“…Post-switch dose increase to maintain target Hb: 46% of patientsNR | NR | Morosetti et al 2017 [79] a | With chronic renal failure ( N = 87) | 87 | ESA, 6 months | Biosimilar, 6 months | Pre- vs post-switch Hb, ferritin, transferrin saturation: all P NS; mean monthly epoetin consumption/patient: 52,460 vs 49,517 Ul ( P NS) | No changes in incidence of thrombosis or cardiovascular events | NR |
Balili et al 2015 (abstract) [83] | With T2DM ( N = 24) | 24 | Humulin 70/30, duration NR | Wosulin 70/30, duration NR | Pre- to post-switch mean HbA1c decreased by 1.3%, total insulin dose/day increased by 2.4 units. Target HbA1c was achieved (specific results NR) | NR | NR |
Segal et al 2013 [87] | With T1DM or T2DM ( N = 77) | 77 | Actraphane, Humulin 30/70 or Insuman, insulin duration 7 years | Biosulin 30/70, 6 months | Baseline (at switch) vs post-switch: no significant change in HbA1c, neither overall nor in subgroups by type of diabetes; small, significant increase in insulin dose | No severe hypoglycaemic episodes reported; other details NR | NR |
Flodmark et al 2013 [88] (comment: Ekelund et al 2014 [134]) | With growth disturbances ( N = 98) | 98 | Genotropin RP, duration NR (graph suggests up to 2 years) | Omnitrope ® , duration NR (graph suggests up to 1.5–2 years) | Growth in height after switch: modelled vs actual data suggest no impact of switch on growth | Number of patients with TEAEs in 12 months after switch: 18 patients; injection site pain: 18 (of whom 6 subsequently switched back to originator preparation) | NR |
Gila et al 2014 (abstract) [89] | With growth disturbances ( N = 20) | 20 | rhGH RP, mean duration 38 months | Omnitrope ® , follow-up 36 months | Height velocity, 18 months before switch: 9 ± 2 cm/year; at switch: 6 ± 1 cm/year; 18 months after switch: 7 ± 3 cm/year (statistical analysis NR) | No TEAEs reported after switch; 3 patients had transitory problems with Omnitrope ® device | NR |
Rashid et al 2014 [90] | With growth disturbances ( N = 103) | |
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