Gastrointestinal Tolerability and Patterns of Switching in Patients Treated for Primary Osteoporosis: The Swedish Adherence Register Analysis (SARA)

Landfeldt, Erik; Lang, Andrea; Robbins, Sean; Ström, O.

doi:10.1007/s00223-011-9511-3

Cited by 4 publications

(3 citation statements)

References 19 publications

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“…The results of the present meta-analysis are consistent with those from previous studies (28)(29)(30)(31)(32)(33)(34)(35)(36), which also observed no significant difference in the frequency of upper GIAEs between placebo-treated and Aln-treated groups, and demonstrated that the GI safety and tolerability profile of Aln resembles the placebo (10,11). However, the present results contradict a previous study that suggested that Aln treatment may be associated with an increased risk of upper GIAEs in patients, as compared with no treatment (17). Furthermore, in the present study, the incidences of the primary individual upper GIAEs, including abdominal pain, nausea, dyspepsia, acid regurgitation, vomiting, gastroesophageal reflux and esophagitis, were not significantly different between the placebo-and Aln-treated groups.…”

Section: Resultssupporting

confidence: 88%

“…Previous studies have demonstrated that Aln is able to effectively reduce the risk of vertebral, non-vertebral, hip and wrist fractures (7)(8)(9). The safety and tolerability of Aln has previously been investigated in various randomized controlled trials (RCTs) and retrospective studies (10)(11)(12)(13)(14)(15)(16)(17)(18), and the majority of these have reported similar side effects, including gastrointestinal tract adverse events (GIAEs), for the Aln-treated and placebo-treated groups. It has been reported that oral administration of bisphosphonates, particularly those containing a nitrogen atom, may be accompanied by digestive tract disturbances (19).…”

Section: Introductionmentioning

confidence: 99%

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Upper gastrointestinal safety and tolerability of oral alendronate: A meta-analysis

Zhou

Zheng

et al. 2015

Experimental and Therapeutic Medicine

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Osteoporosis (OP), which is a common bone disease associated with reduced bone mineral density and disordered bone microstructure, may result in an increased risk of bone fracture. The present study aimed to investigate the frequency of alendronate (Aln)-associated upper gastrointestinal tract adverse events (GIAEs) in postmenopausal women with OP. The following databases were searched in order to identify relevant studies: Medline (using PubMed as the search engine), Embase, the Web of Science and the Cochrane Central Register of Controlled Trials (up to December 2014). Studies were selected for inclusion if they were randomized, double-blind, placebo-controlled trials, which had investigated the safety of Aln versus a placebo for the treatment of postmenopausal women with OP. The primary outcomes of the included studies were total adverse events (AEs) and upper GIAEs, whereas individual upper GIAEs were considered as secondary outcomes. The general characteristics and outcomes of each study were abstracted by two independent researchers, and Review Manager 5.3 software was used for data syntheses and the meta-analysis. A total of nine studies, including 15,192 randomized patients, met the inclusion criteria and contributed to some or all of the meta-analysis outcomes. The Mantel-Haenszel method was used to calculate risk ratios, and their 95% confidence intervals (CI) were determined using either the fixed or random effects model, depending on the level of heterogeneity. The relative risk (95% CI) of AEs associated with Aln treatment, as compared with the placebo group, was 1.01 (0.97-1.06), and the relative risk (95% CI) of discontinued Aln treatment due to AEs was 1.04 (0.91-1.19). In addition, the relative risk (95% CI) of upper GIAEs was 1.02 (0.99-1.06), and the relative risk (95% CI) of discontinued Aln treatment due to upper GIAEs was 1.23 (0.97-56). In addition, these results remained robust to sensitivity analyses. The results of the present study suggested that Aln has a good GI tract tolerability, and that daily treatment with 10 mg Aln sodium does not increase the risk of GIAEs in postmenopausal women with OP.

