Showing papers by "Marc C. Hochberg published in 2011"
TL;DR: Patients using a TNF antagonist experienced a reduced risk of the primary composite cardiovascular endpoint and the risk reduction associated with TNF antagonists was also observed for non-fatal cardiovascular events.
Abstract: Objective To examine the association of cardiovascular events with tumour necrosis factor (TNF) α antagonist use compared with non-biological disease-modifying antirheumatic drug (DMARD) utilisation in patients with rheumatoid arthritis (RA). Methods The study population included 10 156 patients enrolled in the Consortium of Rheumatology Researchers of North America RA registry. Three study cohorts were defi ned based on three mutually exclusive drug use categories, including TNF antagonists, methotrexate and other non-biological DMARDs. HR were calculated adjusting for cardiovascular risk factors, RA disease characteristics and prednisone use. The primary study outcome was a composite of non-fatal myocardial infarction (MI), transient ischaemic attack (TIA) or stroke and cardiovascular-related death. Results There were 88 cardiovascular events, including 26 MI, 45 TIA/strokes and 17 cardiovascular-related deaths. After adjusting for age, gender, cardiovascular risk factors and RA disease characteristics, patients using a TNF antagonist experienced a reduced risk of the primary composite cardiovascular endpoint (HR 0.39, 95% CI 0.19 to 0.82) compared with users of nonbiological DMARDs. Methotrexate was not associated with a reduced risk (HR 0.94, 95% CI 0.49 to 1.80). Prednisone use was associated with a dose-dependent increased risk (p=0.04). The risk reduction associated with TNF antagonists was also observed for non-fatal cardiovascular events (HR 0.35, 95% CI 0.16 to 0.74). Conclusion TNF antagonist use was associated with a reduced risk of cardiovascular events in patients with RA.
315 citations
TL;DR: The design and conduct of clinical trials for new OA treatments should address the heterogeneity of the disease, treatment-associated structural changes in target joints and patient-reported outcomes.
310 citations
TL;DR: The proportions of men and women who met public health physical activity guidelines were substantially less than those previously reported based on self-reported activity in arthritis populations, which support intensified public health efforts to increase physical activity levels among people with knee OA.
Abstract: Objective
Osteoarthritis (OA) clinical practice guidelines identify a substantial therapeutic role for physical activity, but objective information about the physical activity of this population is lacking. The aim of this study was to objectively measure levels of physical activity in adults with knee OA and report the prevalence of meeting public health physical activity guidelines.
Methods
Cross-sectional accelerometry data from 1,111 adults with radiographic knee OA (49–84 years old) participating in the Osteoarthritis Initiative accelerometry monitoring ancillary study were assessed for meeting the aerobic component of the 2008 Physical Activity Guidelines for Americans (≥150 minutes/week moderate-to-vigorous–intensity activity lasting ≥10 minutes). Quantile regression was used to test median sex differences in physical activity levels.
Results
Aerobic physical activity guidelines were met by 12.9% of men and 7.7% of women with knee OA. A substantial proportion of men and women (40.1% and 56.5%, respectively) were inactive, having done no moderate-to-vigorous activity that lasted 10 minutes or more during the 7 days. Although men engaged in significantly more moderate-to-vigorous activity (average daily minutes 20.7 versus 12.3), they also spent more time in no or very-low-intensity activity than women (average daily minutes 608.2 versus 585.8).
Conclusion
Despite substantial health benefits from physical activity, adults with knee OA were particularly inactive based on objective accelerometry monitoring. The proportions of men and women who met public health physical activity guidelines were substantially less than those previously reported based on self-reported activity in arthritis populations. These findings support intensified public health efforts to increase physical activity levels among people with knee OA.
206 citations
Paris Descartes University1, University of Geneva2, University of Leeds3, St. Vincent's Health System4, Lund University5, Toronto Western Hospital6, Royal North Shore Hospital7, Charles University in Prague8, University of Padua9, University of Southern Denmark10, University of Sydney11, University of Alabama at Birmingham12, University of Texas MD Anderson Cancer Center13
TL;DR: Although symptom levels were higher in patients recommended for TJR, pain and functional disability alone did not discriminate between those who were and were not considered to need TJR by the orthopaedic surgeon.
169 citations
TL;DR: How standard clinical practice diverges from evidence-based recommendations, some key challenges facing clinicians with regard to optimizing the quality of care delivery in OA, and steps to improve OA health care quality are reviewed.
