Pramlintide-Related Improvements in Diabetes Benefit Patients' Psyche: Presented at ADA
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Pramlintide-Related Improvements in Diabetes Benefit Patients' Psyche: Presented at ADA

By Jill Stein

SAN FRANCISCO -- June 8, 2008 -- The initiation of pramlintide treatment in type 2 diabetics is associated with a reduction in distress, primarily because of its effect in improving glucose control, researchers announced here at the American Diabetes Association (ADA) 68th Scientific Sessions.

Richard R. Rubin, PhD, Johns Hopkins University, Baltimore, Maryland, led a team in evaluating the efficacy and safety of the addition of pramlintide or placebo to an established regimen of insulin glargine and the subsequent e ffects on diabetes-related distress in 211 type 2 diabetics.

"Diabetes-related distress is common among diabetics and is associated with poor glycaemic control, elevated lipids, problematic self-care behaviour, and less effective self-care problem solving," Dr. Rubin noted here on June 7 in a poster presentation.

In this trial, clinical markers (haemoglobin [Hb] A1C, postprandial glucose [PPG], body mass index [BMI]/weight, and basal insulin dose) and the Diabetes Distress Scale (DDS) were evaluated at the time of enrolment and at week 16.

Week 16 changes in Hb A1C, PPG, and weight favoured pramlintide-treated patients (all P <= .05).

The change in insulin dose was not significantly different between arms. Reduction in insulin dose was associated with lower total DDS scores and with lower emotional burden as well as regimen-related and interpersonal subscale scores at study end (all P < .01).

Reduction in postprandial glucose level was associated with lower total DDS scores and with lower physician-related and interpersonal subscale scores at study end (all P < .05).

Reduction in Hb A1C level was associated with lower emotional burden and regimen-related subscale scores at study end (both P < .05).

Change in weight was not significantly associated with any end-of-study DDS score.

These changes in clinical markers explained significant increments to variance in end-of-study DDS scores: total DDS = 0.06, emotional burden = 0.05, physician-related = 0.01, regimen-related = 0.07, and interpersonal = 0.04.

Dr. Rubin said that the difference between treatment arms in diabetes-related distress can be ascribed to the differential impact of treatment on glucose control, because a change in Hb A1C satisfied the conditions for mediation of regimen distress, and changes in Hb A1C met the conditions for mediation of overall diabetes.

Dr. Rubin added that these results suggest that improvements in diabetes clinical outcomes are recognised by patients and make a difference in their diabetes-related psychological well-being.

Finally, Dr. Rubin noted that, in clinical practice, patient-related outcomes might be enhanced if patients were given personalised feedback at regular intervals during long-term interventions, summarising and emphasising any major clinical benefits that are achieved.

"The assessment of patient-reported outcomes, including diabetes-related distress, is now recognised as an important issue when determining the efficacy of a new diabetes treatment," Dr. Rubin concluded. "Treatments or other interventions that reduce diabetes distress may encourage treatment adherence and subsequent metabolic control, while treatments that increase diabetes duration may have the opposite effect."

Funding for this study was provided by Amylin Pharmaceuticals, Inc.

[Presentation title: Clinical Outcomes and Diabetes-Related Distress in Patients With Type 2 Diabetes Using Pramlintide. Abstract 1859-P]

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