Common heart pill under scrutiny for older patients as study weighs risks of stopping

The STREAM trial, presented at the American Heart Association Scientific Sessions and published in the New England Journal of Medicine, evaluated whether stopping statin medications in older patients has a cost. According to Medscape, the Swiss-led trial involved more than 1800 older adults with a mean age of 77 who had at least two comorbidities and were taking statin drugs for primary prevention. A strategy of stopping statins was compared against continuing statins. Medical Daily reported that stopping statins met the STREAM trial's main test of non-inferiority, but more older adults experienced heart attacks, strokes, or died. The trial measured a primary outcome of myocardial infarction, stroke, or death from any cause, alongside quality of life measures, pain, falls, muscle function, and sarcopenia as counters. Medscape noted that the trialists reported restricted mean survival times (RMST), representing the area under the event-free survival curve up to 2 years. The RMST for the primary outcome was 98.5 weeks in the continuation arm versus 96.5 weeks in the discontinuation arm. The minus 2.0 week difference had 95% confidence intervals from minus 3.7 to minus 0.3 weeks. Medscape explained that patients who discontinued statins had significantly less event-free survival, with a primary outcome occurring in 12.7% of patients in the discontinuation arm compared to 9.2% in the continuation arm. Rates of myocardial infarction, stroke, and death from all causes were higher with stopping, and the data and safety monitoring board recommended that patients in the discontinuation arm be advised to restart their statin after reviewing the last interim analysis. Medscape criticized the New England Journal of Medicine conclusion that discontinuation was noninferior, arguing that the actual primary outcome event rate was way lower than the anticipated 34%, sitting instead at 10%. Fox News reported that the common heart pill is under scrutiny for older patients as the study weighs risks of stopping. Conversely, the American Heart Association website stated that discontinuing statins is generally safe for older adults without heart disease. Medscape detailed that secondary outcomes showed no differences in quality of life, pain, number of falls, or sarcopenia between the groups. The absolute risk increase for the full follow-up of 2 years was 3.5%, translating to a number needed to harm from stopping statins of 28. Medscape concluded that statin drugs provide patients like those in the trials a clinically meaningful reduction in the risk of myocardial infarction, stroke, and death.