Abstract: Introduction Disability due to osteoarthritis (OA) and increasing disease prevalence are colliding to create a major public health problem. By 2020, the number of people with OA will have doubled, due in large part to the exploding prevalence of obesity and the graying of the “baby boomer” generation (1). Despite growing concern, there remain few safe and effective interventions. Although practice patterns may vary, current clinical management for OA is often limited to the use of analgesic and/or antiinflammatory medication and cautious waiting (2) for the eventual referral for total joint replacement. Recent doubts about the safety of several commonly prescribed OA medications have served to highlight deficiencies in the traditional medical approach to management (3). With few conservative options offered by their doctors, increasing numbers of patients are turning to untested folk remedies and aggressively marketed dietary supplements with little substantive evidence to support their efficacy (4). It is in this context that we appraise the current quality of clinical management of OA. It is critical to assess the consistency, or lack thereof, between evidence-based recommendations and actual clinical practice. A number of recent studies have highlighted that there is a great divergence from such recommendations despite numerous efforts to disseminate the many recommendations that exist. Concerns over the quality of health care delivery raise serious questions about the legitimacy of prior efforts not only to disseminate, but more importantly ensure implementation of, what is best practice. Some cautious steps to encourage implementation, including the development of quality indicators, have occurred, but have made little impact. Quality indicators are elements of health care for which evidence or consensus exists that they are indicative of the quality of health care (5,6). A number of quality indicators have been developed in OA that thus far have not been widely used or systematic in considering the breadth of OA management. In this era of health care reform, it is critical that appropriate efforts toward improved delivery of quality care in this burdensome disease are made. What follows is a narrative review of how standard clinical practice diverges from evidence-based recommendations, some key challenges facing clinicians with regard to optimizing the quality of care delivery in OA, and steps to improve OA health care quality. This is written as a potential roadmap for those developing and enforcing policy decisions, as well as for clinicians who could be provided further encouragement to enact practice change.
92 citations
TL;DR: Patients with hip fracture who participate in a yearlong, in-home exercise program will increase activity level compared with those in UC; however, no significant changes in other targeted outcomes were detected.
Abstract: Hip fracture is a common problem with devastating consequences. At present, more Than 310 000 hip fractures occur annually in the United States,1 with an estimated cost of between $14 and $20 billion.2-7 By 2050, the number of hip fractures is expected to in crease to 700 000 in the United States and almost to 4 million worldwide.8 Between 16% and 32% of patients die with in a year.9-12 Among survivors, 50% need assistance to walk and 90% need assistance to climb stairs after 1 year.13 Furthermore, there are substantial changes in body composition;including loss of bone mineral density (BMD) of 4% to 7% per year, loss of lean body mass up to 6% within 2 months, and increase in fat mass of 3% to 4% in a year.13-16
On the basis of these findings under conditions of usual hip fracture care, it is important to identify novel interventions that older patients will comply with to ameliorate significant postfracture changes in order for gains to be realized beyond the 6-month recovery plateau observed for most functioning after hip fracture.17 Exercise is generally well tolerated by older adults after hip fracture with few serious adverse events18-20 and has the potential for increasing BMD and strength. Research has shown that weight-bearing, aerobic-type exercises alone or in combination with resistance exercises can slow or halt the rate of BMD loss in postmenopausal women.21-26 Unfortunately, the success of exercise in hip fracture rehabilitation, specifically, has varied. It is notable that few previous programs with this patient group lasted more than a few months,19,20,27 most began late in the recovery period,18,28 and with few exceptions19,27,29-31 most were gym or clinic based, rather than home based, which can limit access. Therefore, we designed a yearlong exercise program that could be delivered in patients’ homes in order to overcome the limitations of an extended center-based exercise program.
This study was designed to test the feasibility and identify preliminary indications of efficacy of the Exercise Plus Program, an aerobic and resistive exercise program administered after fracture by an exercise trainer in the home setting.32 We hypothesized that those randomized to the intervention, compared with those randomized to usual care (UC), would experience reduced losses in BMD, muscle mass, and strength; less increase in fat mass; greater increases in physical activity; improvements in ability to carry out physical and instrumental tasks of daily living; and increases in physical and psychosocial functioning.
