Nosocomial Infections and Role of Nanotechnology.

Nosocomial infections, termed hospital-acquired infections (HAIs), are acquired from a healthcare or hospital setting. HAI is mainly caused by bacteria, such as Acinetobacter baumannii, Klebsiella pneumoniae, Escherichia coli, Enterococci spp., Methicillin-resistant Staphylococcus aureus (MRSA), and many more. Due to growing antibacterial resistance, nanotechnology has paved the way for more potent and sensitive methods of detecting and treating bacterial infections. Nanoparticles have been used with molecular beacons for identifying bactericidal activities, targeting drug delivery, and anti-fouling coatings, etc. This review addresses the looming threat of nosocomial infections, with a focus on the Indian scenario, and major initiatives taken by medical bodies and hospitals in spreading awareness and training. Further, this review focuses on the potential role nanotechnology can play in combating the spread of these infections.

Reasons for Not Treating Women with Postmenopausal Osteoporosis with Prescription Medications: Physicians' and Patients' Perspectives.

BACKGROUND: In the United States, between one-third and two thirds of postmenopausal women do not begin treatment with a prescription osteoporosis medication after a diagnosis of osteoporosis. The objective of this study was to understand the reasons for this lack of treatment. MATERIALS AND METHODS: Online physician and patient surveys were administered in 2013. The physician survey included a chart review of untreated postmenopausal women recently diagnosed with osteoporosis and gathered data on physicians' practices regarding the management of osteoporosis in postmenopausal women. The patient survey was given to untreated postmenopausal women with a recent osteoporosis diagnosis. RESULTS: The physician survey was completed by 224 physicians, who also reviewed 811 patient charts. A total of 165 patients completed the patient survey. In the chart review, physicians reported that 19% of the postmenopausal women they diagnosed with osteoporosis were not prescribed an osteoporosis medication. The patient declined a physician's recommendation for pharmacological treatment in 81% and 52% of cases in the physician and patient surveys, respectively. The most frequent reasons for physicians not recommending treatment were: low calcium and/or vitamin D levels, patients potentially at risk of medication side effects, pre-existing gastrointestinal problems, and polypharmacy. The most frequent reasons for patients deciding against treatment were: concerns about side effects, considering nonprescription options and behavioral modifications, and questioning the potential benefit of taking the medication. CONCLUSIONS: Patients decided against pharmacological treatment of newly diagnosed osteoporosis in at least half of the cases of nontreatment. The principal reasons for not being treated with a prescription medication, given by both physicians and patients, were that there were alternatives and concern about the risks of prescription medications.

High rate of non-treatment among osteoporotic women enrolled in a US Medicare plan.

OBJECTIVE: To estimate the rate of non-treatment among elderly women with osteoporosis (OP) and to examine the association between patient characteristics and receiving treatment. RESEARCH DESIGN AND METHODS: This cross-sectional, retrospective, observational study utilized patient information and claims from the Humana database to identify Medicare covered women aged ≥65 years old and continuously enrolled with evidence of either an OP diagnosis or an OP-related fracture during 2007-2011. The main outcome was receipt of pharmacological treatment of OP during 2012 (follow-up). The percentage of non-treatment was calculated and a stepwise selection logistic regression model was employed to estimate the association between baseline demographic and clinical characteristics and receiving treatment. RESULTS: A total of 109,829 patients were included. Mean age was 75.7 years and 79.4% were identified with OP through OP diagnosis codes and did not have evidence of a prior fracture. Approximately one-third (32%) of patients had used OP medications during the baseline period, and 39% had experienced at least one gastro-intestinal event during baseline. Among all patients, 71.4% did not receive OP therapy during follow-up. The strongest factor associated with receiving treatment was prior use of OP therapy (odds ratio [OR] = 31.3; p < .001). Among the subgroup of patients with baseline fractures, 75.9% did not receive OP therapy during follow-up and the strongest factor associated with receiving treatment remained prior use of OP therapy (OR = 20.4; p < .001). Those with high comorbidity burden were less likely to receive treatment in both the overall cohort and within the subgroup with baseline fractures. CONCLUSIONS: Among Medicare-eligible women aged ≥65 identified with OP between 2007 and 2011, 71.4% did not receive OP treatment during 2012, including 75.9% of the subgroup of patients with a prior fracture. The use of diagnosis and procedures codes to identify patients with osteoporosis is subject to variation in coding.

