Medication adherence assessment: high accuracy of the new Ingestible Sensor System in kidney transplants
Ute Eisenberger, Rudolf P Wüthrich, Andreas Bock, Patrice Ambühl, Jürg Steiger, Allison Intondi, Susan Kuranoff, Thomas Maier, Damian Green, Lorenzo DiCarlo, Gilles Feutren, Sabina De Geest, Ute Eisenberger, Rudolf P Wüthrich, Andreas Bock, Patrice Ambühl, Jürg Steiger, Allison Intondi, Susan Kuranoff, Thomas Maier, Damian Green, Lorenzo DiCarlo, Gilles Feutren, Sabina De Geest
Abstract
Background: This open-label single-arm exploratory study evaluated the accuracy of the Ingestible Sensor System (ISS), a novel technology for directly assessing the ingestion of oral medications and treatment adherence.
Methods: ISS consists of an ingestible event marker (IEM), a microsensor that becomes activated in gastric fluid, and an adhesive personal monitor (APM) that detects IEM activation. In this study, the IEM was combined to enteric-coated mycophenolate sodium (ECMPS). Twenty stable adult kidney transplants received IEM-ECMPS for a mean of 9.2 weeks totaling 1227 cumulative days.
Results: Eight patients prematurely discontinued treatment due to ECMPS gastrointestinal symptoms (n=2), skin intolerance to APM (n=2), and insufficient system usability (n=4). Rash or erythema due to APM was reported in 7 (37%) patients, all during the first month of use. No serious or severe adverse events and no rejection episode were reported. IEM detection accuracy was 100% over 34 directly observed ingestions; Taking Adherence was 99.4% over a total of 2824 prescribed IEM-ECMPS ingestions. ISS could detect accurately the ingestion of two IEM-ECMPS capsules taken at the same time (detection rate of 99.3%, n=2376).
Conclusions: ISS is a promising new technology that provides highly reliable measurements of intake and timing of intake of drugs that are combined with the IEM.
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References
- Butler JA, Roderick P, Mullee M, et al. Frequency and impact of nonadherence to immunosuppressants after renal transplantation: a systematic review. Transplantation 2004; 77: 769.
- Dew MA, DiMartini AF, De Vito Dabbs A, et al. Rates and risk factors for non-adherence to the medical regimen after adult solid organ transplantation. Transplantation 2007; 83: 858.
- Pinsky BW, Takemoto SK, Lentine KL, et al. Transplant outcomes and economic costs associated with patient noncompliance to immunosuppression. Am J Transplant 2009; 9: 2597.
- Kidney Disease: Improving Global Outcomes (KDIGO) Transplant Work Group Clinical practice guideline for the care of kidney transplant recipients. Am J Transplant 2009; 9: S1
- Sabaté E, ed. Adherence to Long-term Therapies. Geneva, Switzerland: The World Health Organization; 2003
- Fine RN, Becker Y, De Geest S, et al. Nonadherence consensus conference summary report. Am J Transplant 2009; 9: 35.
- Osterberg L, Blaschke T. Adherence to medication. N Engl J Med 2005; 35: 487.
Source: PubMed