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Screening Period (screening + period)
Selected AbstractsEfficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes inadequately controlled by glyburide monotherapyDIABETES OBESITY & METABOLISM, Issue 2 2009R. E. Pratley Aim:, To evaluate the efficacy and safety of alogliptin, a potent and highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor, in combination with glyburide in patients with type 2 diabetes inadequately controlled by sulphonylurea monotherapy. Methods:, After a 2-week screening period, adult patients 18,80 years of age entered a 4-week run-in/stabilization period in which they were switched from their own sulphonylurea medication to an equivalent dose of glyburide (open label) plus placebo (single blind). After the run-in period, patients were randomly assigned to double-blind treatment with alogliptin 12.5 mg (n = 203), alogliptin 25 mg (n = 198), or placebo (n = 99) for 26 weeks. The primary end-point was change from baseline to week 26 in glycosylated haemoglobin (HbA1c). Secondary end-points included clinical response rates and changes in fasting plasma glucose, ,-cell function (fasting proinsulin, insulin, proinsulin/insulin ratio, and C-peptide, and homeostasis model assessment ,-cell function), body weight, and safety end-points [adverse events (AEs), clinical laboratory tests, vital signs and electrocardiographic readings]. Results:, The study population had a mean age of 57 years and a mean disease duration of 8 years; it was well balanced for gender (52% women) and was mainly white (71%). The mean baseline HbA1c was approximately 8.1% in each group. Significantly greater least squares (LS) mean reductions in HbA1c were seen at week 26 with alogliptin 12.5 mg (,0.38%) and 25 mg (,0.52%) vs. placebo (+0.01%; p < 0.001), and more patients in the alogliptin 25-mg group had HbA1c levels ,7.0% at week 26 (34.8%, p = 0.002) vs. placebo (18.2%). Proportionately more patients in the alogliptin 12.5 mg (47.3%) and 25 mg (50.5%) groups had an HbA1c reduction ,0.5% from baseline compared with patients in the placebo group (26.3%; p < 0.001). Minor improvements in individual markers of ,-cell function were seen with alogliptin, but no significant treatment group differences were noted relative to placebo. Minor LS mean changes in body weight were noted across groups (placebo, ,0.20 kg; alogliptin 12.5 mg, +0.60 kg; alogliptin 25 mg, +0.68 kg). AEs were reported for 63,64% of patients receiving alogliptin and 54% of patients receiving placebo. Few AEs were treatment limiting (2.0,2.5% across groups), and serious AEs (2.0,5.6%) were infrequent, similar across groups, and generally considered not related to treatment. The incidences of hypoglycaemia for placebo, alogliptin 12.5 mg and alogliptin 25 mg groups were 11.1, 15.8 and 9.6% respectively. Conclusions:, In patients with type 2 diabetes inadequately controlled by glyburide monotherapy, the addition of alogliptin resulted in clinically significant reductions in HbA1c without increased incidence of hypoglycaemia. [source] Adding biphasic insulin aspart 30 once or twice daily is more efficacious than optimizing oral antidiabetic treatment in patients with type 2 diabetesDIABETES OBESITY & METABOLISM, Issue 5 2007W. M. W. Bebakar Aim:, To evaluate the efficacy and safety of adding biphasic insulin aspart 30 (BIAsp30; NovoMix® 30) to existing oral antidiabetic agents (OADs) vs. optimizing OADs in a subgroup of Western Pacific patients with type 2 diabetes inadequately controlled on oral monotherapy or oral combination therapy. Methods:, This 26-week, multi-centre, open-labelled, randomized, two-arm parallel trial consisted of a 2-week screening period, followed by 24 weeks of treatment. Subjects randomized to BIAsp30 treatment (n = 129) received BIAsp30 once daily (o.d.) at dinnertime between Week 2 and Week 14, and those not reaching treatment targets were switched to twice daily (b.i.d.) BIAsp30 at Week 14 (n = 50). Subjects randomized to the OAD-only arm (n = 63) continued with their previous OAD treatment and, in an attempt to reach treatment goals, the dose was optimized (but OAD unchanged) in accordance to local treatment practice and labelling. Results:, Significantly greater reductions in HbA1c over Weeks 0,13 with BIAsp30 (o.d.) vs. OAD-only treatment (1.16 vs. 0.58%; p < 0.001), and over Weeks 0,26, with BIAsp30 (o.d.) and BIAsp30 (b.i.d.) treatments vs. OAD-only treatment (1.24 vs. 1.34 vs. 0.67%; p < 0.01). Hypoglycaemic episodes were reported in 54% of the patients in BIAsp30 (o.d. and b.i.d. pooled) and 30% of the patients in OAD-only group. All episodes were minor or symptomatic, except for one in each treatment group, which was major. Conclusions:, Initiating BIAsp30 treatment is a safe and more effective way to improve glycaemic control in Western Pacific patients with type 2 diabetes inadequately controlled with oral