Proportion and Characteristics of Patients in Sweden Remaining at High Risk of Fracture Despite Prior Treatment.

PURPOSE: Fragility fractures are a clinical consequence of osteoporosis (OP). Evidence suggests however, current OP treatments may be inadequate in reducing fracture risk. The purpose of this study was to estimate the proportion and characteristics of Swedish patients who remain at high risk of fracture after 2 years of treatment, as evidenced by osteoporotic bone mineral density (BMD), a decrease in BMD, or the occurrence of new fractures. METHODS: This was a retrospective, descriptive analysis of a subset of participants obtained from a Swedish osteoporosis patient registry from 1991 to 2009. Patients were required to be osteoporotic, to be treatment naive at baseline, to have returned for at least 1 follow-up visit, and to have reported osteoporosis treatment use for ≥2 years after the baseline visit with a BMD T score. Two overlapping cohorts remaining at high risk of fracture were defined using the BMD T score measured after 2 years of treatment from baseline. The osteoporosis cohort comprised patients who remained osteoporotic, whereas the BMD decrease cohort included patients whose total hip or lumbar spine T score decreased by ≥3%. FINDINGS: A total of 3292 osteoporotic patients were identified in the registry, of whom 392 met the study inclusion criteria. The mean (SD) patient age was 68.3 (8.5) years, with most patients being female (92.3%). Among all patients, 297 (75.8%) remained osteoporotic after at least 2 years of treatment, 90 (23.0%) experienced a BMD decrease of ≥3%, and 23 (5.9%) reported an incident fracture between the baseline and first follow-up visit. More than three-quarters (76.8%) of all patients reported taking bisphosphonates, whereas only 72.4% and 47.8% reported this in the osteoporosis and BMD decrease cohorts, respectively. Raloxifene was the only nonbisphosphonate used, with 24.2% of all patients reportedly taking it. IMPLICATIONS: This study highlighted that despite 2 years of osteoporosis treatment, a high percentage of patients remain at high risk of fracture. There is a need for improved treatment strategies that reduce fracture risk and improve patient outcomes in the real-world setting.

Association between gastrointestinal events and osteoporosis treatment initiation in women diagnosed with osteoporosis in France: a retrospective analysis.

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.

Relationship Between Gastrointestinal Events and Compliance With Osteoporosis Therapy: An Administrative Claims Analysis of the US Managed Care Population.

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.

Cost and Consequences of Nonadherence With Oral Bisphosphonate Therapy: Findings From a Real-World Data Analysis.

BACKGROUND: Adherence to osteoporosis treatment remains poor despite available treatments and physician and patient education. This study aims to determine the effect of low adherence in real-world data. OBJECTIVE: To examine the association between adherence with oral bisphosphonate therapy and fracture risk as well as health care resource utilization. METHODS: Women included in this retrospective analysis were 55 years or older and had started oral bisphosphonate therapy between 2005 and 2011 in a large not-for-profit health care center in Israel. Adherence to therapy was measured by the medication possession ratio (MPR) during the first year from therapy initiation. Patients with MPR lower than 70% were considered nonadherent. Study outcomes were osteoporotic fracture events and health care utilization (including physician visits and hospitalizations) during the second year from therapy initiation. RESULTS: Among the 17 770 women included in the analysis (mean age = 66.5 years; SD = ±8.3 years), 48.9% were nonadherent to therapy during the first year of treatment. Osteoporotic fracture risks during the second year among adherent and nonadherent patients were 2.1% and 2.5%, respectively (P = 0.1). When analysis was limited to patients 75 years or older, nonadherence with bisphosphonates was associated with an adjusted odds ratio of 1.49 (95% CI = 1.08-2.04) for osteoporotic fractures compared with adherent patients. Nonadherent patients had 13.4% higher medical costs than their adherent counterparts among patients 75 years and older (P = 0.002). CONCLUSIONS: In patients 75 years and older, nonadherence with oral bisphosphonates can be associated with significantly greater short-term risk of osteoporotic fractures and higher utilization of health care services.

