Drug-Eluting Stents Outperform Bare Stents in Heart Attack Mar 31, 2008
The new study, which involved 16 medical centers, enrolled 745 patients who were set to undergo PCI for STEMI. Patients were randomly assigned to an infusion of abciximab or high-dose tirofiban (25 microgram/kg) and, in a second round of randomization, to treatment with either uncoated or sirolimus-eluting stents. To judge the effectiveness of tirofiban and abciximab, researchers examined electrocardiograms -- 722 of which were interpretable -- to determine the proportion of patients with at... (PR Newswire)
Group-Randomized Cancer Trials Often Statistically Flawed Mar 29, 2008
" The findings came from a review of 75 group-randomized clinical trials, which the authors defined as comparative studies involving random assignment of identifiable groups to protocol-specified conditions. Individuals within the randomized groups are observed to assess the effects of an intervention. "The group-randomized trial is the gold standard in public health and medicine when randomization of individuals is not possible," the authors noted. "Group randomization will be required whenever... (MedPage Today)
Perioperative Eloxatin(R)-Based Regimen Significantly Reduced the Risk of Relapse Versus Surgery Alone in Eligible Colorectal Cancer Patients with Initially Resectable Liver Metastases Mar 21, 2008
PFS is the time from randomization until disease progression/recurrence or death. The EORTC 40983 Intergroup study is also referred to as the EPOC (Eloxatin(R) for Peri-Operative Use) trial. (PR Newswire)
Alcohol Intake Increases Risk Of Hypertension, High Blood Pressure In Certain Populations Mar 6, 2008
Journal reference: Chen L, Davey Smith G, Harbord R, Lewis SJ (2008) Alcohol and blood pressure: A systematic review implementing a mendelian randomization approach. PLoS Med 5(3): e52. (Science Daily)
Regular Drinking Raises Blood Pressure, Meta-Analysis Affirms Mar 5, 2008
" In the three studies that reported hypertension outcomes for a total of 4,219 participants, men who drank more were at higher risk. Men with the *1*1 genotype had 2.42-fold higher risk than those with the *2*2 genotype (95% CI 1.66 to 3.55, P=0.0000048). Men with the *1*2 genotype had 1.72-fold higher risk than those with the *2*2 genotype (95% CI 1.17 to 2.52, P=0.006). The same effect was seen in the five studies that reported blood pressure outcomes for a total of 7,658 participants. Mean... (MedPage Today)
Surgery for Spinal Stenosis Provides Better Outcome Feb 23, 2008
The study consisted of a randomized group of patients given surgery or nonsurgical care and an observational cohort of patients who declined randomization. However, there were incidents of frequent crossovers in both directions in the randomized and observational groups and was therefore not definitive, the researchers said. (MedHeadlines)
Penwest Announces Results of Phase IIa Clinical Study of Nalbuphine ER Feb 4, 2008
The study group included a 2-to-1 randomization of patients on drug versus placebo. Nalbuphine ER, designed to be taken as a twice-daily tablet, is formulated using Penwest's TIMERx(r) drug delivery technology. (Primezone Releases)
Ustekinumab Phase 3 data show long-term improvement of chronic plaque psoriasis Feb 3, 2008
After the randomization at week 40, 46 percent and 49 percent of patients continuing treatment with 45 mg and 90 mg ustekinumab, respectively, experienced at least one AE, compared with 56 and 48 percent of patients switched to placebo. Serious AEs were observed in 0 and 1 percent of patients continuing treatment with 45 mg and 90 mg ustekinumab, compared with 0 and 2 percent of patients switched to placebo. (EurekAlert!)
