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Purpose: A large proportion of women with osteoporosis do not comply with current osteoporosis therapies, resulting in diminished therapeutic effect. Noncompliance may be due to the occurrence of gastrointestinal (GI) events during the course of therapy. The objective of this study was to estimate the rate of GI events among women taking oral bisphosphonates and to determine the association between GI events and compliance with bisphosphonate therapy., Methods: This was a retrospective analysis of data from a US Medicare claims database (HUMANA). The study period was from January 2007 to June 2013. The index date was the date of the first oral bisphosphonate prescription (alendronate, ibandronate, or risedronate) occurring between January 2008 and June 2012. The pre- and postindex periods were the 1-year periods before and after the index date, respectively. The analysis included women 65 years of age and older who were naïve to all osteoporosis treatments before the index date. GI events included nausea/vomiting; dysphagia; esophagitis; esophageal reflux; esophageal, gastric, duodenal, and peptic ulcer; stricture, perforation, or hemorrhage of the esophagus; acute gastritis; and GI hemorrhage. GI events were assessed during the preindex period and at 3, 6, and 12 months in the postindex period. Compliance was defined as a medication possession ratio of ≥80%. The medication possession ratio was calculated as the total days׳ supply of bisphosphonate in the postindex period divided by 365 days. The association of postindex GI events with compliance was assessed using multivariate logistic regression., Findings: The analysis included 37,886 women initiating oral bisphosphonate therapy. In the preindex year, 37.5% of the women experienced a GI event, and in the postindex year, 38.9% had a GI event. Patients with preindex GI events had numerically higher rates of postindex GI events than patients without preindex GI events (61.8% vs 25.1% at 12 months postindex). Patients who experienced postindex GI events were less likely to be compliant with bisphosphonate therapy, with odds of compliance of 0.76 (95% CI, 0.72-0.80) after 12 months., Implications: Among US women who were prescribed oral bisphosphonates, on-treatment GI events were associated with decreased compliance at 1 year., (Copyright © 2016. Published by Elsevier Inc.)

Background: A substantial portion of women diagnosed with osteoporosis (OP) do not initiate pharmacotherapy to reduce fracture risk. In clinical practice, gastrointestinal (GI) events have been linked with OP therapy discontinuation. However, there is limited research examining GI events as barrier to treatment initiation following an OP diagnosis. The objective of this study was to examine the association between gastrointestinal (GI) events and osteoporosis (OP) treatment initiation among post-menopausal women diagnosed with osteoporosis in France., Methods: A retrospective claims analysis of the Mediplus France database during 1997 to 2010 identified women aged ≥ 55 with an OP diagnosis and without prior OP treatment (first diagnosis date was defined as the index date). GI events were identified during the 1 year pre-index and up to 1 year post-index. OP treatment initiation post-index was identified based on the presence of claims for any bisphosphonate (BIS) or non-BIS OP medication within 1 year post-index. Multivariate models (logistic regression, Cox proportional hazards regression and discrete choice) adjusted for pre-index patient characteristics were used to assess the association of pre- and post-index GI events with the likelihood of initiating OP treatment, and the type of treatment initiated (BIS vs. non-BIS)., Results: A total of 10,292 women (mean age 70.3 years) were identified; only 25% initiated OP treatment. Post-index GI events occurred in 11.5% of patients, and were associated with a 75.7% lower likelihood of initiating OP treatment. Among treated patients, a discrete choice model estimated that patients with post-index GI events were 34.6% less likely to receive BIS vs non-BIS as compared to patients without post-index GI events., Conclusion: Among women aged ≥ 55 years with an OP diagnosis, post-index GI events were associated with a lower likelihood of OP treatment initiation.

