Abstract
ABSTRACTUpper gastrointestinal (GI) side effects are a main reason for discontinuing bisphosphonate treatment, an important therapeutic option for osteoporosis patients. Consequently, the development of novel formulations with improved tolerability is warranted. In this multicenter prospective, observational, postauthorization safety study conducted in Italy and Spain, postmenopausal women (PMW) with osteoporosis (naïve to bisphosphonates) were treated weekly with a buffered soluble alendronate 70 mg effervescent (ALN‐EFF) tablet (Binosto®) and followed for 12 ± 3 months. Information was collected on adverse events (AEs), medication errors, persistence, and compliance using the Morisky‐Green questionnaire. Patients (N = 1028) aged 67 ± 9 years (mean ± SD) received ALN‐EFF weekly. The cumulative incidence of upper GI AEs (oesophageal toxicity, gastritis, gastric ulcers, and duodenitis) related to ALN‐EFF (primary endpoint) was 9.6% (95% confidence interval [CI] 7.9–11.6%), the vast majority being of mild intensity. The most frequently occurring upper GI AEs related to ALN‐EFF were dyspepsia (2.7%), gastroesophageal reflux disease (2.4%), and nausea (2.2%). None of the relevant upper GI AEs listed in the primary endpoint and no serious AEs were reported. At least one medication error occurred in 29.9% (95% CI 27.1–32.8%) of patients. However, the majority of medication errors were associated with administration instructions applicable to any oral bisphosphonate and only seven medication errors were associated with the ALN‐EFF formulation. ALN‐EFF was discontinued in 209 of 1028 (20.3%) patients. The most frequent reasons for discontinuation were AEs related to ALN‐EFF (46.9%) and patients' decision (42.6%). Compliance with ALN‐EFF was high, reflected by a mean Morisky‐Green score of 92.8 ± 18.6. PMW with osteoporosis treated with ALN‐EFF in a real‐world setting experienced few upper GI AEs. In addition, they had a low discontinuation and high compliance compared with other formulations, suggesting that ALN‐EFF may increase patient satisfaction and therefore long‐term adherence and efficacy. © 2021 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.
Highlights
Osteoporosis is characterized by abnormalities in bone mass and structure in bone tissue leading to impaired skeletal strength and increased susceptibility to fractures.[1]
N GI EVENTS AND MEDICATION ERRORS AFTER alendronate mg effervescent tablet formulation (ALN-EFF) FORMULATION 7 of 10 did not comply with at least one of the alendronate dosing instructions, mostly waiting 30 minutes before food and using liquid other than water. These two dosing instruction errors were observed in two-thirds of patients reporting medication errors.[29] the results of our study show that the use of the ALN-EFF-specific alendronate formulation is not associated with an increased risk of medication errors compared with standard oral alendronate formulations
Based on the results of this study, it is suggested that ALN-EFF may represent an alendronate treatment for patients with postmenopausal osteoporosis that is associated with preferable pharmacologic properties translating into clinical benefit for patients
Summary
Osteoporosis is characterized by abnormalities in bone mass and structure in bone tissue leading to impaired skeletal strength and increased susceptibility to fractures.[1]. ALN-EFF is ingested as a buffered solution of fully dissolved alendronate to prevent the pH of gastric juice from further decreasing in the presence of alendronate, diminishing potential damage in cases of esophageal reflux and preventing contact of solid alendronate with the esophageal mucosa.[5]. It has to be taken at least 30 minutes before the first meal of the day to permit adequate absorption. ALN-EFF is bioequivalent to Fosamax and was approved as a hybrid medicine in 2011 in the European Union and by the US Food and Drug Administration (FDA) in 2012.(23,24)
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