Study Arms (study + arm)

Distribution by Scientific Domains


Selected Abstracts


Recent Use of Proton Pump Inhibitor-Based Triple Therapies for the Eradication of H. pylori: A Broad Data Review

HELICOBACTER, Issue 2 2003
Hans-Joachim Ulmer
abstract Introduction. For the eradication of Helicobacter pylori a 1-week triple therapy combining proton pump inhibitors with two antibiotics has been recommended as a gold standard therapy. However, a recent broad data review on the efficacy of the different regimens is missing. Therefore, the aim of this study was to systematically review the recent literature. Methods. We undertook a broad data review of the efficacy of nine different 7-day triple therapies consisting of a proton pump inhibitor (lansoprazole, pantoprazole, omeprazole) in its standard dosage and two antibiotics. Relevant original papers on H. pylori eradication in adults, published in English or German between 1995 and 2000, were identified from MEDLINE searches. Studies were reviewed and selected according to predefined criteria. Results. Our predefined criteria were fulfilled by 79 full paper articles including 112 study arms with 8383 patients on intention-to-treat, or 6787 patients on per-protocol basis, respectively. The mean eradication rates unweighted or weighted by the number of patients in the study arm vary from 71.9% to 83.8% for intention-to-treat analysis and from 78.5% to 91.2% for per-protocol analysis. Conclusions. All nine PPI based triple therapy regimens are very effective in H. pylori eradication. The current literature review underlines that the use of either lansoprazole, omeprazole, or pantoprazole combined with two antibiotics yield similar high eradication rates. [source]


Resistance and Agility Training Reduce Fall Risk in Women Aged 75 to 85 with Low Bone Mass: A 6-Month Randomized, Controlled Trial,

JOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 5 2004
Teresa Liu-Ambrose PhD
Objectives: To compare the effectiveness of group resistance and agility-training programs in reducing fall risk in community-dwelling older women with low bone mass. Design: A randomized, controlled, single-blind 25-week prospective study with assessments at baseline, midpoint, and trial completion. Setting: Community center. Participants: Community-dwelling women aged 75 to 85 with low bone mass. Intervention: Participants were randomly assigned to one of three groups: resistance training (n=32), agility training (n=34), and stretching (sham) exercises (n=32). The exercise classes for each study arm were held twice weekly. Measurements: The primary outcome measure was fall risk (derived from weighted scores from tests of postural sway, reaction time, strength, proprioception, and vision), as measured using a Physiological Profile Assessment (PPA). Secondary outcome measures were ankle dorsiflexion strength, foot reaction time, and Community Balance and Mobility Scale score. Results: Attendance at the exercise sessions for all three groups was excellent: resistance training (85.4%), agility training (87.3%), and stretching program (78.8%). At the end of the trial, PPA fall-risk scores were reduced by 57.3% and 47.5% in the resistance and agility-training groups, respectively, but by only 20.2% in the stretching group. In the resistance and agility groups, the reduction in fall risk was mediated primarily by improved postural stability, where sway was reduced by 30.6% and 29.2%, respectively. There were no significant differences between the groups for the secondary outcomes measures. Within the resistance-training group, reductions in sway were significantly associated with improved strength, as assessed using increased squat load used in the exercise sessions. Conclusion: These findings support the implementation of community-based resistance and agility-training programs to reduce fall risk in older women with low bone mass. Such programs may have particular public health benefits because it has been shown that this group is at increased risk of falling and sustaining fall-related fractures. [source]


Dasatinib 100 mg once daily minimizes the occurrence of pleural effusion in patients with chronic myeloid leukemia in chronic phase and efficacy is unaffected in patients who develop pleural effusion,

