The benefits of statins highly offset the associated risks in appropriate patients, according to a scientific statement issued by the American Heart Association.
“The review covers the general patient population, as well as demographic subgroups, including the elderly, children, pregnant women, East Asians, and patients with specific conditions.” wrote Connie B. Newman, MD, of New York University, together with her colleagues. The report is in Arteriosclerosis, Thrombosis, and Vascular Biology.
After an extensive review of the literature pertaining to statin safety and tolerability, Dr. Newman and her colleagues reported the compiled findings from several randomized controlled trials, in addition to observational data, where required. They found that the risk of serious muscle complications, such as rhabdomyolysis, attributable to statin use was less than 0.1%. Furthermore, they noted that the risk of serious hepatotoxicity was even less likely, occurring in about 1 in 10,000 patients treated with therapy.
“There is no convincing evidence for a causal relationship between statins and cancer, cataracts, cognitive dysfunction, peripheral neuropathy, erectile dysfunction, or tendinitis,” the experts wrote. “In U.S. clinical practices, roughly 10% of patients stop taking a statin because of subjective complaints, most commonly muscle symptoms without raised creatine kinase,” they further reported.
Contrastingly, data from randomized trials have shown that the change in the incidence of muscle-related symptoms in patients treated with statins versus placebo is less than 1%. Moreover, the incidence is even lower, with an estimated rate of 0.1%, in those who stopped statin therapy because of these symptoms. Given these results, Dr. Newman and her colleagues said that muscle-related symptoms among statin-treated patients are not due to the pharmacological activity of the statin.
“Restarting statin therapy in these patients can be challenging, but it is important, especially in patients at high risk of cardiovascular events, for whom prevention of these events is a priority,” they added.
A large proportion of the population takes statin therapy to lower the risk of major cardiovascular events, including ischemic stroke, myocardial infarction, and other adverse effects of cardiovascular disease. At maximal doses, statins may decrease LDL-cholesterol levels by roughly 55%-60%. In addition, given the multitude of available generics, statins are an economical treatment option for most patients.
However, Dr. Newman and her colleagues suggested that, when considering statin therapy in special populations, particularly in patients with end-stage renal failure or severe hepatic disease, commencing treatment is not recommended.
“The lack of proof of cardiovascular benefit in patients with end-stage renal disease suggests that initiating statin treatment in these patients is generally not warranted,” the experts wrote. “Data on safety in people with more serious liver disease are insufficient, and statin treatment is generally discouraged,” they added.
With respect to statin-induced adverse effects, they are usually reversible upon discontinuation of therapy, with the exception of hemorrhagic stroke. However, damage from an ischemic stroke or myocardial infarction may result in death. As a result, in patients who would benefit from statin therapy, based on most recent guidelines, cardiovascular benefits greatly exceed potential safety concerns.
Dr. Newman and her coauthors disclosed financial affiliations with Amgen, Kowa, Regeneron, Sanofi, and others.
SOURCE: Newman CB et al. Arterioscler Thromb Vasc Biol. 2018 Dec 10.