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Up Front | Feb 2014

Medical Updates

A summary of general medicine news that affects your patients, your practice, and you.

Vitamin, Mineral Supplements May Not be Beneficial for Prevention of Cancer, CVD

Limited evidence supports any benefit from vitamin and mineral supplementation for the prevention of cancer or cardiovascular disease (CVD), according to a study published in the Annals of Internal Medicine.1

Stephen P. Fortmann, MD, of Kaiser Permanente Center for Health Research, and colleagues conducted a review of evidence for the benefits and harms of vitamin and mineral supplements in nutrient-sufficient adults for the primary prevention of CVD and cancer. The investigators searched Medline, Embase, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Database of Abstracts of Reviews of Effects from January 2005 to January 2013, as well as reference lists and gray literature.

Two investigators independently selected and reviewed fair- and good-quality trials for benefits and fair- and good-quality trials and observational studies for harms.

The review included a total of 26 studies (24 randomized, controlled trials and two cohort studies). Two large trials (n = 27,658) reported lower cancer incidence in men taking a multivitamin for more than 10 years (pooled unadjusted relative risk, 0.93; 95% CI, 0.87–0.99). The study that included women showed no effect in that group.

A total of 24 studies (n = 324,653) of single and paired nutrients such as vitamins A, C, or D; folic acid; selenium; or calcium were heterogeneous and showed no clear evidence of benefit or harm, the investigators found. Neither vitamin E nor beta-carotene prevented CVD or cancer, and beta-carotene increased lung cancer risk in smokers.

“We identified [two] multivitamin trials that both found lower overall cancer incidence in men,” the study authors wrote. “Both trials were methodologically sound, but the lack of an effect for women (albeit in [one] trial), the borderline significance in men in both trials, and the lack of any effect on CVD in either study makes it difficult to conclude that multivitamin supplementation is beneficial.”

  1. Fortmann SP, Burda BU, Senger CA, et al. Vitamin and mineral supplements in the primary prevention of cardiovascular disease and cancer: an updated systematic evidence review for the US Preventive Services Task Force. Ann Intern Med. 2013;159(12):824-834.

Mistimed Sleep May Disrupt Rhythm of Genes

The daily rhythms of many genes may be disrupted when sleep times shift, a study published in Proceedings of the National Academy of Sciences suggests.1

Investigators at the Sleep Research Centre, of the University of Surrey, United Kingdom, placed 22 people on a 28-hour day schedule in a controlled environment without a natural light-dark cycle. As a result, their sleep-wake cycle was delayed by 4 hours each day, until sleep occurred 12 hours out of sync with their brain clock and in the middle of what would have been their normal daytime. Blood samples were then collected to measure the patients' rhythms of gene expression.

During the disruption of sleep timing, there was a sixfold reduction in the number of genes that displayed a circadian rhythm. This included many regulators associated with transcription and translation.

“Over 97% of rhythmic genes became arrhythmic with mistimed sleep, and this really underlines why we feel so bad during jet lag or if we have to work irregular shifts,” first author Simon Archer, PhD, said in a news release.

  1. Archer SN, Laing EE, Moller-Levet CS, et al. Mistimed sleep disrupts circadian regulation of the human transcriptome [published online ahead of print December 18, 2013]. Proc Nat Acad Sci USA. doi:10.1073/pnas.1316335111.

Positive Results for Patients Using Personalized Cellular Therapy

Researchers at the Hospital of the University of Pennsylvania and the Children's Hospital of Philadelphia reported positive results from a study of 59 patients with leukemia who were treated with an investigational, personalized cellular therapy known as CTL019. The results were reported at the American Society of Hematology Annual Meeting in New Orleans and in a news release.1

The investigational treatment begins by removing a patient's T cells via an apheresis process and reprogramming them with a gene transfer technique using a lentivirus vector. The newly built T cells target tumor cells using chimeric antigen receptor, an antibody-like protein that is expressed on the surface of the T cells and designed to bind to the CD19 protein, which is found on the surface of cancerous B cells associated with chronic lymphocytic leukemia (CLL) and acute lymphoblastic leukemia (ALL). The modified cells are infused back into the patient's body following lymphodepleting chemotherapy. A signaling domain built into the chimeric antigen receptor promotes rapid growth of these cells, building an army of tumor-killing cells that tests reveal can grow to more than 10,000 new cells for each single engineered cell patients receive. Cells in the patient that do not express CD19 are left untouched by the modified T cells.

Two of the first three patients with CLL who participated in the study, which started in 2010, remain in remission, with tests revealing reprogrammed cells still circulating in their bodies, the news release said. Additionally, an 89% complete response rate among adult and pediatric patients with ALL has been observed.

The researchers reported findings from three patient groups: (1) 15 of 32 adults with CLL who responded to the therapy, seven of whom experienced complete remission of their disease, (2) results of the completed pilot study of 14 patients with CLL and results thus far of the first 18 patients treated in a phase 2, dose-optimization trial, and (3) 19 of 22 pediatric patients with ALL who experienced complete remission. The first pediatric patient treated, now 8 years old, is still in remission 20 months after treatment. Five patients have relapsed, including one whose tests revealed new tumor cells that do not express the protein targeted by the reprogrammed cells. All five of the first adult patients with ALL treated experienced complete remission, the longest of which continues 6 months after treatment. One patient subsequently underwent a bone marrow transplant and remains in remission, and one patient relapsed after 3 months with disease that also tested negative for the engineered cell target, the news release said.

  1. Penn Med team reports on study of first 59 leukemia patients who received personalized cellular therapy [news release]. Philadelphia, PA: Penn; December 7, 2013. http://www.upenn.edu/pennnews/news/penn-med-team-reports-study-first-59-leukemia-patients-who-received-personalized-cellular-thera. Accessed December 20, 2013.

FDA Warns Against Combination Drugs High in Acetaminophen

The US Food and Drug Administration (FDA) has recommended that health care professionals stop prescribing combination drug products that contain more than 325 mg acetaminophen per dosage unit.1 The FDA said there are no available data to show that taking more than this provides additional benefit that outweighs the risks for liver injury.

In January 2011, the FDA asked manufacturers of prescription combination drugs products containing acetaminophen to limit the amount of acetaminophen to no more than 325 mg by January 14, 2014. According to the FDA, more than half of manufacturers have voluntarily complied with its request.

  1. US Food and Drug Administration. Acetaminophen prescription combination drug products with more than 325 mg: FDA statement—recommendation to discontinue prescribing and dispensing. January 1, 2014. Available at www.fda.gov/safety/ medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm381650.htm. Accessed January 18, 2014.

–Compiled by Callan Navitsky, Senior Editor

Feb 2014