Naslov
Efficacy and safety of empagliflozin by baseline age in patients with type 2 diabetes

Autori
Roden, Michael ; Lund, Soeren ; Pfarr, Egon ; Kohler, Sven ; Naderali, Ebrahim ; Giljanovic Kiš, Sanja

Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, ostalo

Izvornik
IDF 2015: Abstracts / - , 2015, Abstract:0368-PD

Skup
IDF (International Diabetes Federation) world diabetes congress

Mjesto i datum
Vancouver, Kanada, 30.11.2015. - 04.12.2015

Vrsta sudjelovanja
Poster

Vrsta recenzije
Međunarodna recenzija

Ključne riječi
empagliflozin; type 2 diabetes; baseline age

Sažetak
Aim To assess the influence of age on efficacy and safety of empagliflozin in patients with type 2 diabetes. Method Using pooled data from four Phase III trials in which patients (n=2477 ; mean [SD] HbA1c 7.99 [0.85]%) received empagliflozin 10 mg, 25 mg or placebo as monotherapy or add-on therapy for 24 weeks, we assessed efficacy and safety in subgroups by baseline age (<50, 50 to <65, 65 to <75, and ≥75 yrs). Results Across treatment groups and subgroups, mean baseline HbA1c was 7.70–8.10%. At week 24, adjusted mean (SE) differences vs placebo in change from baseline in HbA1c (%) in patients aged <50 yrs were -0.75 (0.07) and -0.87 (0.07) for empagliflozin 10 mg and 25 mg, respectively, in patients aged 50 to <65 yrs were -0.59 (0.05) and -0.63 (0.05), respectively, and in patients aged 65 to <75 yrs were -0.58 (0.09) and -0.55 (0.10), respectively (all p<0.001 vs placebo). In patients aged ≥75 yrs, mean (SE) differences were -0.21 (0.22)% and -0.33 (0.24)% for empagliflozin 10 mg and 25 mg, respectively (both p=ns vs placebo). For interaction between treatment and age, p=0.0218. Weight and systolic blood pressure (SBP) were significantly reduced vs placebo for both empagliflozin doses in all age groups (p=ns for interactions). In all age groups, empagliflozin was well tolerated, but with an increased risk of confirmed hypoglycemic adverse events (AEs) and AEs consistent with genital infection vs placebo (Table). The incidence of confirmed hypoglycemic AEs and AEs consistent with urinary tract infection, genital infection and volume depletion with empagliflozin did not appear to increase with increasing age

Izvorni jezik
Engleski

Znanstvena područja
Kliničke medicinske znanosti

POVEZANOST RADA