Safety and efficacy of risedronate for patients with esophageal varices and liver cirrhosis: a non-randomized clinical trial

Autor(es)

Lima, Talles Bazeia ^[1] ; Amaral Santos, Livia Alves ^[1] ; de Carvalho Nunes, Helio Rubens ^[2] ; Silva, Giovanni Faria ^[1] ; Caramori, Carlos Antonio ^[1] ; Qi, Xingshun ^[3] ; Romeiro, Fernando Gomes ^[1]

Afiliação do(s) autor(es)

^[1] Sao Paulo State Univ UNESP, Gastroenterol Div, Internal Med Dept, Botucatu Med Sch, Sao Paulo, SP - Brazil

^[2] Sao Paulo State Univ UNESP, Botucatu Med Sch, Publ Hlth Dept, Sao Paulo, SP - Brazil

^[3] Gen Hosp Shenyang Mil Command, Sheng, Liaoning - Peoples R China

• Tipo de documento: Artigo Científico
• Fonte: SCIENTIFIC REPORTS; v. 9, DEC 12 2019.
• Citações Web of Science: 0

Resumo

Despite the high prevalence of osteoporosis in liver cirrhosis, the indication of bisphosphonates for patients with esophageal varices has been avoided due to risk of digestive mucosal damage. Therefore, this study aimed to evaluate the safety profile of risedronate treatment for patients with osteoporosis, liver cirrhosis and esophageal varices with low risk of bleeding. A total of 120 patients were allocated into two groups according to their bone mineral density measured by dual-energy X-ray absorptiometry. In the intervention group, 57 subjects with osteoporosis received oral risedronate at 35 mg weekly plus daily calcium and vitamin D supplementation. In the control group, 63 subjects with osteopenia received only calcium and vitamin D. The groups received the treatment for one year and underwent surveillance endoscopies at six and 12 months, as well as a control dual-energy X-ray absorptiometry after a 12-month follow-up. The study received Institutional Review Board approval. The groups had not only comparable Model for End-stage Liver Disease score and esophageal varices degree, but also similar incidence of digestive adverse effects. A significant improvement was achieved in the intervention group in the lumbar spine T score (p < 0.001). The results suggest that risedronate may be safely used in liver cirrhosis and esophageal varices with low bleeding risk under endoscopic surveillance, thus allowing bone mass recovery. (AU)

• Processo FAPESP: 14/22572-9 - Resposta ao tratamento da osteoporose e da osteopenia em portadores de cirrose hepática
• Beneficiário: Lívia Alves Amaral Santos
• Modalidade de apoio: Bolsas no Brasil - Doutorado
• Processo FAPESP: 16/07117-9 - Risedronato no tratamento de osteoporose em portadores de cirrose com varizes esofágicas: avaliação sobre segurança e eficácia na recuperação da massa óssea
• Beneficiário: Fernando Gomes Romeiro
• Modalidade de apoio: Auxílio à Pesquisa - Regular