Vs Baseline (v + baseline)

Distribution by Scientific Domains


Selected Abstracts


Hyaluronic acid treatment of facial fat atrophy in HIV-positive patients

HIV MEDICINE, Issue 8 2007
H Bugge
Objectives Facial lipoatrophy can be devastating for HIV-infected patients, with negative effects on self-esteem. In this study, we treated facial fat atrophy in the nasogenian area with hyaluronic acid (Restylane SubQ; Q-Med AB, Uppsala, Sweden). Methods Twenty patients were included in the study. Treatment effects were evaluated at baseline, and at weeks 6, 24 and 52 using ultrasound, the Global Aesthetic Improvement Scale, the Visual Analogue Scale and the Rosenberg Self-Esteem Scale. Results Mean (±standard deviation) total cutaneous thickness increased from 6±1 mm at baseline to 15±3 mm at week 6 (P<0.001), and declined to 10±2 mm at week 52 (P<0.001 vs baseline). The response rate (total cutaneous thickness >10 mm) was 100% at week 6, 85% at week 24 and 60% at week 52. At week 6, all of the patients classified their facial appearance as very much improved or moderately improved. They also reported increased satisfaction with their facial appearance and had higher self-esteem scores. At week 52, 15 of 19 patients still classified their facial appearance as very much improved or moderately improved, although the mean total cutaneous thickness had gradually declined. Conclusions Our results indicate that Restylane SubQ is a useful and well-tolerated dermal filler for treating HIV-positive patients with facial lipoatrophy. [source]


Efficacy and tolerability of quetiapine in patients with schizophrenia who switched from haloperidol, olanzapine or risperidone

HUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 8 2005
Ilkka Larmo
Abstract A post hoc analysis of the SPECTRUM trial was carried out to evaluate whether the improvements in efficacy and tolerability gained on switching to quetiapine occurred consistently for patients previously treated with either: haloperidol (n,=,43); olanzapine (n,=,66); or risperidone (n,=,55) monotherapy. Patients were initiated with quetiapine to 400,mg/day over 7 days, and then flexibly dosed (300,750,mg/day) for 11 weeks. The mean (SD) modal dose of quetiapine was 501 (138),mg/day in the haloperidol subgroup, 472 (147),mg/day in the olanzapine subgroup and 485 (141),mg/day in the risperidone subgroup at the study endpoint. Switching to quetiapine induced significant improvements from baseline in PANSS scores, with least square mean changes in total scores of ,32.5, ,15.4, and ,18.5 for patients previously treated with haloperidol, olanzapine and risperidone, respectively, (all p,<,0.001 vs baseline). Significant improvements were also noted in CDSS scores, particularly for patients clinically depressed at baseline (all p,<,0.001 vs baseline). There were significant reductions in EPS on the SAS and BAS for all subgroups (all p,<,0.001 vs baseline). Switching to quetiapine produced efficacy and tolerability benefits regardless of whether their previous antipsychotic was haloperidol, olanzapine or risperidone. Copyright © 2005 John Wiley & Sons, Ltd. [source]


Plasma serotonin response to carbohydrate-rich food in chronic schizophrenic patients: clozapine versus classic antipsychotic agents

HUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 5 2001
Yaffa Vered
Abstract Researchers have reported a stimulatory effect of carbohydrate-rich intake on platelet-poor plasma (PPP) serotonin (5-HT) levels in healthy human subjects. Dietary manipulation may serve as a safer and less invasive means than pharmacologic challenge to provoke serotonergic responsivity in studies of schizophrenia. In the present study, we used the carbohydrate-rich meal test as an indicator of 5-HT activity in 12 patients with chronic schizophrenia maintained for at least 6 months on clozapine. PPP 5-HT levels were measured at baseline and at 1, 2 and 3,h after administration of the test. Findings were compared with those in schizophrenic patients treated with classic antipsychotic agents for the same duration. The maximal PPP 5-HT response was reached 120 min after meal administration in the clozapine-treated group and 60 min after in the classic antipsychotic-treated group (P<0.05 vs baseline for both). The 5-HT level (as percentage of baseline) at 60 min was significantly lower in the clozapine-treated group (P<0.02), as were individual PPP 5-HT peak values (P<0.05). The individual time to reach the peak response was similar in the two groups. Our results indicate that in patients with chronic schizophrenia 5-HT responsivity to the natural challenge of carbohydrate-rich meals is lower in those treated with clozapine than in those given classic antipsychotic agents. Values in both groups were lower than those in an appropriate historical comparative group of healthy subjects. We suggest that both clozapine and classic antipsychotic agents suppress serotonergic system sensitivity, but to a different degree. Copyright © 2001 John Wiley & Sons, Ltd. [source]


Effects of extra-fine inhaled beclomethasone/formoterol on both large and small airways in asthma

ALLERGY, Issue 7 2010
N. Scichilone
To cite this article: Scichilone N, Battaglia S, Sorino C, Paglino G, Martino L, Paternò A, Santagata R, Spatafora M, Nicolini G, Bellia V. Effects of extra-fine inhaled beclomethasone/formoterol on both large and small airways in asthma. Allergy 2010; 65: 897,902. Abstract Background:, Airway inflammation in asthma involves both large and small airways, and the combination of inhaled corticosteroids (ICS) and long acting beta-2 agonists (LABA) is the mainstay of therapy. Available inhaled combinations differ in terms of drug delivery to the lung and the ability to reach small airways. Aim:, To evaluate whether treatment with an extra-fine inhaled combination provides additional effects vs a nonextra-fine combination on airway function. Methods:, After a 1- to 4-week run-in period, patients with asthma were randomized to a double blind, double dummy, 12-week treatment with either extra-fine beclomethasone/formoterol (BDP/F) 400/24 ,g daily or fluticasone propionate/salmeterol (FP/S) 500/100 ,g daily. Methacholine (Mch) bronchoprovocation challenge and single breath nitrogen (sbN2) test were performed. Results:, Thirty patients with asthma (15 men), mean age 43, mean forced expiratory volume in the first second (FEV1) 71.4% of predicted, were included. A significant increase (P < 0.01) versus baseline was observed in predose FEV1 in both BDP/F and FP/S groups (0.37 ± 0.13 l and 0.36 ± 0.12 l, respectively). PD20FEV1 Mch improved significantly from 90.42 (±30.08) ,g to 432.41 (±122.71) ,g in the BDP/F group (P = 0.01) but not in the FP/S group. A trend toward improvement vs baseline was observed for BDP/F in closing capacity (CC), whereas no differences were recorded in other sbN2 test parameters. Conclusion:, The findings of this pilot study suggest that an extra-fine inhaled combination for the treatment of asthma has beneficial effects on both large and small airways function as expressed by Mch and sbN2 tests. [source]


Lipoxin A4 generation is decreased in aspirin-sensitive patients in lysine-aspirin nasal challenge in vivo model