87 citations
TL;DR: Duloxetine added to oral NSAID therapy provided additional significant pain reduction, improved function, and patient-rated impression of improvement in patients with osteoarthritis of the knee.
Abstract: Objective:To determine the efficacy, tolerability, and safety of duloxetine when added to oral nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with osteoarthritis (OA) of the knee with pain of moderate or greater severity.Research design and methods:This was a 10-week randomized, double-blind, flexible-dose (duloxetine 60/120 mg/day), placebo-controlled trial that enrolled adult outpatients who had persistent moderate pain (≥4 on a 0–10 numerical rating scale) due to OA of the knee, despite, per protocol, having received optimized oral NSAID therapy (specific drug, dose, and frequency at investigator discretion).Clinical trials registration:ClinicalTrial.gov identifier: NCT01018680.Main outcome measure:Patients entered daily pain ratings in a telephone-based diary. The primary efficacy outcome was the weekly mean of the daily average pain rating at week 8. Safety outcomes were assessed during the entire 10-week study.Results:A total of 524 patients randomly received duloxetine 60/120 mg/...
83 citations
University of Paris1, Johns Hopkins University2, University of Utah3, University of Leeds4, University of Toronto5, Dresden University of Technology6, University of Maryland, Baltimore7, University of North Carolina at Chapel Hill8, Harvard University9, Leiden University10, St. Vincent's Health System11, Lund University12, University of Burgundy13, French Institute of Health and Medical Research14, University of Sydney15, Indiana University16, Charles University in Prague17, University of Padua18, University of Southern Denmark19, University of Alabama20, University of Texas MD Anderson Cancer Center21
TL;DR: The results do not support a specific level of pain or function that defines an indication for joint replacement, however, a tentative cutpoint for pain and physical function levels is proposed for further evaluation.
Abstract: Objective. To define pain and physical function cutpoints that would, coupled with structural severity, define a surrogate measure of "need for joint replacement surgery," for use as an outcome measure for potential structure-modifying interventions for osteoarthritis (OA). Methods. New scores were developed for pain and physical function in knee and hip OA. A cross-sectional international study in 1909 patients was conducted to define data-driven cutpoints corresponding to the orthopedic surgeons' indication for joint replacement. A post hoc analysis of 8 randomized clinical trials (1379 patients) evaluated the prevalence and validity of cutpoints, among patients with symptomatic hip/knee OA. Results. In the international cross-sectional study, there was substantial overlap in symptom levels between patients with and patients without indication for joint replacement; indeed, it was not possible to determine cutpoints for pain and function defining this indication. The post hoc analysis of trial data showed that the prevalence of cases that combined radiological progression, high level of pain, and high degree of function impairment was low (2%-12%). The most discriminatory cutpoint to define an indication for joint replacement was found to be [pain (0-100) + physical function (0-100) > 80]. Conclusion. These results do not support a specific level of pain or function that defines an indication for joint replacement. However, a tentative cutpoint for pain and physical function levels is proposed for further evaluation. Potentially, this symptom level, coupled with radiographic progression, could be used to define "nonresponders" to disease-modifying drugs in OA clinical trials. (J Rheumatol 2011;38:1765-9; doi:10.3899/jrheum.110403)
81 citations
TL;DR: Naproxen/esomeprazole magnesium has comparable efficacy to celecoxib for the management of pain associated with osteoarthritis of the knee over 12 weeks, and Acetaminophen use and patient expectation of receiving active treatment may have contributed to a high placebo response observed.
Abstract: Objective:To demonstrate that a fixed-dose combination of enteric-coated naproxen 500 mg and immediate-release esomeprazole magnesium 20 mg has comparable efficacy to celecoxib for knee osteoarthritis.Research design and methods:Two randomized, double-blind, parallel-group, placebo-controlled, multicenter phase III studies (PN400-307 and PN400-309) enrolled patients aged ≥50 years with symptomatic knee osteoarthritis. Following an osteoarthritis flare, patients received naproxen/esomeprazole magnesium twice daily, celecoxib 200 mg once daily, or placebo for 12 weeks.Clinical trial registration:NCT00664560 and NCT00665431.Main outcome measures:Three co-primary efficacy endpoints were mean change from baseline to week 12 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain and function subscales, and Patient Global Assessment of osteoarthritis using a visual analog scale (PGA-VAS).Results:In Study 307, 619 patients were randomized and 614 treated. In Study 309, 615 patients were randomi...