Proportion of osteoporotic women remaining at risk for fracture despite adherence to oral bisphosphonates.

BACKGROUND: Adherence to oral bisphosphonates is often low, but even adherent patients may remain at elevated fracture risk. The goal of this study was to estimate the proportion of bisphosphonate-adherent women remaining at high risk of fracture. METHODS: A retrospective cohort of women aged 50years and older, adherent to oral bisphosphonates for at least two years was identified, and data were extracted from a multi-system health information exchange. Adherence was defined as having a dispensed medication possession ratio≥0.8. The primary outcome was clinical occurrence of: low trauma fracture (months 7-36), persistent T-score≤-2.5 (months 13-36), decrease in bone mineral density (BMD) at any skeletal site≥5%, or the composite of any one of these outcomes. RESULTS: Of 7435 adherent women, 3110 had either pre- or post-adherent DXA data. In the full cohort, 7% had an incident osteoporotic fracture. In 601 women having both pre- and post-adherent DXA to evaluate BMD change, 6% had fractures, 22% had a post-treatment T-score≤-2.5, and 16% had BMD decrease by ≥5%. The composite outcomes occurred in 35%. Incident fracture was predicted by age, previous fracture, and a variety of co-morbidities, but not by race, glucocorticoid treatment or type of bisphosphonate. CONCLUSION: Despite bisphosphonate adherence, 7% had incident osteoporotic fractures and 35% had either fracture, decreases in BMD, or persistent osteoporotic BMD, representing a substantial proportion of treated patients in clinical practices remaining at risk for future fractures. Further studies are required to determine the best achievable goals for osteoporosis therapy, and which patients would benefit from alternate therapies.

Association of gastrointestinal events with osteoporosis treatment initiation and treatment compliance in Germany: An observational study.

BACKGROUND: Gastrointestinal (GI) events are common in postmenopausal women treated for osteoporosis. The influence of GI events on treatment initiation and treatment compliance is the subject of ongoing research. OBJECTIVE: The objectives of this study were (i) to determine the association of GI events with receipt of treatment in patients newly diagnosed with osteoporosis, and (ii) among treated patients, to determine the association of GI events with treatment compliance. METHODS: This was a retrospective analysis of claims data carried out in Germany using the Mediplus database. Data were collected from January 1992 through December 2010. The dual-objective study design required two distinct cohorts. Cohort 1 comprised women aged ≥ 55 with a diagnosis of osteoporosis. GI events were recorded for the 12 month periods before and after the date of diagnosis. Time-varying Cox regression and discrete choice models were used, respectively, to assess the association of post-diagnosis GI events with the initiation of pharmacologic treatment (yes versus no) and the type of treatment initiated (bisphosphonates versus non-bisphosphonates). Cohort 2 comprised women aged ≥ 55 who initiated an oral bisphosphonate (alendronate, ibandronate, or risedronate). GI events were recorded for the 12 month periods before and after the date of bisphosphonate initiation, and a logistic regression model was employed to determine if pre-treatment or post-treatment GI events were associated with patient compliance, defined as a medication possession ratio (MPR) of ≥ 60%, with sensitivity analyses at MPR ≥ 80%. RESULTS: In cohort 1 (N = 18,813), 13.8% of patients had GI events in the pre-diagnosis period, and 14.8% had GI events in the post-diagnosis period. Among the patients with post-diagnosis GI events, 93.2% remained untreated during the post-index year, 6.2% were treated with bisphosphonates, and 0.6% received non-bisphosphonates. The respective percentages in patients without post-diagnosis GI events were 81.3%, 16.7%, and 1.9%. A post-diagnosis GI event decreased the likelihood of receiving any osteoporosis treatment (versus no treatment) by 83% (HR 0.17, 95% CI 0.14-0.20) and also decreased the likelihood of receiving a bisphosphonate (versus a non-bisphosphonate) by 39% (OR 0.61, 95% CI 0.54-0.68). In cohort 2 (N = 6040), 17.1% of patients had GI events in the year before treatment initiation, and 19.1% had GI events in the year after treatment initiation. At 12 months post-treatment initiation, GI events were more frequent in patients with pre-treatment GI events (53.2%) than in those without pre-treatment GI events (12.0%). Post-treatment GI events decreased the likelihood of attaining compliance defined as an MPR ≥ 60% (OR 0.84, 95% CI 0.73-0.97) but not an MPR ≥ 80% (OR 0.91, 95% CI 0.79-1.06). CONCLUSIONS: In German women newly diagnosed with osteoporosis, GI events decreased the likelihood of receiving treatment and were associated with the choice of treatment. In women initiating oral bisphosphonates, post-treatment GI events were associated with reduced patient compliance.