Objectives: To examine the rate of osteoporosis (OP) undertreatment and the association between gastrointestinal (GI) events and OP treatment initiation among elderly osteoporotic women with Medicare Part D drug coverage., Methods: This retrospective cohort study utilized a 20% random sample of Medicare beneficiaries. Included were women ≥66 years old with Medicare Part D drug coverage, newly diagnosed with OP in 2007-2008 (first diagnosis date as the index date), and with no prior OP treatment. GI event was defined as a diagnosis or procedure for a GI condition between OP diagnosis and treatment initiation or at the end of a 12-month follow-up, whichever occurred first. OP treatment initiation was defined as the use of any bisphosphonate (BIS) or non-BIS within 1 year postindex. Logistic regression, adjusted for patient characteristics, was used to model the association between 1) GI events and OP treatment initiation (treated versus nontreated); and 2) GI events and type of initial therapy (BIS versus non-BIS) among treated patients only., Results: A total of 126,188 women met the inclusion criteria: 72.1% did not receive OP medication within 1 year of diagnosis and 27.9% had GI events. Patients with a GI event were 75.7% less likely to start OP treatment (odds ratio [OR]=0.243; P<0.001); among treated patients, patients with a GI event had 11.3% lower odds of starting with BIS versus non-BIS (OR=0.887; P<0.001)., Conclusion: Among elderly women newly diagnosed with OP, only 28% initiated OP treatment. GI events were associated with a higher likelihood of not being treated and, among treated patients, a lower likelihood of being treated with BIS versus non-BIS.

Background: Among patients on osteoporosis therapy, including oral bisphosphonates (BIS), upper gastrointestinal (GI) conditions have been linked with lower adherence to treatment and increased treatment discontinuation in clinical practice. Patients who are nonadherent to treatment have a higher risk of osteoporotic fractures and, consequently, have greater use of health care services. The burden of upper gastrointestinal events on health care resource utilization (HCRU) among women initiating oral BIS has not been well investigated., Objective: To examine the association of upper GI events and HCRU in women initiating oral BIS. , Methods: Using a U.S. national claims database, this retrospective study identified women aged ≥ 55 years who were prescribed oral BIS during 2001-2011 and had no history of GI events 12 months prior to treatment initiation. Patients with medical claims for an upper GI event ≤ 4 months posttreatment initiation were cases; all others were controls. The date of the first upper GI event among cases and a randomly assigned date ≤ 4 months posttreatment initiation among controls was the index date. Cases were matched 1:1 to controls by propensity scores derived from logistic regression of pre-index patient characteristics. Outcomes were all-cause and osteoporosis (OP)-related HCRU in the 6-month post-index period. Differences were assessed using McNemar's test., Results: Of the 62,863 eligible patients, 4,751 (7.6%) experienced an upper GI event ≤ 4 months posttreatment initiation (cases); 4,739 cases were matched with 4,739 controls. Compared with controls, cases had higher rates of all-cause HCRU (outpatient: 99.3% vs. 87.8%; inpatient: 20.2% vs. 6.4%; emergency room [ER]: 12.5% vs. 7.4%; all P  less than  0.0001) and OP-related HCRU (outpatient: 24.6% vs. 18.2%; inpatient: 3.4% vs. 1.0%; ER: 0.7% vs. 0.4%; all P  less than  0.05)., Conclusions: Patients with upper GI events had higher rates of all-cause and OP-related health care utilization. Upper GI events may pose an incremental HCRU burden among patients initiating BIS.

Objectives: The Medication Use Patterns, Treatment Satisfaction, and Inadequate Control of Osteoporosis Study (MUSIC OS-EU) was designed to better understand the rate and burden of gastrointestinal (GI) events on clinical and health care outcomes among postmenopausal women with osteoporosis., Methods: MUSIC OS-EU is a prospective, multinational, observational cohort study of postmenopausal women ≥50 years of age diagnosed with osteoporosis and enrolled in physician clinics in six countries: France, Italy, the Netherlands, Sweden, the United Kingdom, and Canada. The MUSIC OS-EU study has three components: (i) a physician survey to describe their management of osteoporotic patients with GI events; (ii) a retrospective chart survey to describe the receipt and type of osteoporosis medication prescribed; and (iii) a prospective cohort study including untreated and treated patients diagnosed with osteoporosis to investigate the rate of GI events and association with osteoporosis medication use patterns, health-related quality of life, treatment satisfaction and resource utilisation among postmenopausal women with osteoporosis., Results: Physicians at 97 sites completed the physician questionnaire and data for 716 patients were abstracted for the retrospective chart review. Enrolment and the baseline data collection for the prospective cohort study were conducted between March 2012 and June 2013 for 292 untreated and 2,959 treated patients, of whom 684 were new users and 2,275 were experienced users of oral osteoporosis medications., Conclusions: The results of MUSIC OS-EU will illuminate the association of GI events with the management of osteoporosis and with patient-reported outcomes among postmenopausal women with osteoporosis in Europe and Canada.

