Physicians' Academy for Cardiovascular Education

Time to benefit varies among clinical trials of lipid-lowering therapies

Variations in Time to Benefit Among Clinical Trials of Cholesterol-Lowering Drugs

Literature - Barter PJ, and Waters DD. - J Clin Lipidol 2018; published online ahead of print

Introduction and methods

Time to benefit (TTB) is important because it may help understand how a treatment works, it helps deciding whether or not, and when, to stop a clinical trial because of futility, and it supports the decision of whether to treat elderly patients with multiple diseases and a reduced life expectancy

Large, randomized, controlled, double blind, cardiovascular clinical outcome trials with statins have been completed, as well as several studies with other lipid-lowering drugs, including cholestyramine, gemfibrozil, ezetimibe, evolocumab, alirocumab and anacetrapib. The objective of this analysis was to compare the TTBs of 24 clinical studies with lipid-lowering drugs. For this purpose, benefit curves were created by subtracting the placebo or comparator drug curves from the active treatment curves. TTB was determined by visual inspection of the outcome curves for the primary endpoint.

Main results

Conclusion

TTB varies among lipid-lowering therapies. In some studies, particularly those with atorvastatin, benefit was obvious within the first year, but early benefit should not be expected with all LDL-c lowering drugs. Eventual benefit cannot be precluded, even if the outcome curves do not separate before 30 months of treatment. The results of this analysis should be of interest to those who design, or evaluate the design of clinical trials of cholesterol-lowering drugs.

References

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Find this article online at J Clin Lipidol 2018