CANCER, Issue 2 2010
Kimmo Porkka MD
Abstract BACKGROUND: Dasatinib, a highly potent BCR-ABL inhibitor, is an effective treatment for patients with chronic myeloid leukemia in chronic phase (CML CP) after resistance, suboptimal response, or intolerance to prior imatinib. In a phase 3 dose optimization trial in patients with CML CP (CA180-034), the occurrence of pleural effusion was significantly minimized with dasatinib 100 mg once daily (QD) compared with other treatment arms (70 mg twice daily [twice daily], 140 mg QD, or 50 mg twice daily). METHODS: To investigate the occurrence and management of pleural effusion during dasatinib treatment, and efficacy in patients with or without pleural effusion, data from CA180-034 were analyzed. RESULTS: With 24-month minimum follow-up, 14% of patients treated with dasatinib 100 mg QD incurred pleural effusion (grade 3: 2%; grade 4: 0%) compared with 23% to 26% in other study arms. The pleural effusion rate showed only a minimal increment from 12 to 24 months. In the 100 mg QD study arm, median time to pleural effusion (any grade) was 315 days, and after pleural effusion, 52% of patients had a transient dose interruption, 35% had a dose reduction, 57% received a diuretic, and 26% received a corticosteroid. Three patients in the 100 mg QD study arm discontinued treatment after pleural effusion. Across all study arms, patients with or without pleural effusion demonstrated similar progression-free and overall survival, and cytogenetic response rates were higher in patients with a pleural effusion. CONCLUSIONS: Pleural effusion is minimized with dasatinib 100 mg QD dosing and its occurrence does not affect short- or long-term efficacy. Cancer 2010. © 2010 American Cancer Society. [source]


Non-invasive bioengineering methods in an intervention study in 1020 male metal workers: results and implications for occupational dermatology

CONTACT DERMATITIS, Issue 5 2010
Birgitta Kütting
Background: Measurements of transepidermal water loss (TEWL) as an indicator of skin barrier function and colorimetry for quantifying erythema have been recommended for monitoring persons at risk of occupational hand dermatitis. Objective: This study examines the practicability and usefulness of biophysical measurements at the workplace. Patients/Material/Methods: A sample of 1020 male metal workers was enrolled; 800 participants were followed up for 1 year. TEWL results and colorimetry (a* value), respectively, were used as effectiveness outcomes, comparing the findings in the four study arms (skin care, skin protection, both combined, and control group). Results: At 1 year follow-up, the TEWL was slightly but significantly lower in the group of participants randomized for application of barrier cream alone, indicating a protective effect. However, addressing both the individual absolute change of a* value and the differences of TEWL (delta-TEWL) of the dominant hand over the study period, no significant difference was found between the four groups. Conclusions: Dermatological examinations at the workplace cannot be replaced by bioengineering techniques. The supplementary benefit is apparently low, possibly because of difficulties in achieving standardized measurement conditions and other technical reasons. [source]


Eradication of Helicobacter pylori Does Not Reduce the Incidence of Gastroduodenal Ulcers in Patients on Long-term NSAID Treatment: Double-Blind, Randomized, Placebo-Controlled Trial

HELICOBACTER, Issue 5 2007
Helena T.J.I. De Leest
Abstract Background:,,Helicobacter pylori and nonsteroidal antiinflammatory drugs (NSAIDs) are the major causes of gastroduodenal ulcers. Studies on the benefit of eradication of H. pylori in NSAID users yielded conflicting results. Objective:, To investigate whether H. pylori eradication in patients on long-term NSAIDs reduces the incidence of gastroduodenal ulcers. Methods:, Patients on long-term NSAID treatment and who are H. pylori positive on serologic testing, were randomly assigned to either H. pylori eradication (omeprazole, amoxicillin, and clarithromycin) or placebo. Primary endpoint was the presence of endoscopic gastric or duodenal ulcers 3 months after randomization. Results:, One hundred sixty-five (48%) of a total of 347 patients were on gastroprotective medication. At endoscopy, gastroduodenal ulcers were diagnosed in 6 (4%) and 8 (5%) patients in the eradication and placebo group, respectively (p = .65). During follow-up of 12 months, no symptomatic ulcers or ulcer complications developed. No significant differences were found in the development of gastroduodenal erosions, dyspepsia, or in quality of life. Conclusion:,H. pylori eradication therapy in patients on long-term NSAID treatment had no beneficial effect on the occurrence of ulcers, erosions, or dyspepsia. Ulcer rates in both study arms are remarkably low, in both patients with and without gastroprotective therapy. [source]


Recent Use of Proton Pump Inhibitor-Based Triple Therapies for the Eradication of H. pylori: A Broad Data Review