Purpose: Our purpose was to characterize the occurrence of gastrointestinal (GI) events among women on oral bisphosphonate therapy., Methods: This was a retrospective cohort study that used a United States (US) claims database. The study period was from January 1, 2000, to December 31, 2011. The index date was the date of the first oral bisphosphonate (alendronate, ibandronate, or risedronate) prescription and occurred between January 1, 2001, and December 31, 2010. The pre- and post-index periods were the 1-year periods before and after the index date, respectively. The analysis included women with osteoporosis aged ≥55 years at the index date who were naive to all osteoporosis treatments before the index date and were continuously enrolled in the health plan for at least 1 year before and 1 year after the index date. Patients with a diagnosis of malignant neoplasm during the pre- or post-index periods or a diagnosis of Paget disease anytime in the claims history were excluded. The occurrence of GI events (defined as esophagitis; gastroesophageal reflux disease; ulcer, stricture, perforation, or hemorrhage of the esophagus; gastric, duodenal, or peptic ulcer; acute gastritis; duodenitis; GI hemorrhage; nausea/vomiting; or dysphagia) was assessed during the pre-index period and at 3, 6, and 12 months in the post-index period. The rate of GI events was defined as the percentage of patients having at least 1 GI event in each analysis period (ie, pre-index and post-index periods). GI events in the post-index period were also stratified by the presence of GI events in the pre-index period., Findings: A total of 75,593 women were included in the analysis. The average age at the index date was 64.4 years. Gastroprotective agents were used by 17.9% of patients. Approximately one fourth of patients (26.6%; n = 20,073) had ≥1 GI events in the pre-index period. Approximately the same proportion of patients (28.0%; n = 21,142) experienced GI events in the post-index period. The cumulative rate of GI events during the post-index period was higher among patients who had GI events in the pre-index period (51.2%) than among patients without a GI event in the pre-index period (19.6%)., Implications: Among women with osteoporosis enrolled in a US commercial plan, GI events were common regardless of bisphosphonate use. Approximately one fourth of US women on bisphosphonate therapy experienced GI events within the year after initiation of therapy, and one half of US women with a previous GI event had another event while taking bisphosphonates., (Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: A large proportion of patients do not persist with osteoporosis (OP) therapy. Gastrointestinal (GI) events (e.g., gastroesophageal reflux disease and nausea/vomiting) are common among OP patients receiving OP therapy and may impact persistence with treatment., Objective: To examine the association of GI events and persistence with OP therapy., Methods: Using a large U.S. administrative claims database, we studied women aged ≥ 55 years who received oral bisphosphonate (BIS) as their first OP therapy from 2002-2009. The index date was the first pharmacy claim date recorded for oral BIS therapy; the baseline period was 12 months pre-index, and follow-up was 12 months post-index. Patients were considered persistent with therapy if they had continuous refills of the index drug class without additional drug therapy from a different drug class from the index date until the end of the follow-up period with no gaps in supply greater than 45 days. Discontinuation was defined as the first gap greater than 45 days during which there was no evidence of refills of OP medication. The association between post-treatment GI events and the risk of discontinuation or switching was modeled with Cox regression stratified by presence of baseline GI events and adjusted for baseline clinical and demographic characteristics., Results: Of the 75,593 women who met eligibility criteria, 59.9% discontinued BIS; 39.3% were persistent; and 0.5% switched to non-BIS. GI events were diagnosed in 20,073 patients (26.6%) during baseline and in 21,142 (28.0%) in the post-treatment period (12-month follow-up post-index). Patients with post-treatment GI diagnosis were 35.6% more likely to discontinue or switch treatment (HR = 1.356, 95% CI = 1.318-1.396) during the 12-month follow-up compared with those without post-treatment GI diagnosis. GI events that occurred closer to treatment discontinuation or switching were associated with a greater risk of discontinuation or switching: 37.9% (HR = 1.379, 95% CI = 1.338-1.421) for GI events within 6 months of discontinuation or switching and 45.6% (HR = 1.456, 95% CI = 1.408-1.505) for GI events within 3 months of discontinuation or switching., Conclusions: Among women aged 55 years or older in a U.S. managed care population, post-treatment GI events were associated with a higher risk of discontinuation of oral BIS or switching to non-BIS.