ALLERGY, Issue 12 2009
M. Kupczyk
Background:, Lipoxins represent a group of lipoxygenase derived eicosanoids which, in contrast to leukotrienes, are potent anti-inflammatory mediators. The aim of our study was to determine lipoxin A4 (LXA4) and leukotriene C4 (LTC4) levels in nasal lavages after intranasal challenge with aspirin in aspirin intolerant (AIA) in comparison to aspirin tolerant (ATA) asthmatics and after allergen challenge in patients suffering from allergic rhinitis. Methods:, Twelve AIA, 8 ATA and 20 allergic patients were challenged with placebo, 16 mg of lysine-aspirin (Lys-ASA) or allergen (grasses). Nasal lavages were collected and eicosanoids' levels were determined using ELISA. Results:, Clinically positive Lys-ASA challenge in AIA resulted in influx of leukocytes (eosinophils and basophils) to nasal secretions and increase of LTC4 to 106.82 pg/ml (P < 0.05 vs baseline (26.58 pg/ml)) on first hour after the challenge. We did not observe any differences in LTC4 level before and after ASA challenge in ATA. In AIA group the mean level of LXA4 was 43 ± 21.5 pg/ml after placebo and decreased in 2 h after Lys-ASA challenge (29 ± 17 pg/ml, P = 0.015). We found an increase in LXA4 in ATA after ASA provocation as compared to placebo (33 ± 16 pg/ml vs 52 ± 31 pg/ml, P = 0.046). In atopic patients baseline level of LXA4 was 33.49 ± 16.95 pg/ml with no difference after the clinically positive allergen challenge (36.22 ± 13.26 pg/ml, P = 0.23). Conclusions:, Results of our study confirm that AIA have diminished LXs' biosynthesis capacities in vivo after ASA challenge. Taking into consideration anti-inflammatory properties of lipoxins this phenomenon may be partially responsible for the development of chronic inflammation in AIA patients. [source]


Comparison of roflumilast, an oral anti-inflammatory, with beclomethasone dipropionate in the treatment of persistent asthma

ALLERGY, Issue 1 2006
J. Bousquet
Background:, Roflumilast is an oral, once-daily phosphodiesterase 4 inhibitor with anti-inflammatory activity in development for the treatment of asthma. Roflumilast was compared with inhaled beclomethasone dipropionate (BDP) in patients with asthma. Methods:, In a double blind, double-dummy, randomized, noninferiority study, 499 patients (forced expiratory volume in 1 s [FEV1] = 50,85% predicted) received roflumilast 500 ,g once daily or BDP 200 ,g twice daily (400 ,g/day) for 12 weeks. Lung function and adverse events were monitored. Results:, Roflumilast and BDP significantly improved FEV1 by 12% (270 ± 30 ml) and 14% (320 ± 30 ml), respectively (P < 0.0001 vs baseline). Roflumilast and BDP also significantly improved forced vital capacity (FVC) (P < 0.0001 vs baseline). There were no significant differences between roflumilast and BDP with regard to improvement in FEV1 and FVC. Roflumilast and BDP showed small improvements in median asthma symptom scores (,0.82 and ,1.00, respectively) and reduced rescue medication use (,1.00 and ,1.15 median puffs/day, respectively; P < 0.0001 vs baseline). These small differences between roflumilast and BDP were not considered clinically relevant. Both agents were well tolerated. Conclusions:, Once daily, oral roflumilast 500 ,g was comparable with inhaled twice-daily BDP (400 ,g/day) in improving pulmonary function and asthma symptoms, and reducing rescue medication use in patients with asthma. [source]


Clinical efficacy of sublingual and subcutaneous birch pollen allergen-specific immunotherapy: a randomized, placebo-controlled, double-blind, double-dummy study

ALLERGY, Issue 1 2004
M. S. Khinchi
Background:, Both sublingual allergen-specific immunotherapy (SLIT) and subcutaneous immunotherapy (SCIT) have a documented clinical efficacy, but only few comparative studies have been performed. Objective:, To investigate the clinical efficacy of SLIT vs SCIT and secondary to compare SLIT and SCIT with placebo and to evaluate the relative clinical efficacy in relation to systemic side-effects. Methods:, A 3-year randomized, placebo-controlled, double-blind, double-dummy study including 71 adult birch pollen hay fever patients treated for two consecutive years after a baseline year. Allocation to treatment groups was based on disease severity in the baseline season, gender and age. Results:, Clinical efficacy was estimated in 58 patients completing the first treatment year by subtracting baseline data and by calculating the ratio first treatment season vs baseline. SLIT diminished the median disease severity to one-half and SCIT to one-third of placebo treatment. No statistical significant difference between the two groups was observed. Both for symptoms and medication scores actively treated patients showed statistically significant and clinical relevant efficacy compared with placebo. SLIT treatment only resulted in local mild side-effects, while SCIT resulted in few serious systemic side-effects. Conclusion:, Based on the limited number of patients the clinical efficacy of SLIT was not statistically different from SCIT, and both treatments are clinically effective compared with placebo in the treatment of birch pollen rhinoconjunctivitis. The lack of significant difference between the two treatments does not indicate equivalent efficacy, but to detect minor differences necessitates investigation of larger groups. Due to the advantageous safety profile SLIT may be favored. [source]


