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Biomedical subjects

Daniel H Solomon

Publications and source records attributed to Daniel H Solomon.

At least 19 recordsLinked to original sources

Incidence and economic burden of osteoporosis-related fractures in the United States, 2005-2025.

UNLABELLED: This study predicts the burden of incident osteoporosis-related fractures and costs in the United States, by sex, age group, race/ethnicity, and fracture type, from 2005 to 2025. Total fractures were >2 million, costing nearly $17 billion in 2005. Men account for >25% of the burden. Rapid growth in the disease burden is projected among nonwhite populations. INTRODUCTION: The aging of the U.S. population will likely lead to greater prevalence of osteoporosis. Policy makers require precise projections of the disease burden by demographic subgroups and skeletal sites to effectively target osteoporosis intervention and treatment programs. MATERIALS AND METHODS: A state transition Markov decision model was used to estimate total incident fractures and costs by age, sex, race/ethnicity, and skeletal site for the U.S. population 50 years of age for 2005-2025. RESULTS: More than 2 million incident fractures at a cost of $17 billion are predicted for 2005. Total costs including prevalent fractures are more than $19 billion. Men account for 29% of fractures and 25% of costs. Total incident fractures by skeletal site were vertebral (27%), wrist (19%), hip (14%), pelvic (7%), and other (33%). Total costs by fracture type were vertebral (6%), hip (72%), wrist (3%), pelvic (5%), and other (14%). By 2025, annual fractures and costs are projected to rise by almost 50%. The most rapid growth is estimated for people 65-74 years of age, with an increase>87%. An increase of nearly 175% is projected for Hispanic and other subpopulations. CONCLUSIONS: Osteoporosis prevention, treatment, and education efforts should address all skeletal sites, not just hip and vertebral, and appropriate attention is warranted for men and diverse race/ethnicity subgroups.

Cost of Illness↗

Osteoporosis management in patients with rheumatoid arthritis: Evidence for improvement.

OBJECTIVE: Osteoporosis in patients with rheumatoid arthritis (RA) is increasingly recognized as a major comorbidity. We examined past management patterns for glucocorticoid-induced osteoporosis and attempted to improve care through an educational intervention. The goal was to examine the frequency of osteoporosis management in patients with RA treated at a large academic rheumatology practice. METHODS: We performed a structured chart review on randomly selected patients seen during 2004 for RA. Osteoporosis management was defined as a bone mineral density test or receipt of a medication for osteoporosis in the prior 24 months. The frequency of osteoporosis management among our study group was assessed. We also examined how glucocorticoid dosage affected osteoporosis management in adjusted models. RESULTS: We reviewed the records for 193 patients, 99 had not used glucocorticoids in the prior 24 months, and 94 had used them. Of the total study population, 48% had received a bone mineral density test or medication for osteoporosis. Some form of osteoporosis management was present for 64% of patients taking > or =5 mg prednisone for > or =3 months compared with 38% for patients taking none (P = 0.002). Predictors of osteoporosis management included older age, female sex, glucocorticoid dosage, and prior osteoporosis diagnosis or fracture. CONCLUSION: The frequency of osteoporosis management appears to have increased compared with a prior chart review.

Aged↗

Development of classification and response criteria for rheumatic diseases.

RELEVANCE TO THE CLINICIAN: Clinicians already know that not all patients who are diagnosed with rheumatic diseases really have them. Moreover, determining which patients have improved and by how much is also difficult. Classification criteria allow clinical researchers to recruit patients with similar diseases (e.g., rheumatoid arthritis or systemic lupus erythematosus) into studies. Response criteria help to determine whether treatments really work, i.e., whether they actually produce clinically important improvement. As the science of clinical research advances, we must update our standards for considering classification and response criteria. In this editorial, members of the American College of Rheumatology (ACR) Subcommittee on Classification and Response Criteria describe the purpose of criteria sets, their development and validation, and the role of the ACR in adopting them.

Americas↗

The validity of a rheumatoid arthritis medical records-based index of severity compared with the DAS28.

