There was no significant difference in safety outcomes among the groups of patients, including rates of death, bleeding strokes, or muscle, liver or retinal abnormalities. What's more, the patients who achieved LDL levels of 60 mg/dl or lower had fewer major cardiac events, including death, heart attack, stroke, recurrent coronary artery blockages or treatment to reopen coronary arteries.
Dr. Wiviott said the results offer reassurance to patients and clinicians using high doses of statins following acute coronary syndromes.
"In order to achieve the greatest benefit following acute coronary syndromes, patients should be treated early with intensive statin therapy. There is no need to reduce the dose in follow-up just because LDL is well below targeted levels," he said.
Dr. Wiviott noted that the PROVE IT trial was not originally designed to answer questions about the safety of very low LDL levels.
"This type of analysis should be considered 'hypothesis generating' and needs to be confirmed in other studies," he said.
John J.P. Kastelein, M.D. from the Academic Medical Center at the University of Amsterdam, Netherlands, who was not connected with this study, but who is helping to lead two large long-term studies of intensive statin therapy, welcomed this first solid information about the safety of low LDL levels.
"What's very important for me is that this trial is the first indication that very low LDL levels are actually safe. Of course, the time frame is modest, but it is the first indication that we can sustain low LDL levels without any cost in terms of extra side effects," Dr. Kastelein said.