monotherapy or oral combination therapy compared with optimizing oral combination therapy alone. In patients not reaching treatment target on BIAsp30 (o.d.), treatment with BIAsp30 (b.i.d.) should be considered. [source] Results of longterm hospital based cytological screening in asymptomatic womenDIAGNOSTIC CYTOPATHOLOGY, Issue 3 2006Jata S. Misra Ph.D., M.I.A.C. Abstract Routine cytological screening has been carried out in 27,062 asymptomatic women attending Gynaec and Family Planning O.P.D. of Queen Mary's Hospital, Lucknow, India (April 1971,December 2004). Incidence of squamous intraepithelial lesion (SIL) was found to be 5.9% in the series, while cervical malignancy was seen in 0.6% of cases. The study highlighted the immense utility of cytological screening in minimizing the incidence of carcinoma cervix in the segment of the urban population screened, as the incidence dropped down to 0.5% in the second half from 1.1% noticed in the first half of the screening period. The study also emphasized the utility of clinically downstaging the cervical cancer as 7,316 women showing clinical lesions of cervix were found to harbor SIL in 15.3% and carcinoma cervix in 1.3% of cases as against the incidence of 2.5% for SIL and 0.6% for frank cancer in women with normal cervix. The investigation into different risk factors involved in cervical carcinogenesis revealed that the incidence of SIL and cancer cervix showed a rise with increasing age and parity and prolonged sexual period. The incidences of both cervical cytopathologies were also higher in women of low socio-economic status while religion was found to have no bearing on the occurrence of the disease. Among the four sexually transmitted diseases (STDs) diagnosed in the cervical smears, Trichomonas vaginalis was found to be more prevalent (2.6%), while human papillomavirus (HPV) and Herpes simplex was seen in 0.4 and 0.2% of cases, respectively Herpes simplex was found to have strong affinity with both SIL and carcinoma cervix, while only SIL incidence was high with HPV infection. The study emphasizes need of proper education to women of low socio-economic class for creating awareness regarding hazards and risk factors of cervical cancer as well as management and cure of the disease. Diagn. Cytopathol. 2006;34: 184,187. © 2006 Wiley-Liss, Inc. [source] Efficacy screening trials of paroxetine, pentoxifylline, riluzole, pramipexole and venlafaxine in cocaine dependenceADDICTION, Issue 2005Domenic A. Ciraulo ABSTRACT Aims The two studies presented here were conducted to assess the efficacy of paroxetine, pentoxifylline, riluzole, venlafaxine and pramipexole as medications for the treatment of cocaine dependence. Design A multi-arm, modified blinded, placebo-controlled design was used. Setting The studies were conducted at the Boston VA Healthcare System and the Boston University School of Medicine Medication Development Research Unit (MDRU). Participants Participants met criteria for cocaine dependence during a 2-week screening period. Intervention Following random assignment to one of the treatment groups, subjects received active medication or placebo for 8 weeks in combination with cognitive behavioral counseling. In the first study the efficacy of the antidepressant paroxetine (20 mg daily), the phosphodiesterase inhibitor pentoxifylline (1200 mg daily) and the glutamate release inhibitor riluzole (100 mg daily) was assessed. The antidepressant venlafaxine (150 mg daily) and the dopamine agonist pramipexole (1.5 mg daily) were evaluated in the second study. Measurements Urine benzoylecgonine (BE) concentrations, self-report of cocaine use and global impression scores served as primary outcome measures. Secondary measures included assessments of cocaine craving and psychiatric functioning. Adverse events were monitored during the treatment period. Findings None of the active medications produced greater reductions in urine BE concentrations over the treatment period than did placebo. There were trends for BE levels to become reduced in the pentoxifylline group during the first 4 weeks of treatment and for Addiction Severity Index (ASI) drug composite scores to be lower in the pentoxyfylline group at end-point compared to the placebo group. Significant within-group reductions in reported cocaine use and craving were found for all treatment groups, but none of the active medications were superior to placebo on these measures. The accuracy of self-reported cocaine use declined over the study period. Overall, the active medications were well tolerated. Conclusions This study does not support the use of paroxetine, pentoxifylline, riluzole, venlafaxine or pramipexole for the treatment of cocaine dependence. However, these results need to be interpreted with caution because of the small size and lack of homogeneity of the experimental 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] An Open-Label, Multicenter, Flexible