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Treatment escalation options for patients with type 2 diabetes after failure of exenatide twice daily or glimepiride added to metformin: results from the prospective European Exenatide (EUREXA) study.
Diabetes Obes Metab. 2015 Jul; 17(7):689-98.DO

Abstract

AIMS

To evaluate third-line thiazolidinedione (TZD) or glimepiride therapy in patients inadequately controlled on metformin + exenatide twice daily, and third-line exenatide twice daily in patients inadequately controlled on metformin + glimepiride.

METHODS

In this randomized, open-label, multicentre trial, 144 patients with type 2 diabetes inadequately controlled [glycated haemoglobin (HbA1c) >9% (75 mmol/mol) after 3 months' treatment or >7% (53 mmol/mol) at two consecutive visits 3 months apart, after 6 months' treatment] on metformin + exenatide twice daily were re-randomized to add-on TZD or glimepiride, and 166 patients inadequately controlled on metformin + glimepiride received add-on exenatide twice daily. Changes in HbA1c, body mass index (BMI), lipids, hypoglycaemia and vital signs were evaluated.

RESULTS

The median duration of triple therapy was ∼2 years. In patients inadequately controlled on metformin + exenatide twice daily, add-on TZD decreased HbA1c levels significantly better than add-on glimepiride: 130-week difference 0.48% [95% confidence interval (CI) 0.19-0.77] or 5.2 mmol/mol (95% CI 2.1-8.4; p = 0.001), but with significantly increased BMI and systolic blood pressure. The ratio of documented symptomatic (blood glucose ≤70 mg/dl [3.9 mmol/l]) hypoglycaemia rates for add-on glimepiride to add-on TZD was 8.48 (p < 0.0001). Add-on exenatide twice daily after metformin + glimepiride significantly reduced HbA1c levels: mean [standard deviation (s.d.)] change from baseline -0.35 (0.89)% [-3.8 (9.7) mmol/mol] and BMI: mean (s.d.) change from baseline -0.82 (1.9) kg/m(2) at 130 weeks, with a slightly increased rate of documented symptomatic hypoglycaemia from metformin + glimepiride (ratio 1.49).

CONCLUSIONS

TZD, but not glimepiride, was an effective and well tolerated third-line therapy in patients without glycaemic control after long-term therapy with metformin + exenatide twice daily. Exenatide twice daily was an effective and well tolerated third-line therapy in patients inadequately controlled on metformin + glimepiride.

Authors+Show Affiliations

Rudolfstiftung Hospital, Vienna, Austria.Celaya Center for Specialist Medicine, Guanajuato, Mexico.Diabetes Unit, Policlinico Le Scotte, University of Siena, Siena, Italy.Hospital Brabois and CIC Inserm, University of Lorraine, Vandoeuvre-Lès-Nancy, France.Vall d'Hebron Research Institute and CIBERDEM Carlos III Health Institute, Barcelona, Spain.Eli Lilly and Company, Vienna, Austria.Eli Lilly Polska, Warsaw, Poland.Bristol-Myers Squibb, San Diego, CA, USA.Department of Medicine IV, Eberhard-Karls-University Tübingen, Tübingen, Germany.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25846577

