In early December 2013, the FDA will formally recommend to the US Department of Health and Human Services (HHS) that hydrocodone combination products be reclassified as Schedule II drugs. The proposed change would tighten the controls on these products, which now are classified as Schedule III. The recommendation follows the US Drug Enforcement Administration’s (DEA) 2009 request for guidance from HHS regarding hydrocodone combination products such as Vicodin. The FDA’s determination is the result of an analysis of the scientific literature, a review of hundreds of public comments on the issue, and several public meetings, according to a statement by Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research. The recommendation will influence the DEA’s final decision on the appropriate scheduling of these products.
Influenza vaccination may reduce patients’ risk of major adverse cardiovascular events, including stroke, according to a meta-analysis published October 23 in JAMA. Researchers conducted a systematic review of randomized clinical trials listed in MEDLINE, EMBASE, and the Cochrane Library Central Register of Controlled Trials that compared influenza vaccine with placebo or control in patients at high risk of cardiovascular disease. Six trials encompassing 6,735 patients were included. Influenza vaccine was associated with a lower risk of composite cardiovascular events (2.9% vs 4.7%) in published trials. A treatment interaction was detected between patients with and without recent acute coronary syndrome. The greatest treatment effect was observed among the highest-risk patients with more active coronary disease, and a larger trial is warranted to assess these findings, said the researchers.
Short sleep duration and poor sleep quality may be associated with greater β-amyloid burden among community-dwelling older adults, according to research published online ahead of print October 21 in JAMA Neurology. Investigators performed a cross-sectional study of 70 adult participants (mean age, 76) in the neuroimaging substudy of the Baltimore Longitudinal Study of Aging. The study’s main outcome measure was β-amyloid burden, measured by carbon 11-labeled Pittsburgh compound B PET distribution volume ratios. After adjustment for potential confounders, the researchers found an association between reports of shorter sleep duration and greater β-amyloid burden, measured by mean cortical distribution volume ratio and precuneus distribution volume ratio. Reports of lower sleep quality were associated with greater β-amyloid burden, measured by precuneus distribution volume ratio.
High blood glucose levels may adversely affect cognition, even among patients without type 2 diabetes or impaired glucose tolerance, researchers reported online ahead of print October 23 in Neurology. The effect may be mediated by structural changes in learning-relevant brain areas, the authors noted. The group tested memory in 141 individuals using the Rey Auditory Verbal Learning Test and acquired peripheral levels of fasting HbA1c, glucose, and insulin. Clinicians performed 3-T MRI scans to assess hippocampal volume and microstructure. Lower HbA1c and glucose levels were significantly associated with better scores in delayed recall, learning ability, and memory consolidation. In multiple regression models, HbA1c remained strongly associated with memory performance. Mediation analyses indicated that beneficial effects of lower HbA1c on memory are partly mediated by hippocampal volume and microstructure.
Among older adults, arterial stiffness may be associated with b-amyloid plaque deposition in the brain, independent of blood pressure and APOE ε4 allele, according to a study published online ahead of print October 16 in Neurology. Investigators studied 91 dementia-free participants between ages 83 and 96. Participants underwent brain MRI and PET imaging with Pittsburgh compound B. The researchers measured resting blood pressure (BP), mean arterial pressure (MAP), and arterial stiffness by pulse wave velocity (PWV) in the central, peripheral, and mixed vascular beds. A total of 44 subjects were β-amyloid positive on PET scan. The investigators found that β-amyloid deposition was associated with mixed PWV, systolic BP, and MAP. One SD increase in brachial ankle PWV resulted in a twofold increase in the odds of being β-amyloid positive.
The FDA has approved Vizamyl (flutemetamol F 18 injection), a radioactive diagnostic drug, for use with PET imaging of the brain in adults being evaluated for Alzheimer’s disease and dementia. Vizamyl attaches to β-amyloid and produces a PET image that is used to evaluate the presence of β-amyloid. The drug’s effectiveness was established in two clinical studies of 384 participants with a range of cognitive function. All participants were injected with Vizamyl and scanned. The images were interpreted by five independent readers masked to all clinical information. A portion of scan results was also confirmed by autopsy. Following the approval of Amyvid (Florbetapir F 18 injection) in 2012, Vizamyl, manufactured by Medi-Physics (Arlington Heights, Illinois), becomes the second diagnostic drug available for visualizing β-amyloid on a PET scan of the brain.