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UKPDS data show benefits of glucose control at 30 years: metformin, insulin have a 'legacy effect.'.

ROME--Sustained improvements in diabetes-related end points were achieved with early rather than delayed use of intensive glucose control in patients with newly diagnosed type 2 diabetes, according to results from a landmark diabetes study follow-up.

Particular benefits were seen in patients in the United Kingdom Prospective Diabetes Study (UKPDS) who started metformin earlier in the course of their disease. The benefits of intensive blood pressure lowering appeared to be lost after the trial ended.

Presentation of the 10-year post-trial follow-up data at the annual meeting of the European Association for the Study of Diabetes coincided with their publication online in the New England Journal of Medicine (doi: 10.1056/NEJMoa0806470).

"These data show that there is a legacy effect for earlier glucose control," said Dr. Rury Holman, professor of diabetic medicine at the Oxford (England) Centre for Diabetes, Endocrinology, and Metabolism.

The main 20-year intervention study ran from 1977 to 1997 and included 5,102 patients with newly diagnosed type 2 diabetes. A substudy of the benefits of "tight" vs. "less tight" blood pressure control involved 1,148 members of the cohort.

After the UKPDS trial ended, all surviving patients were monitored for another 10 years. Patients were treated as usual within the community or hospital setting and underwent annual clinic-based evaluation for the first 5 years and then assessment via questionnaires. All patients and their physicians were advised of the need to maintain good glucose and blood pressure control, but no attempt was made to keep patients in their originally randomized treatment groups.

At the end of the intervention study, hemoglobin [A.sub.1c]. levels were significantly reduced in patients who were randomized to metformin plus insulin versus dietary therapy. Between-group differences disappeared, however, 1 year after the study ended. These data showed how the UKPDS influenced clinical practice, Dr. Holman suggested, with equal improvements in Hb[A.sub.1c] levels being seen in patients who were given usual care.

The benefits of tight vs. less tight blood pressure control were lost after 2 years' follow-up, Dr. Holman said, suggesting that continued antihypertensive management is necessary to maintain the benefits of tight control.

In comparing the effects of earlier glucose therapy with dietary control, the relative risk reduction (RRR) in the development of any diabetes end point was 12% at the end of the 20-year intervention study in 1997 and 9% at the end of the 10-year post-trial follow-up in 2007. Diabetes end points included sudden death, death from hyper-or hypoglycemia, fatal/non-fatal myocardial infarction, angina, heart failure, fatal/nonfatal stroke, renal failure, amputation, vitreous hemorrhage, retinal photocoagulation, blindness in one eye, or cataract extraction. The development of microvascular disease remained significantly reduced at both time points, at 25% and 24%, respectively

However, the RRR in myocardial infarction and all-cause mortality--which were not significantly reduced in 1997 (16% and 6%)--were significant at the 10-year follow-up, at 15% for myocardial infarction and 13% for death from any cause.

Similar findings were seen for the earlier use of metformin, but not for more intensive blood pressure lowering. "This does not mean that blood pressure [management] does not work," Dr. Holman said. "It means that blood pressure [lowering] has its maximum effect early--you get all the benefit at the time you are treating, and in the years to come there is no extra benefit from it."

Conversely, the earlier use of metformin and insulin produces effects that emerge gradually and that are not only sustained, but improve in the long term. "That's what we call a legacy effect," he concluded.

Dr. Holman has received research support and/or honoraria from a number of pharmaceutical companies, including Amylin Pharmaceuticals Inc., Bristol-Myers Squibb Co., Eli Lilly & Co., Glaxo-SmithKline Inc., Novo Nordisk A/S, Pfizer Inc., and Sanofi-Aventis.

BY SARA FREEMAN Contributing Writer
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Title Annotation:News; United Kingdom Prospective Diabetes Study
Author:Freeman, Sara
Publication:Internal Medicine News
Geographic Code:4EUUK
Date:Oct 1, 2008
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