The objective of this work was to assess the convergent validity of a previously developed rheumatoid arthritis medical records-based index of severity (RARBIS) by comparing it with the 28-joint Disease Activity Score (DAS28). This study was conducted in subjects within the Brigham and Women's Hospital Rheumatoid Arthritis Sequential Study (BRASS). We selected 100 patients with rheumatoid arthritis (RA) from the BRASS with DAS28 scores equally distributed in four quartiles. The medical records were reviewed to calculate the RARBIS, which includes indicators from the following categories: prior surgical history, radiologic and laboratory findings, clinical and functional status, and extra-articular manifestations. The Spearman correlation between the RARBIS and the DAS28 was assessed in the total study population and in relevant subgroups. We re-weighted on subscales and recalculated the RARBIS score. This was performed based on findings of correlations between the DAS28 and subscales; and also the result from a multiple linear regression with the DAS28 (as a dependent variable) and five subscales (as independent variables). The mean RARBIS was 4.36 (range 0-11). Among the total study cohort, the RARBIS was moderately correlated with the DAS28 (r = 0.41, 95% confidence interval [CI] 0.23-0.56). In subgroup analyses, including age, gender, rheumatoid factor status, and disease duration, we found no statistically significant differences in the correlations. After re-weighting, the correlation between the RARBIS and the DAS28 was somewhat improved (r = 0.48, 95% CI 0.31-0.62). In conclusion, the RARBIS correlated moderately well with the DAS28 in this population. The RARBIS has both face and convergent validity for patients with RA and relevant subgroups and may have application for medical records studies in patients with RA.

Arthritis, Rheumatoid↗

Prescription opioid use among older adults with arthritis or low back pain.

OBJECTIVE: To examine patterns of chronic opioid use in selected groups with arthritis and low back pain and compare them with patterns among persons with ischemic heart disease. METHODS: The study database consisted of Medicare beneficiaries who were enrolled in a drug benefit program for low-to-moderate income Pennsylvania residents. We identified selected patients who had a diagnosis of rheumatoid arthritis, osteoarthritis, chronic low back pain, or ischemic heart disease since 1995. Chronic opioid use, defined as at least six 30-day prescriptions in a year, was the endpoint of interest. We examined the proportion of patients meeting this definition during the period 1996-2001 and determined predictors based on multivariable Cox proportional hazards models. RESULTS: Four percent of subjects with rheumatoid arthritis used opioids chronically in 2001, compared with <1% in each of the other groups. There was no increase in the chronic use of opioids over the 6-year study period. Low-potency opioids were the most commonly prescribed preparations for chronic users from all patient groups. The prior use of medicines for psychiatric illness, including benzodiazepines or barbiturates, was associated with chronic prescription opioid use across all diagnoses. However, subjects with a prior diagnosis of psychiatric illness were less likely to receive chronic opioids. CONCLUSION: Chronic opioid use is relatively uncommon, even among older individuals with arthritis or low back pain. The proportion of these individuals receiving such medicines has not increased in the late 1990s. There seems to be a complex relationship between psychiatric medication use, psychiatric diagnoses, and the use of chronic opioids among these individuals.

Aged↗

Development of a preliminary index that predicts adverse events after total knee replacement.

