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Summaries for Patients are a service provided by Annals to help patients better understand the complicated and often mystifying language of modern medicine.
[Editor's note: Since this study was done, troglitazone has been taken off the market in the United States. Other, similar antidiabetes drugs are still available, however.]
SUMMARIES FOR PATIENTS
Using Troglitazone To Treat People with Lipoatrophy Syndromes
15 August 2000 | Volume 133 Issue 4 | Page 263
Summaries for Patients are presented for informational purposes only. These summaries are not a substitute for advice from your own medical provider. If you have questions about this material, or need medical advice about your own health or situation, please contact your physician. The summaries may be reproduced for not-for-profit educational purposes only. Any other uses must be approved by the American College of Physicians-American Society of Internal Medicine.
The summary below is from the full report titled "Efficacy and Safety of Troglitazone in the Treatment of Lipodystrophy Syndromes." It is in the 15 August 2000 issue of Annals of Internal Medicine (volume 133, pages 263-274). The authors are E. Arioglu, J. Duncan-Morin, N. Sebring, K.I. Rother, N. Gottlieb, J. Lieberman, D. Herion, D.E. Kleiner, J. Reynolds, A. Premkumar, A.E. Sumner, J. Hoofnagle, M.L. Reitman, and S.I. Taylor.
What is the problem and what is known about it so far?
Lipoatrophy syndromes are rare conditions associated with abnormally small amounts of body fat. This results in high blood levels of fatty substances called triglycerides and in insulin resistance. Insulin is a hormone that regulates how the body uses carbohydrates, protein, and fat. Insulin resistance means the tissues no longer respond well to the effect of insulin. To overcome insulin resistance, the body makes more insulin, leading to high insulin levels in the bloodstream. When these high levels fail to overcome tissue resistance, blood sugar levels increase and diabetes may develop. Troglitazone is an antidiabetes drug that works by increasing tissue sensitivity to insulin; it has also led to development of fat cells in test tubes. Troglitazone might therefore be useful in treating lipoatrophy.
Why did the researchers do this particular study?
To see whether treating lipoatrophy with troglitazone lowers blood sugar and triglyceride levels and increases the amount of body fat.
Who was studied?
The study included 20 patients with lipoatrophy and insulin resistance. Fourteen of the patients had diabetes.
How was the study done?
At the beginning of the study, the researchers measured patients' levels of triglycerides, body fat, and hemoglobin A1c. (By measuring hemoglobin A1c, a physician can determine how high blood sugar levels have been during the preceding 3 months.) All study patients then received 6 months of therapy with troglitazone. The researchers instructed patients not to change their usual diet and exercise habits during the study. Patients were reevaluated after 6 weeks, 3 months, and 6 months of treatment.
What did the researchers find?
Of the 20 patients, 19 completed the study (13 with diabetes and 6 without diabetes). In the 13 patients with diabetes, hemoglobin A1c improved with treatment, indicating better sugar control. In all 19 patients, triglyceride levels decreased and body fat increased slightly. One patient dropped out of the study because of liver damage that may have been related to troglitazone. In addition, after 10 months of therapy, 1 patient developed serious liver damage that was clearly related to troglitazone.
What were the limitations of the study?
The study included only 20 patients, who had different types of lipoatrophy. It is impossible to tell from this small study whether one type of lipoatrophy responds better to troglitazone than do other types. The study also did not include a comparison group of patients who did not receive troglitazone; it is possible that troglitazone did not cause the improvements observed. In addition, the study lasted only 6 months.
What are the implications of the study?
Troglitazone may help to improve blood sugar levels, triglyceride levels, and body fat content in persons with lipoatrophy syndromes. However, patients and doctors must balance the potential side effect of liver damage caused by this drug against the potential benefits of treatment.
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