An energy algorithm improves symptoms in some patients with gastroparesis and treated with gastric electrical stimulation

NEUROGASTROENTEROLOGY & MOTILITY, Issue 4 2006
N. Abidi
Abstract, Gastric electrical stimulation (GES) is effective to improve symptoms of nausea and vomiting in most patients, but very little is known about the effect of varying stimulation parameters. We analysed stimulation parameters in a pilot study of 22 patients (12 idiopathic, four diabetic and four postsurgical) with drug-refractory gastroparesis who did not respond optimally to initial settings. Patients underwent high-frequency/lowenergy GES using identical initial stimulation parameters: 5 mA of current, 330 ,s pulse width, 14 Hz for 0.1 s on and 5.0 s off. Due to lack on optimal response, 22 patients underwent alteration of an algorithm using stimulation parameters. At follow-up (mean of 4.3 years) a dose,response relationship for charge, power and energy were compared with baseline for the whole group and for each diagnostic subgroup by anovadata are reported as mean ± SE. Based on the mean of individual dose,response curves, differences in data are charge, current per pulse and energy per pulse were noted for the whole group at follow up vs baseline. The subgroup of patients with postsurgical gastroparesis required the most energy using the algorithm. In conclusion, an algorithmic approach to identify optimal stimulation parameters in GES for individual patients is associated with symptom improvement. Also, certain subgroups appear to have different energy parameters. Based on this preliminary data, the use of an algorithm for some patients with GES is feasible and may have potential for clinical application. A randomized-controlled trial of different stimulation parameters for GES seems warranted. [source]


Measuring the acute effect of insulin infusion on ATP turnover rate in human skeletal muscle using phosphorus-31 magnetic resonance saturation transfer spectroscopy

NMR IN BIOMEDICINE, Issue 8 2010
Ee Lin Lim
Abstract Mitochondrial dysfunction has been proposed to underlie the insulin resistance of type 2 diabetes. However, the relative time course of insulin action in stimulating ATP turnover rate and glucose uptake in skeletal muscle has not been examined. These two parameters were measured in young healthy subjects using the 31P MRS saturation transfer method in conjunction with the euglycaemic hyperinsulinaemic clamp technique respectively. Glucose infusion rate rose rapidly from 0 to 2.90,±,0.11,mg/kgffm/min during the first 10,min of insulin infusion and further to 6.17,±,0.57,mg/kgffm/min between 15 and 45,min. In contrast, baseline ATP turnover rate was 9.0,±,0.4,µmol/g/min of muscle and did not change during the first 45,min of insulin infusion. Between 50 and 80,minutes ATP turnover rate increased by 8% and remained steady to 150,minutes (9.7,±,0.5 µmol/g/min of muscle, p,=,0.03 vs baseline). The in vivo time course of insulin stimulation of skeletal muscle ATP turnover rate is not consistent with a rate limiting effect upon the initiation of insulin-stimulated glycogen synthesis. Copyright © 2010 John Wiley & Sons, Ltd. [source]


Preserving bone health in patients with hormone-sensitive prostate cancer: the role of bisphosphonates

