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New Data Demonstrate Treatment With ‘Januvia®’ (Sitagliptin) Reduces Hypoglycaemia In Elderly Populations

New data announced at the 48th European Association for the Study of Diabetes (EASD) annual meeting show results of post-hoc pooled analysis of patients with type 2 diabetes aged 65 or older.[1] Those treated with ‘Januvia®’ (sitagliptin) 100 mg/day achieved similar blood sugar reductions as those treated with a sulphonylurea (SU), with significantly less hypoglycaemia (low blood sugar).[1] Nearly a third (28.2%) of patients taking an SU experienced hypoglycaemia compared with just 6% of those treated with sitagliptin, a DPP-4 inhibitor licensed for the treatment of type 2 diabetes.[1]

Sitagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus as initial therapy, alone or in combination with metformin, or a PPARy agonist, or as an add-on to metformin, PPARy agonist, sulphonylurea, sulphonylurea + metformin or PPARy agonist + metformin when the current regimen, with diet and exercise does not provide adequate glycaemic control. Sitagliptin can also be used as an adjunct to diet and exercise to improve glycaemic control in combination with insulin (with or without metformin).

Hypoglycaemia occurs when the level of glucose in the blood falls too low; usually less than 4mmol/l.[2] Hypoglycaemia can be more of a challenge in elderly patients as their ability to recognise the symptoms of hypoglycaemia may be diminished.[3] When hypoglycaemia happens the person often experiences ‘warning signs’, which occur as the body tries to raise the blood glucose level. These ‘warning signs’ vary from person to person but often include feeling shaky, sweating, tingling in the lips, going pale, heart pounding, confusion and irritability.[2]

In a young person, whilst there can still be a need for medical assistance, the consequences are potentially less severe than in the elderly where the effects of dizziness and blurred vision can lead to an increased number of falls. These injuries can have serious consequences such as fractured neck of femur which has mortality between 12 and 20% greater than the comparative age-sex group within one year.[4] A recent study published in the Journal of the American Geriatric Society showed that patients whose HbA1c (glycated haemoglobin) was less than 6% were more than twice as likely to have a hip fracture compared to those with a HbA1c higher than 8%.[5] Hypoglycaemia was likely to be a contributing factor. Furthermore, 76% of the patients who suffered a hip fracture were taking a sulphonylurea compared to no patients taking sitagliptin.[5]

Research suggests that moderate or severe hypoglycaemia can affect up to 45% of people with type 2 diabetes in the UK over a 12 month period,[6] meaning that up to 1.3 million of the UK’s 2.9 million[7] people living with type 2 diabetes could be affected. In 2011, NHS spending on diabetes was almost £10 billion – or £1 million per hour – and 80% of this goes into managing potentially avoidable complications.[8] Every time someone is admitted to hospital because of severe hypoglycaemia, it costs the NHS about £1,000.[9]

“The general effects of aging complicate the treatment of diabetes in the elderly; in particular, hypoglycaemia is of greater concern in this population and may lead to dizziness and accidents or falls, which are more likely to be dangerous”,[5] said Dr Wasim Hanif, Consultant Physician, University Hospital Birmingham, “Therefore, careful consideration of treatment options for older patients is important.”

Living with Diabetes; Journey for Control

Also at EASD, MSD announced the launch of ‘Living with Diabetes; Journey for Control’. The programme’s aim is to give people with type 2 diabetes and their healthcare professionals, tools and support to help them effectively manage diabetes according to individual lifestyles. As part of this initiative, MSD carried out a survey among over 100 physicians in the UK regarding treatment of type 2 diabetes. Of these, 88% of doctors perceived sulphonylureas to have a high/very high risk of increasing the incidence of hypoglycaemia.[11] In comparison only a third (30%) of doctors perceived there to be a risk of hypoglycaemia with DPP-4 inhibitors.[10] There is also a webcast for journalists unable to attend EASD (for more information, please see Notes to Editors).

As part of their continued commitment to raising awareness of issues relating to diabetes, MSD have launched a new website. The website (containing advice from Dr Sarah Jarvis) www.saynotohypos.co.uk asks people to pledge to discuss the issues of hypoglycaemia with their doctor or nurse to raise awareness of the issue and includes a Hypo Highway game for people to test their knowledge.

The Study Methodology

This post-hoc analysis pooled data of elderly patients that completed trials through 30 weeks from three double-blind clinical studies of sitagliptin 100 mg/day (as monotherapy and in combination with metformin) compared to sulphonylureas (in titrated doses; glipizide or glimepiride).[1] The analysis compared the effects of sitagliptin 100 mg once daily or a sulphonylurea (in titrated doses) on change from baseline in HbA1c[1], fasting plasma glucose, body weight and the proportion of patients that experienced one or more episodes of symptomatic hypoglycaemia. In two studies, patients on diet alone or metformin were randomised to receive sitagliptin 100 mg/day (as a monotherapy or in combination with metformin) or glipizide (SU) (as a monotherapy or in combination with metformin) for 104 weeks, and in the third study patients were randomized to receive sitagliptin or glimepiride (SU) for 30 weeks. Since the third study was 30 weeks in duration, the analysis focused on results at or close to 30 weeks and included the 373 elderly patients who completed the trials through this time point.

Elderly patients taking sitagliptin 100 mg/day (n=178; 0.73 percent LS mean HbA1c reduction from a baseline of 7.5 percent) achieved similar blood sugar reductions as patients taking a sulphonylurea (n=195; 0.78 LS mean percent HbA1c reduction from a baseline of 7.5 percent).[1] Of the patients taking a sulphonylurea, 28.2 percent experienced one or more episodes of symptomatic hypoglycaemia, compared to 6.2 percent of patients taking sitagliptin.[1]

Source

[1] HbA1c is a measure of a person’s average blood glucose over a two- to three-month period.

1. Shankar R, Engel SS, Xu L, Golm GT, Davies MJ, Kaufman MD, Goldstein BJ. Sitagliptin provides similar glycaemic improvement with less hypoglycaemia in the elderly with type 2 diabetes mellitus compared to sulphonylurea. Poster presented 4th October 2012 at EASD

2. Diabetes.co.uk. Hypoglycaemia. http://www.diabetes.co.uk/Diabetes-and-Hypoglycaemia.html Accessed September 2012

3. Chau D, et al. Clinical Management of Diabetes in the Elderly. Clinical Diabetes October 2001; 19 (4)

4. Todd CJ, Freeman CJ. Differences in mortality after fracture of hip: the East Anglian audit.BMJ 1995; 310:904–908

5. Puar T, Khoo J, Cho L et al. Association between Glycaemic control and hip fracture. JAGS 2012; 60:1493-1497

6. Álvarez F, Guisasola, S. et al. Hypoglycaemic symptoms, treatment satisfaction, adherence and their associations with glycaemic goal in patients with type 2 diabetes mellitus: findings from the Real-Life Effectiveness and Care Patterns of Diabetes Management (RECAP-DM) Study. Diabetes Obesity and Metabolism. 2008;10 Suppl 1:25-32

7. Diabetes UK. What is diabetes? http://www.diabetes.org.uk/Guide-to-diabetes/Introduction-to-diabetes/What_is_diabetes/ Accessed September 2012

8. Diabetes UK. State of the Nation Report 2012

9. Amiel SA et al. Hypoglycaemia in Type 2 diabetes. Diabetic Medicine. 2008; 25: 245–254

10. MSD data on file

MSD