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Europe Approves Actos (Pioglitazone HCI) Monotherapy For Treatment Of Type 2 Diabetes

LONDON, ENGLAND -- September 5, 2003 -- Takeda UK Ltd announced today that the European Commission has granted marketing authorisation for the use of Actos (pioglitazone HCI) as oral monotherapy at doses up to 45 mg in type 2 diabetes mellitus patients, particularly overweight patients, inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance.

"The approval of the EU monotherapy indication is excellent news for physicians and patients," said Professor David Matthews, Professor of Diabetic Medicine, University of Oxford. "Many patients require a treatment approach that addresses one of the universal features of type 2 diabetes - namely insulin resistance. Giving therapies that sensitise the body to insulin is one logical approach, reducing both excess insulin levels and elevated fasting plasma glucose."

Actos is the first thiazolidinedione (TZD) in the EU by Takeda and Lilly to be approved for oral monotherapy in type 2 diabetes patients. Additionally, Actos is also indicated for oral combination treatment in type 2 diabetes at doses up to 45mg in patients with insufficient glycaemic control despite maximal tolerated dose of oral monotherapy with either metformin or sulphonylurea as follows:

- In combination with metformin particularly in overweight patients
- In combination with a sulphonylurea only in patients who show intolerance to metformin or for whom metformin is contraindicated

Takeda and Lilly anticipate launching the new Actos monotherapy indication throughout the European Union. The Actos 45mg tablet has been given a positive CPMP opinion and is currently going through the Commission phase.

"The approval of Actos for monotherapy is a significant step forward in the treatment of type 2 diabetes," added Dr David Eckland, Takeda Europe R&D Centre. "There is a growing realisation among physicians that improving glycaemic control alone is not enough. Researchers believe most cases of type 2 diabetes have insulin resistance which is a potential link between metabolic abnormalities and diabetic vascular complications - it is therefore critical to reduce insulin resistance."

Growing body of evidence

Data, very recently presented at the International Diabetes Federation (IDF) meeting in Paris, France demonstrated that Actos as monotherapy at doses up to 45mg, or in combination with metformin or sulphonylurea sustains improvements in blood glucose control and improves estimates of insulin sensitivity over the long term (52 weeks).¹

In addition, further data presented at the IDF demonstrated that treatment with Actos:
- Improved not only fasting, but also post prandial glucose² and post prandial lipids³
- Produced a favourable modification over metformin and glicazide in urinary albumin: creatinine ratio, a known cardiovascular risk factor⁴
- Showed class leading improvements in triglyceride and HDL-C levels in type 2 diabetes patients where diabetic dyslipidaemia is commonly present⁵
- Is not associated with any excess of cardiovascular morbidity compared to non-pioglitazone treatment.⁶
Up to 92% of patients with type 2 diabetes demonstrate insulin resistance⁷ that can result in hyperglycaemia, a major factor in the development of vascular disease. Insulin resistance is also commonly associated with lipid and coagulation factor abnormalities and places the patient at greater risk of hypertension and cardiovascular disease.⁷

Actos is a clinically proven, once a day medicine that belongs to a class of oral Type 2 Diabetes drugs called thiazoildinediones. Actos acts by reducing insulin resistance, and improving insulin sensitivity in the liver, skeletal muscle and adipose tissues. Actos is always taken once a day and also helps to lower and control blood sugar levels. In addition Actos also lowers triglyceride levels and raises HDL-cholesterol levels in Type 2 Diabetic patients with no statistically significant changes in LDL-cholesterol levels compared to Placebo.

Takeda UK Ltd is a wholly owned subsidiary of Takeda Chemical Industries, Ltd, the largest pharmaceutical company in Japan. Takeda is a research-based company and is one of the industry's leaders worldwide. Takeda is committed to strive towards better health for individuals and progress in medicine by developing superior pharmaceutical products.

References:
1. Edwards GC et al., Long-Term Combination Therapy with Pioglitazone plus Metformin for Type 2 Diabetes: Randomised Comparative Study with Gliclazide plus Metformin. Presented at International Diabetes Federation (IDF) meeting in Paris, France, August 2003.
2. Edwards GE et al., The effects of Pioglitazone, Metformin and Gliclazide as monotherapy or in combination on 3-hour OGTT investigations: Presented at International Diabetes Federation (IDF) meeting in Paris, France, August 2003.
3. Almajali KMS, et al., Impact of Lipid and Lipoprotein Metabolism in Type 2 Diabetes: Pioglitozone vs Sulphonylurea-Based Therapy at Similar Glycemic Control. Presented at International Diabetes Federation (IDF) meeting in Paris, France, August 2003.
4. Urquhart R et al., The Effects of Pioglitzone, Metformin or Gliclazide Therapy on Urinary Albumine Creatinine Ratio - Modification of a Cardiovascular Risk Marker. Presented at International Diabetes Federation (IDF) meeting in Paris, France, August 2003.
5 Lee CE et al., Favourable Effects of Pioglitazone Mono or Combination Therapy on the Atherogenic Index of Plasma - A Surrogate Marker of LDL Particle Size. Presented at the American Diabetes Association Annual Meeting, June 2003.
6. Eckland D et al., Cardiac Safety of Pioglitazone in comparison with Metformin and Gliclazide. Presented at International Diabetes Federation (IDF) meeting in Paris, France, August 2003.
7. Haffner SM, et al. Insulin sensitivity in subjects with Type 2 Diabetes. Relationship to cardiovascular risk factors: the Insulin Resistance Atherosclerosis Study. Diabetes Care. 1999;22:562-568.


SOURCE: Magellan Medical Communications

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