Table 2.
Statistically Significant Adverse Events – Antimuscarinic versus Placebo
| Outcome | Total Comparisons | Total Studies | All Studies | Oxybutynin IR | Oxybutynin ER | Tolterodine IR | Tolterodine ER | Trospium | Darifenacin | Solifenacin | Fesoterodine |
|---|---|---|---|---|---|---|---|---|---|---|---|
| RR (95% CI) | RR (95% CI)(Szonyi et al., 1995) | RR (95% CI)(Lackner et al., 2008) | RR (95% CI)(Malone-Lee et al., 2001) | RR (95% CI)(DuBeau et al., 2012; Wagg et al., 2014; Zinner et al., 2002) | RR (95% CI)(Sand et al., 2011) | RR (95% CI)(Chapple et al., 2007a; Foote et al., 2005) | RR (95% CI)(Wagg et al., 2006) | RR (95% CI)(Dubeau et al., 2014; DuBeau et al., 2012; Kraus et al., 2010b; Wagg et al., 2013) | |||
| AEs | 11 | 10 | 1.26 (1.12–1.43) NNH = 8.3 |
-- | 0.82 (0.38–1.78) | 1.14 (0.89–1.47) | 1.21 (1.00–1.45) | 0.99 (0.71–1.38) | 1.27 (1.09–1.48) NNH = 7.8 |
-- | 1.56(1.32–1.84) NNH =4.9 |
| Constipation | 14 | 13 | 2.39 (1.76–3.23)* NNH =15.4 |
0.99 (0.61–1.63) | 4.63 (0.23–91.81) | 0.96 (0.10–9.02) | 1.87 (1.14–3.08) NNH =35.5 |
13.03 (0.77–219.66) | 2.40 (1.36–4.23)* NNH =9.4 |
3.61 (2.22–5.89) NNH =9.0 |
3.14(2.15–4.57) NNH = 17.5 |
| Constipation, Mild-Moderate | 1 | 1 | 3.42
(2.10–5.59) NNH=9.7 |
-- | -- | -- | -- | -- | -- | 3.42
(2.10–5.59) NNH=9.7 |
-- |
| Dizziness | 9 | 9 | 1.43 (0.83–2.46) | -- | 0.31 (0.01–7.23) | 0.64 (0.17–2.46) | 1.63 (0.55–4.83) | 0.14 (0.01–2.81) | 1.60 (0.07–38.97) | -- | 2.22 (1.04–4.37) NNH =70 |
| Dry Mouth | 14 | 13 | 3.94 (2.82–5.50)* NNH =5.1 |
0.99 (0.61–1.63) | 0.92 (0.06–13.95) | 4.25
(1.63–11.07) NNH=3.3 |
3.89 (2.08–7.27)* NNH =8.1 |
3.07 (0.69–13.70) | 5.82 (3.11–10.90) NNH =5.1 |
5.49 (3.51–8.59) NNH =4.7 |
4.88 (3.81–6.26) NNH = 4.2 |
| Dry Mouth, Mild | 2 | 2 | 5.57 (3.65–8.49) NNH =5.5 |
-- | -- | -- | -- | -- | -- | -- | 5.57 (3.65–8.49) NNH =5.5 |
| Dry Mouth, Mild-Moderate | 1 | 2 | 5.49
(3.46–8.70) NNH=5 |
-- | -- | -- | -- | -- | -- | 5.49
(3.46–8.70) NNH=5 |
-- |
| Dry Mouth, Moderate | 2 | 2 | 4.00 (1.92–8.34) NNH =20.0 |
-- | -- | -- | -- | -- | -- | -- | 4.00 (1.92–8.34) NNH =20.0 |
| Dry Mouth, Severe | 4 | 4 | 4.80 (1.65–13.95) NNH =73.3 |
-- | -- | -- | -- | -- | -- | 5.42 (0.68–13.95) NNH =96.2 |
4.59 (1.32–15.94) NNH =64.0 |
| Dyspepsia | 7 | 7 | 2.01 (0.82–4.90)* | -- | 0.31 (0.01–7.23) | 0.40 (0.11–1.43) | 1.74 (0.42–7.18) | -- | 5.31 (0.69–40.97) | -- | 4.12 (1.59–10.63) NNH =47.8 |
| Headache | 10 | 9 | 1.62 (0.95–2.79)* | -- | 2.78 (0.12–65.08) | 2.57 (0.33–19.95) | 1.97 (1.07–3.65) NNH =99.0 |
-- | 0.11 (0.01–2.20) | -- | 1.46 (0.52–3.63) |
| Treatment-related AEs | 2 | 2 | 1.96 (1.39–2.76) NNH =5.8 |
-- | -- | -- | -- | 1.67 (0.83–3.36) | 2.06 (1.39–3.06) NNH = 5.2 |
-- | -- |
| Urinary Retention | 10† (8) | 9† (8) | 3.60 (1.67–7.76) NNH =95.1 |
-- | 2.78 (0.12–65.08) | † | 2.08 (0.19–22.82)† | 3.43 (0.17–70.17) | -- | 2.48 (0.70–8.85) | 6.02 (1.81–20.00)* NNH =65.6 |
| Urinary Tract Infection | 8 | 8 | 1.17 (0.81–1.71) | -- | -- | -- | 0.87 (0.40–1.89) | 3.43 (0.17–70.17) | 0.18 (0.01–4.33) | 1.93
(1.04–3.58) NNH=35.0 |
1.02 (0.61–1.70) |
*
I2 >25%;
†
Adverse Event noted in Study but 0 count,
AEs = Adverse Events; CI = confidence intervals; ER = extended release; IR = immediate release; NNH = Number Needed to Harm; RR= rate ratio