Safety of Injectable HPβCD-Diclofenac in Older Patients with Acute Moderate-to-Severe Postoperative Pain: A Pooled Analysis of Three Phase III Trials

Drugs & Aging
Jacques E ChellyChristian Russel D Reyes

Abstract

Hydroxypropyl-β-cyclodextrin-diclofenac (HPβCD-diclofenac) is an NSAID used to treat acute moderate-to-severe postoperative pain. This post hoc analysis investigated the safety of HPβCD-diclofenac in patients aged ≥ 65 years. Data from three phase III trials of HPβCD-diclofenac in adult patients with acute moderate-to-severe postoperative pain were pooled (NCT00448110, NCT00507026, and NCT00726388). Patients who received one or more dose of HPβCD-diclofenac or placebo were included and stratified according to age: < 65, 65-74, or ≥ 75 years. Numerical and categorical variables were compared across the groups using ANOVA and Cochran-Mantel-Haenszel tests, respectively. Cochran-Mantel-Haenszel relative risks compared with placebo were calculated, adjusted by study. Overall, 1289 patients were included: 878, 282, and 129 in the < 65, 65-74, and ≥ 75-years groups, respectively. Overall incidence of treatment-emergent adverse events (TEAEs) was similar in the three groups (p = 0.4360). Incidences of postoperative anemia (p < 0.0001), constipation (p = 0.0017), and hypotension (p = 0.0003) increased significantly across the age groups, whereas headache (p = 0.0008) and flatulence (p = 0.0118) decreased significantly. Relative risks f...Continue Reading

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Citations

Aug 22, 2018·International Journal of Pharmaceutics·Érika Yoko SuzukiValeria Pereira de Sousa

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Clinical Trials Mentioned

NCT00448110
NCT00507026
NCT00726388

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