Search

Objective To compare the efficacy, discontinuation rates, and safety of once nightly versus twice daily dosing of pregabalin in a community-based trial. Methods This multicenter, double-blind, 8-week randomized clinical trial compared the effects of 300-mg daily doses of pregabalin given either twice daily or once nightly for the treatment of fibromyalgia in 177 patients. The primary outcome was the comparison of end point mean pain scores derived from a daily diary. Results Both twice daily (88 patients randomized) and once nightly (89 patients) pregabalin significantly reduced the average severity of pain experienced by patients ( P < 0.001 for both). Treatment-emergent adverse events were reported by significantly more patients in the twice daily group than those in the once nightly group ( P = 0.023). There were no significant differences between the groups for the frequencies of individual adverse events ( P > 0.05 for all). There was no significant difference in adverse events or efficacy in patients taking both pregabalin and a selective serotonin and norepinephrine reuptake inhibitor or selective serotonin uptake inhibitor. Conclusion While a nightly dosing schedule of pregabalin has been used by clinicians hoping to improve treatment, this study showed no significant difference (either beneficial or detrimental) between either treatment option. While there was a decrease in total patient-reported adverse events in the once nightly arm, the lack of specificity in relation to a particular adverse event suggested no real difference in adverse events. [ABSTRACT FROM AUTHOR]

Objective The office time required for primary care physicians (PCPs) to diagnose, treat and manage fibromyalgia (FM) patients can be extensive. The study objective was to determine if PCPs can positively impact practice economics by requiring fewer patient visits and less office time, while still achieving an acceptable quality of life, as reported by the physician. Study design Survey of PCPs who diagnose, manage and treat FM patients. Methods Surveys were administered to US private practice PCPs, obtaining information on the number of office visits, and time spent with FM patients. PCPs were allotted into two groups: FM-efficient (FME; n = 40) and FM usual care (FMUC; n = 54), based on their reported ability to achieve an acceptable quality of life for ≥50% of their FM patients in less than four office visits post FM diagnosis. An economic model estimated the monetary value of each PCP cohorts' time spent with a newly diagnosed FM patient over a 2-year timeframe. Results Significant office time cost differences across 2 years exist between FME PCPs and FMUC PCPs ($840 vs. $1117, P < 0.05). FME PCPs had a significantly lower cost of scheduled time to confirm diagnosis ($243 vs. $339, P < 0.05) and time to find right treatment ($264 vs. $365, P < 0.05) than FMUC PCPs. Both groups incurred costs related to excess visit time, but it was less for FME PCPs ($119, 29 minutes) than FMUC PCPs ($182, 44 minutes, P < 0.01), driven by quicker diagnosis confirmation ( P < 0.01) and treatment initiation ( P < 0.01). Conclusions Research suggests that efficient FM care delivery during diagnosis and treatment can be associated with improved practice economics. [ABSTRACT FROM AUTHOR]

To evaluate changes in health-care resource use and costs after initiating pregabalin or duloxetine in employees with fibromyalgia (FM). Employees (18 to 64 years old) with at least one claim for an FM-attributable medication within 60 days following an FM diagnosis were identified using the Thomson Reuters MarketScan Commercial Database (2006 to 2008). Patients newly initiated on pregabalin were propensity score matched to patients newly initiated on duloxetine. These treatment cohorts were evaluated for changes between the 6-month pre- and post-initiation periods in health-care utilization including prescriptions, imputed medically related work loss and expenditures. Pre- to post-initiation changes were compared between pregabalin and duloxetine using a difference-in-difference approach based on univariate statistics and multivariable models. A total of 731 employees with FM initiated on pregabalin (89.9% female, mean age 47.1 ± 9.7 years) were matched with 731 employees initiated on duloxetine (89.5% female, mean age 47.1 ± 9.8 years); other demographic and clinical characteristics were also comparable between cohorts. The adjusted marginal effects were not statistically significant for pre- to post-changes in opioid utilization ( P = 0.856), number of FM-attributable ( P = 0.151) or FM-related medications ( P = 0.462), and all-cause ( P = 0.323) or FM-attributable ( P = 0.991) expenditures. Pregabalin was associated with a significantly lower probability of any medically related work loss of 3.2 percentage points ( P = 0.030) compared with duloxetine, but changes in indirect costs were not significantly different ( P = 0.600). The changes in health resource utilization and costs after initiation of pregabalin were not significantly different than the changes observed after initiation of duloxetine. These results not only demonstrate an overall similarity of resource utilization, but also suggest cost neutrality between pregabalin and duloxetine. [ABSTRACT FROM AUTHOR]

