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Maintenance Period (maintenance + period)

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Medical Sciences	88%

Selected Abstracts

Safety of pramlintide added to mealtime insulin in patients with type 1 or type 2 diabetes: a large observational study

DIABETES OBESITY & METABOLISM, Issue 6 2010
R. Pencek
The objective of this Phase 4, open-label, multicentre, observational study was to fulfil food and drug administration (FDA) postapproval requirement to evaluate in healthcare practices the risk of insulin-induced severe hypoglycaemia following initiation of pramlintide therapy in N = 1297 patients with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) with inadequate glycaemic control. The duration of the study was approximately 6 months. During the adjustment period (0,3 months), the incidence and event rate of patient-ascertained severe hypoglycaemia (PASH) were 4.8% and 0.33 events/patient-year in patients with T1DM and 2.8% and 0.19 events/patient-year in patients with T2DM. During the maintenance period (>3,6 months), the incidence and event rate of PASH declined in patients with T1DM or T2DM. This study confirms that in healthcare practices, the risk of insulin-induced severe hypoglycaemia following the initiation of pramlintide is low in patients with T1DM or T2DM. [source]

Adjunctive lacosamide for partial-onset seizures: Efficacy and safety results from a randomized controlled trial

EPILEPSIA, Issue 3 2009
Péter Halász
Summary Purpose:, To evaluate the efficacy and safety of lacosamide (200 and 400 mg/day) when added to one to three concomitant antiepileptic drugs (AEDs) in patients with uncontrolled partial-onset seizures. Methods:, This multicenter, double-blind, placebo-controlled trial randomized patients (age 16,70 years) with partial-onset seizures with or without secondary generalization to placebo, lacosamide 200, or lacosamide 400 mg/day. The trial consisted of an 8-week baseline, a 4-week titration, and a 12-week maintenance period. Results:, Four hundred eighty-five patients were randomized and received trial medication. Among these, 87% were taking two or more concomitant AEDs. Median percent reduction in seizure frequency per 28 days from baseline to maintenance period (intent-to-treat, ITT) was 20.5% for placebo, 35.3% for lacosamide 200 mg/day (p = 0.02), and 36.4% for 400 mg/day (p = 0.03). In the per protocol population, the reductions were 35.3% for lacosamide 200 mg/day (p = 0.04) and 44.9% for 400 mg/day (p = 0.01) compared to placebo (25.4%). The 50% responder rate for lacosamide 400 mg/day (40.5%) was significant (p = 0.01) over placebo (25.8%), but was not for 200 mg/day (35.0%). In the per protocol population, the 50% responder rate for lacosamide 400 mg/day (46.3%) was significant (p < 0.01) compared with the placebo responder rate (27.5%). Dose-related adverse events (AEs) included dizziness, nausea, and vomiting. Clinically relevant changes in the mean plasma concentrations of commonly used AEDs were not observed. Discussion:, Results of this trial demonstrated the efficacy and tolerability of adjunctive lacosamide 200 and 400 mg/day and support that lacosamide may be an advantageous option for the treatment of partial-onset seizures in patients with epilepsy. [source]