Dose Study to Evaluate the Efficacy and Safety of Viagra® (Sildenafil Citrate) in Korean Men with Erectile Dysfunction and Arterial Hypertension who are Taking Antihypertensive AgentsTHE JOURNAL OF SEXUAL MEDICINE, Issue 10 2008Hyun Jun Park MD ABSTRACT Introduction., Erectile dysfunction (ED) is common among men taking antihypertensive agents to control blood pressure. Aim., We evaluated the efficacy and safety of sildenafil citrate in men with ED taking antihypertensive agents. Methods., A total of 198 male subjects, aged 20 years and older were enrolled. This study was conducted for 10 weeks as an open-label, multicenter and flexible dose trial with a 2-week screening period and an 8-week treatment phase. Main Outcome Measures., Subjects were asked to complete Event Log Worksheets, as well as the International Index of Erectile Function (IIEF) and the Global Efficacy Assessment Questions (GEAQ) questionnaires during the study period. Results., The average age among the 167 subjects who completed the study was 55.8 (31.7 to 77.1). The scores for questions 3 and 4 of IIEF improved from 2.3 and 1.8 at baseline to 3.7 and 3.4 at week 4 and 3.8 and 3.4 at week 8, respectively. There were 86.3% of the patients reported improved erectile function at week 8; 88.3% of the patients reported improved ability to achieve sexual intercourse at week 8. There were no significant differences observed in the responses to questions 3 and 4 of IIEF and GEAQ by the number of antihypertensive agents taken. The adverse events were facial flushing (20.1%), headache (11.7%), palpitation (5.0%), rhinitis (2.8%), URI (2.8%), dizziness (2.2%), dyspnea (2.2%), and nausea (1.7%). Conclusions., Sildenafil citrate is an effective treatment for ED; it is safe and well tolerated by patients with ED taking multiple antihypertensive agents for arterial hypertension. Park HJ, Park NC, Shim HB, Park JK, Lee SW, Park K, Kim SW, Moon KH, Lee DH, and Yoon SJ. An open-label, multicenter, flexible dose study to evaluate the efficacy and safety of Viagra® (sildenafil citrate) in Korean men with erectile dysfunction and arterial hypertension who are taking antihypertensive agents. J Sex Med 2008;5:2405,2413. [source] Long-term efficacy and safety results of the two-stage implantation technique in sacral neuromodulationBJU INTERNATIONAL, Issue 9 2002W.A. Scheepens Objective ,To assess the long-term efficacy and safety of two-stage sacral neuromodulation with an implantable pulse generator (IPG) in patients treated for urinary urge incontinence (UI) and/or urinary retention (UR). Patients and methods ,The two-stage technique is used if patients have a good response during the acute phase of the percutaneous nerve evaluation (PNE) test, but have a poor response during the following 4,7 days (subchronic phase). In the first stage only the permanent electrode was implanted and connected to a temporary external stimulator, allowing patients to be assessed for longer. If the main symptoms improved by more than half the patient proceeded to the second stage, the insertion of the IPG. We reviewed all patients who underwent two-stage implantation; all had signed an informed consent and were asked to complete voiding diaries and a questionnaire to assess the subjective effects of the therapy. Safety was assessed from relevant medical events, management, and relative to the thera-py and resolution. Residual urine was assessed by self-catheterization. The long-term voiding diary results were compared with baseline estimates and analysed statistically using the two-sided Student's t -test. Results ,Between 1991 and 1998, 15 patients (13 women and two men, mean age 53 years, range 44,66) underwent the two-stage technique; the mean (median, range) follow-up was 4.9 (5.2, 2.5,7.5) years. Seven patients had UI and seven had UR, with one having both. The mean (range) number of PNEs undertaken in each patient was 2.1 (1,4) and these all failed in the subchronic phase. All patients underwent a first- and second-stage implant after a mean (range) screening period of 12.2 (2,29) days. One patient was explanted after implantation of only the first stage, and two others explanted in a later phase because the IPG was ineffective during the follow-up. The voiding diary results of the remaining 12 patients showed improvement in all the main variables, and in the subjective assessment 11 reported an improvement and were satisfied with the therapy. There were 17 adverse events, 14 of which were resolved and seven of which required surgical intervention. Conclusion ,The long-term results of the two-stage implantation show clinically and statistically significant improvements, probably because the implantation of the lead (first stage) more closely resembles the final therapy. If a temporary PNE test is not optimal (lead migration, longer testing needed), the two-stage technique can offer a good and safe alternative