Abstract: TH-PO1115
Treatment of dRTA with an Innovative Combination Product as Compared to Current Standards of Care
Session Information
- Fluid, Electrolyte, Acid-Base Disorders
November 02, 2017 | Location: Hall H, Morial Convention Center
Abstract Time: 10:00 AM - 10:00 AM
Category: Fluid, Electrolytes, and Acid-Base
- 704 Fluid, Electrolyte, Acid-Base Disorders
Authors
- Bertholet-Thomas, Aurélia, Centre de référence des maladies rénales rares, Bron, France
- Guittet, Catherine, Advicenne, Nîmes, France
- Manso, Maria Asuncion, Advicenne, Nîmes, France
- Granier, Luc andre, Advicenne, Nîmes, France
Group or Team Name
- B21CS study investigators
Background
Patients suffering from distal renal tubular acidosis (dRTA) require long-term treatment in order to restore and maintain physiological blood pH values. Products currently used as standards of care (SoC) require several daily administrations and are characterised by gastro-intestinal (GI) tolerability issues and bitter taste.
A new innovative age-adaptable prolonged-release granule combination product (ADV7103), achieving adequate bicarbonataemia (blood bicarbonate ≥22 mM) with only two daily doses, together with improved tolerability and palatability, is proposed as an alternative.
The objective of this work is to discuss the ability to restore bicarbonataemia with ADV7103 in comparison with SoC in dRTA patients.
Methods
A multicentre (N=13), open-label, non-inferiority, sequential study was performed. Adult and paediatric dRTA patients (N=37, 30 evaluable for bicarbonataemia) received their SoC and then ADV7103 at the most appropriate doses, both during 5-day periods. The alkali doses administered and the blood bicarbonate levels at steady state treatment conditions were compared.
GI tolerability, palatability, easiness of administration and swallowing, were evaluated using visual analogue scales or 5-point facial hedonic scales.
Results
Blood bicarbonate levels were suboptimal in children and infants with the SoC and improved with two daily administrations of ADV7103. Less variability was observed with ADV7103 in adults and similar results were obtained with both treatments in adolescents.
Improved GI tolerability, palatability and easiness of administration were observed in all age groups with ADV7103 compared to SoC.
The improved ability to correct metabolic acidosis of ADV7103 was associated to the possibility of optimising dosing, while poor tolerability and acceptability appeared to limit further dosing increases with SoC.
Conclusion
ADV7103 is the first prolonged-release alcalinizing product improving bicarbonataemia control in dRTA patients compared with SoC, with less GI side effects and very good acceptability.
Funding
- Commercial Support –