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Secondary Endpoints (secondary + endpoint)
Selected AbstractsPlasma urocortin in acute myocardial infarction patientsEUROPEAN JOURNAL OF CLINICAL INVESTIGATION, Issue 10 2010Arintaya Phrommintikul Eur J Clin Invest 2010; 40 (10): 874,882 Abstract Background, Despite its proposed cardioprotective effect, the role of plasma urocortin in acute myocardial infarction (AMI) remains unknown. We investigated plasma profile of urocortin in AMI patients and evaluated its long-term prognostic performance. Material and methods, Sixty-six AMI patients and 21 healthy subjects were included in this study. Blood samples for urocortin were collected on days 0 (onset), 1, 3 and 5 and at 3 and 6 months. Primary endpoint was mortality within 1 year of follow-up. Secondary endpoint was combined death and nonfatal adverse cardiac events (i.e. myocardial reinfarction, urgent revascularization or hospitalization due to heart failure) within 1 year. Results, During follow-up at 1 year, 38 (57·6%) patients were alive without cardiac events, nine (13·6%) had nonfatal cardiac events and 17 (25·8%) died. Plasma urocortin in AMI patients were increased on days 0, 1, 3 and 5 (P < 0·05 vs. control). The receiver-operating characteristic curve showed an area under curve (AUC) of day 0 urocortin to be 0·750 with 95% confidence interval (CI) of 0·619,0·881 (P = 0·004), whereas AUC of NT-proBNP was 0·857 (95% CI, 0·722,0·992; P = 0·003). Sensitivity values for predicting the mortality of urocortin NT-proBNP and a combined urocortin and NT-proBNP were 0·81 (95% CI, 0·54,0·95), 0·86 (95% CI, 0·42,0·99) and 1·0 (95% CI, 0·56,1·0), respectively. Conclusions, Plasma urocortin level is elevated in AMI patients for 5 days from onset. High plasma urocortin within 24 h after the onset is associated with increased mortality. Combined urocortin and NT-proBNP enhance prognostic performance in AMI patients. [source] Influence of needle size on metabolic control and patient acceptanceEUROPEAN DIABETES NURSING, Issue 2 2007G Kreugel RN, MSc Clinical Nurse Specialist in Diabetes Abstract Aim: To investigate whether the length of the needle used for intermittent subcutaneous insulin administration affects metabolic control, injection-related side effects and patient preference. Method: In a crossover study, 68 patients with type 1 and type 2 diabetes, body mass index , 18 kg/m2, were randomised into two groups; 52 patients completed the trial. Patients in group A used a 5 mm needle for their insulin injections over a period of 13 weeks, then switched to a longer needle (8 or 12 mm). Patients in group B used the needles in reverse order. Patients were re-assessed at 26 weeks. Primary endpoints were insulin doses, and frequency and severity of hypoglycaemic events. Secondary endpoints were patient preference and frequency of injection-related bruising, bleeding, insulin leakage and pain. Results: A total of 52 patients completed the study. No change in the mean glycosylated haemoglobin (HbA1c) level was found in group B (baseline, 7.41%; 13 weeks, 7.38%; 26 weeks, 7.34%), whereas a small but significant rise in mean HbA1c level was observed in group A after returning to the longer needle (baseline, 7.67%; 13 weeks, 7.65%; 26 weeks, 7.87%: p<0.05). There were no significant changes in the amount of insulin injected, frequency or severity of hypoglycaemic events or insulin leakage in either group. The 5 mm needle was associated with a significant decrease in bleeding, bruising and pain (p<0.05). Most patients (86%) showed a preference for the 5 mm needle (p<0.05).Conclusion: For insulin injection, a 5 mm needle length is associated with unchanged HbA1c levels, unchanged frequency or severity of hypoglycaemic events and less discomfort for patients compared with 8 or 12 mm needles. The use of 5 mm needles is as safe as 8 or 12 mm needles. Further research is advisable involving thin and obese patients using 5 mm needles, in order for shorter needles to be recommended as standard practice. Copyright © 2007 FEND [source] Effects of peer-assisted training during the neurology clerkship: a randomized controlled studyEUROPEAN JOURNAL OF NEUROLOGY, Issue 12 2008J. G. Heckmann Objective:, To determine the efficacy of peer-assisted clinical skills training for students during their neurology clerkship. Methods:, Students (n = 122) were randomized to get clinical skills training from either student (peer) instructors (experimental group) or from experienced clinical staff (control group). The remaining schedule during the clerkship did not differ between both groups. Primary endpoint was students' practical skills and knowledge tested at the end of the course by a written test and objective structured clinical examination (OSCE). Secondary endpoints were evaluation of the practical training and self-estimated gain in theoretical and practical competence. Results:, In the written test, the peer-trained group (n = 66) scored 69.5 ± 10.2 (95% CI 67,72) points of 100 and the postgraduates-trained group (n = 56) 66.7 ± 11.4 (95% CI 63.6,69.8) (P = 0.15). In the OSCE the peer-trained group scored 93.7 ± 6.3 (95% CI 92.1 to 95.2) points of 100 and the postgraduates-trained group 92 ± 5.1 (95% CI 90.6 to 93.4) (P = 0.11). In the evaluation and self-assessment items, there was no significant difference between the two groups except for the postgraduates' higher competence (P = 0.004). Conclusion:, Peer-trained students pass written exam and OSCE as efficient as postgraduates-trained students. Self-assessed learning success is equally rated in both groups. [source] A Double-Blind Comparison of OnabotulinumtoxinA (BOTOX®) and Topiramate (TOPAMAX®) for the Prophylactic Treatment of Chronic Migraine: A Pilot StudyHEADACHE, Issue 10 2009Ninan T. Mathew MD Background., There is a need for effective prophylactic therapy for chronic migraine (CM) that has minimal side effects. Objective., To compare the efficacy and safety of onabotulinumtoxinA (BOTOX®, Allergan, Inc., Irvine, CA) and topiramate (TOPAMAX®, Ortho-McNeil, Titusville, NJ) prophylactic treatment in patients with CM. Methods., In this single-center, double-blind trial, patients with CM received either onabotulinumtoxinA, maximum 200 units (U) at baseline and month 3 (100 U fixed-site and 100 U follow-the-pain), plus an oral placebo, or topiramate, 4-week titration to 100 mg/day with option for additional 4-week titration to 200 mg/day, plus placebo saline injections. OnabotulinumtoxinA or placebo saline injection was administered at baseline and month 3 only, while topiramate oral treatment or oral placebo was continued through the end of the study. The primary endpoint was treatment responder rate assessed using Physician Global Assessment 9-point scale (+4 = clearance of signs and symptoms and ,4 = very marked worsening [about 100% worse]). Secondary endpoints included the change from baseline in the number of headache (HA)/migraine days per month (HA diary), and HA disability measured using Headache Impact Test (HIT-6), HA diary, Migraine Disability Assessment (MIDAS) questionnaire, and Migraine Impact Questionnaire (MIQ). The overall study duration was approximately 10.5 months, which included a 4-week screening period and a 2-week optional final safety visit. Follow-up visits for assessments occurred at months 1, 3, 6, and 9. Adverse events (AEs) were documented. Results., Of 60 patients randomized to treatment (mean age, 36.8 ± 10.3 years; 90% female), 36 completed the study at the end of the 9 months of active treatment (onabotulinumtoxinA, 19/30 [63.3%]; topiramate, 17/30 [56.7%]). In the topiramate group, 7/29 (24.1%) discontinued study because of treatment-related AEs vs 2/26 (7.7%) in the onabotulinumtoxinA group. Between 68% and 83% of patients for both onabotulinumtoxinA and topiramate groups reported at least a slight (25%) improvement in migraine; response to treatment was assessed using Physician Global Assessment at months 1, 3, 6, and 9. Most patients in both groups reported moderate to marked improvements at all time points. No significant between-group differences were observed, except for marked improvement at month 9 (onabotulinumtoxinA, 27.3% vs topiramate, 60.9%, P = .0234, chi-square). In both groups, HA/migraine days decreased and MIDAS and HIT-6 scores improved. Patient-reported quality of life measures assessed using MIQ after treatment with onabotulinumtoxinA paralleled those seen after treatment with topiramate in most respects. At month 9, 40.9% and 42.9% of patients in the onabotulinumtoxinA and topiramate groups, respectively, reported ,50% reduction in HA/migraine days. Forty-one treatment-related AEs were reported in 18 onabotulinumtoxinA-treated patients vs 87 in 25 topiramate-treated patients, and 2.7% of patients in the onabotulinumtoxinA group and 24.1% of patients in the topiramate group reported AEs that required permanent discontinuation of study treatment. Conclusions., OnabotulinumtoxinA and topiramate demonstrated similar efficacy in the prophylactic treatment of CM. Patients receiving onabotulinumtoxinA had fewer AEs and discontinuations. [source] A new oral delivery system for 5-ASA: Preliminary clinical findings for MMxINFLAMMATORY BOWEL DISEASES, Issue 5 2005Cosimo Prantera MD Abstract Background: Multi-matrix (MMx), a new delivery system for mesalazine, seems to release 5-aminosalicyclic acid (5-ASA) preferentially in the sigmoid colon. This study had 2 objectives: (1) to evaluate the therapeutic response to MMx in patients with active left-sided disease and (2) to gain additional insights as to how the therapy would compare with topical 5-ASA. Methods: Patients received either 1.2 g of 5-ASA MMx three times per day plus placebo enema or 4 g of 5-ASA enema plus placebo tablets for 8 weeks. The primary endpoint was clinical remission (clinical activity index ,4) at 8 weeks. Secondary endpoints were endoscopic and histologic remissions. Results: Seventy-nine patients were enrolled. Clinical remission rates at 4 and 8 weeks were 57.5% and 60.0% for patients treated with MMx and 68.4% and 50.0% for patients randomized to 5-ASA enemas, respectively (95% confidence interval for the difference at 8 weeks, ,12 to +32). Endoscopic remission was achieved by 45.0% of patients on 5-ASA MMx and by 36.8% of those on enema, whereas 15.0% and 8% of patients, respectively, showed histologic remission. Compliance was 97.0% for oral and 87.5% for topical therapy. In the enema group, compliance was 88.0% for the patients in remission and 65.5% for those with active disease. Conclusions: Preliminary studies suggest that similar rates for induction of remission can be expected from 5-ASA enemas and MMx for patients with left-sided ulcerative colitis. [source] The effect of desmopressin on blood loss in patients with rheumatoid arthritis undergoing hip arthroplastyACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 7 2010K. A. LEINO Background: Blood loss is an important issue for patients with rheumatoid arthritis undergoing hip surgery. We hypothesised that intraoperative desmopressin treatment would result in a reduction in blood loss in rheumatoid patients undergoing total hip arthroplasty. Methods: Seventy-five patients scheduled for elective total hip arthroplasty were randomised to three groups to receive 0.4 ,g/kg desmopressin (D 0.4), 0.2 ,g/kg desmopressin (D 0.2) or placebo intraoperatively in a double-blind fashion. Blood transfusions were based on calculated safe allowable blood loss and haemoglobin measurements (trigger 90 g/l, 5.59 mmol/l). The primary endpoint was the total blood loss measured till the end of the fourth post-operative day. Secondary endpoints included red cell transfusion requirements and haemoglobin. Results: Total blood loss during the study period was not significantly different between the groups (D 0.4 1829 ± 1068; D 0.2 2240 ± 843 and placebo 2254 ± 1040 ml; P= 0.50). The total amount of red cell transfusions was fewer in group D 0.4 (3.6 ± 1.6 U) when compared with D 0.2 (4.4 ± 1.7 U; P=0.009) and placebo (4.5 ± 2.0 U; P= 0.011) groups. Haemoglobin concentration was lower in the placebo group in the first (5.42 ± 1.16 vs. 5.98 ± 0.47 mmol/l; P=0.033) and the second (6.28 ± 0.66 vs. 6.69 ± 0.47 mmol/l; P=0.033) post-operative mornings compared with group D 0.4. Conclusion: Despite a lack of difference in the primary outcome, total blood loss, intraoperative administration of 0.4 ,g/kg desmopressin resulted in fewer total red cell transfusion requirements in rheumatoid patients undergoing total hip arthroplasty when compared with 0.2 ,g/kg treatment and placebo. [source] Dexamethasone decreases oxycodone consumption following osteotomy of the first metatarsal bone: a randomized controlled trial in day surgeryACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 3 2010K. MATTILA Background: Dexamethasone may improve multimodal pain management following painful orthopedic day surgery procedures, and decrease the need for post-operative opioids. We hypothesized that dexamethasone would reduce the need for oxycodone after surgical correction of hallux valgus. Methods: Sixty patients planned to undergo unilateral osteotomy of the first metatarsal as a day surgery procedure were randomized to receive pre-operatively and 24 h afterwards, orally either dexamethasone 9 mg or placebo. For pain medication, paracetamol and oxycodone capsules for rescue medication were given. The study ended on the evening of the third post-operative day (POD). The primary endpoint was the cumulative oxycodone consumption. Secondary endpoints were maximal pain scores before oxycodone intake and daily oxycodone doses. In addition, adverse effects were documented. Results: Twenty-five patients in both groups completed the study. The total median (range) oxycodone consumption during the study period was 45 (0,165) mg in the dexamethasone group and 78 (15,175) mg in the placebo group (P=0.049). The major differences in oxycodone consumption were seen on PODs 0,1. In the dexamethasone group, patients reported significantly lower pain scores on PODs 0,1, and significantly less nausea on POD 1. On PODs 2,3 no differences were seen. However, at 