Segurança do risedronato na cirrose hepática: análise endoscópica de pacientes com varizes esofágicas em tratamento de osteoporose
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Data
2018-02-28
Autores
Lima, Talles Bazeia
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Universidade Estadual Paulista (Unesp)
Resumo
A osteoporose é uma complicação frequente da cirrose hepática (CH) que pode levar a fraturas, comprometendo a qualidade e a expectativa de vida. Bisfosfonatos são frequentemente utilizados para reduzir o risco de fraturas por osteoporose, mas podem provocar danos à mucosa gastrointestinal. O objetivo deste estudo foi avaliar a segurança do risedronato em pacientes com CH e varizes de esôfago (VE). De 354 pacientes com CH, 164 foram considerados elegíveis e alocados de acordo com a densidade mineral óssea após densitometria. No grupo intervenção, 52 indivíduos com osteoporose receberam tratamento com risedronato oral (35 mg / semana), suplementação de cálcio e vitamina D. No grupo controle, 51 indivíduos com osteopenia receberam apenas suplementação de cálcio e vitamina D. Todos foram submetidos a endoscopias de vigilância durante 1 ano e à densitometria ao final do estudo. A média etária e a proporção de mulheres foi maior no grupo intervenção. O MELD (Model of End-Stage Liver Disease) no grupo intervenção e controle foi 9,6 (5,9-15,5) e 10,3 (6,5-19), respectivamente (p= 0,047). O grupo controle teve mais casos de doença hepática alcoólica (p< 0,001). Em ambos os grupo a maioria dos indivíduos tinha classificação Child-Pugh A e VE de baixo risco de sangramento. Não houve diferença entre os grupos quanto aos achados endoscópicos observados durante a intervenção. Não houve hemorragia digestiva alta no grupo intervenção, mas em 2 casos do grupo controle. O grupo intervenção foi o único em que houve ganho de massa óssea (coluna lombar): média do T score -3,2 e -2,7 pré e pós-tratamento, respectivamente (p= 0,001). Porém houve mais casos de artralgia e mialgia nesse grupo (p= 0,031 e 0,006), respectivamente. Esses resultados, de efeito prático imediato, sugerem que o risedronato é seguro na CH compensada com VE de baixo risco de sangramento sob vigilância endoscópica.
Osteoporosis is a common complication of liver cirrhosis that can lead to fractures, compromising quality of life and survival rate. Bisphosphonates are often used to reduce the risk of fractures caused by osteoporosis, but can lead to digestive mucosal damage. The aim of this study was to evaluate the safety of risedronate for patients with cirrhosis and esophageal varices. Of the 354 cirrhotic patients invited to participate, 164 were considered eligible and allocated according to the bone mineral density after densitometry. In the intervention group, 52 individuals with osteoporosis received oral risedronate 35 mg weekly plus calcium and vitamin D supplementation. In the control group, 51 individuals with osteopenia received only calcium and vitamin D supplementation. All the subjects underwent surveillance endoscopies within 1 year and another bone densitometry at the end of the trial. The mean age and the proportion of women were higher in the intervention group. The Model of End-Stage Liver Disease (MELD) scores in the intervention and control group were 9.6 (5.9-15.5) and 10.3 (6.5-19), respectively (p= 0.047). The control group had more subjects with alcoholic liver disease (p< 0.001). In both groups the majority of the individuals had Child-Pugh A classification and low-risk bleeding esophageal varices. There was no difference between the groups regarding esdoscopic findings during the intervention. There was no upper gastrointestinal bleeding in the intervention group but 2 in the control group. The intervention group was the only one that achieved increase in bone density (lumbar spine): Mean T score -3,2 and -2,7 pre and post treatment, respectively (p= 0,001). However, arthralgia and myalgia were more frequent in this group (p= 0.031 and 0.006 respectively). The results, which are of immediate practical effect, suggest that risedronate is safe in compensated liver cirrhosis with low-risk bleeding esophageal varices under endoscopic surveillance and allowed a gain of bone mass.
Osteoporosis is a common complication of liver cirrhosis that can lead to fractures, compromising quality of life and survival rate. Bisphosphonates are often used to reduce the risk of fractures caused by osteoporosis, but can lead to digestive mucosal damage. The aim of this study was to evaluate the safety of risedronate for patients with cirrhosis and esophageal varices. Of the 354 cirrhotic patients invited to participate, 164 were considered eligible and allocated according to the bone mineral density after densitometry. In the intervention group, 52 individuals with osteoporosis received oral risedronate 35 mg weekly plus calcium and vitamin D supplementation. In the control group, 51 individuals with osteopenia received only calcium and vitamin D supplementation. All the subjects underwent surveillance endoscopies within 1 year and another bone densitometry at the end of the trial. The mean age and the proportion of women were higher in the intervention group. The Model of End-Stage Liver Disease (MELD) scores in the intervention and control group were 9.6 (5.9-15.5) and 10.3 (6.5-19), respectively (p= 0.047). The control group had more subjects with alcoholic liver disease (p< 0.001). In both groups the majority of the individuals had Child-Pugh A classification and low-risk bleeding esophageal varices. There was no difference between the groups regarding esdoscopic findings during the intervention. There was no upper gastrointestinal bleeding in the intervention group but 2 in the control group. The intervention group was the only one that achieved increase in bone density (lumbar spine): Mean T score -3,2 and -2,7 pre and post treatment, respectively (p= 0,001). However, arthralgia and myalgia were more frequent in this group (p= 0.031 and 0.006 respectively). The results, which are of immediate practical effect, suggest that risedronate is safe in compensated liver cirrhosis with low-risk bleeding esophageal varices under endoscopic surveillance and allowed a gain of bone mass.
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Palavras-chave
Cirrose hepática, Osteoporose, Risedronato, Segurança, Varizes esofágicas, Liver cirrhosis, Osteoporosis, Risedronate, Safety, Esophageal varices