HELICOBACTER, Issue 2 2003
Hans-Joachim Ulmer
abstract Introduction. For the eradication of Helicobacter pylori a 1-week triple therapy combining proton pump inhibitors with two antibiotics has been recommended as a gold standard therapy. However, a recent broad data review on the efficacy of the different regimens is missing. Therefore, the aim of this study was to systematically review the recent literature. Methods. We undertook a broad data review of the efficacy of nine different 7-day triple therapies consisting of a proton pump inhibitor (lansoprazole, pantoprazole, omeprazole) in its standard dosage and two antibiotics. Relevant original papers on H. pylori eradication in adults, published in English or German between 1995 and 2000, were identified from MEDLINE searches. Studies were reviewed and selected according to predefined criteria. Results. Our predefined criteria were fulfilled by 79 full paper articles including 112 study arms with 8383 patients on intention-to-treat, or 6787 patients on per-protocol basis, respectively. The mean eradication rates unweighted or weighted by the number of patients in the study arm vary from 71.9% to 83.8% for intention-to-treat analysis and from 78.5% to 91.2% for per-protocol analysis. Conclusions. All nine PPI based triple therapy regimens are very effective in H. pylori eradication. The current literature review underlines that the use of either lansoprazole, omeprazole, or pantoprazole combined with two antibiotics yield similar high eradication rates. [source]


Prevention of hepatocellular carcinoma recurrence with alpha-interferon after liver resection in HCV cirrhosis,,§

HEPATOLOGY, Issue 6 2006
Vincenzo Mazzaferro
Tumor recurrence after resection of hepatocellular carcinoma (HCC) can occur early (<2 years) or late (>2 years) as metastases or de novo tumors. Interferon (IFN) has the potential for chemoprevention against hepatitis C virus (HCV)-related cirrhosis. A predetermined group of 150 HCV RNA,positive patients undergoing resection of early- to intermediate-stage HCC was stratified into 80 HCV-pure (hepatitis B anticore antibody [anti-HBc],negative) and 70 mixed HCV+hepatitis B virus (HBV) (anti-HBc,positive) groups, then randomized to IFN-, (3 million units 3 times every week for 48 weeks [n = 76]) versus control (n = 74). The primary end point was recurrence-free survival (RFS); secondary end points were disease-specific and overall survival. Intention-to-treat and subgroup analysis on adherent patients were conducted. Treatment effects on early/late recurrences were assessed using multiple Cox regression analysis. No patient experienced life-threatening adverse events. There were 28 adherent patients (37%). After 45 months of median follow-up, overall survival was 58.5%, and no significant difference in RFS was detectable between the two study arms (24.3% vs. 5.8%; P = .49). HCC recurred in 100 patients (48 IFN-treated, 52 controls), with a 50% reduction in late recurrence rate in the treatment arm. HCC multiplicity and vascular invasion were significantly related to recurrence (P = .01 and .0003). After viral status stratification, while no treatment effect was apparent in the mixed HCV+HBV population and on early recurrences (72 events), there was a significant benefit on late recurrences (28 events) in HCV-pure patients adherent to treatment (HR: 0.3; 95% CI: 0.09,0.9; P = .04). In conclusion, IFN does not affect overall prevention of HCC recurrence after resection, but it may reduce late recurrence in HCV-pure patients receiving effective treatment. (HEPATOLOGY 2006;44:1543,1554.) [source]


An in-home geriatric programme for vulnerable community-dwelling older people improves the detection of dementia in primary care

INTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, Issue 12 2008
M. Perry
Abstract Background/objective Dementia is under-diagnosed in primary care. This study investigated whether an in-home geriatric assessment and management programme could improve the identification of patients with dementia in primary care. Methods A secondary analysis was performed, using data of a randomised controlled trial that studied the effects of an in-home geriatric evaluation and management programme compared with usual care. In this trial, 151 vulnerable community-dwelling patients, aged 70 years and older, participated: 86 in the intervention group and 66 in de control group. The effect of the programme on the dementia detection rate was determined by comparing the number of new dementia diagnoses in both study arms at 6 months follow-up. Results Of all 151 participants, 38 (25%) had a registered dementia diagnosis at baseline. During follow-up, 23 of 113 patients without a registered dementia diagnosis at baseline were identified as suffering from dementia. The difference between the numbers of new dementia diagnoses in the intervention group (19 of 66 patients) and the control group (4 of 47 patients) was significant. (p,=,0.02) Conclusion An in-home geriatric assessment and management programme for vulnerable older patients improves the detection of dementia and can therefore contribute to overcoming of under-diagnosis of dementia. Copyright © 2008 John Wiley & Sons, Ltd. [source]


