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(Circulation. 2000;102:e9007.)
© 2000 American Heart Association, Inc.
Cardiovascular News |
Cardiovascular News
Ibuprofen as Effective as Indomethacin for Patent Ductus Arteriosus
Ibuprofen is as effective as indomethacin for the treatment of patent ductus arteriosus in premature infants suffering from respiratory distress syndrome, and it has fewer effects on the kidneys, according to a report released early by the New England Journal of Medicine (N Engl J Med. In press; Posted July 11, 2000). The journal elected to post the article before its September 7, 2000 publication date because of its potential therapeutic implications.
In the study, Bart Van Overmeire, MD, of the University Hospital in Antwerp, Belgium, and his multicenter team randomly assigned 148 infants with respiratory distress syndrome and patent ductus arteriosus to receive 3 intravenous doses of either indomethacin or ibuprofen on the third day of life. The group found that the rate at which the ductus closed was similar for the 2 treatments. Ductal closure occurred in 49 of 74 infants who received indomethacin and in 52 of 74 given ibuprofen. The percentage of infants needing a second course of medicine or surgery did not differ significantly among the groups.
Oliguria occurred in 5 infants treated with ibuprofen and in 14 treated with indomethacin. The researchers concluded that ibuprofen therapy given on the third day of life works as well in these infants as indomethacin, with fewer kidney effects.
Panel Opposes Offering Anti-Cholesterol Drugs Over-the-Counter
A panel that advises the US Food and Drug Administration on which medicines should be offered without a physician’s prescription said on July 14, 2000 that it opposed a pharmaceutical company–proposed plan to offer statins over-the-counter. The plan, which was proposed by Merck & Co for its drug Mevacor and by Bristol-Myers Squibb for Pravachol, would have made the cholesterol-lowering medications available in 10-mg dosages.
dward Hemwall, speaking on behalf of Merck, was quoted by the Associated Press as saying, "Consumers are interested in playing roles in their own health care. They deserve better options." The companies pointed out that surveys indicate that only a small fraction of Americans with elevated cholesterol use prescription medication to lower it. Many individuals do not know they have high cholesterol; some lack insurance to cover the cost of such drugs. In addition, many physicians do not prescribe the medication for such patients.
However, according to the Associated Press, the advisory committee of the Food and Drug Administration disagreed with the plan, saying that patients do not understand cholesterol well enough to self-medicate, there is no easy way for patients to obtain blood tests to determine if their cholesterol levels are responding to treatment, and the companies have not proven that 10-mg doses of the statins could prevent heart attacks.
The panel remained unconvinced that providing the drugs in an over-the-counter form would produce any health benefits for those who have mildly elevated cholesterol. However, a dietary supplement called Cholestin apparently contains a low dose of the cholesterol-lowering ingredient found in lovastatin.
Rose Marie Robertson, MD, president of the American Heart Association, said the issue was a difficult one and that the association’s experts were uncertain whether the medication would improve overall health. The determination was made particularly difficult, she said, because people could buy lovastatin over-the-counter in a slightly lower dosage.
Clinical Trials for Transplanting Insulin-Producing Cells
Ten research centers have been named as sites for testing a new technique for transplanting insulin-producing pancreas cells with an immunosuppressive regimen that does not include glucocorticosteroids. In a report published early by the New England Journal of Medicine, Canadian researchers demonstrated that 7 patients who received the transplants were able to live insulin-free afterward (N Engl J Med. In Press; Posted July 6, 2000).
Although all experts involved said the results from the initial trial were promising, they warned that more study is necessary to determine how and when the treatment is best used. This is what the 10-center, 40-patient trial will determine. The tests are the first to be performed as a part of the $144 million Immune Tolerance Network (ITN), an international consortium of clinical researchers dedicated to developing approaches to induce immune tolerance (selective modulation of the immune system to inhibit harmful immune responses while keeping protective ones intact).
The network is spearheaded by the National Institute of Allergy and Infectious Diseases (NSAID) and cofunded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Juvenile Diabetes Foundation International. This fall, the network will spend $5 million to expand studies of the islet-cell transplantation technique to centers in Edmonton, Alberta; Miami, Florida; Minneapolis, Minnesota; Boston, Massachusetts; St Louis, Missouri; Seattle, Washington; and Bethesda, Maryland. In addition, sites are planned in Geneva, Switzerland; Giessen, Germany; and Milan, Italy.
Approximately 40 patients aged 18 to 65 with type 1 diabetes who are unable to control their blood sugar with even the most rigid insulin schedule will be chosen to receive the cell transplants over the next 18 months. "This trial will serve as a platform for future ITN studies to investigate new ‘tolerance therapies,’ treatments that may replace the life-long immunosuppressive drugs that transplant recipients currently require to maintain functioning islets," said NIAID director Anthony S. Fauci, MD.
The treatment was developed by Dr James Shapiro and colleagues at the University of Alberta. The expanded trials will investigate the underlying immunological mechanisms at work after islet cell transplantation. Rather than suppressing the body’s entire immune system, tolerance therapies specifically block just those immune responses that destroy a person’s own tissues or cause them to reject transplanted tissues. Several promising approaches are now under investigation.
"While we have known for nearly a decade that tight control of blood glucose delays or prevents diabetes complications, many people have great difficulty achieving optimal control with current treatment methods. Islet transplantation offers the potential for gaining such control and arresting complications," said NIDDK director Allen Spiegel, MD.
Jeffrey Bluestone, MD, director of the ITN, noted that "the ITN clinical trials represent a very significant step forward in diabetes research, and we hope to someday make this approach available to all people with diabetes."
Centers participating in the trial include the University of Alberta Clinical Islet Transplantation Program, Edmonton, Alberta, Canada; the Diabetes Research Institute, University of Miami, Miami, Florida; the Diabetes Institute for Immunology and Transplantation, University of Minnesota, Minneapolis, Minnesota; the Juvenile Diabetes Foundation Center for Islet Transplantation, Harvard Medical School, Boston, Massachusetts; the Diabetes Research Training Center, Washington University, St Louis, Missouri; the Pacific Northwest Research Institute, Seattle, Washington; the Organ/Tissue Transplant Research Center, National Institutes of Health, Bethesda, Maryland; the Islet Transplant Centre, Justis-Liebig University, Giessen, Germany; the San Raffaele Scientific Institute, University of Milan, Milan, Italy; and the University Hospital, Geneva, Switzerland.
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