| Autor: |
Kesavadev J; Jothydev's Diabetes Research Centre, Trivandrum 695032, India., Gowda A; Fortis Hospital, Cunningham Road, Bengaluru 560052, India., Kumar H; Amrita Institute of Medical Sciences, Kochi 682041, India., Yalamanchi SR; Yalamanchi Hospitals & Research Centres Pvt Ltd., Vijayawada 520002, India., Lodha S; Eternal Heart Care Centre, Jaipur 302017, India., Singh KP; Fortis Hospital, Mohali 160062, India., Basu D; Apollo Gleneagles Hospital, Kolkata 700067, India., Asirvatham A; Arthur Asirvatham Hospital, Madurai 625020, India., Shah N; Sterling Hospital, Ahmedabad 380052, India., Pathan MK; Novo Nordisk India Private Limited, Bengaluru 560066, India., Revanna M; Novo Nordisk India Private Limited, Bengaluru 560066, India., Mukherjee JJ; Apollo Gleneagles Hospital, Kolkata 700067, India. |
| Abstrakt: |
This post-authorization study was conducted to evaluate the safety of insulin degludec/insulin aspart (IDegAsp) in adult patients with diabetes mellitus (DM) during routine clinical care under a real-world setting in India. Eligible patients received IDegAsp for a minimum of 12 months during routine clinical management. Data were collected at 0, 3, 6, and 12 months. In total, 1029 adult patients with DM were included; 65.2% (n = 671) were men; mean age was 55.0 ± 12.2 years, and the mean duration of diabetes mellitus was 10.8 ± 7.4 years. Thirty adverse events were reported in 23 patients (2.2%) during the follow-up: two adverse events in two patients were serious with fatal outcomes, which were unrelated to IDegAsp use. At baseline, there were 176 confirmed hypoglycemic events in 67 (6.7%) patients while they were on their previous treatment options. At 12 months of treatment with IDegAsp, 11 confirmed hypoglycemic events were reported in 11 (1.1%) patients since the previous visit; there were no reported episodes of severe hypoglycemia. Mean glycosylated hemoglobin value reduced from 9.5% ± 1.8% at baseline to 7.7% ± 1.1% at 12 months. This study showed the safety of IDegAsp in patients with diabetes mellitus over a period of 1 year during routine clinical care. |
