The discontinuation rate of tolvaptan due to adverse events during the double-blind period of a clinical trial was 9.5%.
Understanding Tolvaptan Discontinuation
In a notable clinical trial involving patients with later-stage autosomal dominant polycystic kidney disease (ADPKD), the discontinuation rate of tolvaptan was specifically observed concerning adverse events. During the double-blind phase of this study, 65 out of 681 patients receiving tolvaptan discontinued the trial regimen because of adverse events. This translates directly to a discontinuation rate of 9.5% for the tolvaptan group. For comparison, the placebo group experienced a discontinuation rate of 2.2% (15 of 685 patients) due to adverse events.
Comparative Discontinuation Rates in Clinical Trials
The difference in discontinuation rates between tolvaptan and placebo groups highlights the incidence of adverse events associated with tolvaptan treatment. A breakdown of these rates provides a clearer picture:
| Treatment Group | Total Patients | Discontinuations Due to Adverse Events | Discontinuation Rate (Overall AE) | Discontinuations Due to Aquaresis-Related AE | Aquaresis-Related Discontinuation Rate |
|---|---|---|---|---|---|
| Tolvaptan | 681 | 65 | 9.5% | 14 | 2.1% |
| Placebo | 685 | 15 | 2.2% | 1 | 0.1% |
Reasons for Discontinuation
Among the adverse events leading to discontinuation, those related to aquaresis were a notable factor in the tolvaptan group. Aquaresis refers to the excretion of solute-free water, a known effect of tolvaptan. Specifically, 14 patients (2.1%) in the tolvaptan group discontinued treatment due to adverse events related to aquaresis. In contrast, only 1 patient (0.1%) in the placebo group experienced discontinuation for aquaresis-related reasons.
For more detailed information on tolvaptan in autosomal dominant polycystic kidney disease, you can refer to relevant medical literature such as studies published in the New England Journal of Medicine.