Gene Variations Associated With Effectiveness Of Blood Pressure Medications Jan 25, 2008
"We also observed a pharmacogenetic association of NPPA T2238 on change in systolic and diastolic blood pressure 6 months after treatment randomization in a similar direction: generally, minor C allele carriers had greater reductions in blood pressure when randomized to chlorthalidone vs. either lisinopril or doxazosin relative to those with the common TT genotype," the authors write. "This study demonstrates the importance (and sometimes paradoxical findings) of pharmacogenetic research; for... (Science Daily)
Combination Therapy Improves Survival For Certain Prostate Cancer Patients Jan 24, 2008
D., of Brigham and Women's Hospital and Dana Farber Cancer Institute, Boston, and colleagues performed an analysis of overall survival of 206 men with localized but unfavorable--risk prostate cancer in subgroups defined by their level of comorbidity at the time of their randomization to AST and RT vs. RT alone. During a median follow-up of 7. (Science Daily)
Etanercept for Psoriasis Jan 17, 2008
At week 36, 138 patients underwent a second randomization to placebo or etanercept to investigate the effects of withdrawal and retreatment ... During the withdrawal period from week 36 to week 48, response was lost by 29 of 69 patients (42%) assigned to placebo at the second randomization. (New England Journal of Medicine)
Similar Outcomes For Patients With ACS Treated With Different Anticoagulant Regimens Jan 3, 2008
In the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial, randomization of moderate-risk and high-risk patients with ACS undergoing early invasive management to monotherapy with the direct thrombin (blood-clotting enzyme) inhibitor bivalirudin compared with a heparin-based regimen plus glycoprotein (GP) IIb/IIIa inhibitors resulted in noninferior 30-day rates of adverse ischemic events with reduced rates of major bleeding. The long-term effect of bivalirudin... (Science Daily)
Physician-scientist urges improved drug regulation to ensure heart ... Jan 1, 2008
Analysis plans should be designed to incorporate all data collected during development, including results of so-called observational studies (which do not employ randomization to eliminate study bias, and which do not employ "control" groups for comparison) in order to increase statistical power to find problems if they exist. Currently, this kind of analysis plan is not usually employed. (Hindu)
Key hole surgery no better than conservative management Dec 14, 2007
The primary outcome was the Kujala score on patellofemoral pain and function at 9 months following randomization. Secondary outcomes were visual analog scales (VASs) to assess activity-related symptoms. (BioMed Central)
Complete response with oblimersen combination improves survival of CLL patients Dec 10, 2007
Patients were followed for at least three years after randomization or until death or withdrawal from the study. Of the 20 oblimersen-treated patients with a complete response at the end of the first year, 12 survived at least four years. (EurekAlert!)
More on Cetuximab in Head and Neck Cancer Nov 22, 2007
The authors used the Kaplan Meier method to estimate locoregional control, defining its duration as the "time from randomization until the first documented progression or recurrence of locoregional disease or until death from any cause." This. . (New England Journal of Medicine)
Cetuximab for the Treatment of Colorectal Cancer Nov 15, 2007
Methods From December 2003 to August 2005, 572 patients who had colorectal cancer expressing immunohistochemically detectable EGFR and who had been previously treated with a fluoropyrimidine, irinotecan, and oxaliplatin or had contraindications to treatment with these drugs underwent randomization to an initial dose of 400 mg of cetuximab per square meter of body-surface area followed by a weekly infusion of 250 mg per square meter plus best supportive care (287 patients) or best supportive care... (New England Journal of Medicine)
FDA Accepts Chelsea Therapeutics' Investigational New Drug Application for Droxidopa Nov 12, 2007
Both pivotal efficacy trials will utilize an enrichment design where all potential participants are initially screened to demonstrate both a blood pressure and symptomatic improvement with Droxidopa prior to randomization to either placebo or active treatment. The primary endpoint for each trial will be a statistically significant improvement in symptomatic benefit between active and placebo, as defined by Item 1 (assessment of dizziness or light-headedness) of the Orthostatic Hypotension... (Primezone Releases)
Prevention of Preterm Delivery Nov 8, 2007
The elevated infant mortality in the studies cited is probably related to randomization bias, in our view. 2,3 More recent randomized trials4,5 show similar tocolytic efficacy, fewer maternal side effects, and no excess infant deaths with atosiban, as compared with other tocolytic. (New England Journal of Medicine)
Prophylactic Cranial Irradiation in Small-Cell Lung Cancer Nov 8, 2007
Brain imaging was not part of standard staging before randomization unless symptoms suggestive of metastasis were present. Published data suggest that up to 15% of patients have asymptomatic brain metastases, and the prognosis for these patients is similar to that for patients with symptomatic metastases. (New England Journal of Medicine)
Changing the way doctors treat high blood pressure Nov 6, 2007
To examine this question, we conducted a cluster randomization trial. Family practices were randomly assigned to implement a simplified step-care algorithm (STITCH-care) or Guidelines-based care for the management of hypertension. (EurekAlert!)