Integrated Management of Physician-delivered Alcohol Care for Tuberculosis Patients: Design and Implementation

ALCOHOLISM, Issue 2 2010
Shelly F. Greenfield
Background:, While the integration of alcohol screening, treatment, and referral in primary care and other medical settings in the U.S. and worldwide has been recognized as a key health care priority, it is not routinely done. In spite of the high co-occurrence and excess mortality associated with alcohol use disorders (AUDs) among individuals with tuberculosis (TB), there are no studies evaluating effectiveness of integrating alcohol care into routine treatment for this disorder. Methods:, We designed and implemented a randomized controlled trial (RCT) to determine the effectiveness of integrating pharmacotherapy and behavioral treatments for AUDs into routine medical care for TB in the Tomsk Oblast Tuberculosis Service (TOTBS) in Tomsk, Russia. Eligible patients are diagnosed with alcohol abuse or dependence, are newly diagnosed with TB, and initiating treatment in the TOTBS with Directly Observed Therapy-Short Course (DOTS) for TB. Utilizing a factorial design, the Integrated Management of Physician-delivered Alcohol Care for Tuberculosis Patients (IMPACT) study randomizes eligible patients who sign informed consent into 1 of 4 study arms: (1) Oral Naltrexone + Brief Behavioral Compliance Enhancement Therapy (BBCET) + treatment as usual (TAU), (2) Brief Counseling Intervention (BCI) + TAU, (3) Naltrexone + BBCET + BCI + TAU, or (4) TAU alone. Results:, Utilizing an iterative, collaborative approach, a multi-disciplinary U.S. and Russian team has implemented a model of alcohol management that is culturally appropriate to the patient and TB physician community in Russia. Implementation to date has achieved the integration of routine alcohol screening into TB care in Tomsk; an ethnographic assessment of knowledge, attitudes, and practices of AUD management among TB physicians in Tomsk; translation and cultural adaptation of the BCI to Russia and the TB setting; and training and certification of TB physicians to deliver oral naltrexone and brief counseling interventions for alcohol abuse and dependence as part of routine TB care. The study is successfully enrolling eligible subjects in the RCT to evaluate the relationship of integrating effective pharmacotherapy and brief behavioral intervention on TB and alcohol outcomes, as well as reduction in HIV risk behaviors. Conclusions:, The IMPACT study utilizes an innovative approach to adapt 2 effective therapies for treatment of alcohol use disorders to the TB clinical services setting in the Tomsk Oblast, Siberia, Russia, and to train TB physicians to deliver state of the art alcohol pharmacotherapy and behavioral treatments as an integrated part of routine TB care. The proposed treatment strategy could be applied elsewhere in Russia and in other settings where TB control is jeopardized by AUDs. If demonstrated to be effective, this model of integrating alcohol interventions into routine TB care has the potential for expanded applicability to other chronic co-occurring infectious and other medical conditions seen in medical care settings. [source]


Evaluation of renal function in liver transplant recipients receiving daclizumab (Zenapax), mycophenolate mofetil, and a delayed, low-dose tacrolimus regimen vs. a standard-dose tacrolimus and mycophenolate mofetil regimen: A multicenter randomized clinical trial

LIVER TRANSPLANTATION, Issue 9 2005
Eric M. Yoshida
Posttransplant chronic renal failure, secondary to calcineurin inhibitor agents, is emerging as a major problem in liver transplantation. We report a randomized clinical trial comparing daclizumab, delayed low-dose tacrolimus (target trough level 4-8 ng/mL, starting day 4-6), Investigational Arm (n = 72), to standard tacrolimus induction/maintenance dosing, Standard Arm (n = 76), with mycophenolate mofetil and tapering corticosteroids in both study arms. The end-points were renal function indicated by the Modification of Diet in Renal Disease (MDRD). There was no significant difference in patient survival (86.6% Investigational Arm vs. 92.9% Standard Arm; P = 0.21) or acute rejection (23.2% vs. 27.7%, respectively; P = 0.68). Statistically significant differences in median glomerular filtration rate (GFR) were found in favor of the Investigational Arm. With the CG equation, the GFR at the end of the first week was 110.7 vs. 89.6 mL/min (P = 0.019) without significant differences thereafter. With the MDRD, statistically significant differences extended to the first posttransplant month (86.8 vs. 70.1 mL/min/1.73 m2; P < 0.001) with and was seen at month 6 (75.4 vs. 69.5 mL/min/1.73 m2; P = 0.038). In conclusion, delayed low-dose tacrolimus, in combination with daclizumab and mycophenolate mofetil, preserves early renal function post,liver transplantation without the cost of increased acute rejection. (Liver Transpl 2005;11:1064,1072.) [source]


