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The Pharmaceutical Journal Vol 265 No 7111 p288
August 26, 2000 Clinical

NICE favours rosiglitazone use as insulin alternative

Smithkline Beecham's new drug rosiglitazone (Avandia) should be offered as an alternative to injected insulin for certain patients with type 2 diabetes, the National Institute for Clinical Excellence has recommended.
In guidance issued on August 18, the NICE recommends that patients with inadequate blood glucose control on oral monotherapy with metformin or sulphonylurea should first be offered combination therapy with these drugs, unless there are contraindications or tolerability problems. Patients who are unable to take metformin and sulphonylurea combination therapy, and those whose blood glucose remains high despite adequate trial of this treatment, should be offered rosiglitazone combination therapy as an alternative to insulin.
The NICE comments that the combination of rosiglitazone with metformin is preferred to rosiglitazone with sulphonylurea, particularly for obese patients. Rosiglitazone with sulphonylurea may, it says, be offered to patients who show intolerance to metformin or for whom metformin is contraindicated.
Rosiglitazone is not licensed for use in triple therapy with other glucose lowering agents.
The NICE says that the drug is effective at reducing blood glucose when added to monotherapy (metformin or sulphonylurea) for patients who have inadequate glycaemic control on these drugs. It adds that there is no direct evidence from comparative trials that adding rosiglitazone to metformin or sulphonylurea for this group of patients is any more or less effective at improving glycaemic control than moving to a metformin plus sulphonylurea combination or initiating insulin therapy.
The use of rosiglitazone in place of insulin could cost an additional £14.5m a year in England and Wales, the NICE estimates. This is calculated on the basis of SB's estimate that 72,800 patients are potentially suitable for rosiglitazone therapy.
Rosiglitazone cannot be used in patients with heart failure, hepatic failure or severe renal insufficiency.

Avandia
Long-term studies now needed, says the NICE

Further research

The 1998 UK Prospective Diabetes Study (UKPDS) showed that improved glycaemic control in type 2 diabetes reduces the incidence of diabetic complications. The NICE suggests that further research is now needed to determine the effect of rosiglitazone plus metformin or sulphonylurea compared with metformin/sulphonylurea or insulin on longer term impact on cardiovascular risk factors and the incidence of microvascular and macrovascular diabetic complications.

Guidance welcomed

The guidance was welcomed by Smithkline Beecham. While the NICE recommendation to use a metformin/sulphonylurea combination before rosiglitazone suggests more restrictive use of rosiglitazone than the licensed indications (which are for use in patients with insufficient control after monotherapy with metformin or a sulphonlyurea), SB told The Journal that, in practice, there was little difference as the licence effectively restricted use to patients who could not take the metformin/sulphonylurea combination. This was because rosiglitazone was only licensed for use with a sulphonylurea in patients who could not take metformin and only licensed for use with metformin in obese patients, and such patients were unlikely to be given a sulphonylurea, the company said.
Mr Andrew Dillon (NICE chief executive) commented that the guidance should ensure uniform take-up of rosiglitazone throughout the NHS.
The Association of the British Pharmaceutical Industry acknowledged the NICE endorsement of rosiglitazone but questioned what purpose was served by further examination of a drug that had already been approved as effective by the regulatory authorities. The ABPI added: "It is important that the guidance is now implemented quickly and fully to show that appropriate NICE guidance can ensure patients benefit from advances in modern medicines."