Comparison of glucosamine sulfate and a polyherbal supplement for the relief of osteoarthritis of the knee: a randomized controlled trial [ISRCTN25438351] Nov 1, 2007
Subject randomization was effective: age, gender and disease status distribution was similar in both groups. The response rates (20% reduction in WOMAC pain) were substantial for both glucosamine (89%) and reparagen (94%) and supported by investigator and subject assessments. (BioMed Central)
Year End Report for Diamyd Medical AB, Fiscal Year 2006/2007 Oct 26, 2007
In June 2007, a Phase II study in LADA patients was invalidated as non- GCP (Good Clinical Practice) conformances were found at the pharmacy responsible for labeling and randomization of study drug. Net sales were SEK 531,000 (US$ 77,518) compared to SEK 4,323,000 (US$ 631,094) for the prior year. (BusinessWire)
TPF Therapy in Unresectable Head and Neck Cancer Oct 25, 2007
Results A total of 358 patients underwent randomization, with 177 assigned to the TPF group and 181 to the PF group. At a median follow-up of 32. (New England Journal of Medicine)
Corticosteroids Judged Superior for Bell's Palsy Oct 18, 2007
"The high rate of acceptance of randomization and the low dropout rate during the study suggest that our results can probably be applied to other settings with similar populations," they wrote. "It is possible that genetic polymorphisms that are prevalent in some populations or environmental factors such as diet could alter the response.". (MedPage Today)
Early Treatment with Prednisolone or Acyclovir in Bell’s Palsy Oct 18, 2007
Results Final outcomes were assessed for 496 of 551 patients who underwent randomization. At 3 months, the proportions of patients who had recovered facial function were 83. (New England Journal of Medicine)
Statins reduce loss of function, keeping old lungs young - even in smokers Oct 13, 2007
But because of overlap between groups and the lack of randomization and controls in this study, the researchers point out that further data is needed before any definitive conclusions are drawn. Their findings do, however, support the hypothesis that statins reduce the annual loss of lung function that occurs with age. (EurekAlert!)
Depression Management by Phone Called Win-Win Sep 26, 2007
Employees identified as having significant depression but not bipolar disorder, substance disorder, history of recent mental health treatment, or suicidality were eligible for randomization. The patients were assigned to receive a telephone-based outreach and care-management program in which the workers were encouraged by a care manager -- a licensed master's degree-level clinical employed by the managed care company -- to enter outpatient therapy, consisting of psychotherapy and/or... (MedPage Today)
Fewer Heart Attacks Reported with Cypher (Sirolimus-Eluting) Stent Sep 17, 2007
This network meta-analysis design "integrated evidence from direct and indirect comparisons while fully preserving randomization," they wrote. Among the findings. (MedPage Today)
Saline or Albumin in Traumatic Brain Injury Aug 30, 2007
13 on the Glasgow Coma Scale [GCS]), we recorded baseline characteristics from case-report forms, clinical records, and CT scans and determined vital status and functional neurologic outcomes 24 months after randomization. Results We followed 460 patients, of whom 231 (50. (New England Journal of Medicine)
Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients Aug 18, 2007
There were 19 patients enrolled in the study with 18 patients receiving treatment with NEUVENGE. Patients underwent three infusions of NEUVENGE at Weeks 0, 2, and 4 following randomization. Patients who achieved a partial response, or had stable disease lasting through Week 52, were eligible for re-treatment, a booster, using the same protocol and dose as the initial treatment. (PR Newswire)
Prophylactic Cranial Irradiation in Extensive Small-Cell Lung Cancer Aug 16, 2007
7 months after randomization. The 1-year survival rate was 27. (New England Journal of Medicine)
For Screening for Atrial Fibrillation, the Pulse Is the Thing Aug 4, 2007
The cluster randomized trial, conducted at 50 primary care centers in England, included 14,802 patients, 65 or older, with further randomization to the two intervention practices. Screening took place over 12 months from October 2001 to February 2003. (MedPage Today)
Selenium Supplements Linked To Type 2 Diabetes Jul 10, 2007
" They said this is an important result for public health because selenium supplements in 30 to 200 microgram doses are used by people throughout the US and the western world. However the authors said that despite these findings, there is evidence that selenium supplementation may help to prevent cancer. Larger randomized clinical trials are currently looking into this further. The study also had limitations the researchers conceded. First, the main trial was not designed to look at diabetes but... (Medical News Today)
