Glycated haemoglobin (HbA1c; %) before and after discontinuation of rosiglitazone among patients with available prediscontinuation and postdiscontinuation measurements, in northern Denmark and in the United Kingdom, 2000–2011
| Characteristic | Northern Denmark | United Kingdom | ||||
|---|---|---|---|---|---|---|
| 3 months (n=1242) | 6 months (n=1496) | 12 months (n=1162) | 3 months (n=9448) | 6 months (n=12 439) | 12 months (n=8635) | |
| Baseline mean (SD) | 7.8 (1.7) | 7.8 (1.6) | 7.9 (1.7) | 8.7 (2.2) | 8.5 (2.1) | 8.4 (1.9) |
| Follow-up mean (SD) | 7.7 (1.5) | 7.7 (1.5) | 7.7 (1.5) | 8.1 (1.7) | 8.2 (1.8) | 8.2 (1.8) |
| Change from baseline, mean (95% CI) | −0.10 (−3.0 to 2.8) | −0.05 (−3.1 to 3.0) | −0.16 (−3.4 to 3.1) | −0.57 (−0.62 to −0.53) | −0.30 (−0.34 to −0.26) | −0.17 (−0.21 to −0.13) |
| Proportion with a clinically meaningful* increase, per cent (95% CI) | 26 (24 to 29) | 28 (26 to 30) | 28 (26 to 31) | 23 (22 to 24) | 28 (27 to 28) | 29 (28 to 30) |
| Proportion with a clinically meaningful* decrease, per cent (95% CI) | 28 (25 to 30) | 27 (25 to 29) | 30 (27 to 32) | 40 (39 to 41) | 36 (35 to 37) | 34 (33 to 35) |
| N with HbA1c level >7.5% after baseline/N with baseline HbA1c ≤7.5% | 160/670 | 228/827 | 179/610 | 1026/3286 | 1641/4672 | 1246/3408 |
| New postdiscontinuation onset of loss of glycaemic control with HbA1c >7.5%, per cent (95% CI)† | 24 (21 to 27) | 28 (25 to 31) | 29 (26 to 33) | 31 (30 to 33) | 35 (34 to 36) | 37 (35 to 38) |
*Clinically meaningful change defined using the European Medicines Agency's definition as change of more than 0.6% (% is the test unit).
†Assessed in patients without evidence of loss of glycaemic control before discontinuing rosiglitazone.