Harms from taking statins were a major concern of Medscape readers, and commenters reported numerous anecdotal experiences with potentially statin-related side effects, ranging from decreased cognitive ability and fatigue to diabetes and liver and kidney damage. However, the vast majority described myalgia and rhabdomyolysis thought to be related to statin use. Of note, the 2014 Statin Intolerance Panel also suggested that "[m]ost statin intolerance is related to myalgia." Below is a sampling of comments from across the spectrum of familiarity with statins:
• From a clinician treating patients with statins: "In my almost 18 years of prescribing statins, most of the muscle and joint pain complaints come from the elderly patients, both males and females."
• From a general practitioner with a relative on a statin: "My elderly father: in his late 80s with a significant dementia: was on a statin [...] He began to develop troublesome leg pains: had DVT [deep vein thrombosis] scans (negative); but they persisted. I suggested to his family physician stopping his statin for which there was no clear indication. His leg pains have gone. More interestingly: he can once again write his signature; remember what he used to do for a living; and in a fractured way remember some events from earlier in the day or yesterday."
• From a family medicine physician personally taking a statin: "80 years old, HDL 10 [high density lipoprotein level 10 mg/dL]. Was bullied into statins – lasted 1 week. Main gainers [are the] drug companies."
The actual rate of statin-related myopathy has been debated at length. This is likely owing in part to variability in the clinical definition of myopathy and how it is reported in peer-reviewed literature. Clinical reviews[16,17] of observational cohort studies report the incidence of statin-related myopathy at 0.44 to 5.34 per 10,000 person-years and the incidence of fatal rhabdomyolysis at 0.15 deaths per 1 million prescriptions.
Of interest, complaints of myalgia are more common in observational cohorts (11%-29%) than in randomized clinical trials (1%-5%). The substantially lower rate seen in clinical trials of statin use probably reflects specific exclusion of patients with musculoskeletal complaints prior to randomization; thus, clinical trial results are unlikely to accurately characterize the prevalence of myopathy. Among observational studies, in the Prediction of Muscular Risk in Observational Conditions (PRIMO) project, a cohort of 7924 unselected hyperlipidemic patients received high-dose statin therapy in ambulatory settings in France, and 10.5% of patients reported muscular symptoms, with a median time to onset of 1 month after statin initiation. Understanding Statin Use in America and Gaps in Patient Education (USAGE), an Internet-based survey of 10,138 current and former statin users, found that 29% of survey respondents reported a muscle-related side effect while taking a statin; while 25% of current users reported muscle-related side effects, 60% of former users reported that they had experienced this side effect. Given that randomized trials are often insufficiently powered to detect adverse events, some scientists have stated that real-world observational data are needed to truly appreciate the potential for adverse outcomes related to statin use. A recent meta-analysis of 90 observational cohort and case-control studies, which identified an increased risk for myopathy among statin users relative to controls (odds ratio, 2.63; 95% confidence interval, 1.50-4.61), illustrates how such data can better inform the public about the quantitative impact of adverse events potentially related to statin use.
Medscape Family Medicine © 2014 WebMD, LLC
Cite this: Gordon H. Sun. Statins: The Good, the Bad, and the Unknown - Medscape - Oct 10, 2014.