The quality of evidence is downgraded by study limitations (incomplete outcome data; more drop-outs in the single agent group).
A Cochrane review [Abstract] 1 included 10 studies with a total of 10 894 subjects mostly with moderate or severe COPD. Compared to tiotropium alone, treatment with tiotropium plus long-acting beta2-agonists (LABA: salmeterol, formoterol, indacaterol, olodaterol) resulted in a slightly larger improvement in mean health-related quality of life (St George's Respiratory Questionnaire (SGRQ), however, the mean difference (MD) was smaller than the 4 units that is considered clinically important. In responder analysis 7% more participants receiving tiotropium plus LABA had a noticeable benefit (over 4 units) from treatment in comparison to tiotropium alone. There were no significant differences in the other primary outcomes (hospital admission or mortality). None of the secondary outcomes (forced expiratory volume in one second (FEV1), exacerbations, symptom scores, serious adverse events, and withdrawals) showed any statistically significant differences between the groups (table T1). Comparing LABA plus tiotropium treatment with LABA alone, the results were similar as with tiotropium plus LABA (mostly olodaterol) compared to tiotropium alone (table T2).
| Outcome | Relative effect(95% CI) | Assumed risk -Tiotropium | Corresponding risk - Intervention = Tiotropium + LABA (95% CI) | Participants (studies) |
|---|---|---|---|---|
| Change in quality of lifeassessed with: SGRQScale from 0 to 100 (lower score is better) | - | Mean change at 6 months -5.7 units | Mean change - 1.34 units (-1.87 to -0.8) | 6 709(5) |
| Quality of life SGRQ responder analysis at 6 months | OR 1.53(1.31 to 1.79) | 48/1000 | 55/1000 (52 to 57) | 2 923(2) |
| Hospital admission (all cause)Follow-up: 3-12 months | OR 1.02(0.80 to 1.28) | 14/1000 | 14/1000 (12 to 16) | 4 856(4) |
| Mortality (all cause)Follow-up: 3-12 months | OR 1.24(0.81 to 1.90) | 8/1000 | 10/1000 (7 to 15) | 9 633(8) |
| Change in trough FEV1 (L)Follow-up: 3-12 months | - | Mean change at 6 months 0.06 L | Mean change 0.06 L (0.05 to 0.07) | 9 573(10) |
| Outcome | Relative effect(95% CI) | Assumed risk - LABA | Corresponding risk - Intervention = LABA + Tiotropium | Participants (studies) |
|---|---|---|---|---|
| Change in quality of lifeassessed with: SGRQScale from 0 to 100 (lower score is better) | - | Mean change at 6 months -5.7 units | Mean change -1.25 units (-2.14 to -0.37) | 3 378(4) |
| Quality of life SGRQ responder analysis at 6 months | OR 1.53(1.31 to 1.79) | 45/1000 | 55/1000 (51 to 59) | 2 923(2) |
| Hospital admission (all cause)Follow-up: 3-12 months | OR 1.53(1.31 to 1.79) | 14/1000 | 13/1000 (11 to 15) | 2 923(2) |
| Mortality (all cause)Follow-up: 3-12 months | OR 1.15(0.62 to 2.13) | 11/1000 | 13/1000 (7 to 24) | 3 514(3) |
| Change in trough FEV1 (L)Follow-up: 3-12 months | - | Mean change at 6 months 0.05 L | Mean change 0.07 L (0.06 to 0.09) | 3 513 (4) |
Date of latest search: 10 July 2015
Primary/Secondary Keywords