53 citations
TL;DR: To estimate meaningful improvements in gait speed observed during recovery from hip fracture and to evaluate the sensitivity and specificity of gaitspeed changes in detecting change in self‐reported mobility.
Abstract: OBJECTIVES: To estimate meaningful improvements in gait speed observed during recovery from hip fracture and to evaluate the sensitivity and specificity of gait speed changes in detecting change in self-reported mobility.
DESIGN: Secondary longitudinal data analysis from two randomized controlled trials
SETTING: Twelve hospitals in the Baltimore, Maryland, area.
PARTICIPANTS: Two hundred seventeen women admitted with hip fracture.
MEASUREMENTS: Usual gait speed and self-reported mobility (ability to walk 1 block and climb 1 flight of stairs) measured 2 and 12 months after fracture.
RESULTS: Effect size�based estimates of meaningful differences were 0.03 for small differences and 0.09 for substantial differences. Depending on the anchor (stairs vs walking) and method (mean difference vs regression), anchor-based estimates ranged from 0.10 to 0.17 m/s for small meaningful improvements and 0.17 to 0.26 m/s for substantial meaningful improvement. Optimal gait speed cutpoints yielded low sensitivity (0.39�0.62) and specificity (0.57�0.76) for improvements in self-reported mobility.
CONCLUSION: Results from this sample of women recovering from hip fracture provide only limited support for the 0.10-m/s cut point for substantial meaningful change previously identified in community-dwelling older adults experiencing declines in walking abilities. Anchor-based estimates and cut points derived from receiver operating characteristic curve analysis suggest that greater improvements in gait speed may be required for substantial perceived mobility improvement in female hip fracture patients. Furthermore, gait speed change performed poorly in discriminating change in self-reported mobility. Estimates of meaningful change in gait speed may differ based on the direction of change (improvement vs decline) or between patient populations.
45 citations
TL;DR: Naproxcinod 750 mg bid and 375 mg bid demonstrated superior efficacy over placebo for treatment of OA and were well tolerated over 1 year.
TL;DR: Reduced BMD was found to be significantly associated with increased risk for low-energy distal radius fractures in men, suggesting that improvement of BMD by both pharmacological and non-pharmacological initiatives may be a strategy to reduce fracture risk in men.
Abstract: Background: In general there is a lack of data on osteoporosis and fracture in men; this also includes low-energy distal radius fractures. The objectives of this study were to examine BMD and identify factors associated with distal radius fractures in male patients compared with controls recruited from the background population. Methods: In a 2-year period, 44 men 50 years or older were diagnosed with low-energy distal radius fractures, all recruited from one hospital. The 31 men who attended for osteoporosis assessment were age-matched with 35 controls. Demographic and clinical data were collected and BMD at femoral neck, total hip and spine L2-4 was assessed by dual energy X-ray absorptiometry. Results: Apart from weight and living alone, no significant differences were found between patient and controls for demographic variables (e.g. height, smoking) and clinical variables (e.g. co-morbidity, use of glucocorticoids, osteoporosis treatment, falls and previous history of fracture). However, BMD expressed as T-score was significant lower in patients than in controls at all measurement sites (femoral neck: -2.24 vs. -1.15, p < 0.001; Total hip: -1.65 vs. -0.64, p < 0.001; Spine L2-4: -1.26 vs. 0.25, p = 0.002). Among the potential risk factors for fracture evaluated, only reduced BMD was found to be significantly associated with increased risk for low-energy distal radius fractures in men. Conclusion: The results from our study indicate that reduced BMD is an important risk factor for low-energy distal radius fracture in men. This suggests that improvement of BMD by both pharmacological and non-pharmacological initiatives may be a strategy to reduce fracture risk in men.
TL;DR: While good management is available for GIOP, recognition of men at risk is the most important step in improving outcomes.