Bisphosphonates are the gold standard of treatment of postmenopausal osteoporosis, male osteoporosis, and steroid-induced osteoporosis. They have potential use in multiple musculoskeletal conditions other than osteoporosis and have also been shown to treat Paget's disease of the bone and osteogenesis imperfecta. Bisphophonates may have potential use in periprosthetic bone loss, osteonecrosis of the hip, fibrous dysplasia, and calcinosis in juvenile dermatomyositis. [ABSTRACT FROM AUTHOR]

The study aims to determine from the physician's perspective, the conditions and symptoms most relevant to the diagnosis of fibromyalgia (FM) for identifying International Classification of Diseases-diagnosis codes and prescription medications to evaluate FM-related healthcare resource utilization. A questionnaire was administered using an online physician network (SERMO™) from which responses of 102 physicians were evaluated: anesthesiologists ( n = 6), neurologists ( n = 18), primary care physicians ( n = 16), pain specialists ( n = 16), psychiatrists ( n = 15), and rheumatologists ( n = 31). Physicians scored the relative importance to a diagnosis of FM (0 = least relevant/important, 10 = most relevant/important) of 24 conditions and symptoms derived from a list provided by the National Data Bank for Rheumatic Diseases. Conditions and symptoms with mean scores ≥ 5 were considered the most relevant. Other survey questions included treatment goals, assessment of disease severity, medication use, and characterization of the physicians' experience and clinical practice. Ten conditions and symptoms (mean score) were reported as most relevant: Muscle pain (8.7), Fatigue/tiredness (8.5), Insomnia (8.0), Depression (7.8), Thinking/remembering (6.7), Nervousness (6.0), Muscle weakness (5.9), Headache (5.7), Irritable bowel syndrome (5.5), and Pain/cramps in abdomen (5.1). Treatment goals, severity assessment, and use of medications were generally similar across physician specialties. This survey identified 10 conditions and symptoms that physician respondents considered most relevant to a diagnosis of FM. Further evaluation to determine how these conditions and symptoms contribute to FM-associated healthcare resource utilization is warranted. [ABSTRACT FROM AUTHOR]

Our goal globally is to better identify individuals at risk for osteoporotic fracture so that those at high risk can be treated and unnecessary treatment for those at low risk can be avoided. Bone mineral density (BMD) information is not sufficient to identify all patients at high risk. Approximately half of patients in the community with fractures do not have osteoporosis by the 1994 World Health Organization BMD criteria. Furthermore, BMD information based on central DXA is not easily accessible worldwide. The use of clinical risk factors with or without BMD information will improve gradient of risk and help us better identify patients at high risk for fracture. The clinical risk factors identified can be integrated to predict a 10-year absolute risk or probability of fracture. Intervention thresholds based on absolute risk will be defined regionally based on each nation's ability and willingness to pay. [ABSTRACT FROM AUTHOR]

Abstract: We now have a diverse menu of osteoporosis therapies as a result of multiple randomized, controlled trials. These randomized, controlled trials have taught us the value of final endpoints such as incident fractures versus intermediate endpoints such as bone mineral density and bone markers. The success of randomized, controlled trials depends on identification of high-risk patients. Strategies have been developed to identify high-risk patients using risk factors. Finally the importance of both skeletal and extraskeletal safety is discussed. [Copyright &y& Elsevier]

To compare event rates for osteoporotic fractures, cardiovascular events, and breast cancer in postmenopausal women with osteoporosis. A prospective, observational study of the placebo group in the double-blind, randomized Multiple Outcomes of Raloxifene Evaluation trial. One hundred eighty clinical research centers in 25 countries. Postmenopausal women (n=2,565, mean age=67) with osteoporosis were given calcium (500 mg/d) and vitamin D (400–600 IU/d) supplements. The occurrence of at least one new fracture, cardiovascular event, or breast cancer diagnosis at 3 years was identified and adjudicated. The occurrence of any fracture was the most common event in these women. In women without prevalent vertebral fractures (n=1,627), the event rates per 1,000 patient-years were 45.4 for any fracture, 15.2 for vertebral fracture, 4.7 for clinical vertebral fracture, 0.9 for hip fracture, 8.3 for any cardiovascular event, and 5.2 for all breast cancer. In women with prevalent vertebral fractures (n=938), the event rates per 1,000 patient-years were 117.4 for any new fracture, 77.1 for new vertebral fracture, 25.7 for clinical vertebral fracture, 5.8 for hip fracture, 15.1 for any cardiovascular event, and 2.6 for all breast cancer. The effect of prevalent fracture status on event rates was not dependent on whether women were older or younger than 65, but women aged 65 and older had a 3.6 times greater occurrence of cardiovascular events than younger women, irrespective of prevalent fracture status. These data on the relative incidence of clinically significant skeletal and extra-skeletal outcomes may be useful in choosing an agent for health maintenance for postmenopausal women with osteoporosis. [ABSTRACT FROM AUTHOR]