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The Food and Drug Administration (FDA) approved nateglinide (STARLIX) in December 2000 to lower blood sugar levels in patients with type-2 diabetes, also referred to as adult onset or non-insulin-dependent diabetes mellitus. It is now the 13th drug approved for type-2 diabetes in this country and the second member of a new class of diabetes drugs known as meglitinides. We listed the first meglitinide, repaglinide (PRANDIN), as a Do Not Use drug in the July 1998 issue of Worst Pills, Best...
The Food and Drug Administration (FDA) approved nateglinide (STARLIX) in December 2000 to lower blood sugar levels in patients with type-2 diabetes, also referred to as adult onset or non-insulin-dependent diabetes mellitus. It is now the 13th drug approved for type-2 diabetes in this country and the second member of a new class of diabetes drugs known as meglitinides. We listed the first meglitinide, repaglinide (PRANDIN), as a Do Not Use drug in the July 1998 issue of Worst Pills, Best Pills News because there are equally or more effective and less expensive drugs with better understood safety on the market to lower blood sugar. Nateglinide is produced by Swiss drug giant Novartis.
Both nateglinide and repaglinide work in a manner similar to the oldest class of diabetes drugs, the sulfonylureas—glipizide (GLUCOTROL) is an example—by stimulating the release of insulin from cells in the pancreas.
The professional product labeling, or “package insert,” for nateglinide suggests that this drug is minimally effective in lowering blood sugar and another measure of diabetes control, hemoglobin A1c (HbA1c) blood levels. The FDA approved use for nateglinide in patients whose blood sugar cannot be adequately controlled by diet and exercise and who have not been treated with oral diabetes drugs. Patients whose blood sugar has not been controlled with the older sulfonylurea class of drugs should not be switched to nateglinide, nor should nateglinide be added to their treatment. If the older drugs do not help, neither will nateglinide.
Nateglinide is approved for use in combination with metformin (GLUCOPHAGE), a member of the biguanide class of diabetes drugs. Nateglinide should not be substituted for metformin.
A study described in nate-glinide’s package insert found a negligible effect on blood sugar and HbA1c levels even at the drug’s highest recommended dose. These results were statistically significant in favor of nateglinide, but as is often the case with many new drugs, the clinical effect was insignificant.
In another clinical trial summarized in the package insert, involving patients whose blood sugar was not controlled after treatment with a sulfonylurea, the effect of nateglinide was compared with the sulfonylurea glyburide (DIABETA). Patients taking nateglinide had significant increases in their average blood sugar and HbA1c levels compared to those taking glyburide, thus worsening their diabetes control.
The editors of The Medical Letter On Drugs and Therapeutics, a source we often cite because of its reputation for providing independent drug information, reviewed nateglinide in April 2001. Their conclusion was to the point: “Nateglinide is a short-acting hypoglycemic agent that is less convenient and less effective than sulfonylureas and much more expensive. Its long term safety remains to be established.”
The FDA’s Division of Metabolic and Endocrine Drug Products, the group that is responsible for approving new diabetes drugs, has taken Congress’ mandate of a new mission for the FDA to heart as the drug industry’s partner in the development and marketing of new products. This new mission, along with an outmoded drug approval standard written 40 years ago, will continue to enable new drugs to come on the market even though they may be less effective or more dangerous than older ones. Nate-glinide is just one more example of this trend.
Novartis is attempting to create a “hook” to sell nateglinide by spinning its less convenient three times a day dosing requirement into a novel advance in the treatment of type-2 diabetes. The spin goes like this: there is a better correlation between the risk of cardiovascular disease from diabetes and blood sugar levels after eating than there is for fasting blood sugar levels (one of the blood tests usually performed to monitor diabetes treatment). It is thus implied that targeting elevated blood sugar levels after eating reduces cardiovascular risk and this can be accomplished by nateglinide because it must be given three times a day.
A physician associated with Novartis played up post-eating blood sugar levels in the
We have only a partial answer to a critical question: will the control of blood sugar with these compounds prevent the long term complications of type-2 diabetes? We have the answer for diabetics who can only use insulin (type-1 diabetes or insulin dependent diabetes) from a clinical trial called the Diabetes Control and Complications Trial (DCCT) published in the
The partial answer we have to the above question comes from the United Kingdom Prospective Diabetes Study (UKPDS) that was reviewed in the March 2000 issue of Worst Pills, Best Pills News. This study was begun in the late 1970s to examine the effect of drug treatment in reducing the long term complications of type-2 diabetes. The benefits of treatment were found to differ according to the drug and it was found that controlling blood pressure in diabetics with high blood pressure may be a more effective means of preventing complications than strict control of blood sugar.
Nevertheless, nateglinide was too new to be included in the UKPDS study and there is no evidence that it reduces long term complications of diabetes.
What You Can Do
There is no sound reason that you should be started on nateglinide if you require drug treatment to control type-2 diabetes. Diet and lifestyle modifications remain the cornerstone for management of this condition