OBJECTIVE: We undertook this study to assess the relationships between hospital characteristics, volume of procedures, and perioperative outcomes after total knee replacement (TKR), and to use this information to construct a simple predictive index for perioperative outcomes that incorporates hospital- and patient-level characteristics. METHODS: We studied Medicare beneficiaries who underwent TKR in 4 US states in 2000. Orthopedic surgery administrators from hospitals caring for patients in this sample were surveyed about a range of hospital characteristics. The relationships between these hospital characteristics, patient variables, and 90-day postoperative adverse events (including death, pulmonary embolus, pneumonia, deep wound infection, and acute myocardial infarction) were assessed using generalized estimating equations adjusting for hospital volume. These relationships were assessed in low- and high-risk patient groups. Variables from the final multivariate model were used to create an index that was tested against 90-day adverse event rates. RESULTS: Three hundred twenty-seven (3.6%) of the patients undergoing TKR in our sample experienced an adverse event. In the final multivariate regression models, variables that predicted adverse perioperative events included low hospital volume (fewer than 23 TKRs in the Medicare population per year), absence of a preoperative teaching program, fewer TKRs conducted in a dedicated orthopedic surgery operating room, patient age >70 years, male sex, and at least 1 comorbid condition. The effect of volume on perioperative adverse events was evident both in patients with few risk factors and in patients with several risk factors. An index including the 6 patient and hospital variables discriminated well, with adverse events occurring in 2.0% (95% confidence interval [95% CI] 1.4-2.7%) of patients in the lowest risk category and in 7.4% (95% CI 4.5-12.3%) of patients in the highest risk category (P for trend < 0.001). The index predicted adverse event rates both in hospitals with a low volume of TKRs and in those with a high volume of TKRs. CONCLUSION: Characteristics of hospital care, procedure volume, and patient-level factors are all associated with perioperative outcomes of TKR. A preliminary index combining hospital characteristics and volume is moderately predictive of adverse perioperative outcomes. The index is predictive of outcome in low- and high-volume hospitals.

Aged↗

Cardiovascular outcomes in new users of coxibs and nonsteroidal antiinflammatory drugs: high-risk subgroups and time course of risk.

OBJECTIVE: Controversy persists regarding the cardiovascular risks of treatment with selective cyclooxygenase 2 inhibitors (coxibs) and nonselective nonsteroidal antiinflammatory drugs (NSAIDs). This study was undertaken to examine, in a large group of new users of coxibs and NSAIDs, the rate of cardiovascular events, their time course, and whether baseline cardiovascular risk modified the rate ratios (RRs) for future events. METHODS: This cohort study included Medicare beneficiaries who enrolled in a state-run prescription drug plan that fully covered NSAIDs and coxibs without restriction. All study patients started use of a coxib or NSAID after January 1, 1999. The primary composite end point was a hospital admission for either myocardial infarction or ischemic stroke. Predefined exposure groups included the 3 coxibs available in the US during the study period (celecoxib, rofecoxib, and valdecoxib), as well as oral formulations of diclofenac, ibuprofen, naproxen, and a composite of all other NSAIDs. We compared the rate of cardiovascular events associated with each of these agents with that in a reference group of patients who did not use NSAIDs or coxibs, but started other medications unrelated to cardiovascular risk. Daily exposure to all study drugs was assessed based on filled prescription data. A Cox proportional hazards model stratified on calendar year that included other baseline cardiovascular risk factors constituted the primary analysis. RESULTS: We identified 74,838 users of NSAIDs or coxibs, and 23,532 comparable users of other drugs comprised the reference group. Adjusted models demonstrated a significant elevation in the event rate for rofecoxib (RR 1.15, 95% confidence interval [95% CI] 1.06-1.25) and a significant reduction in the rate for naproxen (RR 0.75, 95% CI 0.62-0.92). No other coxib or NSAID was associated with a significant increase or decrease in cardiovascular event rate. The increased rate associated with rofecoxib was seen in the first 60 days of use (adjusted RR 1.14, 95% CI 1.01-1.29) and thereafter (adjusted RR 1.14, 95% CI 1.02-1.28). Kaplan-Meier event curves showed a similar pattern of risk (early and persistent separation of the event curves) among long-term rofecoxib users at low or high baseline cardiovascular risk. CONCLUSION: We found an increased cardiovascular event rate among users of rofecoxib, and a decreased rate with naproxen use. Other coxibs and NSAIDs did not appear to be associated with a difference in event rate compared with users of other drugs. The increase in rate associated with rofecoxib was seen within the first 60 days and persisted. There was no important modification of the event rate based on the patient's baseline cardiovascular risk.

Aged↗

Tumor necrosis factor alpha antagonist use and cancer in patients with rheumatoid arthritis.

