Changes in weight and diabetes compensation (HbA_1c) in patients with diabetes mellitus type 2 after adding exenatide (Byetta) to the current treatment in 28 diabetology departments in the Czech Republic – BIBY-I study (observations lasting 3 to 12 months)

Czech version

Authors: J. Perušičová ¹; I. Haladová ²; P. Piťhová ¹; Pracovní Skupina Diabetologů: D. Ácsová; J. Bělobrádková; A. Belzová; K. Berková; B. Doležalová; H. Dvořáková; K. Hejnicová; M. Hudcová; D. Kallmünzerová; Z. Krejsová; G. Markofová; H. Müllerová; K. Owen; M. Pelikánová; L. Raclavská; E. Račická; O. Škarpová; A. Váchová; A. Veselá; J. Vyoralos; J. Brož; T. Edelsberger; MUDr. Marek Honka; T. Hrdina; P. Chmura; J. Tošovský
Authors‘ workplace: Interní klinika 2. lékařské fakulty UK a FN Motol Praha, přednosta prof. MUDr. Milan Kvapil, CSc., MBA ¹; I. interní klinika Lékařské fakulty UK a FN Plzeň, přednosta prof. MUDr. Martin Matějovič, Ph. D. ²
Published in: Vnitř Lék 2013; 59(3): 165-171
Category: Original Contributions

Overview

BIBY study objective:
To obtain experience with exenatide treatment (Byetta) in patients with diabetes mellitus type 2 in a common clinical practice of diabetology departments.

Type of observation:
Observational study conducted by a randomly selected group of outpatient medical practitioners from 28 diabetology departments in the Czech Republic.

Observed and assessed population:
465 patients underwent at least three months of Byetta treatment; 347 persons (74.6% of the research population) stayed for the extended observation of 6–12 months. Apart from the basic identification data (year of birth, sex, age when diabetes mellitus manifested, height, maximum patient weight before diabetes and when diabetes mellitus manifested), the following information was recorded in three-month intervals: weight, waistline, glycated haemoglobin (HbA_1c), and diabetes mellitus treatment The population included 50.3% women and 49.7% men, and the average age at the time of diabetes manifestation was 48 (20–73 years). The period between the diabetes manifestation and the start of exenatide treatment was 8.3 years on average.

Results:
The average maximum BMI value before the detection of diabetes was 39.05 (± 6.73); at the time of the diabetes manifestation 37.88 (± 6.40); and at the start of Byetta treatment 39.01 (± 6.22). The BMI after three, six, and 12 months of treatment was as follows: 37.86 (± 6.12), 37.18 (± 6.0), and 36.60 (± 6.21); it decreased by ≥ 0.5 in 83.3% patients who were under observation for 12 months. HbA_1c value decreased in the first three months from 7.39% (± 1.57) to 6.41% (± 1.34), p < 0.0001. In the period of three-six months, the value decreased to 6.22% (± 1.34), and after 12 months, HbA_1c was at 6.04 (± 1.20). An improvement in HbA_1c value of 0.5–2.0% occurred after the first year in 49% of our research population. The waistline was measured on a regular basis in only 267 patients (58.9%). The average initial value of 120.7cm was reduced within three months of the treatment to 118.3cm, and within six and 12 months to 117.3 and 112.6cm respectively.

Conclusion:
Adding Byetta to the currently applied treatment of obese patients with diabetes mellitus type 2 led, in 66.8% of the population, to a statistically significant reduction in HbA_1c levels in the first three-six months of the treatment; after 12 months of treatment, 25% of the population was still showing an improvement in HbA_1c of >2.0%. Of observed patients, 74.4% significantly reduced their BMI (by >0.5) during the first three months; 39.6% of patients reduced their BMI in the period of three-six months.

Key words:
diabetes mellitus type 2 – change in weight of a diabetic – exenatide – Byetta – BMI – HbA_1c

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