Upper gastrointestinal tolerability of alendronate sodium monohydrate 10 mg once daily in postmenopausal women: A 12-week, randomized, double-blind, placebo-controlled, exploratory study

Adachi, Jonathan D.; Faraawi, R.; O’Mahony, Michael; Nayar, Arun; Massaad, Rachid; Evans, Judith K.; Yacik, Carol

doi:10.1016/j.clinthera.2009.08.016

Cited by 14 publications

(14 citation statements)

References 6 publications

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“…Abdominal pain and dyspepsia were the most common adverse events, and accounted for more than half of the total events. The types of adverse events in this study did not differ from those reported in other bisphosphonate studies 23,24). The proportion of patients who experienced adverse events that led to discontinuation was 2.8% (16 patients).…”

Section: Discussioncontrasting

confidence: 48%

The Efficacy and Safety of a Combined Alendronate and Calcitriol Agent (Maxmarvil): A Postmarketing Surveillance Study in Korean Postmenopausal Women with Osteoporosis

Suh

Kim

et al. 2012

Korean J Fam Med

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BackgroundCombined therapy with alendronate and calcitriol may have additive effects on bone density. An observational study was performed to evaluate the efficacy and safety of Maxmarvil, a combinative agent of alendronate (5 mg) and calcitriol (0.5 µg), and to identify factors associated with efficacy.MethodsA total of 568 postmenopausal women with osteoporosis were enrolled by family physicians in 12 hospitals. The study subjects took Maxmarvil daily for 12 months. Questionnaires about baseline characteristics, socioeconomic status, and daily calcium intake were completed at the first visit. Adverse events were recorded every 3 months and bone mineral density (BMD) in the lumbar spine was measured using dual-energy X-ray absorptiometry at baseline and after 12 months. We evaluated the efficacy and safety of Maxmarvil, and the factors related to BMD improvement.ResultsA total of 370 patients were included in final analysis. The median BMD was 0.81 ± 0.12 g/cm2 at pre-treatment and 0.84 ± 0.13 g/cm2 after one year. The average BMD improvement was 3.4% ± 6.4% (P < 0.05), and 167 (45.1%) patients showed improvement. Factors associated with improved BMD were continuation of treatment (odds ratio [OR], 2.41; 95% confidence interval [CI], 1.15 to 5.07) and good compliance (OR, 2.54; 95% CI, 1.29 to 5.00). Adverse events were reported by 35 of the 568 patients, with the most common being abdominal pain and dyspepsia.ConclusionMaxmarvil was found to be safe, well tolerated and effective in osteoporosis treatment. Continuation of treatment and good compliance were the factors associated with efficacy.

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Section: Discussioncontrasting

confidence: 48%

The Efficacy and Safety of a Combined Alendronate and Calcitriol Agent (Maxmarvil): A Postmarketing Surveillance Study in Korean Postmenopausal Women with Osteoporosis

Suh

Kim

et al. 2012

Korean J Fam Med

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“…In a sensitivity analysis, we included a bisphosphonate treatment disutility based on reported rates of gastrointestinal and bone adverse effects and reported disutilities associated with these effects. In this analysis, bisphosphonate treatment was associated with an increased incidence of dyspepsia (8%), osteonecrosis of the jaw (ONJ, 0.02%), and atypical femur fractures (0.039%) . Atypical femur fractures were incorporated by increasing hip fracture rates under bisphosphonate treatment.…”

Section: Methodsmentioning

confidence: 85%

The Potential Economic Benefits of Improved Postfracture Care: A Cost-Effectiveness Analysis of a Fracture Liaison Service in the US Health-Care System