Citation

Schernthaner, G, et al. "Treatment Escalation Options for Patients With Type 2 Diabetes After Failure of Exenatide Twice Daily or Glimepiride Added to Metformin: Results From the Prospective European Exenatide (EUREXA) Study." Diabetes, Obesity & Metabolism, vol. 17, no. 7, 2015, pp. 689-98.
Schernthaner G, Rosas-Guzmán J, Dotta F, et al. Treatment escalation options for patients with type 2 diabetes after failure of exenatide twice daily or glimepiride added to metformin: results from the prospective European Exenatide (EUREXA) study. Diabetes Obes Metab. 2015;17(7):689-98.
Schernthaner, G., Rosas-Guzmán, J., Dotta, F., Guerci, B., Simó, R., Festa, A., Kiljański, J., Zhou, M., & Gallwitz, B. (2015). Treatment escalation options for patients with type 2 diabetes after failure of exenatide twice daily or glimepiride added to metformin: results from the prospective European Exenatide (EUREXA) study. Diabetes, Obesity & Metabolism, 17(7), 689-98. https://doi.org/10.1111/dom.12471
Schernthaner G, et al. Treatment Escalation Options for Patients With Type 2 Diabetes After Failure of Exenatide Twice Daily or Glimepiride Added to Metformin: Results From the Prospective European Exenatide (EUREXA) Study. Diabetes Obes Metab. 2015;17(7):689-98. PubMed PMID: 25846577.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Treatment escalation options for patients with type 2 diabetes after failure of exenatide twice daily or glimepiride added to metformin: results from the prospective European Exenatide (EUREXA) study. AU - Schernthaner,G, AU - Rosas-Guzmán,J, AU - Dotta,F, AU - Guerci,B, AU - Simó,R, AU - Festa,A, AU - Kiljański,J, AU - Zhou,M, AU - Gallwitz,B, Y1 - 2015/05/08/ PY - 2014/11/22/received PY - 2015/03/11/revised PY - 2015/03/27/accepted PY - 2015/4/8/entrez PY - 2015/4/8/pubmed PY - 2016/3/18/medline KW - HbA1c KW - body mass index KW - exenatide twice daily KW - glimepiride KW - thiazolidinedione KW - triple therapy KW - type 2 diabetes SP - 689 EP - 98 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 17 IS - 7 N2 - AIMS: To evaluate third-line thiazolidinedione (TZD) or glimepiride therapy in patients inadequately controlled on metformin + exenatide twice daily, and third-line exenatide twice daily in patients inadequately controlled on metformin + glimepiride. METHODS: In this randomized, open-label, multicentre trial, 144 patients with type 2 diabetes inadequately controlled [glycated haemoglobin (HbA1c) >9% (75 mmol/mol) after 3 months' treatment or >7% (53 mmol/mol) at two consecutive visits 3 months apart, after 6 months' treatment] on metformin + exenatide twice daily were re-randomized to add-on TZD or glimepiride, and 166 patients inadequately controlled on metformin + glimepiride received add-on exenatide twice daily. Changes in HbA1c, body mass index (BMI), lipids, hypoglycaemia and vital signs were evaluated. RESULTS: The median duration of triple therapy was ∼2 years. In patients inadequately controlled on metformin + exenatide twice daily, add-on TZD decreased HbA1c levels significantly better than add-on glimepiride: 130-week difference 0.48% [95% confidence interval (CI) 0.19-0.77] or 5.2 mmol/mol (95% CI 2.1-8.4; p = 0.001), but with significantly increased BMI and systolic blood pressure. The ratio of documented symptomatic (blood glucose ≤70 mg/dl [3.9 mmol/l]) hypoglycaemia rates for add-on glimepiride to add-on TZD was 8.48 (p < 0.0001). Add-on exenatide twice daily after metformin + glimepiride significantly reduced HbA1c levels: mean [standard deviation (s.d.)] change from baseline -0.35 (0.89)% [-3.8 (9.7) mmol/mol] and BMI: mean (s.d.) change from baseline -0.82 (1.9) kg/m(2) at 130 weeks, with a slightly increased rate of documented symptomatic hypoglycaemia from metformin + glimepiride (ratio 1.49). CONCLUSIONS: TZD, but not glimepiride, was an effective and well tolerated third-line therapy in patients without glycaemic control after long-term therapy with metformin + exenatide twice daily. Exenatide twice daily was an effective and well tolerated third-line therapy in patients inadequately controlled on metformin + glimepiride. SN - 1463-1326 UR - https://www.unboundmedicine.com/medline/citation/25846577/Treatment_escalation_options_for_patients_with_type_2_diabetes_after_failure_of_exenatide_twice_daily_or_glimepiride_added_to_metformin:_results_from_the_prospective_European_Exenatide__EUREXA__study_ L2 - https://doi.org/10.1111/dom.12471 DB - PRIME DP - Unbound Medicine ER -