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THE STUDY on metformin, also sold as Glucophage, is one of several on diabetes published in Wednesday’s Journal of the American Medical Association. It’s the first JAMA issue devoted entirely to research on diabetes, which has reached epidemic levels and afflicts about 17 million people nationwide.
Glucophage helps the body use insulin and is among the most common drugs for Type II diabetes, which is linked to obesity and is sometimes called adult-onset, although it has started showing up in children.
The drug package insert warns that Glucophage can cause a rare side effect called lactic acidosis, a buildup of lactic acid in the blood that is fatal in about half of all cases. The label says it should not be used by patients with kidney disease or those who are taking drugs for heart failure.
But nearly one-fourth of patients met at least one of those criteria in the study, which involved 100 Glucophage outpatient prescriptions from a University of North Carolina hospital pharmacy in Chapel Hill. Patient charts also were studied, and none had developed lactic acidosis, said lead researcher Cheryl Horlen, who now works at Campbell University in Buies Creek, N.C.
The study “may underestimate the frequency of contraindications and it is difficult to determine whether clinicians are aware they are prescribing metformin against a black-box warning,” the researchers said, referring to highlighted cautionary information required by the government on labels of drugs that could have serious side effects.
University of Pittsburgh researchers and several recent European studies found similar rates of inappropriate use, and Horlen said the problem isn’t unique to the University of North Carolina.
Bonnie Jacobs, a spokeswoman for Glucophage maker Bristol-Myers Squibb Co., said the warnings “are clearly outlined” on the label.
Diabetes impairs the body’s ability to produce or make proper use of insulin, resulting in elevated blood sugar levels that can damage the kidneys, heart, eyes and other organs.
“I can’t imagine anybody in the United States who doesn’t have someone in their family or some close friend with diabetes. It’s such a big problem right now,” JAMA editor Dr. Catherine DeAngelis said.
Recent research from Harvard Medical School and Public Citizen Health Research Group suggested that doctors don’t pay close enough attention to drug warning labels, a problem also raised by the Food and Drug Administration.
Dr. Malcolm Taylor, president of the Association of Black Cardiologists, said patients’ lack of knowledge about diabetes drugs might be partly to blame, and he said many are unaware of diabetes’ major complications, which include heart disease and kidney failure.
His group and the American Association of Diabetes Educators are launching a nationwide education campaign this week, including a new Web site to raise awareness about the link between diabetes and heart disease, the leading cause of diabetes-related death.
OTHER RESEARCH
In other JAMA research, a Kaiser Permanente study suggests that giving blacks and whites similar health care access can help ease racial disparities in rates of complications such as severe kidney disease, which affects blacks disproportionately.
However, the study of 62,432 patients enrolled in a northern California Kaiser insurance plan found some differences persisted despite equal access, suggesting genetic differences may explain the racial disparities, Kaiser scientist Andrew Karter said.
And another study in the journal finds that some children are at high risk for developing life-threatening complications from Type 1 diabetes that can potentially be prevented.
Dr. Arleta Rewers studied 1,243 girls and boys with Type 1 diabetes treated at the Barbara Davis Center for Childhood Diabetes in Denver. From 1996 to 2000, there were 320 hospital admissions and/or ER visits due to lactic acidosis and 768 incidences of severe hypoglycemia events.
Lack of insurance and the presence of psychiatric disorders — such as major depression, bipolar, anxiety or panic disorders — were significant predictors of severe diabetes complications, Rewers said.
Major psychiatric disorders may result in missed insulin injections, missed meals, infrequent blood glucose testing, suicidal attempts, chaotic lifestyle and lack of compliance, he wrote.
In a JAMA editorial, Dr. Christopher Saudek, president of the American Diabetes Association, said the featured studies underscore the need for insurers and policy-makers to adequately address chronic diseases like diabetes, which require a lifetime of treatment rather than a quick fix.
“We should be paying to keep people out of the hospital, to keep them as pain-free as possible and as free from complications,” Saudek said.
The Associated Press contributed to this report.
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