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Long-term safety of tenapanor in patients with irritable bowel syndrome with constipation in the T3MPO-3 study.
Lembo, Anthony J; Friedenberg, Keith A; Fogel, Ronald P; Edelstein, Susan; Zhao, Suling; Yang, Yang; Rosenbaum, David P; Chey, William D.
Afiliación
  • Lembo AJ; Digestive Disease Institute, Cleveland Clinic, Cleveland, Ohio, USA.
  • Friedenberg KA; Great Lakes Gastroenterology, Mentor, Ohio, USA.
  • Fogel RP; Digestive Health Center of Michigan, Chesterfield, Michigan, USA.
  • Edelstein S; Ardelyx, Inc., Waltham, Massachusetts, USA.
  • Zhao S; Ardelyx, Inc., Waltham, Massachusetts, USA.
  • Yang Y; Ardelyx, Inc., Waltham, Massachusetts, USA.
  • Rosenbaum DP; Ardelyx, Inc., Waltham, Massachusetts, USA.
  • Chey WD; Michigan Medicine, Ann Arbor, Michigan, USA.
Neurogastroenterol Motil ; 35(11): e14658, 2023 Nov.
Article en En | MEDLINE | ID: mdl-37668173
BACKGROUND: Tenapanor, a first-in-class, minimally systemic inhibitor of intestinal sodium/hydrogen exchanger isoform 3 (NHE3), is approved for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults based on two randomized, placebo-controlled, phase III studies (T3MPO-1 [NCT02621892], T3MPO-2 [NCT02686138]). The open-label T3MPO-3 extension study (NCT02727751) enrolled patients who completed these studies to investigate long-term safety and tolerability of tenapanor. METHODS: Patients who completed T3MPO-1 (16 weeks) or T3MPO-2 (26 weeks) were eligible for enrollment in T3MPO-3. Patients in T3MPO-3 received open-label tenapanor 50 mg twice a day for up to an additional 39 (T3MPO-1) or 26 (T3MPO-2) weeks. Treatment-emergent adverse events (TEAEs) were evaluated in the entire T3MPO-3 safety population and in patients who received a total of ≥52 weeks of tenapanor. KEY RESULTS: A total of 312 patients were enrolled in T3MPO-3; 90 received ≥52 weeks of tenapanor. TEAEs were reported in 117 (37.5%) patients in the safety population and in 52 (57.8%) patients who received ≥52 weeks of tenapanor. Diarrhea was the most common TEAE, occurring in 10.6% of the safety population and in 11.1% of patients who received ≥52 weeks of tenapanor. Most cases were mild or moderate in severity, with only two severe cases reported in the safety population. No deaths occurred during the T3MPO-3 study. CONCLUSIONS: Tenapanor was tolerable over ≥52 weeks of treatment and showed similar safety to that seen in shorter studies. Combined results of the T3MPO studies indicate that tenapanor is a valuable new treatment option for patients with IBS-C.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Síndrome del Colon Irritable Tipo de estudio: Clinical_trials Límite: Adult / Humans Idioma: En Revista: Neurogastroenterol Motil Asunto de la revista: GASTROENTEROLOGIA / NEUROLOGIA Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Síndrome del Colon Irritable Tipo de estudio: Clinical_trials Límite: Adult / Humans Idioma: En Revista: Neurogastroenterol Motil Asunto de la revista: GASTROENTEROLOGIA / NEUROLOGIA Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido