Linagliptin an Option in Elderly Diabetics: Study

August 30, 2013

NEW YORK (Reuters Health) Aug 30 - The dipeptidyl peptidase-4 (DPP4) inhibitor linagliptin was safe and effective for lowering glycated hemoglobin (HbA1c) in a controlled trial of elderly patients with poorly controlled type 2 diabetes.

Studies of glucose-lowering treatments in elderly diabetics and of the DPP4-inhibitor class in particular are "scarce," the study team notes. They think the DPP4 class can offer some advantages for older patients, including a reduced risk of hypoglycemia and no appreciable weight gain.

The trial, reported online August 13 in the Lancet by Dr. Anthony Barnett of the Heart of England NHS Foundation Trust in Birmingham and colleagues, included 241 type 2 diabetics aged 70 and older with an HbA1c level of 7.0% despite therapy with metformin, sulfonylureas, or basal insulin, or combinations of these drugs.

The patients were randomly assigned to add linagliptin 5 mg or matching placebo once daily for 24 weeks. The study was funded by Boehringer Ingelheim, which markets linagliptin as Tradjenta or Trajenta.

Mean HbA1c was 7.8% at baseline. The placebo-adjusted, mean change in HbA1c with linagliptin was -0�64% at 24 weeks.

Overall safety and tolerability were "much the same" between linagliptin and placebo, the authors report. Although hypoglycemia was reported more often with linagliptin (24.1%) than placebo (16.5%), this difference seems to be because more linagliptin than placebo patients received sulfonylureas; in patients not receiving sulfonylureas, hypoglycemia was not increased with linagliptin (14.9% vs 16.7% with placebo), which is consistent with previous studies, the authors say.

The manufacturer's website says the most common side effects of linagliptin include stuffy or runny nose, sore throat, cough and diarrhea.

The efficacy of linagliptin was unaffected by age, renal impairment, or diabetes duration, an important finding in view of the advanced disease and many comorbidities prevalent in both the study population and clinical practice, the authors say. Linagliptin "might be" a useful option for elderly diabetic patients, they conclude.

The authors did not respond to request for comment by press time.

The authors of an editorial say the study was "well designed and powered" to show a clinically meaningful, significant difference in HbA1c in the groups studied, without an increased risk of hypoglycemia. In general, the patients studied had levels of duration of diabetes and renal impairment commonly noted in older patients with this disorder.

However, the authors of the editorial think it's unfortunate that patients were not characterized as frail and non-frail, an omission they say makes it "unclear how representative of older people with diabetes their groups were."

Editorialists Dr. Alan Sinclair of the Institute of Diabetes for Older People, University of Bedfordshire, UK, and Dr. John Morley, Division of Geriatric Medicine and Endocrinology, Saint Louis University School of Medicine in Missouri, say the study "missed crucial opportunities to provide increased insight into the management of older patients with type 2 diabetes, and those who are frail in particular."

They also think the "description of HbA1c targets is vague and there is no mention of how these targets were discussed, managed, or achieved. Such practical issues are important and should not be neglected," they write.

Dr. Sinclair and Dr. Morley say other "important omissions" are the absence of prestudy assessments of cognition (a limitation acknowledged by the study team), low mood states, self-management ability, or involvement of informal carers - "all issues that have to be addressed in management of older patients."

Drs. Sinclair and Morley also note that attempts to lower HbA1c to 7.0% or less in older diabetics might "seem unnecessary or even dangerous" since higher targets are now recommended by several organizations.

"The investigators accept the limitations of this type of pharma-directed, short duration study. Longer-term monitoring data are needed to ensure safety of patients," the editorialists conclude.

Dr. Barnett has received honoraria for lectures and advisory work from Boehringer Ingelheim. The other five authors are employees of the company. The editorial authors have relationships with several pharmaceutical companies but not Boehringer Ingelheim.

SOURCE: http://bit.ly/1cOZWLw and http://bit.ly/1cOZWLw

Lancet 2013.

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