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How recent papers on diabetes could change the way you practise

Dr Roger Gadsby looks at recent papers on diabetes that could change the way you practise

Dr Roger Gadsby looks at recent papers on diabetes that could change the way you practise

Can people with type 2 diabetes starting on insulin therapy safely titrate their own dose of insulin up?

Paper: Davies M et al for the AT.LANTUS Study Group. Improvement in glycaemic control in subjects with poorly controlled type 2 diabetes. Diabetes Care 2005 28; 1282-1288

Method: This paper reports a prospective multicentre 24-week randomised trial in 4,961 people with type 2 diabetes who were suboptimally controlled. Some were on tablets only, others tablets and insulin. The study compared two treatment algorithms for initiation and titration of insulin glargine, one investigator led, the other patient led.

Results: The patient-led treatment algorithm resulted in a greater drop of HBA1c of 1.22 per cent compared with 1.08 per cent in the investigator led one, with no difference in hypoglycaemia.

Study conclusions: Insulin glargine is safe and effective in improving glycaemic control in a large diverse population with longstanding type 2 diabetes. A simple subject-administered titration algorithm conferred significantly improved glycaemic control with a low incidence of severe hypoglycaemia compared with a physician-managed titration.

What I am going to do: Allow people to titrate their dose of long-acting insulin up by following the treatment algorithm.

Does pioglitazone reduce CVD risk as well as lower glucose?

Paper: Dormandy JA et al on the behalf of the PROactive investigators. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive study (PROspective pioglitAzone Clinical Trial in macroVasular Events): a randomised controlled trial. Lancet 2005 366; 1279-1289

Method: Prospective randomised controlled trial in 5,238 patients with type 2 diabetes who had evidence of macrovasular disease. People were given pioglitazone titrated from 15 to 45mg or placebo in addition to all other treatments. The primary endpoint was a composite including endovascular or surgical intervention, and the predefined secondary endpoint was death plus non-fatal stroke or myocardial infarction.

Results: Average time of observation was 34.5 months. There were 514 in the pioglitazone group and 572 in the placebo group who had at least one event in the primary composite endpoint. This reduction in the primary endpoint of 9 per cent did not reach statistical significance. The reduction of 16 per cent in the secondary endpoint did. The safety and tolerability of pioglitazone was good. Some 6 per cent of the pioglitazone group and 4 per cent of the placebo group were admitted to hospital with heart failure. Mortality rates for heart failure did not differ between the groups. There was a 47 per cent reduction in numbers starting insulin in the pioglitazone group. There was more oedema and heart failure in the pioglitazone group, but admissions for heart failure were similar in both groups.

Study conclusions: This was a well-executed placebo-controlled study with a large number of subjects in a very high-risk population in which the primary endpoint did not reach statistical significance, but a clinically significant secondary endpoint did reach statistical significance. The results of this study have engendered a lot of debate. The reduction in the need for insulin in the pioglitazone group is interesting.

What I am going to do: I think this study gives hard endpoint data to suggest that pioglitazone has an effect in reducing CVD risk, and gives evidence to use pioglitazone as the first addition to metformin therapy in people with type 2 diabetes, rather than using a sulphonylurea, which is known not to reduce CVD risk.

Should we treat gestational diabetes?

Paper: Crowther C et al for the Australian Carbohydrate Intolerance Study in Pregnant women (ACHOIS) Trial Group. Effect of Treatment of Gestational Diabetes Mellitus on Pregnancy Outcomes.N Eng J Med 2005 352; 2477 - 86

Method: A randomised clinical trial in which 510 women between 24 and 34 weeks with gestational diabetes received routine care and an intervention group of 490 women received dietary advice, blood glucose monitoring and insulin therapy as needed.

Results: The rate of serious perinatal complications was significantly lower among the infants in the intervention group (1 per cent v 4 per cent) LSCS rates were similar in the two groups but there was a high rate of induction of labour in the intervention group and children were more likely to be admitted to the neonatal nursery. Three months after delivery, data on mood and quality of life from 573 women revealed lower rates of depression and higher scores, consistent with improved health status in the intervention group.

Study conclusions: The authors concluded that treatment of gestational diabetes reduces serious perinatal morbidity and may also improve the woman's health-related quality of life.

What I am going to do: There has been a lack of evidence as to whether diagnosing and treating gestational diabetes is worthwhile. As a result different hospitals have different policies. This good-quality randomised trial clearly indicates a benefit from treatment and is therefore likely to change policy and management. I need to check that this is happening at my local hospital.

Statin treatment in people with type 2 diabetes reduces risk of adverse CHD events but is it cost-effective?

Paper: Heart Protection Study Collaborative Group. Cost-effectiveness of simvastatin at different levels of vascular disease risk: economic analysis of a randomised trial in 20536 individuals. Lancet 2005 365; 1779-1785

Method: The paper is a cost-effectiveness analysis from the Heart Protection Study.

Results: Using 2001 prices they calculate that the cost of preventing a major vascular event ranges from £4,500 to those with the highest risk (a 42 per cent five-year risk) to £31,000 in those with more modest risk a 12 per cent five-year rate). The cost of preventing a vascular death ranges from £20,700 in patients with the highest risk to £296,300 in those with a more modest risk.

Study conclusions: Statin therapy is cost-effective for a wider range of individuals with vascular disease or diabetes than previously recognised. It would be appropriate to consider reducing the estimated level of vascular event risk at which statin therapy is recommended.

What I am going to do: Be more confident that treating people with type 2 diabetes is cost-effective

How can diabetes care be improved?

Paper: O'Connor PJ et al. Randomised trial of Quality Improvement Intervention to Improve Diabetes Care in Primary Care settings. Diabetes Care 2005 28; 1890-1897

Method: Randomised controlled trial of 12 GP practices in the US randomised to intervention or control. Intervention clinic staff were trained in a seven-point quality improvement (QI) change process to improve diabetes care. Surveys and medical records review of 754 patients, surveys with 329 clinic staff, interviews with clinic leaders and analysis of training session videos eval-uated compliance with and impact of theintervention.

Results: All intervention clinics had broader staff participation in QI activities, used patient registers more often and had better process rates for HbA1c and BP measurements. The intervention did not improve HbA1c, blood pressure or a composite of these outcomes.

Study conclusions: This paper shows how hard it is to get a positive result from an RCT of an intervention to improve care. The authors approached about 100 clinics before getting 12 to agree to take part. The levels of process achievement in both groups for HbA1c were around 70-77 per cent, BP 90 per cent, cholesterol 45 per cent, creatinine 40 per cent, retinal screening 39 per cent, foot exam 58 per cent, flu vaccination 33 per cent and average HbA1c was around 8 per cent.

What I am going to do: All the results obtained in this US trial are much lower than in the UK QOF. I am very pleased with the results coming from the QOF for diabetes in the UK, and I will try to score more diabetes points this year.

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