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Biomedical subjects

Candace Bramson

Publications and source records attributed to Candace Bramson.

7 recordsLinked to original sources
PubMed2006

Effects of lasofoxifene on the pharmacokinetics and pharmacodynamics of single-dose warfarin.

AIM: To investigate the effect of steady-state lasofoxifene on the pharmacokinetics and pharmacodynamics of warfarin. METHODS: Twelve healthy postmenopausal women received warfarin (single 20-mg dose) alone and during lasofoxifene. R- and S-warfarin concentrations, prothrombin time (PT) and international normalized ratio (INR) were determined with each treatment. RESULTS: Lasofoxifene had no clinically meaningful effect on R- or S-warfarin pharmacokinetics. The S-warfarin area under the plasma concentration-time curve (AUC) was 23% and 67% larger in subjects with *1/*2 and *1/*3 heterozygous mutations, relative to *1/*1, respectively. The mean PT AUC and Cmax ratio (90% confidence interval) was 91.9 (89.6, 94.2) and 84.2 (80.6, 87.8), respectively. INR results were similar. CONCLUSIONS: Lasofoxifene has no clinically meaningful effect on the pharmacokinetics of warfarin. Although the decrease in PT/INR may not be clinically meaningful, more frequent INR monitoring may be considered during lasofoxifene introduction and discontinuation, consistent with warfarin's label.

Adult↗
PubMed2006

A single-dose pharmacokinetic study of lasofoxifene in healthy volunteers and subjects with mild and moderate hepatic impairment.

Lasofoxifene, a selective estrogen receptor modulator for osteoporosis management, is metabolized primarily by hepatic oxidation and conjugation. This study compared the pharmacokinetics of 0.25 mg lasofoxifene in subjects with mild (Child-Pugh grade A, n = 6) or moderate (Child-Pugh grade B, n = 6) hepatic impairment and healthy volunteers (n = 6). Analysis of variance was used to calculate 90% confidence intervals for the ratios (impaired/healthy) of least squares mean log maximum plasma concentration (C(max)) and area under the curve (AUC) values. Lasofoxifene pharmacokinetics was similar between healthy and mild hepatic impairment subjects: ratios of C(max) and AUC from 0 to infinity (AUC([0-infinity])) were 101% (75.0-138) and 95.5% (77.9-117), respectively. In subjects with moderate hepatic impairment, ratios of C(max) and AUC([0-infinity]) were 121% (89.6-165) and 138% (112-169), respectively; mean terminal half-life was 252 hr compared to 193 hr in healthy subjects. Dose adjustment should not be required for subjects with mild to moderate hepatic impairment.

Administration, Oral↗
PubMed2006

Bioavailability of amlodipine besylate/atorvastatin calcium combination tablet.

The bioequivalence of combination tablets containing amlodipine besylate/atorvastatin calcium with coadministered matching doses of amlodipine besylate and atorvastatin calcium tablets was investigated in randomized, 2-way crossover studies in healthy volunteers (N = 126). Subjects received a single dose of the amlodipine/atorvastatin tablet or coadministered matching doses of amlodipine and atorvastatin at the highest (10/80 mg; n = 62) and lowest (5/10 mg; n = 64) dose strengths. Atorvastatin geometric mean ratios for maximum plasma concentration (C(max)) and area under the plasma concentration-time curve (AUC) for the highest and lowest dose strengths were 94.1 and 98.8, and 104.5 and 103.8, respectively. Amlodipine geometric mean ratios for C(max) and AUC for the highest and lowest dose strengths were 100.8 and 103.4, and 100 and 102.7, respectively. The 90% confidence intervals for all comparisons were within 80% to 125%, demonstrating bioequivalence for amlodipine and atorvastatin at both dose strengths. Use of amlodipine/atorvastatin combination tablets may provide a more integrated approach to treatment of cardiovascular risk.

Adolescent↗
PubMed2005

Using acupressure to modify alertness in the classroom: a single-blinded, randomized, cross-over trial.

