Effect of Adjunctive Pramlintide Treatment on Treatment Satisfaction in Patients With Type 1 Diabetes

Abstract

OBJECTIVE -To assess the effect of adjunctive pramlintide treatment on treatment satisfaction in patients with type 1 diabetes treated with intensive insulin regimens. [MDI] or continuous subcutaneous insulin infusion [CSII] pump therapy) patients with type 1 diabetes completed a study-specific treatment satisfaction questionnaire following 29 weeks of either placebo (n ϭ 136) or pramlintide (n ϭ 130) treatment in a double-blind, noninferiority pramlintide dose titration trial. End points included patient reported outcomes, their relationship to insulin treatment regimen, A1C, weight, and insulin use. RESEARCH DESIGN AND METHODS -Intensively treated (multiple daily injectionRESULTS -Pramlintide-treated patients reported greater treatment satisfaction in most questionnaire responses. Treatment satisfaction was similar for pramlintide-treated patients regardless of intensive insulin regimens (MDI versus CSII). Mean A1C was reduced to a similar degree in both pramlintide-(Ϫ0.39 Ϯ 0.07%) and placebo-treated (Ϫ0.45 Ϯ 0.07%) patients. However, pramlintide treatment was associated with reductions in mean body weight (Ϫ1.50 Ϯ 0.33 kg; P Ͻ 0.0001) and mealtime insulin use (Ϫ19.05 Ϯ 5.17%; P Ͻ 0.005) over 29 weeks, while placebo treatment resulted in weight gain (1.28 Ϯ 0.25 kg) and a smaller reduction in mealtime insulin use (Ϫ2.20 Ϯ 3.33%).CONCLUSIONS -Despite similar reductions in A1C, pramlintide treatment resulted in greater treatment satisfaction compared with placebo treatment. This was independent of insulin delivery method. Diabetes Care 30:210 -216, 2007

Adjunct therapy for type 1 diabetes mellitus

“…Pramlintide adjunctive therapy in patients with T1DM is associated with an increased sense of wellbeing and satisfaction compared with the outcome of placebo administration, as assessed by a studyspecific treatment satisfaction questionnaire. 59 The mechanism under lying this effect is not known, but may be related to the activa tion of the nucleus accumbens by pramlintide. The decrease in postprandial glucose excursions seen with pramlintide adjunctive therapy is, moreover, associated with a decrease in measures of oxidative stress, such as nitrotyrosine and oxidized LDLcholesterol levels, and a modest improvement in selected biomarkers of vascular risk, such as weight and plasma triglyceride levels.…”

Efficacy and Harms of the Hypoglycemic Agent Pramlintide in Diabetes Mellitus

“…Our searches identifi ed 166 citations; of these, 7 randomized controlled trials (RCTs), [5][6][7][8][9][10][11] 3 companion articles, [12][13][14] and 4 pooled analyses [15][16][17][18] fulfi lled inclusion criteria. We also identifi ed 2 unpublished trials (study #137-117 and #137-123) from the FDA medical and statistical reviews.…”

“…13 More patients reported that pramlintide provided better control of blood glucose, helped with weight loss and appetite suppression, and increased ability to function compared with placebo.…”

Pramlintide Improved Measures of Glycemic Control and Body Weight in Patients With Type I Diabetes Mellitus Undergoing Continuous Subcutaneous Insulin Infusion Therapy

“…Details about the questionnaires and treatment satisfaction results from both studies have been reported. 14-16 Marrero et al 16 reported treatment satisfaction among patients treated with CSII therapy in the RCT. In the present analysis, we report treatment satisfaction results for patients with T1DM who underwent CSII therapy in the clinical practice trial.…”