Association between gastrointestinal events and compliance with osteoporosis therapy.

PURPOSE: The aim of this study was to estimate the rate of gastrointestinal (GI) events, and association between GI events and compliance with osteoporosis therapy among osteoporotic women. METHODS: A retrospective cohort study using a large administrative claims database in the United States from 2001 through 2010 was conducted. We studied women ≥ 55 years old who were continuously enrolled in a health plan for at least 2 years, a baseline year before and a follow-up year after the date of the first prescription of oral bisphosphonate as the first oral osteoporosis treatment. Compliance with osteoporosis therapy was measured using the medication possession ratio (MPR), with compliance defined as MPR ≥ 0.8. Multivariate logistic regression was used to assess the association between occurrence of GI events and compliance with osteoporosis therapy after controlling for demographic and clinical characteristics. RESULTS: A sample consisting of 75,593 women taking at least one oral bisphosphonate with mean (SD) age of 64 (8) years was identified. A total of 21,142 (28%) patients experienced at least one GI event during the follow-up period. Only 31,306 (41%) patients were compliant with osteoporosis therapy. Patients who experienced GI events after initiation of oral bisphosphonates were 29% less likely to adhere to osteoporosis therapy as compared to patients who did not experience GI events (odds ratio [95% CI], 0.71 [0.69-0.74]; P < .001). CONCLUSIONS: Less than half of the patients were compliant with osteoporosis therapy within one year after initiating oral bisphosphonates, and the likelihood of compliance was significantly lower by 29% among women with GI events.

Gastrointestinal events and association with initiation of treatment for osteoporosis.

BACKGROUND: Preexisting gastrointestinal (GI) events may deter the use of pharmacologic treatment in patients diagnosed with osteoporosis (OP). The objective of this study was to examine the association between preexisting GI events and OP pharmacotherapy initiation among women diagnosed with OP. METHODS: The study utilized claims data from a large US managed care database to identify women aged ≥55 years with a diagnosis code for OP (index date) during 2002-2009. Patients with a claim for pharmacologic OP treatment in the 12-month pre-index period (baseline) were excluded. OP treatment initiation in the post-index period was defined as a claim for bisphosphonates (alendronate, ibandronate, risedronate, zoledronic acid), calcitonin, raloxifene, or teriparatide. During the post-index period (up to 12 months), GI events were identified before treatment initiation. A time-dependent Cox regression model was used to investigate the likelihood of initiating any OP treatment. Among patients initiating OP treatment, a discrete choice model was utilized to assess the relationship between post-index GI events and likelihood of initiating with a bisphosphonate versus a non-bisphosphonate. RESULTS: In total, 65,344 patients (mean age 66 years) were included; 23.7% had a GI event post diagnosis and before treatment initiation. Post-index GI events were associated with a 75% lower likelihood of any treatment initiation (hazard ratio 0.25; 95% confidence interval 0.24-0.26). Among treated patients (n=23,311), those with post-index GI events were 39% less likely to receive a bisphosphonate versus a non-bisphosphonate (odds ratio 0.61; 95% confidence interval 0.54-0.68). CONCLUSION: GI events after OP diagnosis were associated with a decreased likelihood of OP treatment initiation and an increased likelihood of treatment initiation with a non-bisphosphonate versus a bisphosphonate.

Undertreatment of osteoporosis and the role of gastrointestinal events among elderly osteoporotic women with Medicare Part D drug coverage.

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.

History of cardiovascular events and cardiovascular risk factors among patients initiating strontium ranelate for treatment of osteoporosis.