BACKGROUND: Previous reports have suggested that acupressure is effective in reducing pain and improving sleep quality; however, its effects on alertness have not been characterized. OBJECTIVES: The aim of this study was to determine whether two different acupressure treatments have opposing effects on alertness in a full-day classroom setting. DESIGN: This was a cross-over (two-treatments; three periods), single-blinded, randomized trial. SETTING: The University of Michigan School of Public Health was the setting. SUBJECTS: Students attending a course in clinical research design and statistical analysis at the University of Michigan participated in the study. INTERVENTIONS AND OUTCOME MEASURES: Blinded subjects were randomized to two acupressure treatment sequences: stimulation-relaxation-relaxation or relaxation-stimulation-stimulation. Acupressure treatments were self administered over 3 consecutive days. Pre- and post-treatment alertness scores were assessed each day using the Stanford Sleepiness Scale (SSS). Changes in the SSS score (afternoon-morning) were analyzed using a mixed regression model of fixed and random effects. Important factors that were expected to affect alertness, such as caffeine and previous night's sleep, were also assessed. RESULTS: Baseline characteristics and protocol compliance were similar between the two sequences. Stimulation acupressure treatment yielded a 0.56-point greater difference in score on the SSS, corresponding to less fatigue, compared to the relaxation acupressure treatment (p = 0.019). Day of study (p = 0.004) and hours of overnight sleep (p = 0.042) also significantly affected the change in SSS scores. Incorporating participants' beliefs as to which treatment they received did not significantly alter the observed treatment effect. CONCLUSIONS: Acupressure at stimulation and relaxation points has differential effects on alertness in a classroom setting. Further research is necessary to confirm these findings and to determine whether stimulation and relaxation acupressure are equally effective in influencing alertness.

Acupressure↗
PubMed2005

Effect of lasofoxifene on the pharmacokinetics of digoxin in healthy postmenopausal women.

Lasofoxifene is in late-stage development for the prevention and treatment of osteoporosis. Digoxin is commonly prescribed for arrhythmias and congestive heart failure, has a narrow therapeutic index, and may be coadministered with lasofoxifene. This study was conducted to determine the effect of lasofoxifene (4-mg loading dose on day 11 followed by 0.5 mg/d on days 12-20) on the steady-state pharmacokinetics of digoxin (0.25 mg/d on days 1-20) in 12 healthy postmenopausal women. On days 10 and 20, blood and urine samples were collected for 24 hours to determine digoxin concentrations. The 90% confidence interval (CI) of least squares mean ratio for maximum concentration (C(max)) and area under the plasma concentration-time curve (AUC) was calculated. Lasofoxifene had no effect on digoxin plasma pharmacokinetics with a ratio (90% CI) of 95.4% (84.6%-107%) and 103% (97.7%-108%) for C(max) and AUC(0-24), respectively. The ratio of the percentage of dose eliminated unchanged in urine in 24 hours was 127% (116% to 142%). Coadministration of lasofoxifene had no effect on the steady state pharmacokinetics of digoxin.

Aged↗
PubMed2005

Fibromyalgia syndrome.

The objectives of the first OMERACT Fibromyalgia Syndrome (FM) Workshop were to identify and prioritize symptom domains that should be consistently evaluated in FM clinical trials, and to identify aspects of domains and outcome measures that should be part of a concerted research agenda of FM researchers. Such an effort will help standardize and improve the quality of outcomes research in FM. A principal assumption in this workshop has been that there exists a clinical syndrome, generally known as FM, characterized by chronic widespread pain typically associated with fatigue, sleep disturbance, mood disturbance, and other symptoms and signs, and considered to be related to central neuromodulatory dysregulation. FM can be diagnosed using 1990 American College of Rheumatology criteria. In preparation for the workshop a Delphi exercise involving 23 FM researchers was conducted to establish a preliminary prioritization of domains of inquiry. At the OMERACT meeting, the workshop included presentation of the Delphi results; a review of placebo-controlled trials of FM treatment, with a focus on the outcome measures used and their performance; a panel discussion of the key issues in FM trials, from both an investigator and regulatory agency perspective; and a voting process by the workshop attendees. The results of the workshop were presented in the plenary session on the final day of the meeting. A prioritized list of domains of FM to be investigated was thus developed, key issues and controversies in the field were debated, and consensus on a research agenda on outcome measure development was reached.

Delphi Technique↗