Gender difference in response predictors after 1-year exenatide therapy twice daily in type 2 diabetic patients: a real world experience

Abstract

Purpose: To investigate whether gender affects therapeutic response by exenatide twice a day (BID) in type 2 diabetes by using a database concerning patients monitored by five outpatient clinics in Tuscany, Italy.

Patients and methods: We considered a cohort of 315 (154 male/161 female) patients experiencing therapeutic failure while on oral therapy (metformin, or combination therapy metformin + sulphonylureas), who were given exenatide (10 μg/BID) and who fully completed 4 months, 8 months, and 12 months of follow-ups.

Results: Among patients stratified by gender and well matched for age, body mass index, and hemoglobin A1c (HbA1c), it was found that the length of disease was longer in females than in males (12 ± 8 years versus 10 ± 7 years; P = 0.037), and the ratio of patients on metformin to those on combination therapy was higher in men (P = 0.018). Target glycemic response (1-year HbA1c ≤ 7%) was achieved in a significantly higher proportion of males than females (38% versus 27%; χ(2) = 4.66; P = 0.03). Target weight loss expressed as 1-year weight percent fall from baseline ≥ 75th percentile (8.5%) was significantly higher in females at 8 and 12 months (P < 0.05; for both). One-year glycemic target response was inversely related to baseline HbA1c levels and diabetes duration among males, while metformin therapy (compared to oral combination therapy) was a significant predictor of better glycemic targets among females. Homeostasis model assessment-B, measured in 117 patients, predicted hypoglycemic response only in women (P = 0.009). Target 1-year weight loss was predicted by longer diabetes duration among males and by lower baseline HbA1c among females. Finally, no significant difference between genders was noted as to gastrointestinal side effects after exenatide therapy.

Conclusion: According to this "real world" experience, predictors of glycemic control and body weight loss after 12 months of exenatide BID therapy are different between genders in type 2 diabetes.

Keywords: GLP-1 agonist therapy; exenatide BID; real world setting; type 2 diabetes.

Figure 1

Mean values of HbA_1c and body weight at baseline, and at 4 months, 8 months, and 12 months in males and females. Mean values of HbA_1c (left) and body weight (right) at baseline, and at 4 months, 8 months, and 12 months in males and females (A). The percentage of both male and female patients who achieved target glycemic control (HbA_1c ≤ 7%) (left) and body weight reduction targeted at ≥8.5% (75th percentile of 1-year percent loss from the baseline weight value) over the observation period in males and females (B). ^aHbA_1c ≤ 7%; *P = 0.01; **P = 0.03 versus males (A); ^bweight loss of ≥75th percentile of 1-year percent loss from the baseline weight value; *P = 0.004; **P = 0.0009 versus males (B). Abbreviation: HbA_1c, hemoglobin A_1c.

Figure 2

Relation linking diabetes duration and HbA_1c levels with predicted probability of target 1-year metabolic response (HbA_1c ≤ 7%) after taking into account age, sex, BMI, and background therapy (metformin, sulphonylureas, or their combination). Diabetes duration (A) and baseline HbA_1c levels (B) with predicted probability of target 1-year metabolic response. Abbreviations: HbA_1c, hemoglobin A_1c; BMI, body mass index.