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Section: Resultssupporting

confidence: 88%

Section: Introductionmentioning

confidence: 99%

Upper gastrointestinal safety and tolerability of oral alendronate: A meta-analysis

Zhou

Zheng

et al. 2015

Experimental and Therapeutic Medicine

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“…Such events, or use of medications suggesting their occurrence, have been shown to be associated with reduced adherence (both compliance and persistence) to treatment [6–11] and low treatment satisfaction [12–14]. Increased health care resource use has also been documented among patients with osteoporosis treatment-related GI events [15, 16]. However, such associations have not been assessed in Asian or Australian populations.…”

Section: Introductionmentioning

confidence: 99%

Impact of gastrointestinal events on patient-reported outcomes in Asia-Pacific women with osteoporosis: baseline results of the MUSIC OS-AP study

et al. 2017

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SummaryThe purpose of this study was to describe the impact of gastrointestinal events on patient-reported outcomes and health care resource use among Asia-Pacific women with postmenopausal osteoporosis. The results of this study show that gastrointestinal events decreased adherence, treatment satisfaction, and quality of life in Asia-Pacific women with postmenopausal osteoporosis.PurposeThis study aimed to describe the impact of gastrointestinal (GI) events on patient-reported outcomes and health care resource use among Asia-Pacific women with postmenopausal osteoporosis.MethodsThe MUSIC OS-AP study included an observational cohort study of postmenopausal women with osteoporosis. Women were classified as untreated or treated, with treated patients further classified as new or experienced users. Adherence was measured by the Adherence Evaluation of Osteoporosis treatment (ADEOS) questionnaire, treatment satisfaction by the Osteoporosis Patient Satisfaction Questionnaire (OPSAT) while general health-related and osteoporosis-specific quality of life were measured by the European Quality of Life-5 Dimensions (EQ-5D) questionnaire and the Osteoporosis Assessment Questionnaire (OPAQ), respectively. The association of GI events with these outcomes was determined by covariate-adjusted regression analysis of least squares mean differences in the scores of treated patients with and without GI events. Resource utilization was measured as the number of physician visits over the past 3 months, and multivariate regression analysis was used to assess the association of GI events with the likelihood of a visit.ResultsThe GI event profile, quality of life scores, and resource use were numerically similar in untreated and treated women. The rate of adherence among treated women was higher in experienced than in new users. As indicated by mean scores, experienced users had better quality of life and slightly higher treatment satisfaction and fewer physician visits than new users. Except for adherence in new users, all measures were similarly adversely affected by GI events in both new and experienced users.ConclusionsGI events decreased adherence, treatment satisfaction, and quality of life in Asia-Pacific women with postmenopausal osteoporosis.

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Persistence with osteoporosis medication among newly-treated osteoporotic patients

et al. 2013

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Low persistence with osteoporosis medication is associated with higher fracture risk. Previous studies estimated that 1-year persistence with osteoporosis medication is low. Our aim was to study persistence with osteoporosis medication among patients with long-term follow-up (to 5 years). The InterAction Database (IADB) was used to analyze persistence of 8610 Dutch patients initiating osteoporosis drugs between 2003 and 2011. Drugs under study were alendronate, risedronate, ibandronate, etidronate, raloxifene and strontium ranelate. Cumulative persistence rates were calculated after different time frames (3 months-5 years) using survival analysis. Multivariate Cox proportional hazard analyses were used to identify determinants of non-persistence. Furthermore, switching rates of persistent patients who initiated bisphosphonate therapy were analyzed. Persistence with osteoporosis therapy was 70.7 % (95 % CI, 69.7-71.7), 58.5 % (95 % CI, 57.4-59.6 %), 25.3 % (95 % CI, 24.1-26.5) after 6 months, 1 and 5 years, respectively. Determinants associated with higher risk to non-persistence within the first year were daily dosing regimen [HR, 1.76 (95 % CI, 1.46-2.14)], age <60 years [HR, 1.26 (95 % CI, 1.19-1.34)] and use of glucocorticoids [HR, 1.16 (95 % CI, 1.07-1.26)]. Monthly dosing schedule and use of generic brands of alendronate did not show a significant association with non-persistence. Approximately 4.0 % of patients initiating therapy with weekly alendronate or weekly risedronate switched therapy. Persistence with osteoporosis medication is low. Because low persistence is strongly associated with higher fracture risk, interventions to improve persistence are recommended. This study identified several patient groups in whom such interventions may be most relevant.

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Gastrointestinal Tolerability and Patterns of Switching in Patients Treated for Primary Osteoporosis: The Swedish Adherence Register Analysis (SARA)

Cited by 4 publications

References 19 publications

Upper gastrointestinal safety and tolerability of oral alendronate: A meta-analysis

Upper gastrointestinal safety and tolerability of oral alendronate: A meta-analysis

Impact of gastrointestinal events on patient-reported outcomes in Asia-Pacific women with osteoporosis: baseline results of the MUSIC OS-AP study

Persistence with osteoporosis medication among newly-treated osteoporotic patients

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