The American Heart Association’s annual scientific session in Chicago offered insights on the latest therapies and practices, from statin treatments and screening tools to readmissions and communications. Here is a roundup of presentations from the Nov. 15-19 event.
PCSK9 inhibitor safe, effective in statin-intolerant patients
Treatment with a monoclonal antibody designed to reduce low-density lipoprotein (LDL) cholesterol in at-risk patients who were statin intolerant lowered lipid levels and improved adherence compared with statins in the ODYSSEY ALTERNATIVE study.
“I don’t think people realize how complex these patients are,” says lead investigator Patrick M. Moriarty, MD, director of clinical pharmacology at the University of Kansas Medical Center in Kansas City. He presented safety and efficacy results for alirocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, during a late-breaking clinical trial session.
The study enrolled patients who were very high-, high- or moderate-risk who had a history of statin intolerance, which was defined as the inability to tolerate at least two different statins because of skeletal-muscle symptoms. During a single-blind run-in period, all patients received placebo subcutaneous injections and placebo pills. Those who reported muscle-related adverse events were excluded.
The remaining 314 patients were randomized to alirocumab 75 mg and a daily oral placebo (126 patients); a placebo subcutaneous injection and daily oral ezetimibe 10 mg, a recommended option for statin-intolerant patients (125 patients); or a placebo subcutaneous injection and daily oral atorvastatin 20 mg (63 patients). The study also included a three-year open-label treatment period.
At 24 weeks, the alirocumab group experienced a greater change in LDL cholesterol from baseline compared with the ezetimibe group and more patients in the alirocumab group reached target lipid levels. For safety, fewer patients in the alirocumab group reported skeletal-muscle-related treatment-emergent adverse events than in the ezetimibe group and the atorvastatin group and fewer discontinued treatment as a result.
Almost 90 percent of patients continued on the open-label study. Discontinuation due to adverse events dropped to 1.4 percent in the open-label period. “[Alirocumab] is safer, more efficacious than ezetimibe and more potent,” Moriarty says. He calls it a win-win for patients with the potential to dramatically change treatment for statin-intolerant patients.
Warfarin plus antiplatelet therapy may raise dementia risk
Patients with atrial fibrillation who often are over-anticoagulated on warfarin and receive antiplatelet therapy may be at increased risk of developing dementia. “Of all the variables in multivariate analysis, the only ones that truly predicted dementia risk in the population was over-anticoagulation percent time [of 25 percent of more] vs. over-anticoagulation that was good, or less than 10 percent,” says presenter Thomas Jared Bunch, MD. “It is quite a strong marker for dementia risk.”
Bunch, director of electrophysiology research at the Intermountain Medical Center Heart Institute in Murray, Utah, and colleagues have proposed that repetitive cerebral injury from microbleeds or small clots from under- or over-anticoagulation may contribute to dementia. In this study, they focused on patients with no history of clinical dementia who received antiplatelet agents in addition to warfarin. The study included 1,031 patients receiving antiplatelet therapy and warfarin at the center, with a follow-up of 4.5 years.
Patients with international normalized ratios (INRs) of 3 on 25 percent or more of their blood tests were more than twice as likely to be diagnosed with dementia as patients with INRs of 3 on 10 percent of tests, they determined.
N.J.'s mandatory newborn pulse-ox screening shows success
Critical screening for newborns in New Jersey bears fruit: 13 more babies were identified with critical congenital heart defects than had been previously identified through prenatal screening or physical exam, according to one study.
Secondarily, babies with other kinds of congenital heart defects and serious medical conditions were identified solely through the mandatory pulse oximetry program.
In June of 2011, New Jersey enacted legislation that required all hospitals and birthing centers in the state to evaluate all live births using noninvasive pulse oximetry screening to determine infant risks for