Nieuw "wondermedicijn" tegen cholesterol werkte niet.*
Een nieuw medicijn tegen een verhoogd cholesterolgehalte, Torcetrapib, werkt niet. Het nieuwe medicijn, dat door het Amerikaanse farmacieconcern Pfizer ontwikkeld is, had voor een doorbraak moeten zorgen in de behandeling van hart- en vaatziekten. Torcetrapib zou aderverkalking door cholesterol moeten tegengaan, maar ondanks tot wel 60% hogere waarden HDL (goede cholesterol) en 20% lagere LDL (slechte cholesterol) blijkt aderverkalking gewoon toe te nemen. Ook de bloeddruk werd doorgaans hoger. In de laatste testfase van dit medicijn is de ontwikkeling voortijdig beëindigd. De sterfte onder deelnemers bleek om onbekende reden zestig procent hoger dan patiënten die alleen "reguliere" medicijnen kregen toegediend.
Cholesterol
Drug Fails To Slow Progression Of Coronary Disease, Cleveland Clinic Study
Reports
Cleveland
Clinic researchers today report that the drug torcetrapib, despite raising high
density lipoprotein cholesterol (HDL) or the "good" cholesterol by
more than 60%, did not slow the progression of plaque buildup in the coronary
arteries as measured using an ultrasound probe.
Steven Nissen, M.D., Chairman of Cardiovascular Medicine at Cleveland Clinic and
lead investigator of this clinical trial, will present the study on Monday,
March 26 at 8:30 a.m. at the American College of Cardiology's (ACC) 56th Annual
Scientific Session. Dr. Nissen is also President of the ACC. The study will be
simultaneously published in the New England Journal of Medicine.
All development of this drug was terminated on Dec. 2, 2006 after the safety
board monitoring a separate large clinical outcomes trial reported that
torcetrapib increased the risk of death and other adverse cardiovascular
outcomes.
"We found that the torcetrabip/atorvastatin combination markedly increased
good cholesterol levels and lowered bad cholesterol in patients. Unfortunately
this drug also substantially raised blood pressure and failed to slow the
buildup of plaque," Dr. Nissen said. "It is yet to be determined of
this failure represents a problem unique to torcetrapib or predicts a lack of
efficacy for the entire class of similar drugs. These findings further
demonstrate the great difficulty in developing therapies to disrupt the
atherosclerotic disease process."
The development of drugs to raise HDL has been a key research priority because,
despite lowering LDL (low-density lipoprotein, or "bad") cholesterol
with statin drugs, many patients continue to experience heart attacks, stroke or
sudden cardiac death.
A total of 1,188 coronary artery disease patients were enrolled in the "Investigation
of Lipid Level management using coronary UltraSound To assess Reduction of
Atherosclerosis by CETP Inhibition and HDL Elevation" (ILLUSTRATE) trial.
All patients had a clinical indication for cardiac catheterization, had a
baseline intravascular ultrasound (IVUS) and received 10-80 gm of atorvastatin
adjusted during a two- to 10-week period until LDL levels reached national
guidelines.
Patients were then randomized to receive either 60 mg of torcetrapib or a
matching placebo for two years. At the end of the treatment period, a second
IVUS was performed, examining the same coronary arteries. Researchers measured
the change in plaque volume in the artery, comparing the baseline to the
follow-up ultrasound. They also measured patients' blood cholesterol levels and
biomarkers of inflammation at several points during the trial.
Patients in the torcetrapib/atorvastatin group experienced a 61 percent relative
increase in HDL cholesterol levels and a 20 percent relative decrease in LDL
levels, as compared with patients in the atorvastatin-only group. Despite those
results, there was no statistical difference between the two groups in plaque
volume changes. Plaque volume increased by 0.19 percent in the atorvastatin-only
patients and 0.12 percent in the combination group, p = 0.72. Torectrapib was
also associated with a substantial increase in blood pressure, averaging 4.6 mm.
IVUS is a technique in which a tiny ultrasound probe is inserted into the
coronary arteries, providing a precise and reproducible method for determining
the change in plaque, or atheroma, burden during treatment.
(April 2007) (Opm. Medicijnen zijn er alleen voor als het echt nodig is. De meeste mensen kunnen op natuurlijke manier en zonder bijwerkingen hun cholesterol verbeteren, kijk maar hier.)