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Is all that intensive drug treatment worthwhile?
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A paper published in 2006 demonstrated that
laboratory findings do not constitute disease. And
altering measurements such as blood pressure or
cholesterol if you are elderly show little or no
benefit (despite what the pharmaceutical industry and
many doctors would have us believe).
One thing that seems to be
forgotten is that we are not an immortal species; we
all have to die eventually and if one thing doesn't get
us, something else will. That is why it is so
important, when evaluating treatments, not just to
consider deaths due to the disorder being treated, but
also to look at deaths from all causes. This is
frequently not done - particularly in papers about
diseases of the heart.
The Finnish researchers
enrolled 400 home-dwelling people between the ages of
75 years and 90 years with CVD. These people were
randomly selected from the population living in
Helsinki and randomly assigned, using concealed
allocation, to receive either usual care from their
primary care physician or to receive specialized care
based on current evidence-based European guidelines for
chronic cardiovascular disease (CVD).
The strength of this study is
that the researchers randomly invited patients from the
general population to participate, making the results
applicable to typical primary care.
The interventions included
stopping smoking, changing their diets, being medicated
for high blood pressure and cholesterol, taking
beta-blockers following a heart attack,
angiotensin-converting enzyme (ACE) inhibitors for
heart failure, anticoagulant drugs in selected patients
and aspirin.
Over an average 3.4 years,
beta-blocker, ACE inhibitor, diuretic, and statin use
was significantly higher in the intervention group. Was
there any benefit? No! Blood pressure and cholesterol
control were significantly better in the intervention
group. However, patient-oriented outcomes, which were
common, were not improved.
- The incidence of heart
attacks, congestive heart failure, stroke, or
cardiovascular death were similar between the two
groups.
- Deaths due to any cause
occurred at similar rates in both groups (18% vs
17%).
- The time until a first
cardiovascular event did not differ between the two
groups.
In other words, all that time spent by
doctors, the inconvenience to patients of having tests,
the drugs used and money spent, the side effects that
the intervention group inevitably had to endure from
the drugs they were prescribed, as well as the
inconvenience of having to give up pleasures such as
smoking and eating an enjoyable diet, probably made
their quality of life worse without adding so much as a
day to their life-expectancy.
The study and abstract is below.
Strandberg TE, Pitkala KH, Berglind S, et
al. Multifactorial intervention to prevent
recurrent cardiovascular events in patients 75
years or older: The Drugs and Evidence-Based
Medicine in the Elderly (DEBATE) study: a
randomized, controlled trial. Am
Heart J 2006; 152: 585-592.
Department of Public Health Science and
General Practice, University of Oulu,
University Hospital, Oulu, Finland.
timo.strandberg@oulu.fi
Abstract
OBJECTIVE: We aimed to
examine whether better use of preventive
methods and treatments of cardiovascular
disease would reduce recurrent events in
home-dwelling patients 75 years or older.
METHODS: This was a
randomized, controlled trial (a practical
clinical trial, the DEBATE), conducted in 2000
to 2003 in Helsinki, Finland. We recruited 400
vascular patients with mean age of 80 years
from the community, and they were randomly
assigned to the intervention group (n = 199)
where both nonpharmacological and
pharmacological cardiovascular treatments were
optimized by a geriatrician according to
current guidelines. The control group (n = 201)
received the usual care. Main outcome measures
were major cardiovascular disease events and
total mortality and changes in risk factors and
medications.
RESULTS: The groups were
balanced at baseline. Mean duration of
follow-up was 3.4 years. At 3 years, drug
treatments had become more evidence-based in
the intervention group. Consequently, total and
low-density lipoprotein cholesterol levels (P
< .0001) and systolic (P = .005) and
diastolic (P = .009) blood pressure were
significantly improved in the intervention
group. However, neither primary end points (52
and 53 events in the intervention and control
groups, respectively) nor total mortality (36
and 35 deaths) were significantly different
between the two groups. No special adverse
effects were encountered.
CONCLUSION: It was possible
and safe to institute evidence-based
cardiovascular treatments and improve risk
factors in patients 75 years or older in a
pragmatic setting. During 3.4 years, however,
this was not converted to clinical benefits.
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Last updated 17 May 2009
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