Abstract: Osteoporosis and fractures are a common consequence of glucocorticoid therapy for inflammatory disorders. Men fracture approximately 10 yr later in life than women and receive less attention as regards osteoporosis risk, including in glucocorticoid-induced osteoporosis (GIOP). In addition, while men are less likely to have certain rheumatologic disorders often treated with glucocorticoids, men are more likely to have chronic obstructive pulmonary disease, inflammatory bowel disease, and organ transplantation as reasons for use of oral glucocorticoids. Attempts to improve recognition of GIOP in general have not been successful, and since men are considered less at risk for osteoporosis in general, attention to men with GIOP is even less. Evaluation of GIOP is similar in men and women, and most modern treatment studies of GIOP have included men. Thus, alendronate, risedronate, and zoledronic acid are Food and Drug Administration (FDA)-approved bisphosphonates for GIOP in men. Teriparatide is also FDA-approved for GIOP. In one 36-month trial of teriparatide vs alendronate for GIOP in men and women, the anabolic agent led to a greater increase in bone density and was associated with a lower incidence of morphologic vertebral fractures. Thus, while good management is available for GIOP, recognition of men at risk is the most important step in improving outcomes.
TL;DR: Naproxen/esomeprazole magnesium has comparable UGI tolerability to celecoxib in patients with osteoarthritis in two 12-week double-blind, placebo-controlled, multicenter, phase III studies.
Abstract: BACKGROUND. Non-steroidal anti-inflammatory drugs are associated with poor upper gastrointestinal (UGI) tolerability and increased ulcer risk, but patient adherence to gastroprotective co-therapy is frequently inadequate. A fixed-dose combination of enteric-coated naproxen 500 mg and immediate-release esomeprazole magnesium 20 mg was evaluated: efficacy is reported by Hochberg et al. (Curr Med Res Opin 2011;27:1243-53); tolerability findings are reported here. PATIENTS AND METHODS. In two 12-week double-blind, placebo-controlled, multicenter, phase III studies (PN400-307 and PN400-309), patients aged ≥ 50 years with symptomatic knee osteoarthritis randomly (2:2:1) received naproxen/esomeprazole magnesium BID, celecoxib 200 mg QD, or placebo. Tolerability end-points included: modified Severity of Dyspepsia Assessment (mSODA); heartburn severity; and UGI adverse events (AEs). RESULTS. Overall, 619 (PN400-307) and 615 (PN400-309) patients were randomized; mSODA scores improved (baseline to week 12) in each group, with no significant treatment differences between naproxen/esomeprazole magnesium and celecoxib (95% CIs: PN400-307: -0.4, 1.9; PN400-309: -1.8, 0.6). Naproxen/esomeprazole magnesium-treated patients reported significantly more heartburn-free days versus celecoxib (95% CIs: PN400-307: 2.1, 12.7; PN400-309: 2.5, 13.4). UGI AE incidence (PN400-307: 17.3%; PN400-309: 20.3%) was similar between treatment groups. UGI AEs resulted in few discontinuations (< 4%, either study). CONCLUSIONS. Naproxen/esomeprazole magnesium has comparable UGI tolerability to celecoxib in patients with osteoarthritis.
TL;DR: Poor self-rated health was associated with decline in walking speed in older women, and the stress of caregiving may have exacerbated its impact.
Abstract: Although poorer self-rated health (SRH) is associated with increased mortality, less is known about its impact on functioning. This study evaluated whether poorer SRH was associated with decline in walking speed and whether caregiving, often considered an indicator of chronic stress, modified this relation. The sample included 891 older US women from the Caregiver-Study of Osteoporotic Fractures. SRH was assessed at the baseline Caregiver-Study of Osteoporotic Fractures interview, conducted in 1999-2001, and was categorized as fair/poor or excellent/good. Rapid walking speed over 2, 3, or 6 m was measured at baseline and 2 annual follow-up interviews. Respondents with fair/poor SRH walked significantly slower at baseline than those with excellent/good health (mean = 0.8 (standard deviation, 0.3) vs. 1.0 (standard deviation, 0.3) m/second, P < 0.001). In adjusted linear mixed models of percentage change in walking speed, respondents with fair/poor SRH experienced a greater decline in walking speed than those with excellent/good SRH (-5.66% vs. -0.60%, P = 0.01). Caregivers with fair/poor SRH declined more than noncaregivers (-9.26% vs. -4.09%). High-intensity caregivers had the largest decline (-12.88%), whereas low-intensity caregivers in excellent/good SRH had no decline (2.61%). In summary, poorer SRH was associated with decline in walking speed in older women, and the stress of caregiving may have exacerbated its impact.
TL;DR: This work applied two reclassification methods, using the National Osteoporosis Foundation treatment thresholds, to compare two risk models: femoral neck bone mineral density and age and FRAX (FRAX model), and found each model classified a substantial number of women differently.
