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Gastrointestinal and renal side effects of bisphosphonates: differentiating between no proof of difference and proof
V Fadda1, D Maratea1, S Trippoli1
1HTA unit, Area Vasta Centro Toscana, Regional Health System, Via San Salvi 12, 50100, Florence, Italy.
Background:
This study was aimed at comparing the safety of bisphosphonates in women with osteoporosis by application of equivalence testing.
Methods:
Gastrointestinal and renal side effects were evaluated based on information published in randomized controlled trials.
Results:
The data on gastrointestinal side effects (47 trials) indicated that alendronate, risedronate etidronate, and zolendronate have similar rates of the adverse effects; application of Bayesian network meta-analysis showed that equivalence was demonstrated according to margins around ±10%. The data on renal safety were more sparse and suffered from the use of different outcome measures; hence, a single trial could be evaluated. This trial showed a similar effect of alendronate and risedronate on renal function at 12 months; equivalence was based on differences between the two agents in renal function with margins of less than ±10.4 ml/min.
Conclusion:
Our study provided quantitative information to determine to what extent bisphosphonates can be considered equivalent in terms of gastrointestinal and renal side effects.
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