- Treating H. pylori Can Have Long-Term Benefits for ITP
- AMG531 (renamed romiplostim) Passes Phase 3 Tests
- GSK Submits NDA for Eltrombopag
- FDA Has New Orphan Drug Head
- Website Resources
- On Hematology
- For Caregivers
- On Health Insurance
- New Coalition to Strengthen FDA
- NHLBI’s Strategic Plan Will Guide Its Next 5 to 10 Years
- News for People Taking Steroids
- Bone Health for Steroid Users
- Poor Sleep Increases Diabetes Risk
- Black Tea May Help
- Aspartame My Stimulate Appetite
- Mediterranean Diet and Exercise each Associated with Longevity
- Want to Be Happy? Try Living Like a Caveman
- Honey Better than Cough Medicine
TREATING H. PYLORI CAN HAVE LONG-TERM BENEFIT FOR ITP
Infection with H. pylori, a bacteria linked with stomach ulcers, appears to be a risk factor for ITP in susceptible individuals. A recent, 5-year study from Italy found that two-thirds of patients with ITP whose only treatment was H. pylori eradication (with antibiotics plus proton-pump inhibitors) experienced a long-term improvement in platelet counts. They further explored the impact of specific genes in the bacteria that make it more or less virulent and found higher levels of a few H. pylori genes in patients with ITP. The authors recommend screening all ITP patients for H. pylori so that treatment of the bacterial infection could precede—and perhaps avoid the need for—more aggressive treatments for ITP.
Emilia G, Luppi M, Zucchini P, Morselli M, Potenza L, Forghieri F, Volzone F, Jovic G, Leonardi G, Donelli A, Torelli G. Helicobacter pylori infection and chronic immune thrombocytopenic purpura: long-term results of bacterium eradication and association with bacterium virulence profiles. Blood, December 1, 2007; 110(12):3833-41.
Cines DB. ITP: Time to “bug off”? Blood, December 1, 2007; 110(12):3818.
AMG531 (RENAMED ROMIPLOSTIM) PASSES PHASE 3 TESTS
Amgen presented results of two randomized, double-blind, placebo-controlled phase 3 studies of AMG531, which the company is now calling romiplostim (tradename Nplate). One study was in adults with chronic ITP who had not undergone spleen removal, the other was in patients whose spleen had been removed. In both studies, significantly more patients on romiplostim experienced a durable platelet response (lasting more than six of the final eight study weeks), although the difference was greater in the patients who had not undergone spleen removal. In both studies, a majority of patients who were taking corticosteroids were able to reduce or discontinue this treatment. Romiplostim works by stimulating the thrombopoietin receptors to stimulate bone marrow cells to increase platelet counts. The researchers presented their results at the American Society of Hematology’s annual meeting in December. The company has filed for marketing approval of Nplate in the U.S, European Union, Australia, and Canada.
GSK SUBMITS NDA FOR ELTROMBOPAG
GlaxoSmithKline submitted a new drug application to the FDA for marketing eltrombopag, its oral platelet growth factor, under the tradename Promacta as a treatment for ITP.
FDA HAS NEW DIRECTOR OF ORPHAN DRUG OFFICE
The new director of the FDA’s Office of Orphan Products Development is Timothy Coté, MD, MPH. Coté will be responsible for promoting development of products that demonstrate promise for the diagnosis and treatment of rare diseases and conditions. The Office also provides grant funding for clinical research on rare diseases. Coté was previously at the Centers for Disease Control and Prevention as country director for Rwanda.
WEBSITE RESOURCES ON HEMATOLOGY
A new website, “HematologyTimes.com”, covers clinical practice in hematology. It provides late-breaking news, upcoming events, continuing medical education, discussion forums, and a resources page. A search of “ITP” yielded several reports of presentations from an October conference in San Diego, Cytopenias in 2007: Emphasis ITP.
The November/December 2007 issue of AARP magazine listed organizations that offer classes, online chats, and other services for caregivers.
Family Caregiver Alliance, National Center on Caregiving: 800-445-8106; http://www.caregiver.org
The National Alliance for Caregiving: 301-718-8444;
The Relaxation Response:
To learn the nine steps, go to:
ON HEALTH INSURANCE
Families USA provides details on health insurance, including Medicare and Medicaid, for consumers on its website. Most recently, it’s December 2007 report, “Too Great A Burden: America’s Families at Risk,” states that America’s families are shouldering a greater portion of health care costs. The problem is not just for the uninsured, but also those with health insurance.
NEW COALITION TO STRENGTHEN FDA
Two organizations will merge to form the Alliance for a Stronger FDA. Merging of the Coalition for a Stronger FDA and the FDA Alliance will “create a stronger, more multi-faceted organization dedicated to securing more Congressional funding for the FDA.” The group believes that the FDA needs better funding to fulfill its mission of protecting the public health. Seven former FDA commissioners and three former HHS secretaries are honorary co-chairs.
NHLBI’S STRATEGIC PLAN WILL GUIDE ITS NEXT 5 TO 10 YEARS
After extensive input from researchers, patient advocates, and professional societies, the National Heart, Lung, and Blood Institute (NHLBI) has published its strategic plan. It includes basic research to identify biomarkers of disease and new molecular targets for prevention, diagnosis, and treatment. Its clinical and translational research goal aims for personalized preventive and therapeutic regimens based on genetics combined with environmental factors.
