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Starlix

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Starlix

SIDE EFFECTS

In clinical trials, approximately 2,600 patients with Type 2 diabetes were treated with Starlix® (nateglinide). Of these, approximately 1,335 patients were treated for 6 months or longer and approximately 190 patients for one year or longer. Hypoglycemia was relatively uncommon in all treatment arms of the clinical trials. Only 0.3% of Starlix patients discontinued due to hypoglycemia. Symptoms suggestive of hypoglycemia have been observed after administration of nateglinide. These symptoms included sweating, trembling, dizziness, increased appetite, palpitations, nausea, fatigue, and weakness.

Gastrointestinal symptoms, especially diarrhea and nausea, were no more common in patients using the combination of Starlix and metformin than in patients receiving metformin alone. Likewise, peripheral edema was no more common in patients using the combination of Starlix and rosiglitazone than in patients receiving rosiglitazone alone. The following table lists events that occurred more frequently in Starlix patients than placebo patients in controlled clinical trials.

Common Adverse Events ( ≥ 2% in Starlix® patients) in Starlix® Monotherapy Trials (% of patients)

Preferred Term Placebo
N=458
Starlix®
N=1441
Upper Respiratory Infection 8.1 10.5
Back Pain 3.7 4.0
Flu Symptoms 2.6 3.6
Dizziness 2.2 3.6
Arthropathy 2.2 3.3
Diarrhea 3.1 3.2
Accidental Trauma 1.7 2.9
Bronchitis 2.6 2.7
Coughing 2.2 2.4
Hypoglycemia 0.4 2.4

During post-marketing experience, rare cases of hypersensitivity reactions such as rash, itching and urticaria have been reported. Similarly, cases of jaundice, cholestatic hepatitis and elevated liver enzymes have been reported.

Laboratory Abnormalities

Uric Acid: There were increases in mean uric acid levels for patients treated with Starlix alone, Starlix in combination with metformin, metformin alone, and glyburide alone. The respective differences from placebo were 0.29 mg/dL, 0.45 mg/dL, 0.28 mg/dL, and 0.19 mg/dL. The clinical significance of these findings is unknown.

Read the Starlix (nateglinide) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Nateglinide is highly bound to plasma proteins (98%), mainly albumin. In vitro displacement studies with highly protein-bound drugs such as furosemide, propranolol, captopril, nicardipine, pravastatin, glyburide, warfarin, phenytoin, acetylsalicylic acid, tolbutamide, and metformin showed no influence on the extent of nateglinide protein binding. Similarly, nateglinide had no influence on the serum protein binding of propranolol, glyburide, nicardipine, warfarin, phenytoin, acetylsalicylic acid, and tolbutamide in vitro . However, prudent evaluation of individual cases is warranted in the clinical setting.

Certain drugs, including nonsteroidal anti-inflammatory agents (NSAIDs), salicylates, monoamine oxidase inhibitors, non-selective beta-adrenergic-blocking agents, guanethidine, and CYP2C9 inhibitors (e.g. fluconazole, amiodarone, miconazole, oxandrolone) may potentiate the hypoglycemic action of Starlix and other oral antidiabetic drugs.

Certain drugs including thiazides, corticosteroids, thyroid products, sympathomimetics, somatropin, rifampin, phenytoin and dietary supplements (St John's wort) may reduce the hypoglycemic action of Starlix and other oral antidiabetic drugs. Somatostatin analogues may potentiate or attenuate the hypoglycemic action of Starlix.

When these drugs are administered to or withdrawn from patients receiving Starlix, the patient should be observed closely for changes in glycemic control.

Drug/Food Interactions

The pharmacokinetics of nateglinide were not affected by the composition of a meal (high protein, fat, or carbohydrate). However, peak plasma levels were significantly reduced when Starlix was administered 10 minutes prior to a liquid meal. Starlix did not have any effect on gastric emptying in healthy subjects as assessed by acetaminophen testing.

Read the Starlix Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 9/7/2011
This monograph has been modified to include the generic and brand name in many instances.

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