Celecoxib Diclofenac (n = 3105) (n = 1551) Celecoxib Diclofenac SR (n = 2238) (n = 2246) Table 2 | Baseline demograph- ics in non-aspirin users in the CLASS and CONDOR trials J. L. Goldstein et al. Characteristics Women, % Diagnosis, % OA RA OA & RA Mean age, years (s.d.) White, % Previous history of GD ulcer, % H. pylori infection, % 7.8 38.2 CLASS 71.2 68.4 26.4 5.2 70.0 69.6 25.3 5.1 8.4 37.3 CONDOR 82.6 84.1 15.9 – 17.7 – 81.1 84.2 15.8 – 17.8 – 59.5 (11.7) 87.9 59.0 (12.0) 88.5 65.2 (7.8) 55.3 65.3 (7.6) 54.0 Haemoglobin (g ⁄ dL) 13.6 (1.3) 13.6 (1.3) 13.6 (1.1) 13.6 (1.1) GD, gastroduodenal; OA, osteoarthritis; RA, rheumatoid arthritis. CLASS and CONDOR: Patients meeting a ‡2 g ⁄ dL decrease in haemoglobin during 6 months In the non-aspirin using population of the CLASS and CONDOR trials, 1.9% and 2.0% of patients treated with celecoxib developed a ‡2 g ⁄ dL decrease in hae- moglobin during 6 months of treatment, respectively. In contrast, a greater percentage of patients receiving diclofenac developed a ‡2 g ⁄ dL decrease in haemoglo- bin by 6 months; 3.3% in CLASS and 5.7% in CON- DOR, respectively. The corresponding odds ratio for CLASS and CONDOR were both signiﬁcant at 6 months [CLASS: 1.80 (95% CI, 1.22–2.65) and CON- DOR: 2.93 (95% CI, 2.06–4.15), respectively]. As seen in Figure 3a for CLASS and 3b for CONDOR, the time to a decrease in haemoglobin ‡2 g ⁄ dL occurs at a slower rate in the celecoxib arm than in the diclofe- nac arm (log-rank test P < 0.01). Furthermore, based on these Kaplan–Meier curves (Figure 3a,b), the esti- mates of the proportion of patients with a decrease in haemoglobin ‡2 g ⁄ dL were 1.8% and 3.4% in CLASS and 2.2% and 5.7% in CONDOR for the celecoxib and diclofenac arms, respectively. Despite differences in the methodology for calculating these rates (incidence vs. Kaplan–Meier analysis), the rates reported above are consistent with the Kaplan–Meier curves in Fig- ure 3a,b. Aspirin users crude rate In the CLASS trial, a sub-population of aspirin users (£325 mg per day of aspirin) was identiﬁed.8 As seen in Table 3, at 6 months there was a greater percentage of 812 subjects with a decrease in haemoglobin ‡2 g ⁄ dL in those using aspirin plus diclofenac as compared to those receiving aspirin plus celecoxib with a corresponding odds ratio of 1.71 (95% CI, 1.00–2.92). CLASS and CONDOR: Patients meeting a ‡2 g ⁄ dL decrease in haemoglobin and meeting laboratory- deﬁned anaemia criteria during 6 months We have further evaluated the decrease in haemoglobin in both trials using a singular absolute cut-off value at 6 months of £11.5 g ⁄ dL, the laboratory-deﬁned lower limit of normal (LLN) for haemoglobin values in the CONDOR trial (but not the CLASS trial – please refer to text below). Among the celecoxib patients who had a decrease in haemoglobin ‡2 g ⁄ dL, 21.4% (12 ⁄ 56) of patients in CLASS and 18.2% (8 ⁄ 44) of patients in CON- DOR had a ﬁnal haemoglobin value £11.5 g ⁄ dL. In con- trast, in the diclofenac arms 16.0% (8 ⁄ 50) of patients in CLASS and 51.2% (63 ⁄ 123) of patients in CONDOR who had a decrease in haemoglobin ‡2 g ⁄ dL had a ﬁnal haemoglobin value £11.5 g ⁄ dL. As the LLN for haemoglobin values were different for men (<12.7 g ⁄ dL for men aged 12–59 years and <12.5 g ⁄ dL for men aged 60–150 years) and women (<11.6 g ⁄ dL for women aged 12–59 years and <11.5 g ⁄ dL for women aged 60–150 years) in the CLASS trial, we further calculated decreases in haemoglobin ‡2 g ⁄ dL in men and women separately. As such, in the CLASS trial the odds ratio for patients having decreases in haemoglo- bin ‡2 g ⁄ dL was 1.63 for women (95% CI, 0.98–2.72) and 2.06 men (95% CI, 1.14–3.74) (Table S3). Aliment Pharmacol Ther 2011; 34: 808–816 ª 2011 Blackwell Publishing Ltd