Starlix


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  Novartis Pharma US

 

Case Study #1:

SU Candidate ... or Not?

Presentation:

 49-year-old, 5'3", 166-lb female
 Type 2 diabetes diagnosed 3 years ago
 Treated with metformin titrated to 1000 mg b.i.d.
 Significant postprandial hyperglycemia
 Nutritional Counselor recommended weight loss
 A1c: 10.3%

With weight loss:
 BMI: reduced from 28.5 to 25.1
 Fasting glucose dropped from 210 mg/dL to 170  mg/dL
 2-hour postprandial glucose: 254 mg/dL
 A1c remained elevated at 8.5%

Medical History:

 Gestational diabetes 10 years ago

Treatment Consideration:

 Target postprandial glucose level — a significant determinant of patient's   elevated A1c
 Avoid drugs (such as SUs) that may cause an increased risk of   hypoglycemia due to inconsistent mealtimes

STARLIX Treatment and Results:

 Initiated STARLIX 120 mg at meals instead of an SU
 No symptoms of hypoglycemia
 No weight gain
 Fasting glucose reduced to 138 mg/dL
 2-hour postprandial glucose reduced to 183 mg/dL
 A1c decreased to 6.9% in 3 months*

Conclusion:

 STARLIX added mealtime control to get patient to A1c goal

* In clinical trials, when STARLIX was added to metformin there was a mean reduction of 0.6% A1c. Individual patient responses may vary.

Important Safety Information

STARLIX is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

STARLIX is contraindicated in patients with a known hypersensitivity to the drug or its inactive ingredients, in patients with type 1 diabetes, or in patients with diabetic ketoacidosis. Patients with ketoacidosis should be treated with insulin.

All oral blood glucose lowering drugs that are absorbed systemically are capable of producing hypoglycemia. Patients should be advised to take STARLIX 1 to 30 minutes prior to eating a meal and to skip the dose if the meal is missed.

STARLIX should be used with caution in patients with moderate to severe liver disease because such patients have not been studied.

The most common adverse events associated with STARLIX vs placebo were upper respiratory infection (10.5% vs 8.1%), back pain (4.0% vs 3.7%), flu symptoms (3.6% vs 2.6%), dizziness (3.6% vs 2.2%), arthropathy (3.3% vs 2.2%), and diarrhea (3.2% vs 3.1%).

Please see the full prescribing information.


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