2 weeks post-operatively, patient satisfaction to drug therapy did not differ , in both groups 81% would have chosen the same medication again. Conclusion: Oral dexamethasone combined with paracetamol significantly reduced total oxycodone consumption following surgical correction of hallux valgus. [source] Persistent sensory dysfunction in pain-free herniotomyACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 3 2010E. K. AASVANG Background: Persistent post-herniotomy pain may be a neuropathic pain state based on the finding of a persistent sensory dysfunction. However, detailed information on the normal distribution of sensory function in pain-free post-herniotomy patients hinders identification of exact pathogenic mechanisms. Therefore, we aimed to establish normative data on sensory function in pain-free patients >1 year after a groin herniotomy. Methods: Sensory thresholds were assessed in 40 pain-free patients by a standardized quantitative sensory testing (QST). Secondary endpoints included comparison of sensory function between the operated and the naïve side, and correlation between sensory function modalities. Results: QST showed that on the operated side, thermal data were normally distributed, but mechanical pressure and pinch thresholds were normalized only after log-transformation, and cold pain and pressure tolerance could not be normalized. Comparison of QST results revealed significant (P<0.01) cutaneous hypoesthesia/hyperalgesia, but also significant pressure hyperalgesia (P<0.01) and decreased pressure tolerance (P=0.02) on the operated vs. the naïve side. Wind-up was seen in 6 (15%) but with a low pain intensity. Conclusion: Persistent sensory dysfunction is common in pain-free post-herniotomy patients. Future studies of sensory function in persistent post-herniotomy pain should compare the findings to the present data in order to characterize individual patients and potentially identify subgroups, which may aid in allocation of patients to pharmacological or surgical treatment. [source] Does a telephone follow-up intervention for patients discharged with acute myocardial infarction have long-term effects on health-related quality of life?JOURNAL OF CLINICAL NURSING, Issue 9 2009A randomised controlled trial Aims., An earlier combined proactive and reactive telephone follow-up intervention for acute myocardial infarction patients after discharge from hospital showed positive effects after six months. The aim of the present study was to assess whether the intervention has long-term effects up to 18 months after discharge. Design., A prospective randomised controlled trial with 18 months follow-up. Method., The trial was conducted with 288 patients allocated to a telephone follow-up intervention group (n = 156) or control group (n = 132). The primary endpoint was health-related quality of life using the SF-36. Secondary endpoints included smoking and exercise habits, return to work and rehospitalisation due to chest pain. Results., There were significant improvements over time on most dimensions of health-related quality of life in both the intervention and control group to US norm population levels on most SF-36 dimensions and summary scores. The intervention group showed no overall significant improvement beyond six months in the physical or mental summary scores, but there was a significant effect for those aged 70 or above. Although there was a promising effect for rehospitalisation due to chest pain, no significant differences were found between the groups on the secondary endpoints after six months. Conclusion., This study demonstrated that despite positive short-term effects at six months, the telephone follow-up intervention had no long-term effects on health-related quality of life or secondary endpoints. However, the potential for improvement beyond six months was less than anticipated reflecting a reduced morbidity among acute myocardial infarction patients. Relevance to clinical practice., Telephone follow-up after discharge from hospital is an easy implementable follow-up intervention enabling individualised provision of information and support in a time often experienced as stressful by patients. Our study indicates that six months is an adequate support period. Despite positive results six months after discharge no significant added long-term effects of telephone follow-up, compared to usual care were found in this study. [source] Improving clinical outcome in patients with intestinal failure using individualised nutritional adviceJOURNAL OF HUMAN NUTRITION & DIETETICS, Issue 4 2009A. Culkin Abstract Background: Patients with intestinal failure are required to adhere to a complex regimen. Written information may increase knowledge leading to improvements in clinical outcomes. The present study aimed to evaluate the effectiveness of nutrition advice incorporating the use of a booklet. Methods: Each patient completed a questionnaire evaluating their knowledge of the regime and quality of life and kept a diet and gastrointestinal output diary. The diary was assessed and they were given the booklet with a verbal explanation tailored to individual requirements. The booklet explained the causes of intestinal failure, diet and fluid recommendations in relation to intestinal anatomy, information on medications and long-term monitoring. Patients were reassessed at their next appointment using the same tools. The primary endpoint was an improvement in knowledge. Secondary endpoints were an improvement in oral nutritional intake, nutritional status, quality of life and the content of home parenteral nutrition. Results: Forty-eight patients completed the study. Knowledge improved significantly after dietetic intervention in association with the provision of the booklet (P < 0.001). Oral energy (P = 0.04) and fat (P = 0.003) intake increased with an improvement in body mass index (P = 0.02). Patients on home parenteral nutrition showed a reduction in parenteral energy (P = 0.02), nitrogen (P = 0.003), volume (P = 0.02) and frequency (P = 0.003). Conclusions: A booklet for patients with intestinal failure in conjunction with personalised dietary counselling improves knowledge and clinical outcomes. [source] Clinical trial: 2-L polyethylene glycol-based lavage solutions for colonoscopy preparation , a randomized, single-blind study of two formulationsALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 5 2010L. B. Cohen Aliment Pharmacol Ther 2010; 32: 637,644 Summary Background, The 2-L polyethylene glycol (PEG) lavage solutions provide efficacy similar to that of standard 4-L PEG formulations in spite of the reduced volume. The comparative efficacy and tolerability of two formulations of 2-L PEG solution remain unknown. Aims, To assess the efficacy, safety and tolerability of PEG + Bis compared with PEG + Asc, and to study the effect of bowel cleansing quality on adenoma detection rates. Methods, Patients were randomized to receive either 2-L PEG with ascorbic acid (PEG + Asc) or 2-L PEG plus bisacodyl 10 mg (PEG + Bis). The primary endpoint was overall colon cleansing