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Biomedical subjects

Marc L Berger

Publications and source records attributed to Marc L Berger.

27 records · Page 2Linked to original sources
PubMed2002

Prediction of fracture risk in postmenopausal white women with peripheral bone densitometry: evidence from the National Osteoporosis Risk Assessment.

Low bone mineral density (BMD) is a risk factor for fracture. Although the current "gold standard" test is DXA of the hip and spine, this method is not universally available. No large studies have evaluated the ability of new, less expensive peripheral technologies to predict fracture. We studied the association between BMD measurements at peripheral sites and subsequent fracture risk at the hip, wrist/forearm, spine, and rib in 149,524 postmenopausal white women, without prior diagnosis of osteoporosis. At enrollment, each participant completed a risk assessment questionnaire and had BMD testing at the heel, forearm, or finger. Main outcomes were new fractures of the hip, wrist/forearm, spine, or rib within the first 12 months after testing. After 1 year, 2259 women reported 2340 new fractures. Based on manufacturers' normative data and multivariable adjusted analyses, women who had T scores < or = -2.5 SD were 2.15 (finger) to 3.94 (heel ultrasound [US]) times more likely to fracture than women with normal BMD. All measurement sites/devices predicted fracture equally well, and risk prediction was similar whether calculated from the manufacturers' young normal values (T scores) or using SDs from the mean age of the National Osteoporosis Risk Assessment (NORA) population. The areas under receiver operating characteristic (ROC) curves for hip fracture were comparable with those published using measurements at hip sites. We conclude that low BMD found by peripheral technologies, regardless of the site measured, is associated with at least a twofold increased risk of fracture within 1 year, even at skeletal sites other than the one measured.

Absorptiometry, Photon↗
PubMed2002

A metaanalysis of severe upper gastrointestinal complications of nonsteroidal antiinflammatory drugs.

OBJECTIVE: Prior metaanalyses of the risk of upper gastrointestinal (GI) complications associated with nonsteroidal antiinflammatory drugs (NSAID) have focused on the published English language epidemiologic literature and/or only a portion of the relevant evidence, restrictions that are now known to be associated with bias in metaanalysis. We synthesized the published and unpublished evidence to determine the least biased estimates of the risks of perforations, ulcers, and bleeds (PUB) associated with NSAID use from all study designs and all languages. METHODS DATA SOURCES: Using MEDLINE, EMBASE, HEALTHSTAR, and BIOSIS, we searched for English and non-English language studies of NSAID from 1966-1998 reporting primary data on GI complications. We obtained unpublished data from the US Food and Drug Administration (FDA) new drug application (NDA) reviews. NDA were hand searched to identify unpublished studies with inclusion criteria identical to those used for published reports. STUDY SELECTION: Studies had to assess the use of oral NSAID for more than 4 days duration in subjects > 18 years of age and report on the clinically relevant upper GI outcomes of PUB. RESULTS: Two reviewers evaluated 4881 published titles and identified 13 NSAID versus placebo randomized clinical trials and 3 previously unpublished FDA placebo controlled randomized controlled trials, 9 cohort studies, and 23 case control studies sufficiently clinically homogeneous to pool. Two reviewers extracted data about study characteristics and study quality. DATA SYNTHESIS: The majority of clinical trials were of good quality, but observational studies had methodologic limitations. The pooled odds ratio (OR) from 16 NSAID versus placebo clinical trials, comprising 4431 patients, was 5.36 (95% CI: 1.79, 16.1). The pooled relative risk of PUB from 9 cohort studies comprising over 750,000 person-years of exposure was 2.7 (95% CI: 2.1, 3.5). The pooled OR of PUB from 23 case control studies using age and sex matching, representing 25,732 patients, was 3.0 (95% CI: 2.5, 3.7). Data were insufficient to justify subgroup analyses stratified by age, comorbid conditions, drug, or dose. CONCLUSION: These data support an association between the use of NSAID and serious upper GI complications, including estimates from different study designs. Prior pooled estimates about the effect of patient and drug variables on increased risk must be viewed with caution.

Administration, Oral↗
PubMed2002

Growth in use of lipid-lowering therapies: are we targeting the right patients?

