When Frankie Valli and the Four Seasons crooned “Can’t Take My Eyes Off of You” in the late 1960s about a potential love interest, the sugary lyrics may have foreshadowed how many physicians have reacted to statin therapy.

Since the emergence of the JUPITER trial at the 2008 American Heart Association scientific sessions, which evaluated nearly 18,000 patients, even skeptics were convinced in its ability to reduce heart attacks, stroke, target lesion revascularization and all-cause mortality—due to Crestor’s 44 percent reduction rate in these events.

Since that time, a slew of clinical data has emerged on statin therapy, including numerous JUPITER sub-analyses, touting its capabilities to decrease venous thromboembolism events, as well as its potential to prevent osteoporosis and Alzheimer’s disease. Just last month, a study at the Society for Vascular Surgery conference found that use of statins can decrease perioperative and late stroke rates and also reduce mortality for patients undergoing carotid artery stenting.

However, very recent studies have begun to form a chink in statin therapy’s formidable armor. Last week, a meta-analysis published in the Annals of Internal Medicine found that in high-risk primary prevention situations, statin therapy may have no direct benefit on all-cause mortality. The review assessed trials, including ASPEN, JUPITER, MEGA, ALLHAT.

Out of 64,229 patients, Ray et al found that a total of 2,794 deaths occurred—1,447 in the placebo arm and 1,346 deaths in the statin arm.

The study authors wrote that their findings suggest that “all-cause mortality benefits are more modest in the short term, even among high-risk primary prevention populations, thereby indicating the need for further caution when extrapolating the potential benefits of statins on mortality to lower-risk primary prevention populations.”

Also, at the time JUPITER was released, some questioned the potential effects of keeping patients on a particular therapy for 20 years or more. In fact, Dr. Steve Nissen from the Cleveland Clinic, told Cardiovascular Business that “there could be unforeseen risks in the second decade of therapy.”

Of course, only time will tell if statins can sustain the fervor of Valli’s emotion through the test of time:
There's nothing else to compare.
The sight of you leaves me weak.

On these topics, or any others, please feel free to contact me.
 
Justine Cadet
jcadet@cardiovascularbusiness.com