Abstract: Fracture prediction models help to identify individuals at high risk who may benefit from treatment. Area under the curve (AUC) is used to compare prediction models. However, the AUC has limitations and may miss important differences between models. Novel reclassification methods quantify how accurately models classify patients who benefit from treatment and the proportion of patients above/below treatment thresholds. We applied two reclassification methods, using the National Osteoporosis Foundation (NOF) treatment thresholds, to compare two risk models: femoral neck bone mineral density (BMD) and age (simple model) and FRAX (FRAX model). The Pepe method classifies based on case/noncase status and examines the proportion of each above and below thresholds. The Cook method examines fracture rates above and below thresholds. We applied these to the Study of Osteoporotic Fractures (SOF). There were 6036 (1037 fractures) and 6232 (389 fractures) participants with complete data for major osteoporotic and hip fracture, respectively. Both models for major osteoporotic fracture (0.68 versus 0.69) and hip fracture (0.75 versus 0.76) had similar AUCs. In contrast, using reclassification methods, each model classified a substantial number of women differently. Using the Pepe method, the FRAX model (versus the simple model) missed treating 70 (7%) cases of major osteoporotic fracture but avoided treating 285 (6%) noncases. For hip fracture, the FRAX model missed treating 31 (8%) cases but avoided treating 1026 (18%) noncases. The Cook method (both models, both fracture outcomes) had similar fracture rates above/below the treatment thresholds. Compared with the AUC, new methods provide more detailed information about how models classify patients.
TL;DR: Recommendations for measuring bone mineral density in older men as a means of screening for osteoporosis, use of the World Health Organization's Fracture Risk Assessment Tool, useful laboratory tests to evaluate these conditions, newer treatments for men with osteoporeosis that increase BMD and may reduce the risk of fractures, and new data on the prevalence of low BMD in men.
Abstract: During the past year several review articles have been published on the topic of osteoporosis in men These reviews have highlighted recommendations for measuring bone mineral density (BMD) in older men as a means of screening for osteoporosis, use of the World Health Organization's Fracture Risk Assessment Tool for predicting the risk of hip and major osteoporotic fractures, frequency of secondary causes of osteoporosis, useful laboratory tests to evaluate these conditions, newer treatments for men with osteoporosis that increase BMD and may reduce the risk of fractures, and new data on the prevalence of low BMD and osteoporosis in men
TL;DR: A comprehensive report encompassing the recommendations by each working group based on the current state of knowledge on the pre-defined topics outlined with the original notice as well as a series of on-going research recommendations to further inform the evolving areas of structural change and the role of biomarkers in the context of clinical trials.
TL;DR: Serum concentrations of both α- and γ-tocopherol were associated with better physical function after hip fracture, indicating that vitamin E may represent a potentially modifiable factor related to recovery of postfracture physical function.
Abstract: Background. Poor nutritional status after hip fracture is common and may contribute to physical function decline. Low serum concentrations of vitamin E have been associated with decline in physical function among older adults, but the role of vitamin E in physical recovery from hip fracture has never been explored. Methods. Serum concentrations of a- and g-tocopherol, the two major forms of vitamin E, were measured in female hip fracture patients from the Baltimore Hip Studies cohort 4 at baseline and at 2-, 6-, and 12-month postfracture followup visits. Four physical function measures—Six-Minute Walk Distance, Lower Extremity Gain Scale, Short Form-36 Physical Functioning Domain, and Yale Physical Activity Survey—were assessed at 2, 6, and 12 months postfracture. Generalized estimating equations modeled the relationship between baseline and time-varying serum tocopherol concentrations and physical function after hip fracture. Results. A total of 148 women aged 65 years and older were studied. After adjusting for covariates, baseline vitamin E concentrations were positively associated with Six-Minute Walk Distance, Lower Extremity Gain Scale, and Yale Physical Activity Survey scores (p < .1) and faster improvement in Lower Extremity Gain Scale and Yale Physical Activity Survey scores (p < .008). Time-varying vitamin E was also positively associated with Six-Minute Walk Distance, Lower Extremity Gain Scale, Yale Physical Activity Survey, and Short Form-36 Physical Functioning Domain (p < .03) and faster improvement in Six-Minute Walk Distance and Short Form-36 Physical Functioning Domain (p < .07). Conclusions. Serum concentrations of both a- and g-tocopherol were associated with better physical function after hip fracture. Vitamin E may represent a potentially modifiable factor related to recovery of postfracture physical function.