score, assessed by blinded investigators using a validated four-point scale. Secondary endpoints included adenoma detection rate, patient tolerability and compliance and adverse events. Results, Fifty-two patients received PEG + Asc and 55 patients received PEG + Bis. Overall colon cleansing scores (±s.d.) were 1.40 ± 0.69 and 1.75 ± 0.70 (P < 0.003) in the PEG + Asc and PEG + Bis groups, respectively. Excellent and good ratings were recorded in 69% and 23% receiving PEG + Asc compared to 38% and 51% (P = 0.01) of patients receiving PEG + Bis. More adenomas were detected in colonoscopies performed with PEG + Asc (39%) than in those performed with PEG + Bis (20%) (P = 0.04). Patient tolerability and safety were similar with both preparations. Conclusion, The use of PEG + Asc resulted in better colon cleansing and higher adenoma detection rates compared with PEG + Bis. [source] Clinical trial: efficacy and safety of dexlansoprazole MR 60 and 90 mg in healed erosive oesophagitis , maintenance of healing and symptom reliefALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 9 2009C. W. HOWDEN Summary Background, Dexlansoprazole MR, a modified-release formulation of dexlansoprazole, an enantiomer of lansoprazole, effectively heals erosive oesophagitis. Aim, To assess dexlansoprazole MR in maintaining healed erosive oesophagitis. Methods, Patients (n = 451) with erosive oesophagitis healed in either of two dexlansoprazole MR healing trials randomly received dexlansoprazole MR 60 or 90 mg or placebo once daily in this double-blind trial. The percentage of patients who maintained healing at month 6 was analysed using life table and crude rate methods. Secondary endpoints were percentages of nights and of 24-h days without heartburn based on daily diaries. Results, Dexlansoprazole MR 60 and 90 mg were superior to placebo for maintaining healing (P < 0.0025). Maintenance rates were 87% and 82% for the 60 and 90 mg doses, respectively, vs. 26% for placebo (life table), and 66% and 65% vs. 14%, respectively (crude rate). Both doses were superior to placebo for the percentage of 24-h heartburn-free days (60 mg, 96%; 90 mg, 94%; placebo, 19%) and nights (98%, 97%, and 50%, respectively). Diarrhoea, flatulence, gastritis (symptoms) and abdominal pain occurred more frequently with dexlansoprazole MR than placebo, but were not dose-related. Conclusion, Dexlansoprazole MR effectively maintained healed erosive oesophagitis and symptom relief compared with placebo, and was well tolerated. [source] Effect of mesalazine on mucosal immune biomarkers in irritable bowel syndrome: a randomized controlled proof-of-concept studyALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 3 2009R. CORINALDESI Summary Background, Intestinal immune infiltration contributes to symptoms in patients with irritable bowel syndrome (IBS). Aim, To assesses the effect of mesalazine (mesalamine) on mucosal immune cells in patients with IBS, through a pilot study. Methods, A randomized, double-blind, placebo-controlled trial in 20 patients with IBS in tertiary care setting. Patients were randomized to receive placebo or 800 mg mesalazine three times daily for 8 weeks. The primary endpoint was a significant reduction in total colonic immune cells on biopsies obtained at the end of treatment compared to baseline. Secondary endpoints included effects on subsets of immune cells, inflammatory mediators and symptom severity. Intention-to-treat analysis was performed. Results, Mesalazine markedly reduced immune cells as compared with placebo (P = 0.0082); this effect was ascribed to a marked inhibition of mast cells (P = 0.0014). Mesalazine significantly increased general well-being (P = 0.038), but had no significant effects on abdominal pain (P = 0.084), bloating (P = 0.177) or bowel habits. No serious drug-related adverse events were reported during the study. Conclusions, Mesalazine is an effective and safe approach to reduce mast cell infiltration and may improve general well-being in patients with IBS. These results support the hypothesis that immune mechanisms represent potential therapeutic targets in IBS. [source] Clinical trials: healing of erosive oesophagitis with dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed-release formulation , results from two randomized controlled studiesALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 7 2009P. SHARMA Summary Background, Dexlansoprazole MR employs a dual delayed-release delivery system that extends drug exposure and prolongs pH control compared with lansoprazole. Aim, To assess the efficacy and safety of dexlansoprazole MR in healing erosive oesophagitis (EO). Methods, Patients in two identical double-blind, randomized controlled trials (n = 4092) received dexlansoprazole MR 60 or 90 mg or lansoprazole 30 mg once daily. Week 8 healing was assessed using a closed testing procedure , first for non-inferiority, then superiority, vs. lansoprazole. Secondary endpoints included week 4 healing and week 8 healing in patients with moderate-to-severe disease (Los Angeles Classification grades C and D). Life-table and crude rate analyses were performed. Symptoms and tolerability were assessed. Results, Dexlansoprazole MR achieved non-inferiority to lansoprazole, allowing testing for superiority. Using life-table analysis, dexlansoprazole MR healed 92,95% of patients in individual studies vs. 86,92% for lansoprazole; the differences were not statistically significant (P > 0.025). Using crude rate analysis, dexlansoprazole MR 90 mg was superior to lansoprazole in both studies and 60 mg was superior in one study. Week 4 healing was >64% with all treatments in both studies. In an integrated analysis of 8-week healing in patients with moderate-to-severe EO, dexlansoprazole MR 90 mg was superior to lansoprazole. All treatments effectively relieved symptoms and were well tolerated. Conclusion, Dexlansoprazole MR is highly effective in healing EO and offers benefits over lansoprazole, particularly in moderate-to-severe disease. [source] Clinical trial: the glucagon-like peptide-1 analogue ROSE-010 for management of acute pain in patients with irritable bowel syndrome: a randomized, placebo-controlled, double-blind studyALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 2 2009P. M. HELLSTRÖM Summary Background, There is currently no treatment available to manage acute pain attacks in IBS patients regardless of subtype. Aims, To evaluate efficacy and safety of the GLP-1 analogue ROSE-010 in patients with irritable bowel syndrome (IBS) through a randomized, double-blind, placebo-controlled study. Methods, Eligible patients (n = 166) meeting Rome II criteria were randomly assigned to receive single subcutaneous injections of ROSE-010 100 ,g, 300 ,g and placebo in a cross-over design. Safety was assessed from spontaneously reported adverse events and measurement of vital signs. Patient-rated pain relief and intensity were measured on a 100-mm visual analogue scale. The primary efficacy variable was proportion of patients with >50% maximum total pain relief response from 10 to 60 min after treatment. Secondary