Estrogen Therapy and Coronary-Artery Calcification Jun 21, 2007
625 mg per day) as compared with placebo in women who had undergone hysterectomy, we performed computed tomography of the heart in 1064 women aged 50 to 59 years at randomization ... 7 years after randomization) ... Coronary-artery calcium (or Agatston) scores were measured at a central reading center without knowledge of randomization status. (New England Journal of Medicine)
Evidence Lacking To Guide Treatment For Sudden Hearing Loss Jun 20, 2007
"The method of randomization was described in two studies. Validity scores ranged from two to eight (of nine). Positive results were reported favoring systemic steroids, intratympanic [inside the inner ear] steroids, batroxobin, magnesium, vitamin E and hyperbaric oxygen, although there were serious limitations in each study with a positive finding.". This includes the article cited as the landmark study for the use of steroids, which was not described as a randomized trial and therefore may... (Science Daily)
Drug Company Funding Of Drug Trials Greatly Influences Outcome Jun 6, 2007
But this analysis adjusted for "confounders" -- study aspects that can influence the results, such as study design, including randomization, blinding, sample size, even choice of comparison drug in the study. Inclusion of the confounders still pointed to industry sponsorship as the most influential factor related to positive results and conclusions. (Science Daily)
Health Canada's approval of an expanded indication for PLAVIX(R) (clopidogrel bisulfate) now offers protection from all types of heart attacks Jun 5, 2007
Results of the COMMIT/CCS-2 trial demonstrated that in the 28 days following randomization, clopidogrel, taken with aspirin and standard therapy, reduced the relative risk of death in STEMI patients by seven per cent (event rate: 7. 5% vs. 8. (Canada Newswire)
Poniard Pharmaceuticals Announces Results of Picoplatin Phase 2 Trial That Confirm and Extend Survival Benefit in Small Cell Lung Cancer Jun 4, 2007
The trial has a 2:1 randomization comparing the efficacy and safety of intravenous picoplatin plus best supportive care to best supportive care alone. The Company expects to enroll approximately 400 patients in the trial, which is being conducted at clinical sites in Europe and India. (PR Newswire)
Back Surgery Can Quickly Relieve Pain May 31, 2007
"Fifty percent of patients [in the early surgery group] were recovered in 4 weeks after randomization, whereas prolonged conservative care would need 12 weeks before 50 percent were recovered.". "I would recommend to wait a little longer and delay the decision to perform surgery until three to six months after the start of leg pain. If, however, sciatica pain does not allow you to work or care for yourself or your family, early surgery remains a very good option and is safe," said Peul. (Forbes)
Surgery versus Prolonged Conservative Treatment for Sciatica May 31, 2007
The primary outcomes were the score on the Roland Disability Questionnaire, the score on the visual-analogue scale for leg pain, and the patient's report of perceived recovery during the first year after randomization. Repeated-measures analysis according to the intention-to-treat principle was used to estimate the outcome curves for both groups. (New England Journal of Medicine)
Novel Treatments May Help Alleviate Constipation, Irritable Bowel Syndrome In Women May 24, 2007
Endpoints were pain intensity, pain frequency and other symptoms, such as nausea, headache and appetite, which were recorded at baseline, one, two, and three months after randomization and six and 12 months after therapy. Researchers defined "cure" as those who experienced greater than 80 percent improvement in pain. (Science Daily)
Aspirin Aids in Colorectal Cancer Prevention May 12, 2007
Patients were randomized to 300 mg or 1,200 mg aspirin a day or a placebo for one to seven years depending on the date of randomization ... The greatest benefit was seen after five or more years of aspirin use 10 to 14 years after randomization (HR 0. (MedPage Today)
Low-Salt Diet Shakes Off Heart Disease Apr 21, 2007
A 25% reduction in risk of cardiovascular disease among sodium reduction groups versus controls after adjustment for clinic site, demographics, and randomization to weight- loss intervention (relative risk 0. 75, 95% confidence interval 0. (MedPage Today)
Novel transfusion strategy for pediatric patients in intensive care Apr 20, 2007
There were 14 deaths in each group within 28 days after randomization. Furthermore, none of the other outcomes analyzed, including adverse events, revealed any significant differences. (EurekAlert!)