PURPOSE: To estimate the proportion of osteoporosis patients in whom initiating strontium ranelate treatment, under new EMA guidelines, should be contraindicated because of a history of cardiovascular events or risk for cardiovascular events. MATERIALS AND METHODS: This was a retrospective analysis of medical and pharmacy claims using the Clinical Practice Research Datalink database. Patients were included if they had ≥1 prescription of strontium from September 1, 2008 to August 31, 2013, were aged ≥50 as of the index date (the date of the first ever strontium ranelate prescription), and had ≥1 year of medical records pre-index. Cardiovascular events occurring any time pre-index were identified, which included ischemic heart disease, cerebrovascular disease, uncontrolled hypertension, and peripheral arterial disease. Cardiovascular risk factors assessed included 1) diabetes or hypertension any time pre-index; 2) hyperlipidemia in the 12 months pre-index; or 3) obesity in the 12 months pre-index. RESULTS: A total of 7,474 patients were included: 90.4% were women, with an average age of 76.5 years, and 84.5% used osteoporosis therapy, either bisphosphonates or non-bisphosphonates, prior to strontium initiation. A total of 23.6% of patients experienced ≥1 cardiovascular event prior to strontium initiation; the rate was lower among female patients than in male patients (22.4% vs 35.3%, P<0.01). A total of 45.9% had risk factors for cardiovascular events (without cardiovascular event history). CONCLUSION: More than one-fifth of osteoporosis patients in the UK who used strontium had a cardiovascular event history, and one-half had cardiovascular risk factors prior to strontium initiation.

Association Between Gastrointestinal Events and Health Care Resource Utilization Among Patients with Osteoporosis: Analysis of a U.S. Managed Care Population.

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.

Rationale and design of MUSIC OS-EU: an international observational study of the treatment of postmenopausal women for osteoporosis in Europe and Canada.

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.

Reasons for not initiating osteoporosis therapy among a managed care population.

BACKGROUND: Many women with osteoporosis do not initiate osteoporosis treatment. OBJECTIVE: To examine patients' reasons for not initiating osteoporosis treatment among women with osteoporosis. METHODS: Survey recipients were identified from a national US claims database and included women ≥55 years with an osteoporosis diagnosis from January 1, 2010 to March 31, 2012 as defined by: 1) osteoporosis diagnosis coupled with bone mineral density test within 183 days of diagnosis and/or 2) osteoporosis-related fracture. Eligibility required no claims for osteoporosis medication 1) at least 12 months and up to 5 years prior to osteoporosis diagnosis and 2) at least 6 months after osteoporosis diagnosis. Continuous enrollment for 18 months (6 months pre-osteoporosis and 12 months post-osteoporosis diagnosis) was also required. A total of 2,000 patients with the most recent osteoporosis diagnosis were mailed a survey. Respondents reporting that they did not initiate physician-recommended osteoporosis medication, after either their physician told them they had osteoporosis or they experienced a fracture since age 45 years, were asked for reasons why they did not initiate treatment. RESULTS: There were 430 patients who returned a complete survey; mean age was 61% and 21.6% had a fracture. A total of 197 (45.8%) patients reported their physician diagnosed osteoporosis and 117 (59.3%) of those were recommended osteoporosis medication; 44 of the 117 patients (37.6%) did not initiate recommended osteoporosis medication by the time of survey. The primary reasons for not initiating osteoporosis medication were concern over side effects (77.3%), medication costs (34.1%), and pre-existing gastrointestinal concerns (25.0%). CONCLUSION: Among respondents, 41% of patients whose physician diagnosed osteoporosis were not recommended osteoporosis treatment and 38% of patients who were recommended osteoporosis treatment did not initiate treatment within approximately 2 years of diagnosis. Concerns with side effects of osteoporosis treatment, medication costs, and pre-existing gastrointestinal concerns were the most common reasons for not initiating recommended treatment.

Association between gastrointestinal events and persistence with osteoporosis therapy: analysis of administrative claims of a U.S. managed care population.

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.

Gastrointestinal Events Among Patients Initiating Osteoporosis Therapy: A Retrospective Administrative Claims Database Analysis.

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.