Review of comparative studies between conventional and liposomal amphotericin B (Ambisome®) in neutropenic patients with fever of unknown origin and patients with systemic mycosis

MYCOSES, Issue 9-10 2000
I. W. Blau
Summary Fungal infections are an important cause of morbidity and mortality in immunocompromised patients. Treatment with amphotericin B is the main therapeutic approach. However, this treatment is limited by the substantial toxicity. We present the data of the first randomized prospective comparative trial in adults (134 patients with fever of unknown origin) with conventional amphotericin B and a liposomal formulation of amphotericin B (AmBisome®, published in 1997 by Prentice et al. (Br. J. Haematol. 98, 711,718) and the data of adults with documented fungal infections (59 patients), treated in this trial. Patients received either conventional amphotericin B 1 mg kg,1 per day, liposomal amphotericin B 1 mg kg,1 per day or liposomal amphotericin B 3 mg kg,1 per day. Patients were entered if they had fever of unknown origin (FUO), defined as temperature of 38 °C or more, not responding to 96 h of systemic broad-spectrum antibiotic treatment, and neutropenia (<0.5×109 l,1). Efficacy of treatment was assessed, with success defined as resolution of fever for three consecutive days (<38 °C) in the group of patients with FUO and the freedom of clinical signs and/or the elimination of fungus in the group of patients with documented fungal infections. The safety of treatment and renal and hepatic toxicity of liposomal and conventional amphotericin B were compared. No statistically significant difference was found in the treatment efficacy in the three study arms. However, there is a tendency of better treatment results in the two groups of patients, who received liposomal amphotericin B. Thirty-five per cent of patients with documented fungal infections and 46% of patients with FUO responded to amphotericin B. In the patients group, that received 1 mg kg,1 liposomal amphotericin B it was 63 and 49%, in the group of patients that received 3 mg kg,1 liposomal amphotericin B it was 47 and 64%. Evidence of toxicity due to amphotericin B was seen in 50 patients (83%), toxicity due to liposomal amphotericin B, 1 mg kg,1, was seen in 35 patients (50%), and due to liposomal amphotericin B 3 mg kg,1 in 34 patients (54%). This was a statistically significant difference (P=0.001). It was concluded that liposomal amphotericin B was safer than conventional amphotericin B, but both formulations are equivalent in treatment efficacy. The prophylactic use of amphotericin B in these immunocompromised patients is discussed. [source]


Catheter Ablation for Paroxysmal Atrial Fibrillation: A Randomized Comparison between Multielectrode Catheter and Point-by-Point Ablation

PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 9 2010
ALAN BULAVA M.D., Ph.D.
Introduction:,Catheter ablation for paroxysmal atrial fibrillation is widely used for patients with drug-refractory paroxysms of arrhythmia. Recently, novel technologies have been introduced to the market that aim to simplify and shorten the procedure. Aim:,To compare the clinical outcome of pulmonary vein (PV) isolation using a multipolar circular ablation catheter (PVAC group), with point-by-point PV isolation using an irrigated-tip ablation catheter and the CARTO mapping system (CARTO group; CARTO, Biosense Webster, Diamond Bar, CA, USA). Methods:,Patients with documented PAF were randomized to undergo PV isolation using PVAC or CARTO. Atrial fibrillation (AF) recurrences were documented by serial 7-day Holter monitoring. Results:,One hundred and two patients (mean age 58 ± 11 years, 68 men) were included in the study. The patients had comparable baseline clinical characteristics, including left atrial dimensions and left ventricular ejection fraction, in both study arms (PVAC: n = 51 and CARTO: n = 51). Total procedural and fluoroscopic times were significantly shorter in the PVAC group (107 ± 31 minutes vs 208 ± 46 minutes, P < 0.0001 and 16 ± 5 minutes vs 28 ± 8 minutes, P < 0.0001, respectively). The AF recurrence was documented in 23% and 29% of patients in the PVAC and CARTO groups, respectively (P = 0.8), during the mean follow-up of 200 ± 13 days. No serious complications were noted in both study groups. Conclusions:,Clinical success rates of PV isolation are similar when using multipolar circular PV ablation catheter and point-by-point ablation with a three-dimensional (3D) navigation system in patients with PAF, and results in shorter procedural and fluoroscopic times with a comparable safety profile. (PACE 2010; 33:1039,1046) [source]