of comparable efficacy in the long-term. If the two-stage technique had not been available to these 12 patients they would not have been offered neuromodulation. [source] Impact of rapid molecular screening for meticillin-resistant Staphylococcus aureus in surgical wards,BRITISH JOURNAL OF SURGERY (NOW INCLUDES EUROPEAN JOURNAL OF SURGERY), Issue 3 2008M. R. S. Keshtgar Background: This study aimed to establish the feasibility and cost-effectiveness of rapid molecular screening for hospital-acquired meticillin-resistant Staphylococcus aureus (MRSA) in surgical patients within a teaching hospital. Methods: In 2006, nasal swabs were obtained before surgery from all patients undergoing elective and emergency procedures, and screened for MRSA using a rapid molecular technique. MRSA-positive patients were started on suppression therapy of mupirocin nasal ointment (2 per cent) and undiluted chlorhexidine gluconate bodywash. Results: A total of 18 810 samples were processed, of which 850 (4·5 per cent) were MRSA positive. In comparison to the annual mean for the preceding 6 years, MRSA bacteraemia fell by 38·5 per cent (P < 0·001), and MRSA wound isolates fell by 12·7 per cent (P = 0·031). The reduction in MRSA bacteraemia and wound infection was equivalent to a saving of 3·78 beds per year (£276 220), compared with the annual mean for the preceding 6 years. The cost of screening was £302 500, making a net loss of £26 280. Compared with 2005, however, there was a net saving of £545 486. Conclusion: Rapid MRSA screening of all surgical admissions resulted in a significant reduction in staphylococcal bacteraemia during the screening period, although a causal link cannot be established. Copyright © 2007 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. [source] Bacterial colonization of stimulation electrode wires in patients undergoing temporary sacral nerve stimulationCOLORECTAL DISEASE, Issue 2 2010T. Dudding Abstract Objective, In patients undergoing sacral nerve stimulation (SNS), a temporary percutaneous stimulation wire is often used to assess the clinical response to therapy prior to chronic stimulation. The aim of this study was to evaluate the incidence of bacterial colonization of screening wires and risk of clinical infection in patients undergoing prolonged temporary SNS screening. Method, Data were collected prospectively on a consecutive series of patients undergoing temporary SNS for bowel dysfunction. Procedures were performed using a standardized percutaneous technique with a single shot of either co-amoxyclav 1.2 g or cefuroxime 1.5 g given intravenously on induction. Adherent polyurethane dressings were applied to secure the wire. At the end of the screening period the wire and dressings were removed, the skin entry site was cleaned using an alcohol wipe and the wire removed via an aseptic technique. The distal tip of the wire was then cut and sent for culture. Results, Thirteen wires were removed at a median of 21 (range 16,29) days following insertion. There were no signs of local or systemic infection. Seven of the thirteen wires (54%) were found to have deep bacterial colonization. The commonest organisms isolated were staphylococcus species. There was no correlation between the length of time the lead had been implanted and the incidence of bacterial colonization. Conclusion, Bacterial colonization of the temporary stimulation wire is common but appears to be associated with a low risk of clinical infection. A single peri-operative dose of antibiotics does not appear to prevent colonization. [source] Neonatal hip instability: results and experiences from ten years of screening with the anterior-dynamic ultrasound methodACTA PAEDIATRICA, Issue 8 2002JE Andersson Aim: To record the results and experiences from a 10-y screening period with the anterior-dynamic ultrasound method for detecting neonatal hip instability. Methods: An ultrasonographic improvement of the Palmen/Barlow test was used. The screening programme included 22 047 newborns. Decisions about treatment were made solely on the ultrasound result. Results: It was found that 175 infants (7.9/1000) had at least one unstable hip,dislocated or dislocatable. Dislocated hips were found in 1.1/1000. Dislocatable hips were found in 6.8/1000 but only 1.1/1000 needed treatment. The total frequency of treatment was 2.2/1000. All cases but one were diagnosed before discharge from the maternity ward. The rate of surgery was 0.1/1000 newborns. Girls were more affected than boys, by a ratio of 3:1. Among the affected hips 64.4% were a left hip. Conclusion: Neonatal hip instability is always present at birth and can be diagnosed immediately after birth. We have no indications that instability can appear at a later stage. The anterior-dynamic ultrasound screening programme is an efficient tool to diagnose neonatal hip instability and to decide when to begin treatment. [source] | ||||||||||