endpoints included the maximum summed pain intensity difference, time to meaningful pain relief and patient ratings of satisfaction with treatment. Results, Twice as many patients were responders in the primary efficacy endpoint after both ROSE-010 injections compared to placebo (24%P = 0.011, 23%P = 0.005, and 12% after 300 ,g, 100 ,g and placebo injections, respectively). Similar results were obtained for the proportion of patients with total pain intensity response. Times to meaningful and total pain relief were shorter for both doses of ROSE-010 compared with placebo. Compared with placebo, more patients (P < 0.05) were satisfied with ROSE-010 and considered ROSE-010 better than previous IBS medications used. Conclusion, ROSE-010 was well tolerated and provided fast and effective relief of acute pain attacks on demand in IBS patients. [source] Non-invasive assessment of liver fibrosis progression in hepatitis C patients retreated for 96 weeks with antiviral therapy: a randomized studyLIVER INTERNATIONAL, Issue 7 2010Jean-Pierre Zarski Abstract Background: The efficacy of a maintenance therapy in non-responder patients with chronic hepatitis C has been essentially evaluated by histological semiquantitative scores. Aim: The aim was to evaluate the efficiency of 2 years of treatment with peginterferon ,-2a vs ,-tocopherol in these patients by histology, morphometry and blood markers of fibrosis. Method: Hundred and five HCV patients with a Metavir fibrosis score,2 were randomized to receive peginterferon ,-2a 180 ,g/week (PEG) (n=55) or ,-tocopherol (TOCO) 1000 mg/day (n=50) for 96 weeks. The primary endpoint was improvement or stabilization of the Metavir fibrosis score by biopsy performed at week 96. Secondary endpoints included a quantitative assessment of fibrosis by morphometry and changes in blood markers of fibrosis. Results: There was no difference at baseline between PEG and TOCO according to the metavir (83.3 vs 86.8%, P=0.751) stage. The median fibrosis rate, measured with morphometry was 2.72 and 2.86% at day 0, and 3.66 and 2.82% at week 96, in the PEG and TOCO groups (P=0.90) respectively. However, the percentage of patients with metavir activity grade improvement was significantly higher in the PEG group vs the TOCO group (52.8 vs 23.7%, P=0.016). Non-invasive markers analysis did not show any significant change in both groups. Conclusion: Long-term therapy with peginterferon ,-2a did not reduce liver fibrosis degree assessed by morphometry and blood tests as compared with ,-tocopherol. Blood tests could be useful to assess liver fibrosis changes in clinical trials. [source] Efficacy of desloratadine in intermittent allergic rhinitis: a GA2LEN studyALLERGY, Issue 10 2009J. Bousquet Background:, The Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines proposed a classification for allergic rhinitis based on the duration of symptoms (intermittent, persistent) rather than on the time of allergen exposure (seasonal, perennial). There is no placebo-controlled, randomized clinical trial on intermittent allergic rhinitis (IAR) to date. Desloratadine (DL) is recommended for the first-line treatment of seasonal and perennial allergic rhinitis. Objectives:, To assess the efficacy and safety of DL in subjects with IAR based on the ARIA classification. Methods:, Patients over 12 years of age with IAR were assessed over 15 days of treatment with DL 5 mg once daily (n = 276) or placebo (n = 271). The primary endpoint was the AM/PM reflective total 5 symptom score (T5SS). Secondary endpoints included AM/PM instantaneous T5SS and individual symptoms, therapeutic response, symptom severity by visual analogue scale, and quality-of-life. Results:, The mean reduction of AM/PM reflective T5SS was significantly greater with DL than with placebo over 15 days (,3.01 vs,2.13, P < 0.001) and on each individual day (P < 0.05). Mean AM instantaneous T5SS was reduced significantly with DL compared to placebo as early as day 2 (,1.84 vs,0.89; P < 0.001). The therapeutic response and improvement in quality-of-life were significantly greater with DL than with placebo (P < 0.001 for each). The frequency of treatment-related adverse events was low and similar between DL (7.2%) and placebo (7.0%). Conclusions:, This is the first large trial to show that treatment can be effective in IAR. Desloratadine was effective and safe. [source] Modafinil treatment of fatigue in patients with ALS: A placebo-controlled studyMUSCLE AND NERVE, Issue 3 2009Judith G. Rabkin PhD Abstract Our objective was to determine whether modafinil alleviates fatigue in patients with amyotrophic lateral sclerosis (ALS). A placebo controlled trial with a 3:1 modafinil:placebo randomization in doses up to 300 mg/day for 4 weeks was followed by 8 weeks of open maintenance treatment. The primary endpoint was the Clinical Global Impressions-Improvement Scale. Secondary endpoints were the Fatigue Severity Scale, Epworth Sleepiness Scale, Beck Depression Inventory, Role Function Scale, and visual analog scales. Analysis of covariance was used to assess change at Week 4. Thirty-two patients were randomized; 29 completed the 4-week trial. In intention to treat (ITT) analysis, the response was 76% for modafinil versus 14% for placebo. In a completer analysis, the modafinil response rate was 86%, and the placebo response rate remained 14%. The number needed to treat was 1.6 (ITT). No medically serious adverse events were reported. Modafinil may be a promising intervention for fatigue in ALS patients. Replication in a larger study is needed. Muscle Nerve 39: 297,303, 2009 [source] Cardiac Resynchronization Therapy in Non-Left Bundle Branch Block MorphologiesPACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 5 2010JOHN RICKARD M.D. Introduction: In select patients with systolic heart failure, cardiac resynchronization therapy (CRT) has been shown to improve quality of life, exercise capacity, ejection fraction (EF), and survival. Little is known about the response to CRT in patients with right bundle branch block (RBBB) or non-specific intraventricular conduction delay (IVCD) compared with traditionally studied patients with left bundle branch block (LBBB). Methods: We assessed 542 consecutive patients presenting for the new implantation of a CRT device. Patients were placed into one of three groups based on the preimplantation electrocardiogram morphology: LBBB, RBBB, or IVCD. Patients with a narrow QRS or paced ventricular rhythm were excluded. The primary endpoint was long-term survival. Secondary endpoints were changes in EF, left ventricular end-diastolic and systolic diameter, mitral regurgitation, and New York Heart Association (NYHA) functional class. Results: Three hundred and thirty-five patients met inclusion criteria of which 204 had LBBB, 38 RBBB, and 93 IVCD. There were 32 deaths in the LBBB group, 10 in the RBBB, and 27 in the IVCD group over a mean follow up of 3.4 ± 1.2 years. In multivariate analysis, no mortality difference amongst the three groups was noted. Patients with LBBB had greater improvements in most echocardiographic