Study Noted Increase in Type 1 and 2 Diabetes Among Children

The prevalence of type 1 and type 2 diabetes among US children rose sharply between 2001 and 2009, according to a study published in JAMA.1

The study investigators gathered data from 4 geographic areas and 1 managed care plan in the United States. Data on type 1 diabetes were gathered from children age 0 to 19; data on type 2 diabetes were gathered on children age 10 to 19.

In 2001, type 1 diabetes was diagnosed in 4958 of 3.3 million children (1.48 per 1000 [95% CI, 1.44-1.52]) compared with 6666 of 3.4 million children (1.93 per 1000 [95% CI, 1.88-1.97]) in 2009, representing a 21% increase over that time. The prevalence of type 1 diabetes increased in all sex, age, and racial groups except for those with the lowest prevalence (age 0 to 4 years and American Indians). In 2009, white children had the highest prevalence of type 1 diabetes (2.55 per 1000 [95% CI, 2.48-2.62]); American Indian children had the lowest prevalence (0.35 per 1000 [95% CI, 0.26-0.47]).

The rate of type 2 diabetes also increased significantly, with the rate jumping from 0.34 per 1000 (95% CI, 0.31- 0.37) in 2001 to 0.46 per 1000 (95% CI, 0.43-0.49) in 2009, representing an increase of 30.5%. Type 2 diabetes was most prevalent among American Indian children (1.20 per 1000 [95% CI, 0.96-1.51]), followed by black children (1.06 per 1000 [95% CI, 0.93-1.22]), Hispanic children (0.79 per 1000 [95% CI, 0.70-0.88]), and white children (0.17 per 1000 [95% CI, 0.15-0.20]). Prevalence of type 2 diabetes increased from 2001 to 2009 in all sex and age groups and in white, Hispanic, and black racial groups. No significant change was seen in Asian Pacific Islander or American Indian children.

  1. Dabelea D, Mayer-Davis EJ, Saydah S, et al; SEARCH for Diabetes in Youth Study. Prevalence of type 1 and type 2 diabetes among children and adolescents from 2001 to 2009. JAMA. 2014;311(17):1778-1786.

Incidence Rates of Diabetes- Related Complications Declined Between 1990 and 2010

Rates of complications secondary to diabetes declined between 1990 and 2010, according to a study published in The New England Journal of Medicine.1 The study tracked incidence rates of lower-extremity amputation, end-stage renal disease, acute myocardial infarction (MI), stroke, and death from hyperglycemic crisis. Data from the national Health Interview Survey, the National Hospital Discharge Survey, the US Renal Data System, and the US National Vital Statistics System were used in the analysis.

The study authors noted a decline in incidence rates for acute MI (-67.8% [95% CI, -76.2% to -59.3%], death from hyperglycemic crisis (-64.4% [95% CI, -68.0% to -60.9%], diabetes- related stroke (-52.7%) and amputations (-51.4%), and end-stage renal disease (-28.3% [95% CI, -34.6% to -21.6%]). The greatest absolute decline was in the number of cases of acute MI (95.6 fewer cases per 10 000; 95% CI, 76.6 to 114.6); the smallest absolute decline was in the number of deaths from hyperglycemic crisis (-2.7; 95% CI, -2.4 to -3.0).

“Rates of diabetes-related compilations have declined substantially in the past 2 decades, but a large burden of disease persists because of the continued increase in the prevalence of diabetes,” the study authors wrote.

  1. Gregg EW, Li Y, Wang J, et al. Changes in diabetes-related complications in the United States, 1990-2010. N Eng J Med. 2014;370(16):1514-1523.

VEGF Inhibitor Received Approval for Stomach Cancer

The US Food and Drug Administration (FDA) approved ramucirumab (Cyramza, Eli Lilly) for treating advanced stomach cancer or gastroesophageal junction adenocarcinoma (cancer in the region where the esophagus joins the stomach), according to a press release.1 The FDA reviewed the drug under its priority review program and granted the drug orphan product designation.

Ramucirumab is an angiogenesis inhibitor that blocks VEGF receptor-2. The drug is approved for patients with unresectable or metastatic cancer who have already been treated with fluoropyrimidine- or platinum-containing therapy.

