An FDA analysis provides new evidencethat the use of statins does not increasethe prevalence of amyotrophic lateralsclerosis (ALS), known as Lou Gehrig'sdisease.
The agency began the review in 2007after receiving a higher than expectednumber of Adverse Event ReportingSystem reports of ALS in patients on statins.The findings are based on data from41 long-term controlled clinical trials.The results found no increase in the rateof the disease in patients treated with astatin, compared with placebo. The findingswere reported in the September 29,2008, issue of Pharmacoepidemiologyand Drug Safety.
"While the FDA finds the lack of anincrease in the incidence of amyotrophiclateral sclerosis (ALS) in patients treatedwith statins in clinical trials reassuring,given the extensive use of this class ofdrugs and the serious nature of ALS,continued study of this issue is warranted,"said Mark Avigan, MD, director,Division of Pharmacovigilance I, Centerfor Drug Evaluation and Research, FDA.
A new study found that statin use by seniors with atherosclerosisremains suboptimal despite improvements in the lastdecade. Many practice guidelines encourage the use of statinsin patients with atherosclerosis. Several studies, however, haveindicated underuse of statins in this patient population, notedthe researchers in the September 2008 issue of the Journal ofVascular Surgery.
Of the 343,154 participants with atherosclerosis, 68.7% hadcoronary artery disease (CAD), 33.5% had a history of stroke orother cerebrovascular disease, and 7% had peripheral arterydisease (PAD). Between 1995 and 2004, statin use increasedfrom 11.8% to 61.2% in the CAD patients; from 5.3% to 41.2%in cerebrovascular disease patients; and from 6.8% to 43.3% inpatients with PAD.
The researchers concluded that, despite the increases, "theuse of statins in this patient population was still suboptimal."
F A S T F A C T: Among Americans aged 20 andolder, 106.7 million have total blood cholesterollevels of 200 mg/dL and higher.
University of Alabama researchers reported that statin use mayhamper the body's ability to repair muscles. The most commonlyreported side effect of statin therapy is fatigue, with 9%of patients reporting muscle pain.
For the study, the researchers exposed muscle cells to varyingdoses of simvastatin. The findings indicated that as the dosageincreased, the ability of these cells to multiply lowered. Forthe equivalent of 40 mg a day, growth of new muscle cells wasreduced by 50%. As doses were increased, the production ofthese cells continued to decline to the point where they couldnegatively affect the ability of muscles to heal and repair themselves,said the researchers.
"We are very interested in these effects in the older population,'"said lead researcher Anna Thalacker-Mercer, PhD. "Itis possible that older adults may not be able to distinguishbetween muscle pain related to a statin effect or an effect ofaging, and therefore adverse effects of statins in older adultsmay be underreported. Therefore, our next step is to examinestatins among older adults." The findings were recently reportedat the American Physiological Society meeting.
Patients taking statins are more proneto experience delirium following surgery.The study involved >284,000 patients,aged 65 and older, who had surgery inOntario hospitals, according to a studyreported in the September 23, 2008,issue of the Canadian Medical AssociationJournal.
The researchers found that the incidenceof delirium was 1 of of every 90patients, but it was 30% more likely tohappen in patients taking statins priorto surgery. Lead study author DonaldA. Redelmeier, MD, said the statisticsare too low, however, because "there isno question that delirium is often overlookedby the surgeon or family membersor even the patient himself."
Dr. Redelmeier, an internist who doesnot perform surgery, estimates thatdelirium occurs after about 10% of allsurgical procedures, and the incidenceis 13% among patients taking statins. Heproposed that statins might increase therisk of delirium by shunting blood awayfrom the brain to the heart. He suggestedstopping statin therapy for 1 to 2 daysbefore surgery.
In an accompanying editorial in thesame journal, Edward R. Marcantonio,MD, argued against stopping statins. "Wecertainly do not know the effect of takingpatients off these drugs on outcomesother than delirium, such as cardiovascularconditions." He said more study isneeded on the issue.