Stopping statins after 70 meets noninferiority but adds 1 event per 40 patients
Nov 9, 2026
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read by AI voices · all episodesAdults 70 and older who stopped primary-prevention statins had more heart attacks, strokes and deaths, but within a preset noninferiority margin, a 1,880-patient trial reported Nov. 7 in the New England Journal of Medicine.
The STREAM trial enrolled people 70 and older with at least two chronic conditions and no known atherosclerotic disease, and the investigators estimated one additional major cardiovascular event or death over two years for every 40 people who stopped, according to HCPLive. Study author Dr. Rita Redberg called for shared decision-making rather than a blanket recommendation to stop, the report said.
Also at the American Heart Association's Scientific Sessions, Cleerly reported that its AI analysis of coronary CT beat stress-test-guided care at 180 days in a randomized trial whose results have not been peer reviewed. The Food and Drug Administration asked for feedback on robotic devices that act on their own or are run from a distance, and a 1,706-patient trial in Colombia and Jamaica found single-pill combination therapy with team-based care cut systolic pressure 10.1 mm Hg more than usual care.
- FYIEvidence Nov 7, 2026The open-label STREAM trial randomized adults 70 and older with at least two chronic conditions, no known atherosclerotic cardiovascular disease and at least a year of primary-prevention statin use, at 24 sites in Switzerland, the Netherlands and France, to stop or continue lipid-lowering therapy. Two-year restricted mean event-free survival for nonfatal myocardial infarction, nonfatal ischemic stroke or death was 96.5 weeks after stopping and 98.5 weeks with continuation, a difference of 2.0 weeks that fell within the prespecified 5.2-week margin, according to HCPLive's report of the results. Over a median 103 weeks, 12.7% of the discontinuation group and 9.2% of the continuation group had a primary event (hazard ratio 1.38; 95% CI, 1.05 to 1.81), and LDL cholesterol at 12 months was 176.0 mg/dL versus 99.4 mg/dL in a subsample. Quality of life, pain, falls and sarcopenia risk did not differ substantially; the trial had no placebo, and after it ended the data and safety monitoring board advised the discontinuation group to discuss restarting statins with their physicians, the report said.
- FYIEvidence Nov 7, 2026In the open-label PARAMOUNT trial at 21 sites, symptomatic outpatients with suspected coronary artery disease and LDL cholesterol of 100 mg/dL or more were randomized to care guided by Cleerly's AI quantitative coronary CT analysis or to usual care guided by functional stress testing, Cleerly said Nov. 7 after a late-breaking presentation in Chicago. The hierarchical 180-day endpoint favored the AI arm with a win ratio of 2.00 (95% CI, 1.37 to 2.56), driven mostly by greater diagnostic certainty about whether chest pain came from coronary disease, according to the company. Lipid-lowering therapy rose from 31% to 75% of patients in the AI arm and from 32% to 47% with usual care, and among patients sent for invasive angiography, 38% in the AI arm and 60% with usual care had no revascularization. The figures cover 523 patients with locked data, have not been peer reviewed and come from the company's release; full results are expected in early 2027.Source: Cleerly (Business Wire)
- WatchRegulation Nov 6, 2026
FDA takes feedback on docket FDA-2026-N-13135 through Jan. 5, 2027, and will discuss the paper at a Dec. 2 to 3 workshop.
The FDA's device center on Nov. 6 released a discussion paper on robotic devices that perform diagnostic, therapeutic or rehabilitative tasks on patients with some autonomy, remote teleoperation or both, covering surgical and nonsurgical uses and operators from imaging technicians to surgeons. The paper addresses terminology, the benefits and risks of each capability and ways to reduce those risks, and the agency said it is neither draft nor final guidance and proposes no policy change. Feedback from clinicians, patients, manufacturers and the public is due Jan. 5, 2027, and the topics will be taken up at a hybrid FDA workshop Dec. 2 and 3. A separate draft guidance on premarket submissions for robotically assisted surgical devices, which takes comments through Nov. 24, does not cover autonomous or remotely operated systems. - FYIEvidence Nov 8, 2026A cluster randomized trial in 40 primary care clinics in Colombia and Jamaica paired locally purchased single-pill combinations with physician and nurse training, health coaching, home blood pressure monitoring and audit and feedback, against usual monotherapy or polytherapy, JAMA published Nov. 8. Systolic pressure fell 19.1 mm Hg over 18 months with the intervention and 9.0 mm Hg with usual care, a difference of 10.1 mm Hg (95% CI, 6.9 to 13.3), and 69.5% versus 29.2% reached a pressure below 130/80 mm Hg. Serious adverse events, defined as death and hospitalization, occurred in 7.9% and 9.9%. Mean age was 61.4 years, and 98.2% were already taking antihypertensive drugs at baseline, according to the PubMed record.
- FYIRegulation Nov 5, 2026The FDA on Nov. 5 granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) from Janssen Biotech for adults with recurrent or metastatic head and neck squamous cell carcinoma that progressed on or after platinum-based chemotherapy and immunotherapy. The approval excludes HPV-associated oropharyngeal squamous cell carcinoma. In an open-label, multicenter trial of 102 patients, the overall response rate was 42%, and 56% of responders had responses lasting six months or more; the agency said currently approved therapies have response rates of about 20% or less. Labeling warns of hypersensitivity and administration-related reactions, interstitial lung disease, dermatologic and ocular toxicity and embryo-fetal harm, and confirmatory studies are required.Source: FDA