Statins had no overall effect on frequency or severity of muscle pain in a series of n-of-1 trials in UK patients who had previously reported muscle symptoms when taking the drugs. In n-of-1 trials, individuals serve as their own controls, blinded to both placebo and the intervention drug. "Worries about muscle side effects have dented confidence in statins and led patients to stop them or not start them," Dr. Liam Smeeth of the London School of Hygiene and Tropical Medicine told Reuters Health by email. "We have convincingly demonstrated that while aches and pains are common, they are not caused by statins." "Within the same individual," he said, "the level of muscle symptoms during periods taking statins were no higher than in periods when taking a placebo. Deciding whether to take a statin or not is clearly a personal choice affected by a range of factors. The benefits of statins are large and well proven." As reported in BMJ, Dr. Smeeth and colleagues recruited 200 patients (mean age, 69; 58% men; 70% with a history of heart disease) who recently had stopped or were considering stopping statins because of muscle symptoms. Participants were randomized to a sequence of six double-blinded treatment periods (two months each) of atorvastatin 20 mg daily or placebo. They rated their muscle symptoms on a visual analogue scale (0-10) after each treatment period. The analysis included 151 participants who provided symptom scores for at least one statin period and one placebo period. The mean muscle symptom score on the visual analogue scale was lower during statin treatment than during placebo periods (mean, 1.68 vs. 1.85). There was no evidence of an effect of statins on the occurrence of muscle symptoms overall (odds ratio, 1.11) or for muscle symptoms that could not be attributed to another cause (OR, 1.22). Eighteen participants (9%) withdrew because of intolerable muscle symptoms during a statin period, as did 13 (7%) during a placebo period. Most people completing the trial intended to restart treatment with statins. With regard to the large number of people agreeing to take statins after the trial, Dr. Smeeth acknowledged that "to agree to come into the study would suggest people were open to the idea of changing their mind about statins. I imagine people who were adamant they would never go near another statin would not have signed up to the trial." While n-of-1 trials "could play a valuable role in bringing together research and clinical care, especially for reversible symptomatic drug effects, for subjective symptoms, there will often be a need for masking - for example, by use of placebos," he noted. "This is a major barrier to wider use because it means there is a need for special drug packs, placebo supplies, and regulatory oversight." Dr. Guy Mintz, Director of Cardiovascular Health and Lipidology at Northwell Health's Sandra Atlas Bass Heart Hospital in Manhasset, New York, commented in an email to Reuters Health, "This is an important trial which can benefit the 7%-20% of patients who are classified as statin- intolerant due to muscle symptoms. Clinicians should now take this information to 'heart' and work with this group of patients to find a way to get them back on appropriate cardiovascular risk- reduction therapy." That said, he added, "the study only looked at one statin and at one dose. There are six statins that have inherently different characteristics, such as being hydrophilic or lipophilic, and various dosages." "Many muscle-related symptoms can be due to other drugs interacting with the statin, renal disease, or thyroid disease," he noted. "Therefore, the clinician still needs to take the time to engage the patient clinically to find etiologies of muscle symptoms unrelated to the drug itself." —Marilynn Larkin Source
