HbA1c (%) before and after discontinuation of rosiglitazone-containing products, among users who discontinued the drug on or after 23 September 2010 (date of EMA's recommendation to suspend rosiglitazone), in northern Denmark and in the United Kingdom
| Characteristic | Northern Denmark | United Kingdom | ||
|---|---|---|---|---|
| 3 months (n=376) | 6 months (n=455) | 3 months (n=1081) | 6 months (n=338) | |
| Baseline mean (SD) | 7.1 (1.2) | 7.1 (1.2) | 10 (2.5) | 10 (2.5) |
| Follow-up mean (SD) | 7.5 (1.5) | 7.4 (1.4) | 8.0 (2.0) | 8.3 (2.1) |
| Change from baseline, mean (95% CI) | 0.40 (−1.9 to 2.7) | 0.34 (−1.8 to 2.5) | −2.0 (−2.2 to −1.8) | −1.8 (−2.1 to −1.6) |
| Proportion with a clinically meaningful* increase, per cent (95% CI) | 34 (29 to 38) | 33 (29 to 38) | 14 (12 to 16) | 15 (12 to 19) |
| Proportion with a clinically meaningful* decrease, per cent 95% CI) | 13 (9.5 to 16) | 12 (9.3 to 15) | 72 (69 to 75) | 69 (64 to 74) |
| N with HbA1c level>7.5% after baseline/ N with baseline HbA1c≤7.5% | 76/285 | 94/350 | 87/196 | 18/55 |
| New postdiscontinuation onset of loss of glycaemic control with HbA1c>7.5%, per cent (95% CI)† | 27 (22 to 32) | 27 (22 to 32) | 44 (38 to 51) | 33 (22 to 46) |
*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.