endpoints and NYHA functional class than those with IVCD and RBBB. Conclusion: There is no difference in 3-year survival in patients undergoing CRT based on baseline native QRS morphology. Patients with RBBB and IVCD derive less reverse cardiac remodeling and symptomatic benefit from CRT compared with those with a native LBBB. (PACE 2010; 590,595) [source] The Effects of Rate-Adaptive Atrial Pacing Versus Ventricular Backup Pacing on Exercise Capacity in Patients with Left Ventricular DysfunctionPACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 1 2009M.S.C.E., ROD PASSMAN M.D. Background: Atrial rate-adaptive pacing may improve cardiopulmonary reserve in patients with left ventricular dysfunction. Methods: A randomized, blinded, single-crossover design enrolled dual-chamber implantable defibrillator recipients without pacing indications and an ejection fraction ,40% to undergo cardiopulmonary exercise treadmill stress testing in both atrial rate-adaptive pacing (AAIR) and ventricular demand pacing (VVI) pacing modes. The primary endpoint was change in peak oxygen consumption (VO2). Secondary endpoints were changes in anaerobic threshold, perceived exertion, exercise duration, and peak blood pressure. Results: Ten patients, nine males, eight with New York Heart Association class I, mean ejection fraction 24 ± 7%, were analyzed. Baseline VO2 was 3.6 ± 0.5 mL/kg/min. Heart rate at peak exercise was significantly higher during AAIR versus VVI pacing (142 ± 18 vs 130 ± 23 bpm; P = 0.05). However, there was no difference in peak VO2 (AAIR 23.7 ± 6.1 vs VVI 23.8 ± 6.3 mL/kg/min; P = 0.8), anaerobic threshold (AAIR 1.3 ± 0.3 vs VVI 1.2 ± 0.2 L/min; P = 0.11), rate of perceived exertion (AAIR 7.3 ± 1.5 vs VVI 7.8 ± 1.2; P = 0.46), exercise duration (AAIR 15 minutes, 46 seconds ± 2 minutes, 54 seconds vs VVI 16 minutes, 3 seconds ± 2 minutes, 48 seconds; P = 0.38), or peak systolic blood pressure (AAIR 155 ± 22 vs VVI 153 ± 21; P = 0.61) between the two pacing modes. Conclusion: In this study, AAIR pacing did not improve peak VO2, anaerobic threshold, rate of perceived exertion, or exercise duration compared to VVI backup pacing in patients with left ventricular dysfunction and no pacing indications. [source] Darbepoetin alfa 300 or 500 ,g once every 3 weeks with or without intravenous Iron in patients with chemotherapy-induced anemia,AMERICAN JOURNAL OF HEMATOLOGY, Issue 9 2010Michael Auerbach This study evaluated efficacy and safety of darbepoetin alfa administered every 3 weeks (Q3W) at fixed doses of 300 or 500 ,g with or without intravenous (IV) iron in treating anemia in patients receiving multicycle chemotherapy. This Phase 2, double-blind, 2 × 2 factorial study randomized patients to one of four treatment arms; darbepoetin alfa 300 ,g (n = 62), darbepoetin alfa 300 ,g plus IV iron (n = 60), darbepoetin alfa 500 ,g (n = 60), or darbepoetin alfa 500 ,g plus IV iron (n = 60). Patients had nonmyeloid malignancies, hemoglobin levels ,10 g dL,1, and no iron deficiency. Primary endpoint was achievement of target hemoglobin (,11 g dL,1). Secondary endpoints included incidence of transfusions and change in Functional Assessment of Cancer Therapy Fatigue (FACT-F) score from baseline to end of study. Safety was evaluated by incidence of adverse events. No evidence of a statistically significant interaction between darbepoetin alfa dose received and IV iron usage was observed, therefore, results are provided separately comparing darbepoetin alfa doses and comparing IV iron usage groups. Similar proportions of patients receiving darbepoetin alfa 300 or 500 ,g achieved target hemoglobin (75 and 78%, respectively); Kaplan,Meier median time to target hemoglobin was 10 and 8 weeks, respectively. More patients receiving IV iron (82%) than not receiving IV iron (72%) achieved hemoglobin target. Adverse events profiles were similar for darbepoetin alfa treatment groups. Transient anaphylactoid reactions were reported in two patients receiving IV iron. Darbepoetin alfa at 300 ,g Q3W and 500 ,g Q3W showed similar benefit, while added IV iron improved treatment response in these patients. Am. J. Hematol., 2010. © 2010 Wiley-Liss, Inc. [source] An Open-Label Study of the Lidocaine Patch 5% in Painful Idiopathic Sensory PolyneuropathyPAIN MEDICINE, Issue 5 2005David N. Herrmann MBBCh ABSTRACT Objective., Painful idiopathic distal sensory polyneuropathy is common, but has been largely ignored as a model for the evaluation of neuropathic pain therapies. We have therefore conducted a safety, tolerability, and effectiveness study of the lidocaine patch 5% in painful idiopathic distal sensory polyneuropathy. Design., A prospective open-label, flexible dosing, 3-week study period with a 5-week extension. Setting., Peripheral Neuropathy clinics and Anesthesiology Clinical Research Center at a tertiary care facility. Patients., Twenty subjects with a diagnosis of idiopathic distal sensory polyneuropathy (with or without associated impaired glucose tolerance), with a baseline mean pain daily rating of ,4 on a visual analog scale. Intervention., Lidocaine patch 5%, maximum of four patches daily for 18 hours. Main Outcome Measure., Change from baseline week to week 3 mean daily diary pain ratings. Secondary endpoints included assessments of safety and tolerability as well as quality of life measures. Results., Subjects with idiopathic distal sensory polyneuropathy, both with and without impaired glucose tolerance, showed significant improvements in pain and quality of life outcome measures over a 3-week treatment period. These improvements were maintained in a subgroup of patients treated for an additional 5 weeks and permitted a taper of concomitant analgesics in 25% of subjects. The lidocaine patch 5% was well tolerated. Conclusions., The lidocaine patch 5% appeared well tolerated and potentially effective in the management of painful idiopathic distal sensory polyneuropathy. Idiopathic distal sensory polyneuropathy is an appropriate patient population for the conduct of clinical trials of neuropathic pain therapies. [source] Efficacy of prednisolone in children hospitalized for recurrent wheezingPEDIATRIC ALLERGY AND IMMUNOLOGY, Issue 4 2007Tuomas Jartti Data on the efficacy of corticosteroids on respiratory picornavirus-induced wheezing are limited. To determine whether prednisolone is effective in rhinovirus- or enterovirus-induced recurrent wheezing, we conducted a controlled trial comparing oral prednisolone (2 mg/kg/day in three divided doses for 3 days) with placebo in hospitalized wheezing children and studied post hoc virus-specific efficacy in early wheezing (<3 episodes, reported elsewhere) and in recurrent wheezing (,3 episodes). Virus-negative children where excluded. Our primary endpoint was the time until children were ready for discharge. Secondary endpoints included oxygen saturation and exhaled nitric oxide during hospitalization, duration of symptoms, blood eosinophil count, and impulse oscillometry 2 wk after discharge, and occurrence of relapses during the following 2 months. Virus-specific effects were analyzed