Meta-analysis: Lipid-lowering therapy may be most beneficial when started early

American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS — The mortality benefits afforded by lipid-lowering therapy persist after trial randomization in clinical trials where both arms receive active therapy, according to data from a meta-analysis.

William J. Kostis, PhD, MD, of Massachusetts General Hospital in Boston, and colleagues aimed to determine whether the mortality benefit bestowed by lipid-lowering therapy persists after the end of clinical trials when both treatment and placebo groups are advised to take active therapy.

The researchers used Medline, the Cochrane Library, Web of Science and ClinicalTrials.gov to identify eight randomized trials of lipid-lowering medications (including 5 statin trials); all trials included secondary reports describing the results observed at study completion. They then calculated odds ratios for all-cause and cardiovascular mortality for both the randomized and open-label follow-up phases of each trial trial (when all patients were advised to take active therapy). The results were compared using a random-effects meta-analysis.

Data for 44,255 patients and 8,144 deaths were included. According to Kostis, during the randomized phase, patients randomly assigned to active therapy were about six-and-a-half-times more likely to receive it compared with those assigned to placebo.

“The ratio of the percentage of patients receiving active therapy among the group randomized to receive it to the percentage of those receiving active therapy among those randomized to placebo (AMR) was 6.52 (inter quartile ratio (IQR)= 4.88-10.11),” the researchers wrote.

In the open-label phase, the proportion of patients originally assigned to placebo who were administered active therapy was nearly identical to those initially randomly assigned to active therapy (AMR=1.02; IQR=0.92-1.14).

Mortality rates – both all-cause (OR=0.84; 95% CI, 0.76-0.93) and CV (OR=0.72; 95% CI, 0.63-0.82) – were lower in the group assigned to active therapy during the randomization phase. This decrease in mortality continued when both groups received active therapy in the open-label phase (all-cause mortality: OR=0.90; 95% CI ,0.84-0.97; and CV mortality: OR=0.82; 95% CI, 0.73-0.93).

Kostis told Cardiology Today that the results of this analysis demonstrate that patients should be treated earlier, and that long-term statin therapy may not always be necessary. - Stacey L. Fisher

For more information:

Kostis W. Poster 299. Presented at: ACC 60th Annual Scientific Sessions; April 2-5, 2011; New Orleans.

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