Severe osteoporosis: Principles for pharmacological therapy in Mexico

• Published in: Reumatología clinica (Barcelona) 2021-02, Vol.17 (2), p.97-105
• Main Authors: Clark, Patricia, Rivera, Fernando Carlos, Méndez Sánchez, Lucía, Mendoza Gutiérrez, Carlos Fernando, Vargas Neri, Jessica Liliana, Carrillo Vázquez, Sandra Miriam, Xibillé Friedmann, Daniel Xavier, Alvarado Ceballos, Ariana, Aguilera Zepeda, José Manuel, Mercado Cárdenas, Víctor, Ávila Amengol, Hilario
• Format: Article
• Language: English
• Subjects: Denosumab; Fracturas osteoporóticas; Mexico; México; Osteoporosis severa; Osteoporotic fractures; Severe osteoporosis; Teriparatida; Teriparatide
• ISSN: 2173-5743; 2173-5743
• DOI: 10.1016/j.reumae.2019.04.003

This article presents evidence and recommendations regarding the efficacy and safety of the approved and available therapies in Mexico to treat severe or established osteoporosis (OP) with the aim of developing a position regarding therapeutics in this stage of the disease, according to the descriptive cards of the National Drug Formulary of the National General Health Council of Mexico (CBCMSS). We performed a systematic and narrative review of the evidence of teriparatide and denosumab, from their pharmacological profile, effectiveness, and safety derived from clinical trials, as well as an analysis of the general recommendations of the national and international clinical practice guidelines. The evidence establishes that teriparatide and denosumab belong to different therapeutic classes, with biologically opposed mechanisms of action and indications of use, which are clearly differentiated in their respective national codes, therefore these drugs cannot be substitutable or interchangeable in severe OP therapy. Both represent the best options currently available for this stage of the disease; being similar in their efficacy in preventing new vertebral fragility fractures, with an RR of .35 (CI = 95%, .22−.55) for teriparatide, and .32 (CI = 95%, .26−.41) for denosumab. The absolute risk reduction (RRR) is higher with teriparatide 9.3% (21 months) compared with denosumab at 4.8% (36 months). Our results agree with the recommendations available in national and international clinical practice guidelines, with both therapies proposed as a sequential, but not a substitute, treatment. El presente artículo muestra la evidencia y recomendaciones al respecto de la eficacia y seguridad de las terapias hasta hoy aprobadas y disponibles en México para el tratamiento de la osteoporosis (OP) en su etapa severa o establecida, con la finalidad de establecer una postura terapéutica acerca de la eficacia y seguridad para esta etapa del padecimiento, de acuerdo a las cédulas descriptivas del Cuadro Básico y Catálogo de Medicamentos del Sector Salud en México (CBCMSS). Se realizó una revisión sistemática y narrativa de la evidencia de teriparatida y denosumab, desde su perfil farmacológico, efectividad y seguridad derivada de ensayos clínicos, además de un análisis de las recomendaciones generales de las principales guías de práctica clínica nacionales e internacionales. La evidencia establece que teriparatida y denosumab pertenecen a clases terapéuticas distintas, con meca