OBJECTIVE: Concerns persist about a possible association between tumor necrosis factor alpha (TNFalpha) antagonist treatment and development of cancers in patients with rheumatoid arthritis (RA). This study was undertaken to estimate the association between treatment with biologic disease-modifying antirheumatic drugs (DMARDs) and development of cancer in patients with RA. METHODS: We conducted a cohort study pooling administrative databases from 2 US states and 1 Canadian province. A cohort of patients who had received a diagnosis of RA on > or =1 occasion and had been prescribed DMARDs was identified. We categorized patients with a prescription for a biologic DMARD as biologic DMARD users, and those with a prescription for methotrexate (MTX) but no biologic DMARD as MTX users. We used time-varying propensity scores to adjust for the large number of possible confounders and stratified proportional hazards regression to estimate the effects of biologic DMARDs on cancer. The primary end points were hematologic malignancies (lymphoma, multiple myeloma, and leukemia) and common solid tumors (colorectal, lung, stomach, breast, prostate, uterine, ovarian, urinary tract/bladder, and melanoma). RESULTS: The pooled cohort included 1,152 biologic DMARD users and 7,306 MTX users. We identified 11 hematologic malignancies and 46 solid tumors during 2,940 person-years of biologic DMARD use, and 88 hematologic malignancies and 558 solid tumors during 30,300 person-years of MTX use. Comparing biologic DMARD users with MTX users, the propensity score-adjusted pooled hazard ratio was 1.37 (95% confidence interval 0.71-2.65) for hematologic malignancies and 0.91 (95% confidence interval 0.65-1.26) for solid tumors. CONCLUSION: Our results indicate that users of biologic agents are unlikely to have a substantial increase in the risk of hematologic malignancies and solid tumors as compared with MTX users. Despite the use of large combined data sets, studying the effect of an infrequent exposure (biologic DMARDs) on rare diseases (hematologic malignancies) remains a challenge.

Aged↗

Simultaneous assessment of short-term gastrointestinal benefits and cardiovascular risks of selective cyclooxygenase 2 inhibitors and nonselective nonsteroidal antiinflammatory drugs: an instrumental variable analysis.

OBJECTIVE: To simultaneously assess the short-term reduction in risk of gastrointestinal (GI) complications and increase in risk of acute myocardial infarction (MI) by celecoxib compared with rofecoxib and several nonselective nonsteroidal antiinflammatory drugs (NSAIDs) using instrumental variable analysis. METHODS: A population of 49,711 Medicare beneficiaries ages 65 years and older who initiated nonselective NSAID or selective cyclooxygenase 2 inhibitor therapy between January 1, 1999, and December 31, 2002, was identified. The increase in risk of GI complications and MI within 180 days after initiation of NSAID (rofecoxib, diclofenac, ibuprofen, and naproxen compared with celecoxib) therapy was assessed using instrumental variable analysis. RESULTS: Compared with nonselective NSAIDs, celecoxib reduced the risk of GI complications by 1.4 per 100 users but increased the risk of MI by 0.3 per 100 users. Rofecoxib decreased GI complications by 1.1 per 100 users and increased the risk of MI by 0.3 per 100 users. Using celecoxib as the reference exposure showed an increase in the MI risk for rofecoxib (risk difference [RD] 1.40, 95% confidence interval [95% CI] -0.20, 3.01) and diclofenac (RD 6.07, 95% CI -0.02, 12.15). The RD for naproxen as well as its upper 95% CI was the lowest of all NSAIDs (RD -0.30, 95% CI -2.74, 2.14) and there was no significant difference in GI complication rates among all NSAIDs. CONCLUSION: In this instrumental variable analysis, diclofenac and rofecoxib had the least favorable benefit-risk balance among NSAIDs in older adults.

Aged↗

Immunosuppressive medications and hospitalization for cardiovascular events in patients with rheumatoid arthritis.

