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2016 ; 82
(1
): 168-77
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Cholesterol trials and mortality
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Warren JB
; Dimmitt SB
; Stampfer HG
Br J Clin Pharmacol
2016[Jul]; 82
(1
): 168-77
PMID27043432
show ga
An overview of clinical trials can reveal a class effect on mortality that is not
apparent from individual trials. Most large trials of lipid pharmacotherapy are
not powered to detect differences in mortality and instead assess efficacy with
composite cardiovascular endpoints. We illustrate the importance of all-cause
mortality data by comparing survival in three different sets of the larger
controlled lipid trials that underpin meta-analyses. These trials are for
fibrates and statins. Fibrate treatment in five of the six main trials was
associated with a decrease in survival, one fibrate trial showed a
non-significant reduction in mortality that can be explained by a different
target population. In secondary prevention, statin treatment increased survival
in all five of the main trials, absolute mean increase ranged from 0.43% to
3.33%, the median change was 1.75%, which occurred in the largest trial. In
primary prevention, statin treatment increased survival in six of the seven main
trials, absolute mean change in survival ranged from -0.09% to 0.89%, median
0.49%. Composite safety endpoints are rare in these trials. The failure to
address composite safety endpoints in most lipid trials precludes a balanced
summary of risk-benefit when a composite has been used for efficacy. Class
effects on survival provide informative summaries of the risk-benefit of lipid
pharmacotherapy. We consider that the presentation of key mortality/survival data
adds to existing meta-analyses to aid personal treatment decisions.
|Anticholesteremic Agents/therapeutic use
[MESH]
|Cardiovascular Diseases/mortality/*prevention & control
[MESH]
|Cholesterol/*blood
[MESH]
|Clinical Trials as Topic/*methods
[MESH]
|Fibric Acids/therapeutic use
[MESH]
|Humans
[MESH]
|Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use
[MESH]
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