1120 POSTER Evaluation of the association between hemoglobin (Hb) events and safety outcomes in cancer patients (pts) with chemotherapy-induced anemia (CIA): an integrated analysis of patient-level data from 6 randomized, placebo-controlled trials (RCTs) of darbepoetin alfa (DA)

2007 ◽  
Vol 5 (4) ◽  
pp. 147-148 ◽  
Author(s):  
J. Glaspy ◽  
A. Österborg ◽  
H. Ludwig ◽  
A. Fleishman ◽  
T. Lillie ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Darbepoetin Alfa ◽  
Integrated Analysis ◽  
Controlled Trials ◽  
Patient Level Data ◽  
Patient Level ◽  
Level Data ◽  
Safety Outcomes

scholarly journals Initial depression severity and response to antidepressants v. placebo: patient-level data analysis from 34 randomised controlled trials

2016 ◽  
Vol 209 (5) ◽  
pp. 427-428 ◽  
Author(s):  
Jonathan Rabinowitz ◽  
Nomi Werbeloff ◽  
Francine S. Mandel ◽  
François Menard ◽  
Lauren Marangell ◽  
...  
Keyword(s):  
Meta Analysis ◽  
Severe Depression ◽  
Placebo Patient ◽  
Controlled Trials ◽  
Depression Severity ◽  
Patient Level Data ◽  
Patient Level ◽  
Level Data ◽  
Initial Depression ◽  
Randomised Controlled

SummarySeveral often-cited meta-analyses have reported that the efficacy of antidepressant medications depends on the severity of depression. They found that drug–placebo differences increased as a function of initial severity, which was attributed to decreased responsiveness to placebo among patients with severe depression rather than to increased responsiveness to medication. We retested this using patient-level data and also undertaking a meta-analysis of trial-level data from 34 randomised placebo controlled trials (n = 10 737) from the NEWMEDS registry. Although our trial-level data support prevous findings, patient-level data did not show any significant effect of initial depression severity on drug v. placebo difference.

Bortezomib-Based Versus Nonbortezomib-Based Induction Treatment Before Autologous Stem-Cell Transplantation in Patients With Previously Untreated Multiple Myeloma: A Meta-Analysis of Phase III Randomized, Controlled Trials

2013 ◽  
Vol 31 (26) ◽  
pp. 3279-3287 ◽  
Author(s):  
Pieter Sonneveld ◽  
Hartmut Goldschmidt ◽  
Laura Rosiñol ◽  
Joan Bladé ◽  
Juan José Lahuerta ◽  
...  
Keyword(s):  
Peripheral Neuropathy ◽  
Odds Ratio ◽  
Phase Iii ◽  
Integrated Analysis ◽  
Induction Treatment ◽  
Efficacy And Safety ◽  
Post Transplantation ◽  
Patient Level Data ◽  
Patient Level ◽  
Level Data

Purpose To characterize efficacy and safety of bortezomib-based versus nonbortezomib-based induction regimens through an integrated analysis of data from phase III studies in transplantation-eligible patients with previously untreated myeloma. Patients and Methods Patient-level data from the IFM 2005-01 (bortezomib-dexamethasone v vincristine-doxorubicin-dexamethasone [VAD] induction), HOVON-65/GMMG-HD4 (bortezomib-doxorubicin-dexamethasone v VAD), and PETHEMA GEM05MENOS65 (bortezomib-thalidomide-dexamethasone v thalidomide-dexamethasone) studies were pooled in an integrated analysis of efficacy and safety. Study-level data from the GIMEMA MM-BO2005 study (bortezomib-thalidomide-dexamethasone v thalidomide-dexamethasone) supplemented the integrated patient-level analysis. Key efficacy end points were post-transplantation complete plus near-complete response (CR+nCR) rate and progression-free survival (PFS). Results Patient-level data for 1,572 patients (bortezomib-based induction, n = 787; nonbortezomib-based induction, n = 785) were included. Post-transplantation CR+nCR rate was significantly higher following bortezomib-based versus nonbortezomib-based induction (38% v 24%; odds ratio, 2.05; P < .001); the benefit remained similar (pooled odds ratio, 1.96) when GIMEMA MM-BO2005 data were included. Median PFS was 35.9 months versus 28.6 months with bortezomib-based versus nonbortezomib-based induction, respectively (hazard ratio, 0.75; P < .001); 3-year overall survival (OS) rates were 79.7% and 74.7%, respectively (hazard ratio for OS, 0.81; P = .0402). Median duration of induction treatment was 11 weeks in both treatment groups. Rates of peripheral neuropathy during induction were 34% versus 17% (grade ≥ 3, 6% v 1%). Overall, 3% and 4% of patients died during bortezomib-based and nonbortezomib-based induction, respectively. Conclusion Bortezomib-based induction results in significant improvements in response and PFS/OS compared with nonbortezomib-based induction and is generally well tolerated, with a higher rate of peripheral neuropathy but no apparent increase in risk of death during induction.