with interaction analysis in a multivariate regression model. During the study period, 661 patients were hospitalized, 293 randomized, and 59 were accepted in this analysis (mean age 2.6 yr, s.d. 1.3). Prednisolone did not significantly decrease the time until ready for discharge in all patients (prednisolone vs. placebo, medians, 18 vs. 24 h, p = 0.11). However, prednisolone decreased the time until ready for discharge in children with picornavirus infection (respectively, 12 vs. 24 h, p = 0.0022) and more specifically, in children with enterovirus infection (6 vs. 35 h, p = 0.0007). In the secondary endpoints, prednisolone decreased the duration of cough and dyspnea in rhinovirus-affected children (p = 0.033 for both). Prospectively designed clinical trial is needed to test the hypothesis that prednisolone reduces symptoms in picornavirus-affected wheezing children. [source] Prophylactic Bisphosphonate Treatment Prevents Bone Fractures After Liver TransplantationAMERICAN JOURNAL OF TRANSPLANTATION, Issue 7 2007M. Bodingbauer A randomized controlled prospective open-label single center trial was performed. At the time of transplantation patients were randomly assigned to one of two treatment arms: The study group of 47 patients received zoledronic acid (ZOL, 8 infusions at 4 mg during the first 12 months after LT), calcium (1000 mg/d) and vitamin D (800 IE/d). The control group consisted of 49 patients who received calcium and vitamin D at same doses (CON). The incidence of bone fractures or death was predefined as the primary endpoint. Secondary endpoints included bone mineral density (BMD), serum biochemical markers of bone metabolism, parameters of trabecular bone histomorphometry and mineralization density distribution (BMDD). Patients were followed up for 24 months. Analysis was performed on an intention-to-treat basis. The primary endpoint fracture or death was reached in 26% of patients in the ZOL group and 46% in the CON group (p = 0.047, log rank test). Densitometry results were different between the groups at the femoral neck at 6 months after LT (mean+/-SD BMD ZOL: 0.80 ± 0.19 g/cm2 vs. CON: 0.73 ± 0.14 g/cm2, p = 0.036). Mixed linear models of biochemical bone markers showed less increase of osteocalcin in the ZOL group and histomorphometry and BMDD indicated a reduction in bone turnover. Prophylactic treatment with the bisphosphonate zoledronic acid reduces bone turnover and fractures after liver transplantation. [source] Rituximab in patients with primary progressive multiple sclerosis: Results of a randomized double-blind placebo-controlled multicenter trial,ANNALS OF NEUROLOGY, Issue 4 2009Kathleen Hawker MD Objective Rituximab, a monoclonal antibody selectively depleting CD20+ B cells, has demonstrated efficacy in reducing disease activity in relapsing-remitting multiple sclerosis (MS). We evaluated rituximab in adults with primary progressive MS (PPMS) through 96 weeks and safety through 122 weeks. Methods Using 2:1 randomization, 439 PPMS patients received two 1,000mg intravenous rituximab or placebo infusions every 24 weeks, through 96 weeks (4 courses). The primary endpoint was time to confirmed disease progression (CDP), a prespecified increase in Expanded Disability Status Scale sustained for 12 weeks. Secondary endpoints were change from baseline to week 96 in T2 lesion volume and total brain volume on magnetic resonance imaging scans. Results Differences in time to CDP between rituximab and placebo did not reach significance (96-week rates: 38.5% placebo, 30.2% rituximab; p = 0.14). From baseline to week 96, rituximab patients had less (p < 0.001) increase in T2 lesion volume; brain volume change was similar (p = 0.62) to placebo. Subgroup analysis showed time to CDP was delayed in rituximab-treated patients aged <51 years (hazard ratio [HR] = 0.52; p = 0.010), those with gadolinium-enhancing lesions (HR = 0.41; p = 0.007), and those aged <51 years with gadolinium-enhancing lesions (HR = 0.33; p = 0.009) compared with placebo. Adverse events were comparable between groups; 16.1% of rituximab and 13.6% of placebo patients reported serious events. Serious infections occurred in 4.5% of rituximab and <1.0% of placebo patients. Infusion-related events, predominantly mild to moderate, were more common with rituximab during the first course, and decreased to rates comparable to placebo on successive courses. Interpretation Although time to CDP between groups was not significant, overall subgroup analyses suggest selective B-cell depletion may affect disease progression in younger patients, particularly those with inflammatory lesions. Ann Neurol 2009;66:460,471 [source] Randomized trial of two different doses of pyridoxine in the prevention of capecitabine-associated palmar-plantar erythrodysesthesiaASIA-PACIFIC JOURNAL OF CLINICAL ONCOLOGY, Issue 3 2010T CHALERMCHAI Abstract Aim: The aim of the present study was to compare the efficacy of 200 mg versus 400 mg daily of pyridoxine in preventing or delaying the onset of palmar-plantar erythrodysesthesia (PPE) in capecitabine-treated patients. Methods: Patients with histologically confirmed breast cancer or colorectal cancer receiving single agent capecitabine started at 2000 to 2500 mg/m2 daily from day 1 to 14 every 3 weeks were randomly assigned to receive 200 mg or 400 mg daily of pyridoxine for PPE prophylaxis. The primary endpoint was the reduction of incidence of grade 2 or greater PPE. Secondary endpoints were reduction of severe PPE and prolongation of time to development of grade 2 or greater PPE. Results: There were 56 patients in this study. The baseline characteristics were generally similar in both groups. The high dose arm had less PPE than the low dose arm (11 of 28 or 39% vs 20 of 28 or 71%, relative risk = 0.26 [0.08, 0.79], P = 0.031). Grade III PPE developed in 3 of 28 (10.7%) versus none in patients receiving 200 mg versus 400 mg pyridoxine, respectively (relative risk 2.12 [1.594, 2.819], P = 0.24). High dose pyridoxine had a longer time to development of grade 2 or greater PPE compared to the low dose arm, 87 days versus 62 days. The 400 mg pyridoxine group had, however, a worsened tumor response and tended to have greater tumor treatment failure and shorter time to treatment failure. Conclusion: With the limitation of sample size in this study, there was a trend to improve PPE incidence and time to event with a higher dose of pyridoxine. Further validation of these results in a larger population is warranted. [source] Phase 2 trial of combination thalidomide plus temozolomide in patients with metastatic malignant melanoma: Southwest Oncology Group S0508,CANCER, Issue 2 2010Joseph I. Clark MD Abstract BACKGROUND: In limited institution phase 2 studies, thalidomide and temozolomide has yielded response rates (RRs) up to 32% for advanced melanoma, leading to the use of this combination as "standard" by some. We conducted a multicenter phase 2 trial to better define the clinical efficacy of thalidomide and temozolomide and the immune modulatory effects of thalidomide, when combined with temozolomide, in patients with