Changes in weight and diabetes compensation (HbA1c) in patients with diabetes mellitus type 2 after adding exenatide (Byetta) to the current treatment in 28 diabetology departments in the Czech Republic –  BIBY‑II study (observations lasting 24 months)


Authors: J. Perušičová 1;  P. Piťhová 1;  I. Haladová 2;  A. 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. Vyoralová;  J. Brož;  T. Edelsberger;  M. Honka;  T. Hrdina;  P. Chmura;  J. Tošovský
Authors‘ workplace: Interní klinika 2. lékařské fakulty UK a FN Motol Praha, přednosta prof. MU Dr. Milan Kvapil, CSc., MBA 1;  I. interní klinika Lékařské fakulty UK a FN Plzeň, přednosta prof. MU Dr. Martin Matějovič, Ph. D. 2
Published in: Vnitř Lék 2013; 59(4): 249-255
Category: Original Contributions

Overview

BIBY‑II study objective:
To obtain experience with long‑term (24 months) exenatide treatment (Byetta) in patients with diabetes mellitus type 2 from a common clinical practice of diabetology departments in the Czech Republic.

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:
From the original population of 465 patients, who underwent a minimum of three month’s Byetta treatment, 169 patients (36.6%) remained during the second prolonged observation after 18 months, and 76 patients completed 24 months of uninterrupted Byetta treatment. The following basic information about the patients was collected: year of birth, sex, age when diabetes mellitus (DM) manifested, height, maximum weight before diabetes and when DM manifested. The study recorded the following values in three- month intervals: weight, waistline, glycated haemoglobin (HbA1c), and DM treatment. The population of the prolonged observation comprised 50.3% women and 49.7 % men, and the average age at the time of DM2 manifestation was 48.0 (20– 73 years).

Results:
At the beginning of Byetta treatment, the average maximum BMI in the sub‑population observed for 24 months was 38.44; after 3, 6, 9, 12 and 24 months the following levels were measured, respectively: 36.79, 36.22, 35.91, 35.57 and 35.58. The original HbA1c level of 7.44% at the beginning of Byetta treatment decreased after 3, 6, 9, 12 and 24 months to 6.33, 5.98, 5.83, 5.86 and 5.93%.

Conclusion:
Adding Byetta to the currently applied treatment of obese patients with diabetes mellitus type 2 over a period of 24 months has led to an improvement in HbA1c level by 1.51%, and BMI level was reduced by 2.37 after two years of Byetta treatment.

Key words:
diabetes mellitus type 2 –  change in weight of a diabetic –  exenatide –  Byetta – BMI –  HbA1c


Sources

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2. Bergenstal RM, Garrison jr. LP, Miller LA et al. Exenatide BID Observational Study (ExOS): results for primary and secondary endpoints of a prospective research study to evaluate the clinical effectiveness of exenatide BID use in patients with type 2 diabetes in a real- world setting. Curr Med Res Opin 2011; 27: 2335– 2342.

3. Levin PA, Mersey JH, Zhou S et al. Clinical outcomes using long‑term combination therapy with insulin glargine and exenatide in patients with type 2 diabetes mellitus. Endocr Pract 2012; 18: 1– 25.

4. Macconell L, Brown C, Gurney K et al. Safety and tolerability of exenatide twice daily in patients with type 2 diabetes: integrated analysis of 5594 patients from 19 placebo- controlled and comparator- controlled clinical trials. Diabetes Metab Syndr Obes 2012; 5: 29– 41.

5. Monami M, Dicembrini I N et al. Effects of Glucagon- Like Peptide- 1 Receptor Agonists on Body Weight: A Meta‑Analysis. Exp Diabetes Res 2012; 2012: 672658.

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Labels
Diabetology Endocrinology Internal medicine

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