Diagnosis of Ventilator-Associated Pneumonia Apr 5, 2007
8%) of the 365 patients in the bronchoalveolar-lavage group had received new antibiotics within 3 days before randomization, probably after the onset of the first symptoms related to ventilator-associated pneumonia. Since these patients were different from the rest of the patients,2,3 we wonder how decisions concerning. (New England Journal of Medicine)
ACC: Atherosclerosis Impervious to HDL Infusions Mar 27, 2007
All patients had an acute coronary syndrome--unstable angina, or non-ST-segment or ST-segment elevation myocardial infarction-within two weeks prior to randomization. They also had at least one 20% or greater narrowing on coronary angiography at baseline though no greater than 50% stenosis in the left main coronary artery or liver disease. (MedPage Today)
Tykerb (lapatinib) - new anti-cancer treatment approved Mar 15, 2007
The primary endpoint of time-to-progression (TTP) was defined as time from randomization to tumor progression or death related to breast cancer. After the results of a pre-specified interim analysis of 324 patients were made available, further enrollment was discontinued after enrolling 399 patients of a planned 528 patients. (News-Medical.net)
Anemia drugs increase death risk Mar 11, 2007
The dose of pegylated epoetin beta was titrated to maintain the hemoglobin level between 11 and 13 g/dL. An interim analysis, after randomization of 153 patients, demonstrated a numerical imbalance in the number of deaths across the four arms of the study. FDA has not yet received the complete study results, and will review and analyze the data after they are submitted by Hoffmann-La Roche. (Food Consumer)
Free Time: Small World Creating Big Dreams Mar 3, 2007
"They might continue with the randomization process or may do some charitable organizations things with it. They haven't decided exactly what to do.". New Attractions. (WNBC.com, NY)
Some Antioxidant Supplements Linked to Lethality Feb 28, 2007
The trials were classified as high-quality or low-quality, according to the methods (randomization, blinding, and follow-up) used in the studies. The trials were conducted in Europe, North and South America, Asia, and Australia. (MedPage Today)
Data show significant asthma control and improved lung function with Symbicort Feb 25, 2007
Results showed that after the first dose of treatment (day of randomization), the median time to 15% FEV1 improvement was significantly earlier (P. Abstract #972: Changes in asthma control measures were investigated in a 12-week, multicenter, double-blind, placebo-controlled study evaluating 480 patients aged 12 and older with mild-to-moderate persistent asthma receiving inhaled corticosteroids. (EurekAlert!)