BJU INTERNATIONAL, Issue 11 2009
Fred Saad
Men with prostate cancer initiating androgen-deprivation therapy (ADT) may have multiple factors that threaten their skeletal health, including increased fracture risk from bone loss during ADT and the propensity to develop bone metastases, which may lead to skeletal-related events (SREs). Bisphosphonates have utility in oncology for patients with bone metastases to prevent bone loss during hormonal therapy and in the benign setting to treat osteoporosis. These agents have an emerging role in patients with hormone-sensitive prostate cancer (HSPC). Etidronate, alendronate, pamidronate, and zoledronic acid have all shown efficacy in preventing ADT-related bone loss. Alendronate and zoledronic acid have also been shown to increase bone mineral density vs baseline during ADT. Patients with bone metastases from HSPC who received 4 mg zoledronic acid every 3 or 4 weeks had a low incidence of skeletal complications, although controlled study data have not been reported. Bisphosphonate treatment in men with HSPC may be effective for the prevention of ADT-related bone loss, underscoring the importance of treating early to avoid SREs and potentially delay disease progression to metastatic bone disease. [source]


Experience with topiramate monotherapy in elderly patients with recent-onset epilepsy

ACTA NEUROLOGICA SCANDINAVICA, Issue 3 2005
J. Gro
Objectives,,, To evaluate the effect of topiramate in elderly patients with onset of epilepsy after the age of 60, treatment-naive or non-responding to an initial antiepileptic drug. Methods,,, Analysis of patients with epilepsy diagnosed in the preceding 5 years, aged ,65 years (n = 43), enrolled in a larger open-label trial (n = 692). After titration to topiramate 100 mg/day over 4 weeks, the dose was adjusted according to individual response (maximum 400 mg/day). Patients were followed up for at least 7 months. Results,,, After 7 months, 79% of patients remained in the study. Seizure frequency decreased significantly vs baseline (P < 0.001); ,50% reduction in seizure frequency was achieved in 87% of patients, 64% remained seizure-free. Both previously treated and naive patients responded. Fourteen per cent dropped out because of insufficient tolerability. No unexpected or unusual adverse events were observed. Conclusions,,, The results indicate that elderly patients respond well to topiramate monotherapy. The high patient retention rate reflects a favourable tolerability profile in this population. [source]


Is a morphologically intact anal sphincter necessary for success with sacral nerve modulation in patients with faecal incontinence?

COLORECTAL DISEASE, Issue 3 2008
J. Melenhorst
Abstract Objective, Sacral nerve modulation (SNM) for the treatment of faecal incontinence was originally performed in patients with an intact anal sphincter or after repair of a sphincter defect. There is evidence that SNM can be performed in patients with faecal incontinence and an anal sphincter defect. Method, Two groups of patients were analysed retrospectively to determine whether SNM is as effective in patients with faecal incontinence associated with an anal sphincter defect as in those with a morphologically intact anal sphincter following anal repair (AR). Patients in group A had had an AR resulting in an intact anal sphincter ring. Group B included patients with a sphincter defect which was not primarily repaired. Both groups underwent SNM. All patients had undergone a test stimulation percutaneous nerve evaluation (PNE) followed by a subchronic test over 3 weeks. If the PNE was successful, a permanent SNM electrode was implanted. Follow-up visits for the successfully permanent implanted patients were scheduled at 1, 3, 6 and 12 months and annually thereafter. Results, Group A consisted of 20 (19 women) patients. Eighteen (90%) had a positive subchronic test stimulation. Twelve patients had a successful SNM implant during middle-term follow-up. Group B consisted of 20 women. The size of the defect in the anal sphincter varied between 17% and 33% of the anal circumference. Fourteen (70%) had a positive subchronic test stimulation. Twelve patients had a successful SNM implant during middle-term follow-up. In both groups, the mean number of incontinence episodes decreased significantly with SNM (test vs baseline: P = 0.0001, P = 0.0002). There was no significant difference in resting and squeeze pressures during SNM in group A, but in group B squeeze pressure had increased significantly at 24 months. Comparison of patient characteristics and outcome between groups A and B revealed no statistical differences. Conclusion, A morphologically intact anal sphincter is not a prerequisite for success in the treatment of faecal incontinence with SNM. An anal sphincter defect of <33% of the circumference can be effectively treated primarily with SNM without repair. [source]