among patients using the high or intermediate doses
the risk reduction was as high as 40%, while a low dose reduced the risk
by only 20%.
The researchers calculated that, every year, around
300 to 400 statin users in the Netherlands have an avoidable heart
attack because of sub-optimal doses or discontinuing treatment.
They believe the results are likely to be typical
of Europe as a whole and of the USA, which means 7,000 to 9,000
Europeans and 5,000 to 7,000 Americans a year are suffering unnecessary
heart attacks.
"What this clearly tells us," said lead researcher
Dr Penning-van Beest, a research associate at the PHARMO Institute, "is
that our observational study supports robust cholesterol lowering, as
recommended on the basis of clinical trials. But, drugs are only really
effective if they are used properly and persistently.
"Unfortunately, statins are not being used
optimally, so thousands of people are having unnecessary heart attacks.
Getting users to stay on statins and to use them persistently saves
lives, and doctors must get over to patients the message that complying
with treatment is essential."
Different types of statins are used in different
doses, so the researchers dealt with these differences by grading the
five statins they assessed for equipotency (the dose of one type of
statin needed to achieve the same effect as another type).
They found that patients achieving the largest
reduction in heart attacks that needed hospital admission were those
consistently taking the drugs over the whole two-year period at
persistently high or intermediate equipotent doses.
These patients were also relatively more likely to
be using second generation statins i.e. atorvastatin or rosuvastatin,
rather than the first generation types, pravastatin, fulvastatin or
simvastatin.
Higher doses of first generation statins were being
prescribed, but increasing the dose of these older statins is limited by
the maximum safe dose.
"It is preferable to achieve a high equipotent dose
by using the new, highly potent statins," said Co-author Dr Ron Herings,
scientific director of the PHARMO Institute and associate professor of
pharmacoepidemiology at Utrecht University.
"But, the new statins have considerable economic
impact on pharmaceutical budgets and the opposite trend is being
encouraged in the Netherlands and Germany, where reimbursement measures
promote the use of relatively inexpensive generic older types."
"This is fine," he added, "as long as guidelines
for higher doses of these older statins are implemented, and bearing in
mind that there may be limitations to giving the highest doses. But,
restricting the use of older generic statins to standard low doses will
make the problems worse.
"Ideally, to improve the population effectiveness
of statin treatment, persistent drug use and the use of new, potent
statins, should be encouraged." he concluded.
Editor's Notes:
The research was funded by an unrestricted grant
from Nefarma the Dutch association of pharmaceutical industries. But,
the study was designed, conducted and analyzed entirely independently of
the funders.
The European Heart Journal is an official journal
of the European Society of Cardiology.
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