BACKGROUND: Prescription drug spending has been rising at > 10% per year, with volume of use (rather than price) being the primary driver for that growth. Concern exists that industry marketing has led to increased use of medications by patients with marginal indications. OBJECTIVE: To determine whether the increase in the number of patients receiving lipid-lowering therapy represents a shift away from treatment of patients at highest cardiovascular (CV) risk towards patients in lower risk categories. STUDY DESIGN AND METHODS: Cardiovascular risk criteria adapted from guidelines were applied to an administrative database of medical and pharmaceutical claims for 1997 and 1999 that included managed care plan enrollees in 22 states. Patients were assigned to 1 of 7 categories representing CV risk based on documentation of CV disease/risk factors, with category 1 and 2 indicating the highest risk group (secondary prevention). The odds of the treated population being in the highest risk during 1997 versus 1999 were calculated, adjusting for age and sex. RESULTS: Patients treated with lipid medications in the study population increased from 5% in 1997 to 8% in 1999. During the same period, the percentage of treated patients in categories 1 through 6 rose from 17% to 21%. The odds of the treated population being in the highest risk group did not differ significantly between the 2 years (odds ratio (OR) = 0.99; 95% confidence interval, (CI) 0.96-1.01; P = .40). CONCLUSIONS: Despite an increase in the percentage of patients receiving lipid-lowering therapy from 1997 to 1999, treatment rates rose modestly across all categories. Greater overall use did not appear to be associated with a shift in use towards patients with less CV risk.

Cardiovascular Diseases↗
PubMed2002

Do disease management programs for patients with coronary heart disease make a difference? Experiences of nine practices.

OBJECTIVE: To observe the experience of 9 practice sites in implementing provider-defined disease management programs for coronary heart disease patients. STUDY DESIGN: Observational study of provider-defined practice improvement programs. METHODS: Practices chose from a variety of interventions that included provider- and patient-based disease management tools. Data were collected at baseline, 6, and 12 months. RESULTS: Complete baseline, 6-month, and 12-month data were available for 586 patients (58% of the 1013 patients enrolled). Compared with baseline, 6-month data showed more patients whose total cholesterol was less than 200 mg/dL (56% to 76%; P < or = .001), whose low-density lipoprotein (LDL) cholesterol was less than 100 mg/dL (30% to 54%; P < or = .001), and whose high-density lipoprotein cholesterol was at least 35 mg/dL (75% to 81%; P < or = .001); who exercised rigorously for 30 minutes, 3 times a week (40% to 53%; P < or = .001); who used lipid medication (74% to 80%; P < or = .01); and who used aspirin (84% to 92%; P < or = .001). There were no significant improvements in triglyceride levels, blood pressure control, glycemic control among diabetes patients, smoking cessation, body mass index, and beta-blocker use. The 12-month results were similar to the 6-month results. Sites with a practice coordinator had the highest number of patients achieving their LDL goal (72% to 89%). CONCLUSIONS: There may be an opportunity to improve patient care by applying disease management principles with a variety of interventions. Dedicated personnel to help coordinate disease management programs may be critical to the success of such programs.

Adult↗
PubMedDate not supplied

Recency and duration of postmenopausal hormone therapy: effects on bone mineral density and fracture risk in the National Osteoporosis Risk Assessment (NORA) study.

OBJECTIVES: Results from the Women's Health Initiative showed that postmenopausal hormone replacement therapy (HRT) prevents fractures but has an overall unfavorable risk:benefit ratio, leading to the recommendation that HRT be used only for women with troublesome menopause symptoms, and for as short a time as possible. This recommendation has important implications for the timing and duration of HRT and the prevention of osteoporosis. The large number of women participating in the National Osteoporosis Risk Assessment (NORA) program provided the opportunity to evaluate bone mineral density (BMD) and 1-year fracture risk in analyses stratified by duration and recency of HRT. DESIGN: Participants were 170,852 postmenopausal women aged 50 to 104, without known osteoporosis, who were recruited from primary physicians offices across the US. BMD was measured at one of four peripheral sites, and the 1-year risk of osteoporotic fracture was assessed by questionnaire. RESULTS: At baseline, current HRT users had the highest T-scores at every age. Among current hormone users, women who had used HRT longest had the highest BMD levels. Women who had stopped HRT more than 5 years previously, regardless of duration of use, had T-scores similar to never-users. Current but not past hormone use at baseline was associated with a 25% to 29% lower risk of osteoporotic fracture (P < 0.0001) in 1 year, compared with nonusers. These findings were independent of age, ethnicity, body mass index, lifestyle, years postmenopausal, and site of BMD measurement. CONCLUSIONS: We conclude that postmenopausal BMD and fracture are closely associated with current, but not prior, HRT use. Use of HRT for 5 years or less, as proposed for treatment of symptomatic women during menopause transition, is unlikely to preserve bone or significantly reduce fracture risk in later years.

Aged↗
PubMedDate not supplied

Comparative effectiveness: asking the right questions, choosing the right method.

The Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 has placed renewed focus on assessing the comparative effectiveness of various therapeutic options. Unfortunately, all of the evidence needed to fully assess these options is rarely available to drug formulary decisionmakers. Comparative randomized trials frequently fail to find differences when there indeed are some, while decision-modeling approaches are more likely to identify differences where there are none. We consider the consequences of these strategies. This paper proposes a framework for using different methods to assess available evidence. We contend that choosing the appropriate method can occur only when there are clear policy goals.

Decision Making↗