Innovative trial design could reduce time to market Feb 15, 2007
Module A (primary) consists of 180 patients with 2:1 randomization of the VentrAssist to the control arm, which does not require implantation of an LVAD approved by the FDA for DT.. Module B (secondary) consists of up to 45 patients, with randomization of the VentrAssist to an LVAD approved by the FDA for DT.. (EurekAlert! -- Business News)
Pulsed Corticosteroid Therapy for Primary Treatment of Kawasaki Disease Feb 15, 2007
Results At week 1 and week 5 after randomization, patients in the two study groups had similar coronary dimensions, expressed as z scores adjusted for body-surface area, absolute dimensions, and changes in dimensions. As compared with patients receiving placebo, patients receiving intravenous methylprednisolone had a somewhat shorter initial period of hospitalization (P=0. (New England Journal of Medicine)
Endoscopic versus Surgical Drainage of the Pancreatic Duct in Chronic Pancreatitis Feb 15, 2007
Results Thirty-nine patients underwent randomization: 19 to endoscopic treatment (16 of whom underwent lithotripsy) and 20 to operative pancreaticojejunostomy. During the 24 months of follow-up, patients who underwent surgery, as compared with those who were treated endoscopically, had lower Izbicki pain scores (25 vs. 51, P<0. (New England Journal of Medicine)
The HIKCUPS Trial: A multi-site randomized controlled trial of a combined physical activity skill-development and dietary modification program in overweight and obese children. Jan 31, 2007
Details of the programs' methodological aspects of recruitment, randomization and statistical analyses are described here a priori. Discussion. (BioMed Central)
Posaconazole or Fluconazole in Graft-versus-Host Disease Jan 25, 2007
The primary end point was the incidence of proven or probable invasive fungal infections from randomization to day 112 of the fixed treatment period of the study. Results Of a total of 600 patients, 301 were assigned to posaconazole and 299 to fluconazole. (New England Journal of Medicine)
Sentinel-Node Biopsy in Melanoma Jan 25, 2007
Since there was no significant difference in survival between the study groups from the time of randomization, only 119 patients in the biopsy group would be expected to have a palpable nodal recurrence; of these. . (New England Journal of Medicine)
Study Finds Differences Between Blood Pressure Medicines And Newly-diagnosed Diabetes Jan 23, 2007
By only including studies that used randomization to minimize and balance differences between those assigned to different antihypertensive drugs, and by using a novel technique that can attribute risk both between agents that have been directly compared, and those that compare the results indirectly, we can see differences that other techniques cannot, said Elliott. Our indirect comparisons are similar to the way oddsmakers in Las Vegas compute the point spread for Sunday s Bears-Saints playoff... (Science Daily)
'Observational' Studies Can Produce Skewed Results Jan 17, 2007
"The key is that it behaves like randomization," Stukel explained. The study included 122,124 elderly patients on Medicare who had been hospitalized with a heart attack in 1994 or 1995 and were eligible for cardiac catheterization -- a procedure in which a tube or catheter is inserted into a vessel in the arm or leg and then on into the heart or coronary arteries. (Health-Finder)
Antivirals effectively curb influenza virus Jan 17, 2007
"Trials in non-household settings where influenza readily spreads such as schools, homes for the elderly and workplaces would be beneficial not only for planning management of seasonal influenza but also would be invaluable in pandemic planning. Additionally, simple solutions such as standardized randomization and study criteria would greatly facilitate trial comparison in the future. Such further studies will help us ensure we are better prepared not only for annual influenza seasons but... (EurekAlert!)
Basilea Announces Positive Top-Line Results On Second Pivotal Phase III Ceftobiprole Trial Jan 10, 2007
This second pivotal double-blind study (STRAUSS II -- study of resistant Staphylococcus aureus in complicated skin and skin structure infections) treated 828 patients with either ceftobiprole or the combination of ceftazidime plus vancomycin in a 2:1 randomization. Almost one third of patients had diabetic foot infections of which three quarters were moderate to severe cases. (Primezone Releases)
Herceptin for Early HER2 Breast Cancer Extends Overall Survival Jan 6, 2007
7%) at three years after randomization ... 3%) at three years after randomization. (MedPage Today)
Topiramate May Help Prevent Migraine in Teens Dec 27, 2006
Randomization resulted in 12 adolescents assigned to placebo, 11 to topiramate 50 mg/day, 13 to 100 mg/day, and 13 to 200 mg/day. Those taking 100 mg/day saw a 63 percent median drop off in the frequency of monthly migraine attacks and those taking 200 milligrams daily saw a 65 percent reduction in monthly migraine attacks. (MEDLINEplus)
ViroPharma Announces Presentation of Additional Maribavir Data at American Society of Hematology Meeting Dec 12, 2006
Per the final protocol, following transplantation and transplant engraftment, eligible patients will be randomized to receive maribavir or matching placebo in a 2:1 randomization ratio. Patients will receive maribavir 100 mg BID or placebo for a maximum duration of 12 weeks. (PR Newswire)
