College of Cardiology 60th Annual Scientific Sessions
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
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 Endocrine Today that the results of this analysis demonstrate that patients should be treated earlier.
For more information:
- Kostis W. Poster 299. Presented at: ACC 60th Annual Scientific
Sessions; April 2-5, 2011; New Orleans.