Ethnicity & disease · 2017
Insulin Detemir in Combination with Oral Antidiabetic Drugs Improves Glycemic Control in Persons with Type 2 Diabetes in Near East Countries: Results from the Lebanese Subgroup.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Echtay Akram, Andari Emile, Atallah Paola, Moufarrege Roland, Nemr Rita
Аннотация
OBJECTIVE: To evaluate the effectiveness and safety of insulin detemir treatment as add-on therapy in a real-world setting of Lebanese insulin naïve persons, with type 2 diabetes poorly controlled on oral antidiabetic drugs (OADs).
METHODS: Our study was a prospective, observational study representing the Lebanese arm of the multinational prospective and observational study involving 2,155 persons across Near East countries, Lebanon, Pakistan, Israel and Jordan. Effectiveness endpoints were changes in HbA1c, fasting and post-prandial glucose (FPG, PPG) after 24 weeks of treatment with insulin detemir in eligible persons. Safety endpoints were number of hypoglycemic events, incidence of adverse drug reactions (ADRs), serious ADRs, adverse events, and body weight change between baseline and end of treatment.
RESULTS: 868 persons were included (mean age: 59.5 ± 10.4 years, men: 55.3%). Glycemic control improved with significant reduction in mean HbA1c from 9.7 ± 1.6% to 7.2 ± 1% (P<.0001). The percentage of persons who achieved the target of HbA1c<7% increased from .7% at baseline to 39% at week 24. Mean FPG decreased significantly from 213.7 ± 60.1 mg/dL to 120.3 ± 25.7 mg/dL (P<.001), and mean PPG from 271 ± 65.3 mg/dL to 158.1 ± 36.4 mg/dL (P<.0001). The rate of major hypoglycemic episodes decreased from .1498 at baseline to .0448 at week 24. Three adverse events but no ADR or serious ADR were reported. Body weight decreased from 80.4±13.2 Kg to 79.9±12.5 Kg (P<.0001).
CONCLUSIONS: Initiating insulin detemir in a clinical health care setting among Lebanese with type 2 diabetes mellitus on OADs improves glycemic control with no increase in hypoglycemia, adverse events or weight compared with baseline.
METHODS: Our study was a prospective, observational study representing the Lebanese arm of the multinational prospective and observational study involving 2,155 persons across Near East countries, Lebanon, Pakistan, Israel and Jordan. Effectiveness endpoints were changes in HbA1c, fasting and post-prandial glucose (FPG, PPG) after 24 weeks of treatment with insulin detemir in eligible persons. Safety endpoints were number of hypoglycemic events, incidence of adverse drug reactions (ADRs), serious ADRs, adverse events, and body weight change between baseline and end of treatment.
RESULTS: 868 persons were included (mean age: 59.5 ± 10.4 years, men: 55.3%). Glycemic control improved with significant reduction in mean HbA1c from 9.7 ± 1.6% to 7.2 ± 1% (P<.0001). The percentage of persons who achieved the target of HbA1c<7% increased from .7% at baseline to 39% at week 24. Mean FPG decreased significantly from 213.7 ± 60.1 mg/dL to 120.3 ± 25.7 mg/dL (P<.001), and mean PPG from 271 ± 65.3 mg/dL to 158.1 ± 36.4 mg/dL (P<.0001). The rate of major hypoglycemic episodes decreased from .1498 at baseline to .0448 at week 24. Three adverse events but no ADR or serious ADR were reported. Body weight decreased from 80.4±13.2 Kg to 79.9±12.5 Kg (P<.0001).
CONCLUSIONS: Initiating insulin detemir in a clinical health care setting among Lebanese with type 2 diabetes mellitus on OADs improves glycemic control with no increase in hypoglycemia, adverse events or weight compared with baseline.