OBJECTIVE: The risk of cardiovascular disease (CVD) is increased in patients with rheumatoid arthritis (RA), most likely because of increased systemic inflammation. Prior research suggests that immunosuppressive medications may reduce the risk of CVD among RA patients. This study was undertaken to investigate the effects of various immunosuppressive medications on the risk of cardiovascular events among a group of older patients with RA. METHODS: In this nested case-control study, the source cohort was derived from Medicare beneficiaries receiving a drug benefit from the state of Pennsylvania. These individuals were required to have been diagnosed as having RA on at least 2 visits and to have filled a prescription for an immunosuppressive agent. Cases were defined as those patients who were hospitalized for a cardiovascular event such as myocardial infarction or stroke, and 10 control subjects were matched to each case by age, sex, and calendar year of the index date (the time of the first cardiovascular event in each case). Current use of an immunosuppressive medication was defined as having filled a prescription for these agents within the 90 days prior to the index date. Multivariate logistic regression models that included important covariates were assessed to determine the risk of cardiovascular events associated with immunosuppressive agents and their combinations. RESULTS: Among the study cohort, we identified 3,501 RA patients who fulfilled our eligibility criteria. During followup of this cohort, 946 patients were hospitalized for a cardiovascular event. Although the 95% confidence intervals (95% CIs) were wide in adjusted risk regression models with methotrexate (MTX) monotherapy as the reference group, biologic immunosuppressive agents showed neither protective nor deleterious effects (with biologics monotherapy, odds ratio [OR] 1.0, 95% CI 0.5-1.9; with biologics plus MTX combination therapy, OR 0.8, 95% CI 0.3-2.0; and with biologics plus other immunosuppressive agents, OR 1.2, 95% CI 0.7-2.2). Monotherapy with oral glucocorticoids was associated with an increased risk of cardiovascular events (OR 1.5, 95% CI 1.1-2.1), and a similar trend in the direction of risk was seen with glucocorticoid combination therapy (OR 1.3, 95% CI 0.8-2.0). Cytotoxic immunosuppressive agents other than MTX (azathioprine, cyclosporine, and leflunomide) were also associated with an increased risk of cardiovascular events (with both monotherapy and combination treatment, OR 1.8, 95% CI 1.1-3.0). CONCLUSION: When compared with RA patients receiving MTX monotherapy, those receiving biologic immunosuppressive agents had neither an increased nor decreased risk of experiencing a cardiovascular event, whereas use of oral glucocorticoids and cytotoxic immunosuppressive agents was associated with significant increases in the risk of cardiovascular events.

Aged, 80 and over↗

The cardiovascular manifestations of rheumatic diseases.

PURPOSE OF REVIEW: To review the cardiovascular manifestations of several more common rheumatic conditions in the light of the recent reported literature. RECENT FINDINGS: Evidence that chronic inflammation is associated with the occurrence of cardiac events in people both with and without chronic inflammatory joint disease is emerging. Both atherosclerosis and rheumatic diseases, however, have a complicated cause, and it is likely that inflammation contributes to other environmental and host risk factors in these patients. Treatments used to suppress inflammation in many rheumatic conditions have the potential to reduce cardiovascular disease morbidity as well as improve musculoskeletal function. SUMMARY: Cardiovascular morbidity and mortality have been found to be increased in association with many of the rheumatic diseases. In particular, coronary heart disease seems to be associated with inflammatory rheumatic conditions. Whilst it is likely that chronic systemic inflammation promotes accelerated atherosclerosis in these patients, the mechanisms by which this occurs are complex and the effects of treatment and other cardiovascular risk factors need to be considered.

Cardiovascular Diseases↗

Evaluating short-term drug effects using a physician-specific prescribing preference as an instrumental variable.

BACKGROUND: Postmarketing observational studies of the safety and effectiveness of prescription medications are critically important but fraught with methodological problems. The data sources available for such research often lack information on indications and other important confounders for the drug exposure under study. Instrumental variable methods have been proposed as a potential approach to control confounding by indication in nonexperimental studies of treatment effects; however, good instruments are hard to find. METHODS: We propose an instrument for use in pharmacoepidemiology that is based on a time-varying estimate of the prescribing physician's preference for one drug relative to a competing therapy. The use of this instrument is illustrated in a study comparing the effect of exposure to COX-2 inhibitors with nonselective, nonsteroidal antiinflammatory medications on gastrointestinal complications. RESULTS: Using conventional multivariable regression adjusting for 17 potential confounders, we found no protective effect due to COX-2 use within 120 days from the initial exposure (risk difference = -0.06 per 100 patients; 95% confidence interval = -0.26 to 0.14). However, the proposed instrumental variable method attributed a protective effect to COX-2 exposure (-1.31 per 100 patients; -2.42 to -0.20) compatible with randomized trial results (-0.65 per 100 patients; -1.08 to -0.22). CONCLUSIONS: The instrumental variable method that we have proposed appears to have substantially reduced the bias due to unobserved confounding. However, more work needs to be done to understand the sensitivity of this approach to possible violations of the instrumental variable assumptions.