scholarly journals Optimal strategies for monitoring lipid levels in patients at risk or with cardiovascular disease: a systematic review with statistical and cost-effectiveness modelling

2015 ◽  
Vol 19 (100) ◽  
pp. 1-402 ◽  
Author(s):  
Rafael Perera ◽  
Emily McFadden ◽  
Julie McLellan ◽  
Tom Lung ◽  
Philip Clarke ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Primary Prevention ◽  
Density Lipoprotein ◽  
Hdl Cholesterol ◽  
Controlled Trials ◽  
Patient Level Data ◽  
Patient Level ◽  
Monitoring Strategies ◽  
Level Data ◽  
Meta Analyses

BackgroundVarious lipid measurements in monitoring/screening programmes can be used, alone or in cardiovascular risk scores, to guide treatment for prevention of cardiovascular disease (CVD). Because some changes in lipids are due to variability rather than true change, the value of lipid-monitoring strategies needs evaluation.ObjectiveTo determine clinical value and cost-effectiveness of different monitoring intervals and different lipid measures for primary and secondary prevention of CVD.Data sourcesWe searched databases and clinical trials registers from 2007 (including the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, the Clinical Trials Register, the Current Controlled Trials register, and the Cumulative Index to Nursing and Allied Health Literature) to update and extend previous systematic reviews. Patient-level data from the Clinical Practice Research Datalink and St Luke’s Hospital, Japan, were used in statistical modelling. Utilities and health-care costs were drawn from the literature.MethodsIn two meta-analyses, we used prospective studies to examine associations of lipids with CVD and mortality, and randomised controlled trials to estimate lipid-lowering effects of atorvastatin doses. Patient-level data were used to estimate progression and variability of lipid measurements over time, and hence to model lipid-monitoring strategies. Results are expressed as rates of true-/false-positive and true-/false-negative tests for high lipid or high CVD risk. We estimated incremental costs per quality-adjusted life-year.ResultsA total of 115 publications reported strength of association between different lipid measures and CVD events in 138 data sets. The summary adjusted hazard ratio per standard deviation of total cholesterol (TC) to high-density lipoprotein (HDL) cholesterol ratio was 1.25 (95% confidence interval 1.15 to 1.35) for CVD in a primary prevention population but heterogeneity was high (I2 = 98%); similar results were observed for non-HDL cholesterol, apolipoprotein B and other ratio measures. Associations were smaller for other single lipid measures. Across 10 trials, low-dose atorvastatin (10 and 20 mg) effects ranged from a TC reduction of 0.92 mmol/l to 2.07 mmol/l, and low-density lipoprotein reduction of between 0.88 mmol/l and 1.86 mmol/l. Effects of 40 mg and 80 mg were reported by one trial each. For primary prevention, over a 3-year period, we estimate annual monitoring would unnecessarily treat 9 per 1000 more men (28 vs. 19 per 1000) and 5 per 1000 more women (17 vs. 12 per 1000) than monitoring every 3 years. However, annual monitoring would also undertreat 9 per 1000 fewer men (7 vs. 16 per 1000) and 4 per 1000 fewer women (7 vs. 11 per 1000) than monitoring at 3-year intervals. For secondary prevention, over a 3-year period, annual monitoring would increase unnecessary treatment changes by 66 per 1000 men and 31 per 1000 women, and decrease undertreatment by 29 per 1000 men and 28 per 1000 men, compared with monitoring every 3 years. In cost-effectiveness, strategies with increased screening/monitoring dominate. Exploratory analyses found that any unknown harms of statins would need utility decrements as large as 0.08 (men) to 0.11 (women) per statin user to reverse this finding in primary prevention.LimitationHeterogeneity in meta-analyses.ConclusionsWhile acknowledging known and potential unknown harms of statins, we find that more frequent monitoring strategies are cost-effective compared with others. Regular lipid monitoring in those with and without CVD is likely to be beneficial to patients and to the health service. Future research should include trials of the benefits and harms of atorvastatin 40 and 80 mg, large-scale surveillance of statin safety, and investigation of the effect of monitoring on medication adherence.Study registrationThis study is registered as PROSPERO CRD42013003727.FundingThe National Institute for Health Research Health Technology Assessment programme.

scholarly journals Effect of Calcium Supplements on Risk of Myocardial Infarction and Cardiovascular Events: Meta-analysis