The FDA based its ruling on findings from 2 clinical trials. A randomized, double-masked, international, phase 3 clinical trial found that patients treated biweekly with intravenous ramucirumab had a median overall survival of 5.2 months versus 3.8 months for placebo (hazard ratio 0.776; CI 95%, 0.603 to 0.998; P = .047).2 A different randomized, phase 3 trial found that ramucirumab and paclitaxel (Taxol, Bristol-Myers Squibb) improved overall survival versus paclitaxel alone.3

“Although the rates of stomach cancer in the United States have decreased over the past 40 years, patients require new treatment options, particularly when they no longer respond to other therapies,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in the press release.1

  1. FDA approves Cyramza for stomach cancer [press release]. Silver Spring, MD; US Food and Drug Administration; April 21, 2014.
  2. Fuchs CS, Tomasek J, Yong CJ, et al. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebocontrolled, phase 3 trial. Lancet. 2014;383(9911):31-39.
  3. Ramucirumab extends gastric cancer survival. Cancer Discov. 2014;4(4);OF3.

FDA Issued Warning About False Autism Cure Claims

The FDA warned several companies that they could face legal action if they continue to make “false or misleading claims about products and therapies claiming to treat or cure autism,” according to an update on the FDA website.1

The FDA highlighted several so-called autism therapies in the update and said that it has issued warnings against companies that promoted products as off-label cures or treatments for autism. For instance, the FDA singled out chelation therapy, which is distributed as sprays, suppositories, capsules, liquid drops, and clay baths, and which is approved for treating lead poising or iron overload. If used without supervision, chelation therapy can remove important minerals from the body and result in serious and life-threatening outcomes.

The FDA also advised against the use of hyperbaric oxygen therapy, CocoKefir probiotics products, and Miracle Mineral Solution (an oral liquid toxic solution of 28% sodium chlorite which, when mixed with orange juice as directed, produces industrial-grade bleach), all of which were being promoted as cures or treatments for autism.

The FDA warned companies that sell such treatments and cures for autism that legal penalties could result from false claims related to their products' supposed cures for the disorder. The FDA reiterated its stance that autism itself is incurable, but that FDA-approved treatments may help some people manage symptoms related to the disorder.

  1. US Food and Drug Administration. Consumer updates: beware of false or misleading claims for treating autism. http://www.fda.gov/forconsumers/consumerupdates/ucm394757.htm. Revised April 25, 2014. Accessed May 1, 2014.

Vedolizumab Approved for Colitis, Crohn Disease

The FDA approved vedolizumab (Entyvio, Takeda Pharmaceuticals) as a treatment for adults with moderate to severe ulcerative colitis or moderate to severe Crohn disease, according to a press release.1

Vedolizumab is an integrin receptor antagonist that binds to integrin α-4 β-7, blocking inflammatory cell circulation in the gastrointestinal tract. The safety and efficacy of vedolizumab for ulcerative colitis were established in 2 randomized clinical trials that measured stool frequency, rectal bleeding, and endoscopic findings in approximately 900 patients, according to the press release. The safety and efficacy of the drug for Crohn disease were established in 3 clinical trials that included patients who had not responded adequately to corticosteroids, immunomodulators, or tumor necrosis factor blocker medications. The results of these studies “showed that a greater percentage of participants treated with [vedolizumab] compared to a placebo achieved clinical response, achieved clinical remission, and achieved corticosteroid-free clinical remission,” according to the press release.

“Although there is no cure for [ulcerative colitis and Crohn disease], today's approval provides an important new treatment option for patients who have had an inadequate response to conventional therapy to help control their symptoms,” Amy G. Egan, MD, MPH, acting deputy director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research, said in the press release.

  1. FDA approves Entyvio to treat ulcerative colitis and Crohn's disease [press release]. Silver Spring, MD; US Food and Drug Administration; May 20, 2014.

Pancreas and Liver Cancers Projected to Be the Second and Third Deadliest Cancers by 2030

Pancreas and liver cancers are projected to be the second and third leading causes of cancer-related deaths in by 2030, surpassing breast, prostate, and colorectal cancers, according to a study published in Cancer Research.1 Lung cancer is expected to remain the top cause of cancer- related deaths through 2030, according to the study.

The study analyzed changing demographics and the average annual percentage of changes in incidence and death rates to forecast the frequency at which cancers will be diagnosed in 2020 and 2030. Breast, prostate, and lung cancers are projected to remain the top 3 cancer diagnoses in 2030. During that time, thyroid cancer is expected to become number 4 on the list of cancer diagnoses (replacing colorectal cancer), followed by melanoma and uterine cancers.

  1. Rahib L, Smith BD, Alzenberg R, et al. Projecting cancer incidence and deaths to 2030: the unexpected burden of thyroid, liver, and pancreas cancers in the United States [published online ahead of print May 19, 2014]. Cancer Res. doi:10.1158/0008-5472.CAN-14-0155.

David S. Boyer, MD, is a Clinical Professor of Ophthalmology at the University of Southern California Keck School of Medicine, Department of Ophthalmology, in Los Angeles. He is a member of the Retina Today Editorial Board. Dr. Boyer may be reached at +1-310-854-6201; or via email at vitdoc@aol.com.