NEWS FOR PEOPLE TAKING STEROIDS
(Note: Steroids hamper bone-building cells, putting people who take steroids at relatively quick risk of osteoporosis, or bone thinning. Steroids can also raise blood sugar levels and potentially cause diabetes in susceptible individuals.)
BONE HEALTH FOR STEROID USERS
A new study of a drug called teraparatide (Forteo), suggests that it might activate bone-building cells in patients taking steroids. After 18 months, people on teraparatide had stronger gains in hip and vertebral bone density than people taking alendronate (Fosamax), a drug used to preserve bone mass. The study authors conclude that teraparatide appears to be a better option for steroid-induced osteoporosis because it appears to block the ability of steroids to thwart bone formation.
Saag KG, Shane E, Boonen S, Marin F, Donley DW, Taylor KA, Dalsky GP. Marcus R. Teriparatide or Alendronate in Glucocorticoid-Induced Osteoporosis. New England Journal of Medicine. November 15, 2007, 357(20):2028-39.
POOR SLEEP INCREASES DIABETES RISK
A small experiment suggests that disruptions in deep sleep reduces the body’s ability to regulate blood-sugar levels. Previous studies have indicated lack of sleep does the same thing. The University of Chicago authors conclude that this finding adds evidence that poor sleep increases risk for type 2 diabetes.
Tasali E, Leproult R, Ehrmann DA, Van Cauter E. Slow-wave sleep and the risk of type 2 diabetes in humans. Proceedings of the National Academy of Sciences. published online January 2, 2008.
BLACK TEA MAY HELP
Meanwhile, black tea may stimulate the body’s insulin response, reducing blood sugar levels, and reducing type 2 diabetes risk. The researchers attribute the response to the phenol compounds found in tea.
Bryans JA, Judd PA, Ellis PR. The Effect of Consuming Instant Black Tea on Postprandial Plasma Glucose and Insulin Concentrations in Healthy Humans. Journal of American College of Nutrition. October 2007. 26(5):471-77
[In his comments on the study, at mercola.com, Dr. Mercola notes that some conventional teas carry unsafe amounts of fluoride. Look for brands that tout low fluoride content. He also suggests avoiding added sugar and milk.]
ASPARTAME MAY STIMULATE APPETITE
While many people drink diet beverages to reduce calorie intake, aspartame, a sweetener found in many diet drinks, may stimulate appetite and bring on cravings for carbohydrates, according to several reports over the past 10 years. This is relevant for people who take steroids and are trying to reduce the chance of the weight gain that can occur during steroid therapy.
MEDITERRANEAN DIET AND PHYSICAL ACTIVITY EACH ASSOCIATED WITH LONGEVITY
Exercise and a diet high in fruit, vegetables, nuts, whole grains, fish, and little meat and dairy, may help people live longer, according to two large studies that followed people of average age 62 over a 5-year period. The studies relied on data from the National Institutes of Health-AARP Diet and Health Study, For the diet study, more than 380,000 people average age 62 and free of chronic illness were followed. The closer people conformed to a Mediterranean diet, the less likely they were to have died during that period—about 20% less likely. For exercise, researchers followed more than 250,000 people with no chronic diseases. Those who exercised vigorously for 20 minutes, 3 times a week were 32% less likely to die than sedentary people. Vigorous exercise was defined as any exercise that increased breathing or heart rate or caused a sweat. Even people who exercised only a little showed modest reductions in risk of death.
Archives of Internal Medicine, December 10/24, 2007;167(22):2461-2468 and 2453-2460.
WANT TO BE HAPPY, TRY LIVING LIKE A CAVEMAN!
Humans were not designed for a sedentary, socially isolated, indoor, sleep-deprived, poorly nourished life, according to University of Kansas psychologist Stephen Ilardi. He recommends a highly social, active, outdoorsy life. He calls his regimen Therapeutic Lifestyle Change for Depression. His 14-week therapy pairs group therapy with a battery of depression-fighting remedies such as increased sleep, aerobic exercise, omega-3 fatty acids, bright-light exposure, social interaction, and replacing ruminating over negative thoughts with activity. It’s all about moving, interacting, doing. Seventy-seven percent of those on his regiment experienced reduced depression versus 27 percent in the control group that received medication and traditional psychotherapy.
Klein JM. Simply Happy. AARP magazine, November/December 2007, pg. 52-54.
HONEY BETTER THAN COUGH MEDICINE FOR KIDS
A randomized trial compared a spoonful of buckwheat honey versus the over-the-counter cough medicine dextromethorphan, or no treatment in 130 children with cough. Honey, but not dextromethorphan, was better than no treatment in relieving nighttime coughing, and both children and their parents in the honey group slept better compared with the other groups. The study was funded by the National Honey Board.
Paul IM, Beiler J, McMonagle A, Shaffer ML, Duda L, Berlin Jr. CM. Effect of Honey, Dextromethorphan, and No Treatment on Nocturnal Cough and Sleep Quality for Coughing Children and Their Parents. Archives of Pediatrics and Adolescent Medicine, December 2007.161(12):1121.