Systematic Review and Meta-analysis of Real-World Adherence to Drug Therapy for Osteoporosis

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Mayo Clinic Proceedings (Impact Factor: 6.26). 01/2008; 82(12):1493-501. DOI: 10.1016/S0025-6196(11)61093-8
Source: PubMed


To quantify the adherence of patients to drug therapy for osteoporosis in real-world settings via a systematic review and meta-analysis of observational studies.
The PubMed and Cochrane databases were searched for English-language observational studies published from January 1, 1990, to February 15, 2006, that assessed patient adherence to drug therapy for osteoporosis using the following medical subject headings and keywords: drug therapy, medication adherence, medication persistence, medication possession ratio, patient compliance, and osteoporosis. Studies were stratified into 3 groups: persistence (how long a patient continues therapy), compliance (how correctly, in terms of dose and frequency, a patient takes the medication), and adherence (a combination of persistence and compliance). A random-effects model was used to pool results from the selected studies.
Twenty-four studies were included in the meta-analysis. The pooled database-derived persistence rate was 52% (95% confidence interval [CI], 44%-59%) for treatment lasting 1 to 6 months, 50% (95% CI, 37%-63%) for treatment lasting 7 to 12 months, 42% (95% CI, 20%-68%) for treatment lasting 13 to 24 months, returning to 52% (95% CI, 45%-58%) for treatment lasting more than 24 months. Pooled adherence rates decreased from 53% (95% CI, 52%-54%) for treatment lasting 1 to 6 months to 43% for treatment lasting 7 to 12 months (95% CI, 38%-49%) or 13 to 24 months (43%; 95% CI, 32%-54%). The pooled refill compliance estimate was 68% (95% CI, 63%-72%) for treatment lasting 7 to 12 months and 68% (95% CI, 67%-69%) for treatment lasting 13 to 24 months. The pooled self-reported compliance rate was 62% (95% CI, 48%-75%) for treatment lasting 1 to 6 months and 66% (95% CI, 45%-81%) for treatment lasting 7 to 12 months.
One-third to half of patients do not take their medication as directed. Nonadherence occurs shortly after treatment initiation. Terms and definitions need to be standardized to permit comparability of technologies designed to improve patient adherence. Prospective trials are needed to assess the relationship between adherence and patient outcomes.

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Available from: Ronald Joel Halbert
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    • "Bisphosphonates have been shown to effectively reduce the risk of vertebral and hip fractures in osteoporotic patients. Unfortunately, several large studies have found that the majority of postmenopausal women stop bisphosphonate therapy within 1 year of beginning treatment [7] [8] [9]. Reasons for poor persistence include conflicting patient beliefs, patient preferences, financial limitations , and previous adverse effects including rash, myalgia, nausea, and diarrhea [7] [10] [11]. "
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    ABSTRACT: Although denosumab (Prolia) has been shown to be a safe and efficacious therapy for osteoporotic patients in numerous clinical trials, few studies have determined its effectiveness in real world clinical practice. A retrospective review of patients prescribed Prolia assessing the impact that noncompliance from the regular dosing regimen of six months for denosumab has on bone mineral density (BMD) was performed. 924 patient records were reviewed between August 2012 and September 2013 with 436 patients meeting the eligibility criteria. Patients were divided into three groups: subsequent injection of denosumab (1) less than five months, (2) between five and seven months, and (3) more than seven months after their initial subcutaneous injection. A multivariable regression analysis was conducted comparing the differences among the three prespecified groups in BMD change (g/cm 2 ) after one year of denosumab therapy at both the lumbar spine (LS) and femoral neck (FN). The differences in LS and FN BMD have shown that the relationship between the timing of drug administration in these three groups and change in BMD over 1 year was not clinically or statistically significant ( p > 0.05 ). A follow-up study with a larger sample size and longer follow-up duration is required to further characterize this relationship.
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    • "Among them, the oral bisphosphonates, including alendronate, risedronate, and ibandronate, are the most commonly used agents. However, suboptimal compliance with osteoporosis therapies is a common and well-recognized problem in the real world of clinical practice, outside of clinical trials (Cramer et al., 2007; Kothawala et al., 2007; Li et al., 2012); and poor compliance results in increased risk of fracture, higher medical costs, increases in hospitalizations, and wasted medications (Halpern et al., 2011; Sampalis et al., 2011; Ross et al., 2011; Hadji et al., 2012). Improving compliance with osteoporosis therapies is thus an important goal for both policy makers and clinicians. "
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    ABSTRACT: 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.
    Full-text · Article · Oct 2015
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    • "Hence, the commonly used methods of measuring adherence, which classify patients as discontinued after a gap of at least 90 days even if they later restart the same therapy [11,12], or exclude patients if they switch to another anti-osteoporosis medication or different dosage [13,14], may underestimate overall treatment adherence and hinder understanding of the utilization of bisphosphonate therapy. For a study of the efficacy, effectiveness, and/or safety of a specific type, route, or dose of bisphosphonate (e.g., alendronate, risedronate, ibandronate), a narrow definition of discontinuation may be appropriate. "
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    ABSTRACT: Low adherence to bisphosphonate therapy is associated with increased fracture risk. Factors associated with discontinuation of osteoporosis medications have not been studied in-depth. This study assessed medication discontinuation and switching patterns among Medicare beneficiaries who were new users of bisphosphonates and evaluated factors possibly associated with discontinuation. We identified patients initiating bisphosphonate treatment using a 5% random sample of Medicare beneficiaries with at least 24 months of traditional fee-for-service and part D drug coverage from 2006 through 2009. We classified medication status at the end of follow-up as: continued original bisphosphonate, discontinued without switching or restarting, restarted the same drug after a treatment gap (>= 90 days), or switched to another anti-osteoporosis medication. We conducted logistic regression analyses to identify baseline characteristics associated with discontinuation and a case-crossover analysis to identify factors that precipitate discontinuation. Of 21,452 new users followed respectively for 12 months, 44% continued their original therapy, 36% discontinued without switching or restarting, 8% restarted the same drug after a gap greater than 90 days, and 11% switched to another anti-osteoporosis medication. Factors assessed during the 12-month period before initiation were weakly associated with discontinuation. Several Factors measured during follow-up were associated with discontinuation, including more physician visits, hospitalization, having a dual-energy X-ray absorptiometry test, higher Charlson comorbidity index scores, higher out-of-pocket drug payments, and upper gastrointestinal problems. Patterns were similar for 4,738 new users followed for 30 months. Among new bisphosphonates users, switching within and across drug classes and extended treatment gaps are common. Robust definitions and time-varying considerations should be considered to characterize medication discontinuation more accurately.
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