Does Gender Influence the Effectiveness and Safety of Insulin Glargine 300 U/ml in Patients with Uncontrolled Type 2 Diabetes? Results from the REALI European Pooled Analysis
Por:
Gourdy, P, Bonadonna, RC, Freemantle, N, Mauricio, D, Muller-Wieland, D, Bigot, G, Mauquoi, C, Ciocca, A, Bonnemaire, M
Publicada:
1 ene 2022
Ahead of Print:
1 nov 2021
Resumen:
Introduction Gender differences in risk factors and treatment outcomes for type 2 diabetes mellitus (T2DM) may exist. We used the REALI European database to investigate whether there were gender-specific differences in baseline characteristics and clinical outcomes among patients with inadequately controlled T2DM initiated on insulin glargine 300 U/ml (Gla-300). Methods Data were pooled from 14 multicentre, prospective, interventional and non-interventional studies. Impact of gender on glycaemic control, insulin dose, body weight and hypoglycaemia was evaluated after 12 and 24 weeks of Gla-300 treatment. Results Women (N = 3857) were older than men (N = 4376) (median age, 65.0 versus 63.0 years), with greater mean body mass index (32.5 versus 31.6 kg/m(2)) and lower median estimated glomerular filtration rate (77.5 versus 84.0 ml/min/1.73 m(2)). Peripheral arterial disease and a history of myocardial infarction were more frequent in men (20.1% versus 11.7% and 12.0% versus 5.8%, respectively). At baseline, mean haemoglobin A1c (HbA1c) was 8.74% in men and 8.79% in women. Least square (LS) mean (95% CI) reduction in HbA1c from baseline to week 24 was - 1.17% (- 1.21 to - 1.13) in men and - 1.07% (- 1.11 to - 1.02) in women, resulting in a LS mean difference of - 0.10% (- 0.15 to - 0.05; p < 0.0001). At 24 weeks, 21.6% of women and 27.2% of men achieved target HbA1c of < 7.0% (p < 0.001; chi-square). Reported incidence for symptomatic (8.5% versus 8.7%) and severe (0.3% versus 0.5%) any-time-of-the-day or symptomatic (2.4% versus 1.8%) and severe (0.1% versus 0.2%) nocturnal hypoglycaemia was overall low and comparable between men and women. Changes in daily Gla-300 dose and body weight were also similar. Conclusion Despite some gender differences in baseline characteristics, Gla-300 treatment improved glycaemic control, with overall low hypoglycaemia incidences in both men and women. However, women had statistically significantly lower HbA1c reductions than men, although these differences were clinically modest.
Filiaciones:
Gourdy, P:
Toulouse Univ Hosp, Endocrinol Diabetol & Nutr Dept, Toulouse, France
Toulouse Univ, Inst Metab & Cardiovasc Dis, UMR1297, INSERM,UPS, Toulouse, France
Bonadonna, RC:
Azienda Osped Univ Parma, Parma, Italy
Univ Parma, Dept Med & Surg, Parma, Italy
Freemantle, N:
UCL, Inst Clin Trials & Methodol, London, England
Mauricio, D:
Hosp Santa Creu & Sant Pau, CIBERDEM, Dept Endocrinol & Nutr, Inst Recerca, Barcelona, Spain
Muller-Wieland, D:
Univ Hosp Aachen, Dept Med 1, Aachen, Germany
Bigot, G:
IVIDATA, Paris, France
Mauquoi, C:
IDDI, Louvain La Neuve, Belgium
Ciocca, A:
Sanofi, Gen Med, Paris, France
Bonnemaire, M:
Sanofi, Gen Med, Paris, France
gold, Green Published
|