Effects of nicotine on cytochrome P450 2A6 and 2E1 activities

BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue 2 2010
Janne Hukkanen
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT , Smoking slows the metabolism of nicotine and accelerates the metabolism of chlorzoxazone. , Nicotine is a useful probe for phenotyping cytochrome P450 2A6 activity and chlorzoxazone is a frequently used probe for CYP2E1 activity. , The tobacco smoke constituents responsible for the reduced CYP2A6 and increased CYP2E1 activities are unknown. WHAT THIS PAPER ADDS , This study demonstrates that CYP2A6 and CYP2E1 activities are not affected by nicotine dosing. , High-dose nicotine treatment has a low potential of interaction with CYP2A6 and CYP2E1 substrates. , The mechanisms of tobacco smoke-elicited changes in CYP2A6 and CYP2E1 activities are yet to be determined. AIMS Smoking slows the metabolism of nicotine and accelerates the metabolism of chlorzoxazone, which are probe reactions for cytochrome P450 2A6 (CYP2A6) and CYP2E1 activities, respectively. We aimed to determine the role of nicotine in these metabolic effects of cigarette smoking. METHODS The study had a single-blind, randomized, crossover two-arm design. Twelve healthy smokers were given two transdermal patches with 42-mg nicotine a day or placebo patches, each for 10 days. The subjects abstained from smoking during the study arms. Oral chlorzoxazone was given on day 7 and deuterium-labelled nicotine-d2 and cotinine-d4 infusion on day 8. RESULTS There was no significant influence of transdermal nicotine administration on pharmacokinetic parameters of nicotine-d2 or on the formation of cotinine-d2. Nicotine decreased the volume of distribution (62.6 vs. 67.7 l, 95% confidence interval of the difference ,9.7, ,0.6, P= 0.047) of infused cotinine-d4. There were no significant differences in disposition kinetics of chlorzoxazone between the treatments. CONCLUSIONS CYP2A6 and CYP2E1 activities are not affected by nicotine. The tobacco smoke constituents responsible for the reduced CYP2A6 and increased CYP2E1 activities remain unknown. [source]


Dasatinib 100 mg once daily minimizes the occurrence of pleural effusion in patients with chronic myeloid leukemia in chronic phase and efficacy is unaffected in patients who develop pleural effusion,

CANCER, Issue 2 2010
Kimmo Porkka MD
Abstract BACKGROUND: Dasatinib, a highly potent BCR-ABL inhibitor, is an effective treatment for patients with chronic myeloid leukemia in chronic phase (CML CP) after resistance, suboptimal response, or intolerance to prior imatinib. In a phase 3 dose optimization trial in patients with CML CP (CA180-034), the occurrence of pleural effusion was significantly minimized with dasatinib 100 mg once daily (QD) compared with other treatment arms (70 mg twice daily [twice daily], 140 mg QD, or 50 mg twice daily). METHODS: To investigate the occurrence and management of pleural effusion during dasatinib treatment, and efficacy in patients with or without pleural effusion, data from CA180-034 were analyzed. RESULTS: With 24-month minimum follow-up, 14% of patients treated with dasatinib 100 mg QD incurred pleural effusion (grade 3: 2%; grade 4: 0%) compared with 23% to 26% in other study arms. The pleural effusion rate showed only a minimal increment from 12 to 24 months. In the 100 mg QD study arm, median time to pleural effusion (any grade) was 315 days, and after pleural effusion, 52% of patients had a transient dose interruption, 35% had a dose reduction, 57% received a diuretic, and 26% received a corticosteroid. Three patients in the 100 mg QD study arm discontinued treatment after pleural effusion. Across all study arms, patients with or without pleural effusion demonstrated similar progression-free and overall survival, and cytogenetic response rates were higher in patients with a pleural effusion. CONCLUSIONS: Pleural effusion is minimized with dasatinib 100 mg QD dosing and its occurrence does not affect short- or long-term efficacy. Cancer 2010. © 2010 American Cancer Society. [source]