Aged↗

Prior authorization policies for selective cyclooxygenase-2 inhibitors in Medicaid: a policy review.

BACKGROUND: Many state Medicaid programs use prior authorization programs to limit spending on cyclooxygenase-2 selective nonsteroidal anti-inflammatory drugs (coxibs). However, the evidence base for the prior authorization criteria has not been examined previously. METHODS: We determined whether prior authorization was required for coxibs in state Medicaid programs and collected data on what precise criteria needed to be met for a coxib prescription to be authorized. Prior authorization criteria were compared to clinical evidence regarding which patients are most likely to benefit from coxibs. RESULTS: By mid-2004, 35 states had implemented prior authorization requirements for coxibs. Of 5 major clinical factors that identify patients likely to benefit from coxibs, 18 states (51%) included all 5 factors and 9 states (26%) included 2 or fewer. Most states (33/35; 94%) required a previous trial of nonselective nonsteroidal anti-inflammatory drugs before a coxib would be authorized. Several prior authorization programs included factors that had no connection to the clinical evidence. CONCLUSIONS: State Medicaid prior authorization policies for coxibs are heterogeneous in terms both of the criteria required to obtain a coxib and of the relationship of those criteria to clinical evidence. Development of clinically rational prescription drug policies should be a goal for all health insurers and represents an important priority for Medicare's prescription drug benefit program.

Anti-Inflammatory Agents, Non-Steroidal↗

Incidental vertebral fractures on chest radiographs. Recognition, documentation, and treatment.

BACKGROUND: Recognition of incidental vertebral fractures may be an important opportunity for identifying and treating osteoporosis. OBJECTIVE: To assess osteoporosis documentation rates in patients with vertebral fractures, and to define patient and hospitalization characteristics associated with osteoporosis management. DESIGN: Hospital and outpatient records were abstracted for patients with vertebral fractures on inpatient radiograph reports. The primary outcome of interest was discharge summary fracture documentation. Covariates associated with fracture documentation and treatment were examined with multivariate regression models. Secondary outcomes included osteoporosis documentation and management 6 months following discharge. PATIENTS: Women > or =50 years hospitalized at an academic medical center. RESULTS: Among 10,291 women with chest radiographs, 142 (1.4%) had vertebral fractures reported. Among patients with a reported fracture, 58 (41%) had their fracture noted in the findings section but not in the final impression. Only 23 (16%) discharge summaries documented a vertebral fracture. Factors associated with documentation of the fracture in the discharge summary included notation of the fracture in the impression section (odds ratio [OR] 3.7, 95% confidence interval [CI] 1.0 to 13.1), tobacco use (OR 3.7; 95% CI 1.1 to 12.2), discharge from a medical service (OR 7.6; 95% CI 0.9 to 66.2) and glucocorticoid use (OR 3.7; 95% CI 0.8 to 17.0). Only 36% of patients were using any osteoporosis medications at discharge. Fracture notation in the impression section was associated with fracture documentation in subsequent outpatient notes (OR 3.6, 95% CI 0.9 to 13.8). Discharge summary fracture documentation was associated with an increased likelihood of starting an osteoporosis medication by 6 months (OR 2.8; 95% CI 0.8 to 9.2). CONCLUSIONS: Incidental vertebral fractures from inpatient chest radiographs may represent a missed opportunity for osteoporosis management.