Renal impairment among postmenopausal women with osteoporosis from a large health plan in Israel.

UNLABELLED: Bisphosphonates are a first-line treatment for osteoporosis but require adequate renal function. We estimated the prevalence of renal impairment among osteoporotic women in Israeli. Approximately 2.3 % of women had renal impairment at a level that makes them inappropriate for bisphosphonate use, demonstrating the need for alternative therapies for osteoporosis treatment. PURPOSE: The purpose of this study is to estimate the prevalence of renal impairment among postmenopausal osteoporotic women within a large Israeli health plan. METHODS: This was a retrospective analysis of Maccabi electronic medical records, including Israeli women aged ≥55 with either an osteoporosis diagnosis or osteoporosis-related fracture between January 1, 2007, and December 31, 2011. The estimated glomerular filtration rate (eGFR), which was calculated from the lowest serum creatinine levels reported during the study period, was used to classify stage 1-5 renal impairment: normal ≥90, mild 60-89, moderate 30-59, severe 15-29, and failure <15 mL/min/1.73 m(2), respectively. Outcomes were distributions of renal impairment across the study population and stratified by age and osteoporosis-defining event. RESULTS: A total of 15,608 patients met all eligibility criteria. Patients with stage 1-5 renal function accounted for 25.2, 54.9, 18.5, 1.2, and 0.3 %, respectively, of all patients. Of osteoporotic patients, 2.3 % had eGFR levels (<35 mL/min/1.73 m(2)) that make them inappropriate for bisphosphonate use. This rate was 1.6 % among patients with an osteoporosis diagnosis and 3.8 % among patients with osteoporosis-related fracture. Within the group of renally impaired patients, older patients were overrepresented. Of the fracture group, patients with hip fractures had a higher prevalence of renal dysfunction (9.3 %) than those having vertebral fractures (3.2 %) or other fractures (2.0 %). CONCLUSIONS: Among postmenopausal women with osteoporosis, 2.3 % had renal impairment which makes them inappropriate for bisphosphonate use in Israel.

Cost and consequences of noncompliance with osteoporosis treatment among women initiating therapy.

OBJECTIVE: The objective was to evaluate compliance with osteoporosis (OP) treatments and determine the fracture and healthcare burden associated with noncompliance. METHODS: This retrospective analysis of a US claims database identified women initiating an OP medication from 1 January 2002 to 30 June 2009. Patients were ≥55 years and had ≥1 pharmacy claim for a bisphosphonate or non-bisphosphonate (raloxifene, calcitonin, teriparatide); the index date was the first pharmacy claim. There were three study periods: baseline (12 months pre-index); compliance period (0-12 months post-index); and follow-up period (12-24 months post-index). Medication possession ratio (MPR) was calculated during the compliance period to differentiate two cohorts: compliant (MPR ≥ 80%) and noncompliant (MPR < 80%). Outcomes during follow-up were modeled by logistic regression (presence of fracture), Poisson regression (healthcare utilization incidence rate) and gamma regression (healthcare costs), all adjusted for patient demographic and clinical characteristics. RESULTS: Overall, 685,505 women initiating OP therapy were identified and 57,913 (8.4%) met the inclusion criteria: only 23,430 (40.5%) were compliant and 34,483 (59.5%) were noncompliant. Mean age was 64 years. Noncompliance was associated with a 20% higher risk of any fracture (odds ratio: 1.20, 95% CI = 1.07-1.35), a higher incidence rate ratio (IRR) for inpatient utilization (IRR: 1.26, 95% CI = 1.19-1.34) and a lower rate of outpatient utilization (IRR: 0.97, 95% CI = 0.95-0.98). Noncompliant patients had 13% higher medical costs (cost ratio: 1.13, 95% CI = 1.06-1.21) than compliant patients. LIMITATIONS: Inclusion in this study required 36 months of continuous healthcare coverage. Thus, the results are primarily applicable to a stable, managed care population and may not be generalizable to other populations. CONCLUSION: Noncompliance with OP therapy was associated with a higher risk of fracture, higher all-cause medical costs and a higher frequency of inpatient service utilization. Additional research is needed to identify barriers to compliance with OP therapy.