Tetracycline to prevent epidermal growth factor receptor inhibitor-induced skin rashes,

CANCER, Issue 4 2008
Results of a placebo-controlled trial from the North Central Cancer Treatment Group (N03CB)
Abstract BACKGROUND. Epidermal growth factor receptor (EGFR) inhibitors are effective cancer therapies, but they are reported to cause a rash in >50% of patients. In the current study, the authors examined the use of tetracycline for rash prevention. METHODS. This placebo-controlled, double-blinded trial enrolled patients who were starting cancer treatment with an EGFR inhibitor. Patients could not have had a rash at the time of enrollment. All patients were randomly assigned to receive either tetracycline at a dose of 500 mg orally twice a day for 28 days versus a placebo. Patients were monitored for rash (through monthly physician assessment and weekly patient-reported questionnaires), quality of life (using the SKINDEX-16, a skin-specific quality of life index), and adverse events. Monitoring occurred during the 4-week intervention and then for an additional 4 weeks. The primary objective of the current study was to compare the incidence of rash between the study arms, and the enrollment of 30 patients per arm provided a 90% probability of detecting a 40% difference in incidence with a P value of .05 (2-sided). RESULTS. A total of 61 evaluable patients were enrolled. The 2 treatment arms were well balanced with regard to baseline characteristics, dropout rates, and rates of discontinuation of the EGFR inhibitor. The incidence of rash was found to be comparable across treatment arms. Physicians reported that 16 patients treated with tetracycline (70%) and 22 patients treated with placebo (76%) developed a rash (P = .61). Tetracycline appears to have lessened the rash severity, although the high dropout rates invite caution when interpreting these findings. By Week 4, physician-reported grade 2 rash (using the National Cancer Institute's Common Terminology Criteria for Adverse Events [version 3.0]) occurred in 17% of tetracycline-treated patients (n = 4 patients) and in 55% of placebo-exposed patients (n = 16 patients) (P = .04). Patients treated with tetracycline reported better scores, as per the SKINDEX-16, on certain quality-of-life parameters such as skin burning or stinging, skin irritation, and being bothered by the persistence/recurrence of a skin condition. Adverse events were found to be comparable across treatment arms. CONCLUSIONS. In the current study, tetracycline was not found to prevent EGFR inhibitor-induced rashes and therefore cannot be clinically recommended for this purpose. However, preliminary observations of diminished rash severity and improved quality of life suggest this antibiotic merits further study. Cancer 2008. © 2008 American Cancer Society. [source]


A comparison of the effects of dorzolamide/timolol fixed combination versus latanoprost on intraocular pressure and pulsatile ocular blood flow in primary open-angle glaucoma patients

ACTA OPHTHALMOLOGICA, Issue 6 2004
I. Janulevicienë
Abstract. Purpose:,To evaluate the effects of dorzolamide/timolol fixed combination (D/T) compared to latanoprost on intraocular pressure (IOP) and pulsatile ocular blood flow (POBF) in primary open-angle glaucoma (POAG) patients. Methods:,Thirty patients with POAG were randomized in an open-label, cross-over study. Intraocular pressure reduction was achieved by 4 weeks medical therapy with D/T twice daily or latanoprost 0.005% dosed once in the evening. During a 4-week run,in and a 4-week wash-out period between study arms, patients ceased use of all other glaucoma medications and used timolol maleate 0.5% twice daily. Primary efficacy variables were IOP and POBF. Results:,There was no difference in baseline IOP and POBF parameters between the two study arms. Both D/T and latanoprost statistically significantly reduced IOP by 4.6 mmHg (p < 0.0001) and 3.75 mmHg (p < 0.0001) and increased POBF by 2.048 µl/second (p = 0.0030) and 2.147 µl/second (p = 0.0009), respectively. Repeated measures anova detected significant changes in POBF with treatment (p = 0.0361). Dorzolamide/timolol fixed combination statistically significantly increased pulse volume by 0.767 µl (p = 0.0087), while latanoprost therapy had no significant effect (p = 0.2407). Conclusions:,Both drugs had similar effects in terms of IOP reduction. Dorzolamide/timolol significantly increased pulse volume while latanoprost had no effect. Further studies are necessary to establish whether the enhancement of choroidal blood flow can prevent glaucoma progression. [source]