User login
SAN FRANCISCO — Standard therapies for type 2 diabetes are effective at maintaining glycemic control over at least 5 years in community settings, Dr. James Best reported at the annual scientific sessions of the American Diabetes Association.
Dr. Best, of the University of Melbourne, and his colleagues observed a cohort of 4,900 patients with type 2 diabetes who served as controls for the FIELD (Fenofibrate Intervention and Event Lowering in Diabetes) trial. Community-based family physicians at 63 sites in three countries treated these patients—mean age of 63 years—with diet, sulfonureas, metformin, and insulin in a standard progression.
Over a median of 5 years of follow-up, the patients' median hemoglobin A1c level rose only slightly, from 6.85% to 6.9%. Their median body weight declined slightly, from 86.3 kg (190.3 pounds) at baseline to 85.0 kg (187.4 pounds) at the end of the study. While both of those differences reached statistical significance, it's arguable whether such small changes had clinical significance.
In discussing these results, Dr. Best drew a distinction between “efficacy” and “effectiveness.” While any new treatment may show significant efficacy in a clinical trial, it's only truly useful if it proves to be effective in real-world settings.
“I think the glycemic effectiveness of new therapies for type 2 diabetes need to be assessed against what is achievable with standard and widely available current therapy,” Dr. Best said. “An HbA1c target of less than 7% is generally safe and generally achievable.”
Dr. Best conceded that the patients in the FIELD study were self-selected to a certain extent, which might compromise the generalizability of the results. On the other hand, the FIELD study was intended to evaluate cardiovascular outcomes, not glycemic control, in patients given fenofibrate. “They were fairly representative of patients with type 2 diabetes in the community,” he said. And the care they received was representative of the standard diabetes care that type 2 patients would receive anywhere in the community setting.
At the beginning of the study, 1,287 of the control patients were being treated with diet alone. By the end of the 5-year follow-up period, about half of these had been started on one or two oral agents.
Dr. Best said that he had no conflicts of interest related to his presentation.
SAN FRANCISCO — Standard therapies for type 2 diabetes are effective at maintaining glycemic control over at least 5 years in community settings, Dr. James Best reported at the annual scientific sessions of the American Diabetes Association.
Dr. Best, of the University of Melbourne, and his colleagues observed a cohort of 4,900 patients with type 2 diabetes who served as controls for the FIELD (Fenofibrate Intervention and Event Lowering in Diabetes) trial. Community-based family physicians at 63 sites in three countries treated these patients—mean age of 63 years—with diet, sulfonureas, metformin, and insulin in a standard progression.
Over a median of 5 years of follow-up, the patients' median hemoglobin A1c level rose only slightly, from 6.85% to 6.9%. Their median body weight declined slightly, from 86.3 kg (190.3 pounds) at baseline to 85.0 kg (187.4 pounds) at the end of the study. While both of those differences reached statistical significance, it's arguable whether such small changes had clinical significance.
In discussing these results, Dr. Best drew a distinction between “efficacy” and “effectiveness.” While any new treatment may show significant efficacy in a clinical trial, it's only truly useful if it proves to be effective in real-world settings.
“I think the glycemic effectiveness of new therapies for type 2 diabetes need to be assessed against what is achievable with standard and widely available current therapy,” Dr. Best said. “An HbA1c target of less than 7% is generally safe and generally achievable.”
Dr. Best conceded that the patients in the FIELD study were self-selected to a certain extent, which might compromise the generalizability of the results. On the other hand, the FIELD study was intended to evaluate cardiovascular outcomes, not glycemic control, in patients given fenofibrate. “They were fairly representative of patients with type 2 diabetes in the community,” he said. And the care they received was representative of the standard diabetes care that type 2 patients would receive anywhere in the community setting.
At the beginning of the study, 1,287 of the control patients were being treated with diet alone. By the end of the 5-year follow-up period, about half of these had been started on one or two oral agents.
Dr. Best said that he had no conflicts of interest related to his presentation.
SAN FRANCISCO — Standard therapies for type 2 diabetes are effective at maintaining glycemic control over at least 5 years in community settings, Dr. James Best reported at the annual scientific sessions of the American Diabetes Association.
Dr. Best, of the University of Melbourne, and his colleagues observed a cohort of 4,900 patients with type 2 diabetes who served as controls for the FIELD (Fenofibrate Intervention and Event Lowering in Diabetes) trial. Community-based family physicians at 63 sites in three countries treated these patients—mean age of 63 years—with diet, sulfonureas, metformin, and insulin in a standard progression.
Over a median of 5 years of follow-up, the patients' median hemoglobin A1c level rose only slightly, from 6.85% to 6.9%. Their median body weight declined slightly, from 86.3 kg (190.3 pounds) at baseline to 85.0 kg (187.4 pounds) at the end of the study. While both of those differences reached statistical significance, it's arguable whether such small changes had clinical significance.
In discussing these results, Dr. Best drew a distinction between “efficacy” and “effectiveness.” While any new treatment may show significant efficacy in a clinical trial, it's only truly useful if it proves to be effective in real-world settings.
“I think the glycemic effectiveness of new therapies for type 2 diabetes need to be assessed against what is achievable with standard and widely available current therapy,” Dr. Best said. “An HbA1c target of less than 7% is generally safe and generally achievable.”
Dr. Best conceded that the patients in the FIELD study were self-selected to a certain extent, which might compromise the generalizability of the results. On the other hand, the FIELD study was intended to evaluate cardiovascular outcomes, not glycemic control, in patients given fenofibrate. “They were fairly representative of patients with type 2 diabetes in the community,” he said. And the care they received was representative of the standard diabetes care that type 2 patients would receive anywhere in the community setting.
At the beginning of the study, 1,287 of the control patients were being treated with diet alone. By the end of the 5-year follow-up period, about half of these had been started on one or two oral agents.
Dr. Best said that he had no conflicts of interest related to his presentation.