Gastroprotective agents may be needed in postmenopausal women taking bisphosphonates.
Before scientists discovered bisphosphonates’ bone-fortifying effects in the late 1960s, the drugs were used as anti-corrosives, laundry soap, and fertilizer. Now, they are widely prescribed to treat and prevent osteoporosis in postmenopausal women.
Bisphosphonates were prescribed to approximately 14.7 million American women in 2012, a number significantly lower than the peak year of 2007, when 31 million women were treated.
This decline was due to reports of safety problems and questions about optimal duration of use. One significant problem has been gastrointestinal (GI) side effects in general, and acid reflux in particular.
A team of researchers from the academic and private sectors recently characterized GI events among women taking oral bisphosphonate therapy. The study, which was published ahead of print in Clinical Therapeutics, determined GI events are common in this patient population.
The researchers employed a retrospective cohort design and relied on a US claims database to identify women receiving prescriptions for alendronate, ibandronate, or risedronate between January 1, 2000, and December 31, 2011. They included 75,593 women aged older than 55 years who had never been treated for osteoporosis.
The authors defined GI events as ulcer, stricture, perforation, or hemorrhage of the esophagus; esophagitis; gastroesophageal reflux disease; gastric, duodenal, or peptic ulcer; acute gastritis; duodenitis; GI hemorrhage; nausea/vomiting; or dysphagia.
Approximately 18% of the study population used concurrent gastroprotective agents such as proton pump inhibitors, H2 antagonists, and cytoprotectants.
Approximately 27% of patients had experienced a GI event before starting bisphosphonate treatment, and around 28% experienced GI events after starting treatment. Patients who had experienced a GI event before starting bisphosphonates were significantly more likely to experience one during treatment. Half of those who had a history of GI events experienced one during treatment, compared with roughly 20% of patients who had no history of GI events.
In this study, the rate of GI events among women treated with bisphosphonates was higher than the rates reported in previous US studies.
The researchers advised clinicians to monitor women with histories of GI events carefully if they choose to prescribe or dispense a bisphosphonate. Gastroprotective agents may be needed in these patients.