2014 ◽  
Vol 6 (1) ◽  
pp. 62-64
Author(s):  
MJ Bolland ◽  
A Avenell ◽  
JA Baron ◽  
A Grey ◽  
GS MacLennan ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Confidence Interval ◽  
Cardiovascular Events ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Patient Level Data ◽  
Calcium Supplements ◽  
Patient Level ◽  
Level Data ◽  
Meta Analyses

ABSTRACT Objective To investigate whether calcium supplements increase the risk of cardiovascular events. Design Patient level and trial level meta-analyses. Data Sources Medline, Embase, and Cochrane Central Register of Controlled Trials (1966-March 2010), reference lists of meta-analyses of calcium supplements, and two clinical trial registries. Initial searches were carried out in November 2007, with electronic database searches repeated in March 2010. Study Selection Eligible studies were randomized, placebo controlled trials of calcium supplements (. 500 mg/day), with 100 or more participants of mean age more than 40 years and study duration more than 1 year. The lead authors of eligible trials supplied data. Cardiovascular outcomes were obtained from self-reports, hospital admissions and death certificates. Results Fifteen trials were eligible for inclusion, five with patient level data (8,151 participants, median follow-up 3.6 years, interquartile range 2.7-4.3 years) and 11 with trial level data (11,921 participants, mean duration 4.0 years). In the five studies contributing patient level data, 143 people allocated to calcium had a myocardial infarction compared with 111 allocated to placebo (hazard ratio 1.31, 95% confidence interval 1.02-1.67, p = 0.035). Nonsignificant increases occurred in the incidence of stroke (1.20, 0.96-1.50, p = 0.11), the composite end point of myocardial infarction, stroke, or sudden death (1.18, 1.00 to 1.39, p = 0.057), and death (1.09, 0.96-1.23, p = 0.18). The meta-analysis of trial level data showed similar results: 296 people had a myocardial infarction (166 allocated to calcium, 130 to placebo), with an increased incidence of myocardial infarction in those allocated to calcium (pooled relative risk 1.27, 95% confidence interval 1.01-1.59, p = 0.038). Conclusion Calcium supplements (without coadministered vitamin D) are associated with an increased risk of myocardial infarction. As calcium supplements are widely used these modest increases in risk of cardiovascular disease might translate into a large burden of disease in the population. A reassessment of the role of calcium supplements in the management of osteoporosis is warranted.

Coping with the burden of taste alteration, a toxicity of taxane-based chemotherapy.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e19531-e19531
Author(s):  
Rebecca M Speck ◽  
Angela DeMichele ◽  
John T Farrar ◽  
Sean Hennessy ◽  
Jun Mao ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Coping Strategies ◽  
Cancer Patients ◽  
Comparative Method ◽  
Breast Cancer Patients ◽  
Structured Interviews ◽  
Patient Level Data ◽  
Patient Level ◽  
Level Data ◽  
Taste Alteration

e19531 Background: Taste alteration is a poorly recognized toxicity of chemotherapy, with limited research. This study examined the experience of taste alteration in female breast cancer patients treated with taxane chemotherapy. We explored the self-management coping strategies utilized by patients. Methods: A purposive sample of 25 patients currently receiving docetaxel or paclitaxel or within six months of having completed treatment was recruited. This exploratory, descriptive study utilized semi-structured interviews and patient-level data from the electronic medical record. Interview data were analyzed with the constant comparative method. Descriptive statistics were used for patient-level data. Results: Participants were 24-60 years of age, mean 46. Ten patients received docetaxel and 15 received paclitaxel. Of all side effects reported from taxanes, the most common was taste alteration (7 (70%) docetaxel patients, 3 (20%) paclitaxel patients). Taste alteration was described as a metallic taste, bad taste, weird taste, or lack of taste. Taste alteration affected normal or routine behaviors in that they chose not to eat as much, ate on an irregular schedule, and lost interest in preparing meals for themselves and/or their family. Women adopted new behaviors to deal with the taste alteration and its effect, including the use of plastic silverware, eating strongly flavored foods, honoring specific food cravings, eating candy before meals, cutting food with lemon, drinking sweetened drinks, drinking from a straw, brushing their teeth and tongue before meals, and using baking soda and salt or antibacterial mouthwash. The majority (59%) of patients gained weight during taxane treatment (mean = 2.7 lbs; range = 1-12.5 lbs). There was insufficient power to detect a difference in weight gain by taste alteration status. Conclusions: Taste alteration affects breast cancer patients’ normal routine, but they develop management strategies to deal with the effect. However, given the association of obesity with poor treatment outcomes, the potential for increased caloric consumption associated with some coping strategies is cause for concern, and further studies are warranted for the development of appropriate interventions.

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