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Minnesotans are participating in a clinical trial that may dramatically alter the way physicians manage diabetic patients’ risk for cardiovascular disease.
The NIH-funded ACCORD (Action to Control Cardiovascular Risk in Diabetes) study, the largest clinical trial ever on patients with type 2 diabetes, involves more than 10,000 patients in the United States and Canada. The 10-year study, which ends in June 2009, is attempting to determine whether more aggressive control of blood sugar lowers diabetic patients’ risk of developing cardiovascular disease. It’s also examining the effect of tighter blood pressure and cholesterol management. Patients with type 2 diabetes die of cardiovascular disease at rates two to four times higher than those of patients who are not diabetic.
“Basically, we don’t know what the best A1c is for a person with diabetes,” says Kevin Peterson, M.D., M.P.H., director of research for the University of Minnesota’s department of family medicine and community health and a principle investigator at one of the ACCORD sites, the university’s Phalen Village Clinic in St. Paul.
The American Diabetes Association recommends patients have an A1c of 7 or less. But the American College of Endocrinology recommends an A1c of 6.5 or less. “Those are best guesses,” Peterson says, adding that guidelines tend to be “one step ahead” of the evidence.
Peterson says you’d expect to see fewer complications of diabetes in patients with lower blood sugar levels. But he points out that there also are downsides. The likelihood of accidents increases, for example, and the costs associated with more more patient visits and more prescriptions are greater.
JoAnn Sperl-Hillen, M.D., a researcher at HealthPartners Research Foundation, which is also participating in the ACCORD study along with Mayo Clinic, Hennepin County Medical Center, and the university’s department of endocrinology, says that if the study shows that more aggressive blood sugar control lowers cardiovascular disease risk, physicians will have to grapple with increasing numbers of patients needing care and convincing them to comply with the new standards. “We already are struggling to achieve the currently recommended less-aggressive treatment goals,” she says. “It could require a huge additional effort and expense on the part of patients and a burden on our already-strained care systems.”—Carmen Peota
Conquering Mount Everests
On August 22, 1957, University of Minnesota surgeon C. Walt Lillehei, M.D., connected 11-year-old Cindy Lander to an early version of a heart-lung machine and repaired her ventricular septal defect, a congenital condition that was described as “the Mount Everest” of heart defects at the time. Lander, who was one of the first patients to undergo the procedure, returned to the University in August to commemorate the 50th anniversary of her surgery.
Marking another milestone, Swiss chemist Veronika Meyer traveled to the Twin Cities in October to meet the employees of St. Jude Medical in St. Paul who made the mechanical heart valve she received in 1997. The device not only helped Meyer, an avid mountaineer, to conquer aortic valve disease, it also allowed her to reach the world’s highest peak, the summit of Mount Everest, last May.
Chief Sets Course
Only six months into the job, the University of Minnesota’s chief of cardiology, Daniel J. Garry, M.D., Ph.D., can rattle off the university’s accomplishments in cardiac care without missing a beat: first open-heart surgical procedure, first cross-circulation surgical procedure, first artificial valve implant, first heart and heart-lung transplants in Minnesota, world’s longest survivor of heart transplantation, first implantation of a left ventricular assist device in Minnesota, pioneering clinical trials in patients with heart failure.
Garry, however, does not plan to let the university rest on its reputation, and he’s set an ambitious course. Laying out his agenda, Garry says he initially wants to focus on three areas: cell therapy and stem cell biology, cardiovascular genomics, and the use of small molecules to promote or perturb molecular pathways for the treatment of heart failure.
Garry believes advancements in molecular medicine will transform the practice of cardiology. Now, he says, physicians have to “wait and see” whether a therapy works in a particular patient. For example, only one-third of patients who have severely decreased heart function benefit from beta-blocker therapy. “It’s applying these emerging technologies to triage patients—Who should be treated with medical therapies, device therapies, or solid organ and cell therapies?”—Carmen Peota
Don't Hang Up
Cell phones do not interfere with medical devices. So concluded Mayo Clinic researchers, who tested two cell phone makes in 75 different patient care areas between February 15, 2006, and June 29, 2006. The investigators monitored medical device displays and alarms while the phones were in use, finding that none of the 192 medical devices monitored were affected. The research was published in the March 2007 Mayo Clinic Proceedings. The authors of the study suggested that hospitals that restrict cell phone use reconsider their policies. “In the hospital environment where patients and/or families may otherwise be somewhat disconnected from family and friends, cellular telephones allow a convenience that most prefer to have available,” they wrote.
More Cause of Concern
A huge study published in the December 6, 2007, New England Journal of Medicine provides further fodder for concern about childhood obesity. Researchers looked at childhood BMIs for 276,835 Danish subjects and identified those who developed heart disease later in life. The key finding: elevated BMI in childhood raised the risk of having coronary disease in adulthood.
Direct to the Heart
First it was drugs, then artificial joints. Now a medical device maker is marketing cardiac stents directly to consumers.
During the Dallas Cowboys’ routing of the New York Jets on Thanksgiving Day, Cordis Corporation, a subsidiary of Johnson & Johnson, ran a 60-second commercial for its
Cypher drug-eluting stent. The message focused on Cypher’s ability to relieve pain and other symptoms of angina. It also attempted to quell fears about the safety of drug-coated stents.
A December New York Times article said the ad campaign includes print ads in national newspapers and magazines as well as medical journals.
The campaign doesn’t necessarily please physicians. In the story, William E. Boden, M.D., professor of medicine at State University of New York at Buffalo, called the commercial “deplorable” and questioned whether the campaign was “a sign of desperation” on the part of the manufacturer.