Pioglitazone receives new indication for use with insulin

Pioglitazone (Actos; Takeda, High Wycombe) has received a new indication for combination with insulin in the treatment of people with type 2 diabetes.

In February 2007 the European Medicines Agency (EMEA) extended the marketing authorisation for pioglitazone. The EMEA have approved the use of pioglitazone as a combination therapy with insulin in people with type 2 diabetes with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance. Pioglitazone is currently the only glitazone with this new indication across the EU.

Pioglitazone was first granted a marketing authorisation in the EU on 13 October 2000. In addition to the new indication, pioglitazone is currently authorised for the treatment of type 2 diabetes, either as mono, dual or triple oral therapy in combination with metformin and/or a sulphonylurea in people who have insufficient glycaemic control despite oral therapy.

Professor Anthony Barnett, Professor of Medicine at the University of Birmingham and Head of Diabetes Services at the Heart of England NHS Foundation Trust commented that: ‘This is very good news both for people with diabetes and healthcare professionals. Many people with type 2 diabetes are insulin resistant. The combination of insulin with a drug which improves insulin sensitivity is both logical and supported by clinical trial data. This new treatment combination, together with the appropriate monitoring, offers a valuable new option for this group.’

First incretin mimetic launched
Exenatide (Byetta; Eli Lilly and Company, Basingstoke; Amylin Pharmaceuticals, Münster) was launched at the Diabetes UK Annual Professional Conference in Glasgow in March 2007. Exenatide is the first in a new class of medicines for the treatment of type 2 diabetes known as incretin mimetics and was authorised for use in Europe by the EMEA in November 2006. It is expected to be available in the UK from May 2007 as both a 5µg and 10µg prefilled pen injector device.

Exenatide mimics the actions of GLP-1, a naturally occurring incretin hormone that is released from the gut in response to food intake, by stimulating b-cells in the pancreas to produce insulin only in response to raised blood sugar.

Exenatide is licensed for treatment in combination with metformin and/or sulphonylureas in people with type 2 diabetes who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.

Studies have shown that exenatide controlled HbA1c as effectively as insulin glargine and biphasic insulin aspart in people with type 2 diabetes failing to achieve adequate glycaemic control on  metformin and/or a sulfonylurea.

Majority of GPs want QOF updated in line with JBS 2
Despite already being required to meet the targets outlined by the Quality and Outcomes Framework (QOF) of the General Medical Services (GMS) contract, 66% of 1000 GPs surveyed expressed that they want cholesterol targets updated and tightened in line with the evidence-based Joint British Societies’ Guidelines for the Prevention of Cardiovascular Disease in Clinical Practice (JBS 2). This would mean treating patients to an LDL-c level of below 2mmol/l and a total cholesterol (TC) level of below 4mmol/l, rather than the GMS recommended values of 3mmol/l and 5mmol/l for LDL-c and TC respectively.

Over 90% of GPs also feel that people with diabetes and those who have experienced a previous cardiovascular event would particularly benefit from a reduction in TC to below 4mmol/l.

Of the GPs surveyed, 88% are aware of the recommendations outlined by the JBS2, with 96% of that group implementing them in some form within their clinical practice. A lack of knowledge and resources are cited as being key reasons why GPs may not be implementing the JBS2 recommendations for obesity (55%) and screening people over 40 years of age (14%).

Unistik 3 for pain reduction in blood glucose testing
Owen Mumford’s (Oxford) single use disposable capillary blood lancet, Unistik 3, is now available on prescription. The manufacturers describe the Unistik 3 as easy to use, safe and unique. It uses patented ‘Comfort Zone Technology’ – a series of eight raised dots that when pressed against the skin masks the feeling of pain caused by the penetrating lancet.

The design of Unistik 3 ensures a fresh lancet is used every time a blood sample is taken, reducing the risk of possible cross infection. The preloaded lancet remains hidden from view, penetrating the skin to precisely the right depth when fired before automatically retracting, eliminating the risk of needle stick injuries. It is also very easy to teach people to use.

To use, simply twist off a protective cap, place the Comfort Zone platform against the finger and press the release button. The needle automatically retracts making for safe disposal. A fresh lancet is used for each new test.

Dr David Edwards, a GP at the White House Surgery in Chipping Norton adds: ‘While at first glance Unistik 3 may not appear to be much, it is making the lives of those who need to take regular blood samples much easier and more comfortable.’