cendoc bogani publicaciones PMD conductas adictivas

Ficha Bibliografía científica

Safety and tolerability of ALO-02 (oxycodone hydrochloride and sequestered naltrexone hydrochloride) extended-release capsules in older patients: a pooled analysis of two clinical trials

Wilson, Jacquelyn G.; Bass, Almasa; Pixton, Glenn C.; Wolfram, Gernot; Rauck, Richard L.

Año: 2020

Objective: To assess the impact of age on the safety and tolerability of ALO-02, an abuse-deterrent opioid formulation consisting of oxycodone hydrochloride and sequestered naltrexone hydrochloride, in patients with chronic pain. Methods: Data from two clinical studies in patients with chronic low back pain or chronic non-cancer pain were analyzed. Patients aged >= 18 years who required continuous around-the-clock opioid analgesia for an extended period were grouped into >= 65 years and <65 years age groups. Treatment-emergent adverse events (TEAEs), use of concomitant medications, clinical laboratory measurements, and occurrences of opioid withdrawal using reported adverse events (AEs) and Clinical Opiate Withdrawal Scale (COWS) scores assessed safety. Data pooling was employed for the titration and maintenance phases of both studies. Results: Respectively 805 and 436 patients received >= 1 dose of ALO-02 in the titration and maintenance phases; 121 (15.0%) and 83 (14.6%) patients, respectively, were aged >= 65 years in the titration and maintenance phases. Average doses of ALO-02 were lower in the older patients in both phases. Incidences of TEAEs were comparable between age groups in both phases and generally lower in the maintenance phase. Concomitant medications were taken more often by patients aged >= 65 years. Incidences of potentially clinically significant laboratory results were low in both phases with no clinically important differences between age groups. There were few reports of opioid withdrawal events as assessed by reported AEs and COWS scores. One patient aged >= 65 years experienced an AE of opioid withdrawal. Conclusions: The safety and tolerability of ALO-02 is similar in those aged >= 65 years and those aged ClinicalTrials.gov identifiers: NCT01571362, NCT01428583.

Tipo documento:

Artículo

Número/Volumen:

36

Páginas:

91 - 99

Fuente:

CURRENT MEDICAL RESEARCH AND OPINION

Palabras clave:

Abuse-deterrent; chronic pain; extended release; naltrexone; opioid; oxycodone; safety

 

Comparte con otras personas

Compartir Compartir  Compartir

Regidoría de Salut i Consum del Ajuntament de València

Logotipo Universitat de València
Logotipo UISYS
Logotipo CSIC
Logotipo Consellería de Sanitat Universal y Salut Pública de la Generalitat Valenciana

Siguenos en:

 

Última actualización: 23/10/2020

Centro de documentación sobre drogodependencias y otros trastornos adictivos Dr. Emilio Bogani Miquel
Cendoc Bogani

Publicaciones, Artículos, Carteles, Posters y enlaces Web sobre Drogodependencias y Trastornos Adictivos relevantes para profesionales de las Ciencias de la Salud, Educación e Información.

Copyright © Centro de documentación sobre drogodependencias y otros trastornos adictivos Dr. Emilio Bogani Miquel, 2019.
Cendoc Bogani - C/ Amadeo de Saboya, 11 - bajo - 46010 - Valencia
Utilizamos cookies propias y de terceros para mejorar nuestros servicios y con fines estadísticos. Al continuar con la navegación entendemos que se acepta nuestra política de cookies. Más Información