Nearly two-thirds of GPs are unaware that insulin resistance, a fundamental cause of type 2 diabetes, is thought to be present in 92% of people with the disease

November 05, 2001

Nearly two-thirds of GPs are unaware that insulin resistance, a fundamental cause of type 2 diabetes, is thought to be present in 92% of people with the disease

While GPs' understanding of the definition of insulin resistance is excellent (85% know it is the inability of the body to respond to its own insulin1), the number of patients that it affects is being greatly underestimated. An independent survey carried out by Taylor Nelson Sofres* has revealed that 60% of GPs and 85% of practice nurses are unaware that at least 92% of people with type 2 diabetes are insulin resistant1,2,3.

Eighty-seven percent of GPs understand that insulin resistance is related to the development of cardiovascular complications.1 However, it may be extremely difficult to optimise treatment without widespread appreciation of the prevalence of insulin resistance in type 2 diabetes.

'Cardiovascular disease is the principal cause of death amongst these patients4. Treatment of insulin resistance improves glycaemic control and the UKPDS study has shown that maintenance of glycaemic control may reduce the risks of CV complications associated with type 2 diabetes5,6,' comments Dr Peter Tasker of Primary Care Diabetes UK. 'New treatments that increase the body's sensitivity to insulin address this problem and may therefore impact on cardiovascular risk factors. If the prevalence of insulin resistance in type 2 diabetes patients is not appreciated it could be hard to optimise treatment.'

This view is supported by further survey data. Research has shown that increasing the body's sensitivity to its own insulin using drugs such as AVANDIA (rosiglitazone) - a member of the thiazolidinedione (TZD) class of oral antidiabetic agents - can result in improved glycaemic control7,8. Studies have also shown that AVANDIA has positive effects on a range of cardiovascular risk factors9-13. However, the survey shows only 10% of GPs questioned would introduce a TZD in a patient found to be uncontrolled using conventional monotherapy1**, perhaps meaning that the full potential of available treatments is not being realised.

These survey results highlight the need for greater understanding of the prevalence of insulin resistance to enable GPs to make informed treatment decisions. In support of this goal GlaxoSmithKline is launching the TIME2COMBINE initiative to maximise awareness of insulin resistance as a fundamental cause of type 2 diabetes and of treatment combinations that will help patients reach their glycaemic goals. TIME2COMBINE educational meetings are currently being held across the UK for all levels of healthcare professional. Practical tools and services to enable healthcare providers and patients to manage the disease effectively will shortly become available.
-end-
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

For further information please contact: Becky Down or Siân Boisseau, Shire Hall Communications, 0207 313 6300 GSK press contact: Tim Brown, 0208 990 2144

AVANDIA prescribing information can be found on the final page of this document.

Notes to Editors

* Survey commissioned by GlaxoSmithKline - carried out using the Taylor Nelson Sofres Omnimed service

**Conventional monotherapy treatment of type 2 diabetes is treatment with either metformin or sulphonylureas

References

1. Data on file. GP type 2 diabetes survey, commissioned by GlaxoSmithKline. September 2001.

2. Data on file. Practice nurse type 2 diabetes, commissioned by GlaxoSmithKline. September 2001.

3. 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.

4. British Diabetic Association. The Kings Fund. Counting the costs; the real impact of non insulin dependent diabetes mellitus.1996.

5. UKPDS. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35) : prospective observational study. BMJ 2000;321:405-412.

6. UKPDS. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet 1998; 352:854-865

7. Jones NP et al. Long-term efficacy of rosiglitazone as monotherapy or in combination with metformin. Diabetologia 2000;43 (supplement 1) A192, Abs 736.

8. Data on file. SmithKline Beecham. Long term efficacy of rosiglitazone added to sulphonylureas (AVDF0330A). 2000.

9. Bakris GL et al. Rosiglitazone improves blood pressure in patients with type 2 diabetes mellitus. Diabetes 2000. 49(supplement1): A96, Abs 388

10. Data on file. SmithKline Beecham. AVANDIA summary of product characteristics. 2001.

11. Bakris GL et al. Rosiglitazone produces long-term reductions in urinary albumin excretion in type 2 diabetes. Diabetologia 1999;42 (supplement 1) Abs 865 + poster.

12. Freed M et al. Effect of combination therapy with rosiglitazone and Glibenclamide on PAI-1 antigen, PAI-1 activity, and tPA inpatients with type 2 diabetes. Diabetologia 2000;43 (supplement1): A267, Abs 1024 + poster.

13. Greenberg A et al. Rosiglitazone reduces c-reactive protein, a marker of systematic inflammation, in type 2 diabetic patients. Diabetologia 2001;44 (supplement1): A222, Abs 853.Prescribing Information

AVANDIAt

rosiglitazone

Presentations 'Avandia' 4 mg Film-coated Tablets containing 4 mg rosiglitazone in opaque blister packs of 28 EU/1/00/137/006 £26.60 and 56 EU/1/00/137/007 £53.20 and 'Avandia' 8 mg Film-coated Tablets containing 8 mg rosiglitazone in opaque blister packs of 28 EU/1/00/137/011 £54.60 Indications Oral combination treatment of Type 2 diabetes in patients with insufficient glycaemic control despite maximal tolerated dose of either metformin or a sulphonylurea: with metformin in obese patients; with a sulphonylurea in patients who show intolerance to or are contraindicated for metformin. Posology and administration Initiation by a physician experienced in Type 2 diabetes. 4 mg once daily. Can increase to 8 mg/day after 8 weeks in combination with metformin (8 mg od or 4 mg bd). Elderly & mild/moderate renal impairment No dose adjustment required. Hepatic impairment & severe renal insufficiency Should not be used. Children and adolescents Not recommended. Contraindications Hypersensitivity to rosiglitazone or excipients, cardiac failure or history of cardiac failure (NYHA stages I to IV), hepatic impairment, in combination with insulin. Special warnings and precautions No experience in triple combination with oral anti-diabetics. Should not be used in monotherapy. Fluid retention and cardiac failure Can cause fluid retention which may exacerbate or precipitate heart failure. Should be discontinued if deterioration in cardiac status. Increased incidence of cardiac failure in clinical trials when used with insulin. Heart failure reported more frequently when history of heart failure, elderly and mild or moderate renal failure. NSAIDs also associated with fluid retention, concomitant administration may increase risk of oedema. Monitoring of liver function Rare reports of hepatocellular dysfunction post-marketing, periodic monitoring of liver enzymes is therefore recommended. See SPC for details of monitoring and advice on when to discontinue therapy. Therapy should not be initiated in patients with increased baseline levels (ALT >2.5xULN) or other evidence of liver disease. Weight gain Weight should be closely monitored. Anaemia Treatment can be associated with reduced haemoglobin, if levels low before initiation, risk of anaemia increases. Others As a consequence of improving insulin sensitivity, ovulation may resume in patients anovulatory due to insulin resistance. If patients wish to become pregnant, or if pregnancy occurs, treatment should be discontinued. Rosiglitazone not recommended in severe renal impairment. Caution when administering paclitaxel concomitantly. Interactions In vitro studies demonstrate rosiglitazone predominantly metabolised by CYP2C8, with CYP2C9 a minor pathway. Pregnancy and lactation Potential risk for humans unknown. Should not be used during pregnancy nor in women who are breast-feeding. Ability to drive and use machines No effects observed. Undesirable effects Suspected/probable adverse reactions reported as more than an isolated case in combination with sulphonylurea or metformin in double-blind studies, frequencies are: common 1% - 10%; uncommon 0.1% - 1%: IN COMBINATION WITH METFORMIN RBC Common: anaemia. Metabolism Common: hypoglycaemia, hyperglycaemia. Uncommon: hyperlipidaemia, lactic acidosis, diabetes mellitus aggravated, hypercholesterolaemia. Nervous System Common: headache. Uncommon: dizziness. GI Common: diarrhoea, flatulence, nausea, abdominal pain, dyspepsia. Uncommon: vomiting, anorexia, constipation. Body as a Whole Common: fatigue. IN COMBINATION WITH SULPHONYLUREA RBC Uncommon: anaemia. Platelets Uncommon: thrombocytopenia. Metabolism Common: hypoglycaemia, hyperglycaemia, weight increase. Uncommon: hypercholesterolaemia, hyperlipidaemia, hypertriglyceridaemia. Psychiatric Uncommon: somnolence. Nervous System Uncommon: dizziness, headache, paresthesia. Respiratory Uncommon: dyspnea. GI Uncommon: abdominal pain, flatulence, nausea, appetite increased. Skin and appendages Uncommon: alopecia, rash. Body as a Whole Uncommon: fatigue, asthenia. In double blind studies oedema occurred in 3.0% and 4.4% of patients with rosiglitazone + sulphonylurea and + metformin respectively. Incidence of anaemia was higher with rosiglitazone + metformin. Hypercholesterolaemia reported in 3.6% and 2.1% of patients on rosiglitazone + sulphonylurea and + metformin respectively. Increase in both HDLc and LDLc, ratio of total cholesterol:HDLc unchanged or improved in long term studies. These increases were generally mild to moderate and usually did not require discontinuation. In clinical trials elevations of ALT >3xULN were equal to placebo (0.2%). Rare cases (0.01 - 0.1%) of elevated liver enzymes and hepatocellular dysfunction reported post-marketing. Although in very rare cases fatal outcome reported, causal relationship not established. Heart failure occurred uncommonly in double-blind studies of rosiglitazone + sulphonylurea (0.6%) or + metformin (0.3%) but with a 4x higher incidence in combination with insulin (2.5%). Rare cases (0.01 - 0.1%) of congestive heart failure and pulmonary oedema have been reported post-marketing. In 24-month studies, rosiglitazone was associated with a mean weight increase of 3.7% in combination with metformin and 6.3% in combination with sulphonylurea. Overdose In volunteer studies single oral dose of up to 20 mg well tolerated. Supportive treatment should be initiated, dictated by patient's clinical status. Rosiglitazone not cleared by haemodialysis. Marketing Authorisation holder: SmithKline Beecham Pharmaceuticals, Welwyn Garden City, Hertfordshire AL7 1EY. Further information is available from: Customer Contact Centre, GlaxoSmithKline, Stockley Park West, Uxbridge, Middlesex UB11 1BT; customercontactuk@gsk.com; Freephone 0800 221 441.

POM

'Avandia' is a trademark of the GlaxoSmithKline Group of Companies. © July 2001

Shire Hall Communications

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