metastatic melanoma. METHODS: Patients must have had stage IV cutaneous melanoma, no active brain metastases, Zubrod PS 0-1, up to 1 prior systemic therapy excluding thalidomide, temozolomide, or dacarbazine, adequate organ function, and given informed consent. The primary endpoint was 6-month progression-free survival (PFS). Secondary endpoints included overall survival (OS), RR, toxicities, and assessment of relationships between biomarkers and clinical outcomes. Patients received thalidomide (200 mg/d escalated to 400 mg/d for patients <70, or 100 mg/d escalated to 250 mg/d for patients ,70) plus temozolomide (75 mg/m2/d × 6 weeks, and then 2 weeks rest). RESULTS: Sixty-four patients were enrolled; 2 refused treatment. The 6-month PFS was 15% (95% confidence interval [CI], 6%-23%), the 1-year OS was 35% (95% CI, 24%-47%), and the RR was 13% (95% CI, 5%-25%), all partial. One treatment-related death occurred from myocardial infarction; 3 other grade 4 events occurred, including pulmonary embolism, neutropenia, and central nervous system (CNS) ischemia. There was no significant correlation between biomarkers and PFS or OS. CONCLUSIONS: This combination of thalidomide and temozolomide does not appear to have a clinical benefit that exceeds dacarbazine alone. We would not recommend it further for phase 3 trials or for standard community use. Cancer 2010. © 2010 American Cancer Society. [source] Erlotinib plus bevacizumab in previously treated patients with malignant pleural mesotheliomaCANCER, Issue 4 2008David M. Jackman MD Abstract BACKGROUND. We conducted a phase 2, multicenter, open-label study of erlotinib plus bevacizumab in patients with malignant pleural mesothelioma who had previously received 1 prior chemotherapy regimen. These agents have activity in non,small cell lung cancer, but their role in mesothelioma is unclear. The primary endpoint is response rate. Secondary endpoints include time to progression, survival, and toxicity. METHODS. Eligible patients with mesothelioma who had previously received 1 chemotherapy regimen were treated with erlotinib 150 mg per os daily and bevacizumab 15 mg/kg administered intravenously on Day 1 of a 21-day cycle. Treatment continued until disease progression or development of significant toxicity. Tumor response was assessed after every 2 cycles using previously established mesothelioma response criteria from Byrne and Nowak. RESULTS. Twenty-four eligible patients initiated therapy with erlotinib and bevacizumab between February 2004 and October 2006. There were no complete or partial responses, although 12 patients achieved stable disease for at least 2 cycles of treatment. The median time to progression was 2.2 months (95% confidence interval [CI], 1.4 months-5.9 months). The median survival was 5.8 months (95% CI, 2.8 months-10.1 months). The most common toxicities were rash and diarrhea. There were no treatment-related deaths, intracranial bleeding, or hemoptysis. CONCLUSIONS. The combination of erlotinib and bevacizumab was tolerated reasonably well, but there was no evidence of radiographic response. This study demonstrates the feasibility of conducting trials in mesothelioma patients who have failed first-line therapy. More therapeutic studies with effective agents are needed for these patients. Cancer 2008. © 2008 American Cancer Society. [source] Effect of exercise on upper extremity pain and dysfunction in head and neck cancer survivorsCANCER, Issue 1 2008A randomized controlled trial Abstract BACKGROUND. Shoulder pain and disability are well recognized complications associated with surgery for head and neck cancer. This study was designed to examine the effects of progressive resistance exercise training (PRET) on upper extremity pain and dysfunction in postsurgical head and neck cancer survivors. METHODS. Fifty-two head and neck cancer survivors were assigned randomly to PRET (n = 27) or a standardized therapeutic exercise protocol (TP) (n = 25) for 12 weeks. The primary endpoint was change in patient-rated shoulder pain and disability from baseline to postintervention. Secondary endpoints were upper extremity strength and endurance, range of motion, fatigue, and quality of life. RESULTS. Follow-up assessment for the primary outcome was 92%, and adherence to the supervised PRET and TP programs were 95% and 87%, respectively. On the basis of intention-to-treat analyses, PRET was superior to TP for improving shoulder pain and disability (,9.6; 95% confidence interval [95% CI], ,16.4 to ,4.5; P = .001), upper extremity strength (+10.8 kg; 95% CI, 5.4,16.2 kg; P < .001), and upper extremity endurance (+194 repetitions × kg; 95% CI, 10,378 repetitions × kg; P = .039). Changes in neck dissection impairment, fatigue, and quality of life favored the PRET group but did not reach statistical significance. CONCLUSIONS. The PRET program significantly reduced shoulder pain and disability and improved upper extremity muscular strength and endurance in head and neck cancer survivors who had shoulder dysfunction because of spinal accessory nerve damage. Clinicians should consider the addition of PRET in the rehabilitation of postsurgical head and neck cancer survivors. Cancer 2008. © 2008 American Cancer Society. [source] Survival and predictors of outcome in patients with acute leukemia admitted to the intensive care unitCANCER, Issue 10 2008Snehal G. Thakkar MD Abstract BACKGROUND. Predictors of outcome and rates of successful discharge have not been defined for patients with acute leukemia admitted to intensive care units (ICUs) in the US. METHODS. This is a retrospective analysis of 90 patients with acute leukemia (no history of bone marrow transplant) admitted to an ICU from 2001,2004. The primary endpoints were improvement and subsequent discharge from the ICU, discharge from the hospital, and 2-month survival after hospital discharge. Secondary endpoints were 6- and 12-month survival. Univariate and multivariate logistic regression analyses were performed to identify factors predicting outcome. RESULTS. The median age of patients was 54 years and 48 (53%) were male. The most common reason for ICU transfer for all patients was respiratory compromise. The majority of all patients (68%) were eventually placed on ventilator support and approximately half required pressors. During the ICU course, 29 patients (32%) improved and subsequently resumed aggressive leukemia management, and 24 patients (27%) survived to be discharged from the hospital. The 2-, 6-, and 12-month overall survival was 24 (27%), 16 (18%), and 14 (16%), respectively. Higher APACHE II score, use of pressors, undergoing bone marrow transplantation preparative regimen, and adverse cytogenetics predicted worse outcome. Newly diagnosed leukemia, type of leukemia, or age did not. CONCLUSIONS. One of 4 patients with acute leukemia survived an ICU admission to be discharged from the hospital and were alive 2 months later. A diagnosis of acute leukemia should not disqualify patients from an ICU admission. Cancer 2008. © 2008 American Cancer Society. [source] | ||||||||||||||||||||||||||||||||||||||||