Overactive Bladder
Ten international experts in urology, obstetrics, gynaecology, and health ageing compared the benefit-safety balance of 14 OAB drugs. The experts considered four favourable effects:
They identified seven unfavourable effects, but only three, constipation, dry-mouth, and dizziness, showed clinically relevant differences (taking into account incidence rate and severity) among the drugs they considered.
- Urgency: reduction of a compelling desire to urinate which is difficult to defer
- UUI: reduction in the urgency of incontinence episodes
- Frequency: reduction in the frequency of wanting to pass urine
- Nocturia: reduction in instances of getting up at night to urinate
They identified seven unfavourable effects, but only three, constipation, dry-mouth, and dizziness, showed clinically relevant differences (taking into account incidence rate and severity) among the drugs they considered.
The options
The total benefit-safety balance is shown here on a 100-point scale. Green best; Red worst.
The total benefit-safety balance is shown here on a 100-point scale. Green best; Red worst.
- Fesoterodine 4mg or 8mg (flexible dosing) 7
- Solifenacine 5mg/Mirabegron 50mg 65
- Solifenacine 5mg/Mirabegron 25mg 63
- Solifenacine 10mg 60
- Trospium 20mg 59
- Fesoterodine 8mg 59
- Solifenacine 5mg 56
- Tolterodine 4mg ER 49
- Mirabegron 50mg 47
- Fesoterodine 4mg 45
- Mirabegron 25mg 45
- Placebo 31
- Darifenacine 15mg 30
- Oxybutynin10mg ER 29
- Darifenacine 7.5mg 15
The numbers represent the overall added clinical value of each drug. They take into account available data for the effects and judgements by the experts about the clinical relevance of the effects.
Bar graphs
Separate contributions of benefits and safety to the overall totals show different profiles. For example, the three drugs scoring lower than the placebo are all less safe than the placebo, but their benefits are insufficient even to bring their total score above that of the placebo.
Separate contributions of benefits and safety to the overall totals show different profiles. For example, the three drugs scoring lower than the placebo are all less safe than the placebo, but their benefits are insufficient even to bring their total score above that of the placebo.
Benefits versus safety
Another way to look at the benefit and safety information is to show each drug's two assessments before the 75-25 weights are applied.
Another way to look at the benefit and safety information is to show each drug's two assessments before the 75-25 weights are applied.
This figure facilitates comparisons of the drugs. The top rating of fesoterodine 4 or 8 (flexible dosing) is due to its high-scoring benefits, while the two solifenacine/mirabegron combinations are safer, but lower in benefits.
Note that flexible dosing of fes 4 or 8 is more beneficial and safer than 4, 5, 6, 13, 14, and 15, while the sol/mir combinations are more beneficial and safer than most of the remaining drugs. In other words, only fes 4 or 8 and the sol/mir combinations are better than all other drugs for their benefits and/or safety.
Note that flexible dosing of fes 4 or 8 is more beneficial and safer than 4, 5, 6, 13, 14, and 15, while the sol/mir combinations are more beneficial and safer than most of the remaining drugs. In other words, only fes 4 or 8 and the sol/mir combinations are better than all other drugs for their benefits and/or safety.
Effects Table
All the above is based on the following data, culled from available public sources, and experts' weight assessments about the clinical relevance of the evidence. To support patient-oriented prescribing based on the evidence, green identifies the best drug for each favourable effect and red the worst drug for each unfavourable effect.
All the above is based on the following data, culled from available public sources, and experts' weight assessments about the clinical relevance of the evidence. To support patient-oriented prescribing based on the evidence, green identifies the best drug for each favourable effect and red the worst drug for each unfavourable effect.
%delta is the reduction in number of episodes over a 24-hour period.
% is the percentages of patients who experienced the side effect.
% is the percentages of patients who experienced the side effect.
Note that the weighted scores are relative and zero does not mean no value, so only differences between numbers, not their ratios, make sense for comparing the clinical value they represent.
Pfizer initiated this project and Pierre Fabre supported it.
Source: Chapple CR, Mironska E, Wagg A, et al. Multicriteria Decision Analysis Applied to the Clinical Use of Pharmacotherapy for Overactive Bladder Symptom Complex. European Urology Focus 2020; 6: 522-30.
Source: Chapple CR, Mironska E, Wagg A, et al. Multicriteria Decision Analysis Applied to the Clinical Use of Pharmacotherapy for Overactive Bladder Symptom Complex. European Urology Focus 2020; 6: 522-30.