Aged↗

Effect of the Women's Health Initiative on osteoporosis therapy and expenditure in Medicaid.

UNLABELLED: Decreasing HRT use among postmenopausal women may have a reciprocal impact on other osteoporosis therapy. Time series analysis of prescribing trends for millions of Medicaid beneficiaries revealed a 57% decline in HRT without augmenting the pace of bisphosphonate use. Prescribing changes dramatically increased Medicaid spending on osteoporosis therapy over the last decade and requires further evaluation of cost effectiveness. INTRODUCTION: Hormone replacement therapy (HRT) has been commonly prescribed to postmenopausal women, but its use is decreasing because adverse cardiac outcomes were reported by the Women's Health Initiative (WHI) in July 2002. The reciprocal impact of the WHI on other osteoporosis medications use and expenditure is unknown. MATERIALS AND METHODS: We conducted a time series analysis on prescription data from 50 state Medicaid programs between 1995 and 2004. Five medication categories were used: HRT, bisphosphonates, calcium, calcitonin, and raloxifene. RESULTS: HRT was increasing before publication of the WHI, reaching 5 million prescriptions per year by mid-2002 (136 prescriptions per 1000 beneficiaries). Bisphosphonate prescribing rose in parallel until mid-2002. WHI publication was associated with a rapid reduction in HRT use, declining 57% by mid-2004 to an average of 59 prescriptions per 1000 beneficiaries (p = 0.01). WHI publication did not augment bisphosphonates' nearly linear rate of rise (p = 0.43) as their prescribing pace continued, whereas HRT declined. Medicaid spending on osteoporosis therapy also changed dramatically during the last decade, as yearly expenditure increased 664% from 1465 US dollars to 9742 US dollars per 1000 beneficiaries. Over this period, a significant shift from daily to weekly bisphosphonates also occurred. CONCLUSIONS: A dramatic decline in HRT and continued rise in bisphosphonate prescribing has occurred since the publication of the WHI. During this time, there have also been substantial increases in osteoporosis medication spending within Medicaid. Determining whether these trends are clinically appropriate and cost effective for osteoporosis therapy will have important implications for the development of future drug reimbursement programs, especially for elderly patients.

Calcitonin↗

The patient's perspective on the recall of Vioxx.

OBJECTIVE: Rofecoxib was recalled in September 2004 when studies identified increased cardiovascular risk compared with placebo among patients taking rofecoxib. We examined the reactions of people with arthritis to this recall. METHODS: Telephone interviews were conducted between December 2004 and February 2005 in a previously assembled community based cohort (n = 1085) with disabling hip/knee osteoarthritis (OA) residing in 2 regions of Ontario, Canada (one urban, one rural). Respondents' self-reported experience with cyclooxygenase (COX-2) selective nonsteroidal antiinflammatory drugs (NSAID; coxibs), issues around communication of the recall, attitudes about pain medications, and understanding of the rofecoxib-associated cardiovascular risks were assessed. Participants were also asked about contraindications for traditional NSAID use (specific clinical conditions, use of blood thinners and glucocorticoids, and history of gastrointestinal (GI) ulcer and/or bleeding). RESULTS: The response rate was 93.5%; 968 completed the survey. Half (53.0%) had used a coxib for arthritis; 277 (28.6%) had used rofecoxib. Only 3.8% of "ever" coxib users reported previous GI ulcer or hemorrhage. 94.8% of respondents had heard about the recall; most (94.7%) had heard via television. Among the 83 individuals taking rofecoxib at recall, 90.4% had been offered another pain medication, mainly another coxib. Most of the 968 participants (> 60%) were unfamiliar with rofecoxib-associated cardiovascular risks. Of those with an opinion, most overestimated the absolute risk associated with rofecoxib (55.7% cited a risk > 5 events/100 people/year). CONCLUSION: In an elderly community cohort with OA, the prevalence of coxib use was high despite few major contraindications to NSAID. Many were unaware of or overestimated the absolute risks associated with rofecoxib use, highlighting the need for strategies by which physicians/pharmacists can provide their patients with timely and accurate drug safety information.

Aged↗