Table 3.
Oral | Topical | Difference (topical-oral) (95% CI) | |
---|---|---|---|
Total (rate per 100 per year) with first unplanned hospital admission† | |||
Randomised trial: | |||
0-12 months | 2 (1.4) | 6 (4.5) | 3.1 (−1.0 to 7.2) |
0-24 months | 6 (2.6) | 10 (4.6) | 2.0 (−1.5 to 5.5) |
Preference study: | |||
0-12 months | 4 (5.2) | 11 (5.1) | −0.1 (−6.1 to 5.8) |
0-24 months | 6 (4.3) | 19 (4.9) | 0.6 (−3.5 to 4.7) |
No (%) with defined minor adverse effects before 1 year | |||
Randomised trial: | |||
No with data | 144 | 138 | — |
Gastrointestinal | 57 (40) | 58 (42) | 2% (−9% to 14%) |
Renovascular | 22 (15) | 22 (16) | 1% (−8% to 9%) |
Respiratory | 24 (17) | 10 (7) | −9% (−17% to −2%) |
Any minor adverse effect | 80 (56) | 77 (56) | 0 (−11% to 12%) |
Preference study: | |||
No with data | 79 | 224 | — |
Gastrointestinal | 29 (38) | 82 (37) | −1% (−13% to 12%) |
Renovascular | 15 (19) | 34 (15) | −4% (−14% to 6%) |
Respiratory | 14 (18) | 34 (15) | −3% (−13% to 7%) |
Any minor adverse effect | 45 (57) | 118 (53) | −4% (−17% to 8%) |
Other measures of potential adverse effects; changes are one year minus baseline‡ | |||
Randomised trial: | |||
Change in haemoglobin (g/l) | 0.2 (6.6) | 0.7 (7.7) | 0.5 (−1.3 to 2.3) |
Change in loge (ferritin µg/l) | -0.04 (0.50) | 0.50 (0.59) | 0.08 (−0.07 to 0.0.22) |
Change in systolic blood pressure (mm Hg) | 2.5 (14) | 4.4 (14) | 1.9 (−1.7 to 5.5) |
Change in diastolic blood pressure (mm Hg) | −1.0 (8) | −0.5 (7) | 0.5 (−1.3 to 2.4) |
Change in serum creatinine (µmol/l) | 2.4 (11) | −1.3 (10) | −3.7 (−6.5 to −0.9) |
Change in PEF (l/min) | −3 (69) | 4 (58) | 8 (−9 to 24) |
No (%) liver enzyme ≥ upper limit of normal30 | 3 (2.2) | 3 (2.7) | 0.4% (−3.4% to 4.3%) |
Preference study: | |||
Change in haemoglobin (g/l) | 0.06 (6.3) | 0.02 (7.9) | −0.04 (−2.1 to 2.0) |
Change in loge (ferritin µg/l) | 0.03 (0.37) | 0.09 (0.47) | −0.07 (−0.06 to 0.19) |
Change in systolic blood pressure (mm Hg) | 1.3 (14) | 1.4 (14) | 0.2 (−3.8 to 4.2) |
Change in diastolic blood pressure (mm Hg) | 0.6 (8) | 0.3 (8) | −0.3 (−2.4 to 1.8) |
Change in serum creatinine (µmol/l) | 0.3 (11) | −1.7 (11) | −1.9 (−4.8 to 1.0) |
Change in PEF (l/min) | −4 (68) | −1 (63) | 3 (−15 to 20) |
No (%) liver enzyme ≥ upper limit of normal30 | 2 (3) | 2 (1) | −1.7% (−5.7% to 2.2%) |
*Participants were included in denominator for specific category of side effect provided there was at least one instrument from which adverse effect in that category could be identified. Denominators may be lower for individual outcomes.
†First unplanned admission in each person only. Subsequent admissions are not counted.
‡Blood result, either study or practice initiated, closest to one year and taken between six and 18 months. Mean time to follow-up blood test 1.04 years (SD 0.10).