TL;DR: In general, highly cognitively and physically functioning hip fracture patients demonstrated higher vitamin E concentrations than expected, and the relatively high degree of function among this cohort of hip fractures may explain their higher-than-expected Vitamin E concentrations.
TL;DR: These draft 2011 American College of Rheumatology recommendations for the management of patients with hand, hip and knee OA are based on the best available evidence of benefit and safety of both non-pharmacologic and pharmacologic interventions informing the consensus judgment of clinical experts from a wide range of disciplines.
Brown University1, University of Maryland, Baltimore2, Pfizer3, University of Texas Southwestern Medical Center4, Harvard University5, University of Hawaii at Manoa6, Fred Hutchinson Cancer Research Center7, Howard University8, University of Washington9, University of Tennessee Health Science Center10, University of Arizona11
TL;DR: Differences in hgb levels are related to differences in functional outcomes of overall health, physical function, and vitality at clinically important levels in postmenopausal women with self-reported osteoarthritis.
TL;DR: Addition of low-dose LEF is a potent safe alternative for the patients showing unsatisfactory response to current medicines, but need to pay attention for liver function and infection caused by leukopenia, especially with MTX.
Abstract: Background: In Japan, more than 20 rheumatoid arthritis (RA) patients died of interstitial pneumonia (IP) caused by leflunomide (LEF) were reported, but many of them were considered as the victims of opportunistic infection currently. In this paper, efficacy and safety of low-dose LEF classified by body weight (BW) were studied. Methods: Fifty-nine RA patients were started to administrate LEF from July 2007 to July 2009. Among them, 25 patients were excluded because of the combination with tacrolimus, and medication modification within 3 months before LEF. Remaining 34 RA patients administered 20 to 50 mg/week of LEF were followed up for 1 year and enrolled in this study. Dose of LEF was classified by BW (50 mg/week for over 50 kg, 40 mg/week for 40 to 50 kg and 20 to 30 mg/week for under 40 kg). The average age and RA duration of enrolled patients were 55.5 years old and 10.2 years. Prednisolone (PSL), methotrexate (MTX) and etanercept were used in 23, 28 and 2 patients, respectively. In case of insufficient response or adverse effect, dosage change or discontinuance of LEF were considered. Failure was defined as dosages up of PSL and MTX, or dosages down or discontinuance of LEF. Last observation carried forward method was used for the evaluation of failed patients at 1 year. Results: At 1 year after LEF start, good/ moderate/ no response assessed by the European League Against Rheumatism (EULAR) response criteria using Disease Activity Score, including a 28-joint count (DAS28)-C reactive protein (CRP) were showed in 14/ 10/ 10 patients, respectively. The dosage changes of LEF at 1 year were dosage up: 10, same dosage: 5, dosage down: 8 and discontinuance: 11 patients. The survival rate of patients in this study was 23.5% (24 patients failed) but actual LEF continuous rate was 67.6% (11 patients discontinued) at 1 year. The major reason of failure was liver dysfunction, and pneumocystis pneumonia was occurred in 1 patient resulted in full recovery. One patient died of sepsis caused by decubitus ulcer infection. DAS28-CRP score was decreased from 3.9 to 2.7 significantly. Although CRP was decreased from 1.50 to 0.93 mg/dl, it wasn’t significant. Matrix metalloproteinase (MMP)-3 was decreased from 220.0 to 174.2 ng/ml significantly. Glutamate pyruvate transaminase (GPT) was increased from 19 to 35 U/l and number of leukocyte was decreased from 7832 to 6271 significantly. DAS28-CRP, CRP, and MMP-3 were improved significantly with MTX, although they weren’t without MTX. Increase of GPT and leukopenia were seen significantly with MTX, although they weren’t without MTX. Conclusions: It was reported that the risks of IP caused by LEF in Japanese RA patients were past IP history, loading dose administration and low BW. Addition of low-dose LEF is a potent safe alternative for the patients showing unsatisfactory response to current medicines, but need to pay attention for liver function and infection caused by leukopenia, especially with MTX. Disclosure statement: The authors have declared no conflicts of interest.