Solomon

Patrick

Schousboe

et al. 2014

Journal of Bone and Mineral Research

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Fractures related to osteoporosis are associated with $20 billion in cost in the United States, with the majority of cost born by federal health-care programs, such as Medicare and Medicaid. Despite the proven fracture reduction benefits of several osteoporosis treatments, less than one-quarter of patients older than 65 years of age who fracture receive such care. A postfracture liaison service (FLS) has been developed in many health systems but has not been widely implemented in the United States. We developed a Markov state-transition computer simulation model to assess the cost-effectiveness of an FLS using a health-care system perspective. Using the model, we projected the lifetime costs and benefits of FLS, with or without a bone mineral density test, in men and women who had experienced a hip fracture. We estimated the costs and benefits of an FLS, the probabilities of refracture while on osteoporosis treatment, as well as the utilities associated with various health states from published literature. We used multi-way sensitivity analyses to examine impact of uncertainty in input parameters on cost-effectiveness of FLS. The model estimates that an FLS would result in 153 fewer fractures (109 hip, 5 wrist, 21 spine, 17 other), 37.43 more quality-adjusted life years (QALYs), and save $66,879 compared with typical postfracture care per every 10,000 postfracture patients. Doubling the cost of the FLS resulted in an incremental cost-effectiveness ratio (ICER) of $22,993 per QALY. The sensitivity analyses showed that results were robust to plausible ranges of input parameters; assuming the least favorable values of each of the major input parameters results in an ICER of $112,877 per QALY. An FLS targeting patients post-hip fracture should result in cost savings and reduced fractures under most scenarios.

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“…One condition associated with dyspeptic symptoms, GERD, may contribute to the development of AF, FIGURE 2. [13][14][15][16] Some oral anticoagulants currently indicated for stroke prophylaxis in AF patients at moderate risk may cause dyspepsia, among other GI side effects. Values depicted in the graph represent percentage impairment as measured by the work productivity and activity impairment scale.…”

Section: Discussionmentioning

confidence: 99%

Dyspepsia and Disease Burden Among Patients With Atrial Fibrillation

LaMori

Mody

Gross

et al. 2012

Critical Pathways in Cardiology: A Journal of Evidence-Based Medicine

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This retrospective, observational study was conducted to determine overlap of prevalence between atrial fibrillation (AF), an increasingly common condition that primarily affects the elderly population, and dyspepsia, which is also common. Because the overlap of these conditions could interfere with health care including medication selection, the effect on patient outcomes was also evaluated. A demographically representative population of adults in the United States self-administered an Internet-based questionnaire, and responses were evaluated to determine the presence of AF and measures of comorbidity, including CHADS2 score of stroke risk. Health-related quality of life, work productivity and activity impairment, and health care resource utilization were also assessed. The impact of dyspepsia on these patient outcomes was then examined with multiple regressions and generalized linear models. From the sample population, 1297 participants reported being diagnosed with AF, of whom 34% (449/1297) reported diagnosis of dyspepsia. Those with dyspepsia had a higher mean CHADS2 score than those without dyspepsia. Despite this higher risk, significantly fewer AF patients with dyspepsia than those without dyspepsia were taking either prescription medication to treat AF or anticoagulants for stroke prevention. Dyspepsia was associated with significantly lower levels of both mental and physical health-related quality of life. Work and activity impairment and health care resource utilization were also significantly higher among AF patients with dyspepsia than among those without. The burden of dyspepsia in AF patients should be considered during medication selection. Selection of agents associated with lower rates of dyspepsia may lead to greater patient acceptance of and adherence to therapy.

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Upper gastrointestinal tolerability of alendronate sodium monohydrate 10 mg once daily in postmenopausal women: A 12-week, randomized, double-blind, placebo-controlled, exploratory study

Cited by 14 publications

References 6 publications

The Efficacy and Safety of a Combined Alendronate and Calcitriol Agent (Maxmarvil): A Postmarketing Surveillance Study in Korean Postmenopausal Women with Osteoporosis

The Efficacy and Safety of a Combined Alendronate and Calcitriol Agent (Maxmarvil): A Postmarketing Surveillance Study in Korean Postmenopausal Women with Osteoporosis

The Potential Economic Benefits of Improved Postfracture Care: A Cost-Effectiveness Analysis of a Fracture Liaison Service in the US Health-Care System

Dyspepsia and Disease Burden Among Patients With Atrial Fibrillation

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