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Item #2
Statins
Do Not Meet Expected Cholesterol Reductions in Clinical Practice
Level
of LDL cholesterol reduction observed with statin therapy is
significantly less than estimated by package inserts, that from
researchers.
Dr.
Dennis L. Sprecher and colleagues from the Cleveland Clinic Foundation
analyzed data on 367 patients with hyperlipidemia who had not
been taking statins. These patients were given a standard dose of a
statin at their first clinic visit and followed for at least one
additional visit while using the same drug at the standard dose.
The
researchers measured the actual reductions in LDL cholesterol against
the expected reductions in LDL cholesterol based on package guideline
inserts, according to their report in the December 2002 issue of the
American Journal of Medicine.
The
mean reduction in LDL cholesterol seen was 26%, Dr. Sprecher's team
found. This was significantly short of the mean of 34% indicated by
the manufacturer. Almost 10% of the patients had an increase in LDL
cholesterol, they note.
The
ratio of expected to actual reductions in LDL cholesterol did not
differ for the three statins used--atorvastatin, simvastatin and
pravastatin--the investigators add.
Dr.
Sprecher and colleagues conclude that "physicians should be aware
that in the clinical setting, dose-response projections in package
inserts for statins overestimate, on average, the observed LDL
cholesterol lowering. Additionally, the distribution of the LDL
cholesterol response appears to be non-normal, with many patients
experiencing no reduction of LDL cholesterol levels."
They
add that "this disparity is apparent even after the first few
months of therapy, is observed for all of the statins evaluated, and
is likely to contribute to the 'treatment gap' between national
guidelines for cholesterol management and actual clinical
outcomes."
In
an editorial, Dr. Frank M. Sacks from the Harvard School of Public
Health, Boston, believes that low compliance to treatment
"is most likely the reason for the suboptimal changes [in
cholesterol]."
He
notes that clinical practices that incorporate measures such as close
monitoring and rechallenge after suspected adverse events can achieve
adherence rates that are similar to those seen in clinical trials.
Am J Med
2002;113:625-629,685-686
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FACT
Diabetes-related
hospitalizations accounted for 13.9 million hospital days in 1997. The
mean length of stay was 5.4 days (American Diabetes Association,
1998).
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