Five-year maintenance follow-up of early-onset periodontitis patients

JOURNAL OF CLINICAL PERIODONTOLOGY, Issue 6 2003
Joanna J. Kamma
Abstract Objectives: The purpose of this study was to evaluate the clinical and microbiological status of patients with early-onset or aggressive periodontitis (EOP) who had received supportive periodontal care (SPC) every 3,6 months for a period of 5 years, following active periodontal treatment. Material & Methods: The study population consisted of 25 individuals with early-onset periodontitis. Clinical examination and recordings of probing pocket depth (PPD) and clinical attachment level (CAL) were performed at baseline prior to treatment (T0), 3 months following the termination of active periodontal treatment (T1) and annually at the SPC appointments (T2,T3,T4,T5). Microbiological samples were obtained at the 5-year SPC (T5). Subgingival plaque samples for each individual were collected from one deep pocket (>5 mm), based on pretreatment measurements, randomly selected in each quadrant. The levels of Actinobacillus actinomycetemcomitans, Bacteroides forsythus, Porphyromonas gingivalis and Treponema denticola were determined using oligonucleotide probe hybridization. Results: During the 5-year period, the mean of SPC/patient was 12.7 sessions. A significant improvement was observed in PPD, CAL, gingival bleeding index and suppuration following treatment. However, between T1 and T5, 134 sites in 20 patients deteriorated with a CAL loss of,2 mm. Out of these 134 sites showing disease progression, microbial samples were randomly obtained in 13 sites (9.7%) from 8 patients. Among other factors, smoking and stress were found to have significant predictive value on the future attachment loss. P. gingivalis, T. denticola and total bacterial load were statistically significantly higher in patients who experienced disease progression during the 5-year maintenance period. Conclusions: For most EOP patients, regular SPC was effective in maintaining clinical and microbiological improvements attained after active periodontal therapy. However, a small percentage of sites was identified as progressive in 20 patients. Variables found to be related to periodontal progression were the presence of as well as the high bacterial counts of P. gingivalis, T. denticola and total bacterial load, number of acute episodes, number of teeth lost, smoking and stress. Zusammenfassung Erhaltungstherapie über fünf Jahre bei Patienten mit früh einsetzender Parodontitis (EOP) Ziele: Der Zweck dieser Studie war es, 5 Jahre nach aktiver Parodontalbehandlung den klinischen und mikrobiologischen Zustand von Patienten mit früh einsetzender oder aggressiver Parodontitis (EOP), bei welchen alle 3-6 Monate eine parodontale Erhaltungstherapie (SPC) erfolgte, zu evaluieren. Material & Methoden: Die Studienpopulation bestand aus 25 Individuen mit früh einsetzender Parodontitis. Die klinische Untersuchung und Aufzeichnung der Sondierungstiefe (PPD) sowie des klinischen Attachmentniveaus (CAL) erfolgten bei der Eingangsuntersuchung vor der Behandlung (T0), drei Monate nach Beendigung der aktiven Parodontalbehandlung (T1) und jährlich bei den SPC-Terminen (T2,T3,T4,T5). Die mikrobiologischen Proben wurden bei der 5-Jahres-SPC gewonnen (T5). Für jedes Individuum wurden die subgingivalen Plaqueproben in jedem Quadranten aus einer tiefen Tasche (>5mm) entnommen. Dies geschah randomisiert und auf der Grundlage der Messungen vor der Behandlung. Das Niveau von Actinobacillus actinomycetemcomitans, Bacteroides forsythus, Porphyromonas gingivalis und Treponema denticola wurden unter Verwendung der Hybridisierung mit Oligonukleotid-Sonden bestimmt. Ergebnisse: Während der 5-jährigen Periode betrug die mittlere Anzahl der SPC-Sitzungen pro Patient 12,7. Nach der Behandlung wurden bei PPD, CAL, Gingiva-Blutungs-Index und der Pusentleerung signifikante Verbesserungen beobachtet. Jedoch haben sich zwischen T1 und T5 bei 20 Patienten 134 Taschen mit einem CAL-Verlust von=2mm verschlechtert. Bei 8 Patienten wurden aus diesen 134 Taschen, mit Progression der Erkrankung, von 13 Taschen (9,7%) randomisiert mikrobiologische Proben entnommen. Innerhalb anderer Faktoren wurde bei Rauchen und Stress ein signifikanter Vorhersagewert für zukünftigen Attachmentverlust vorgefunden. Bei den Patienten, die in der 5-jährigen Erhaltungsperiode eine Progression der Erkrankung erfuhren lagen P. gingivalis, T. denticola und die bakterielle Gesamtbelastung höher. Schlussfolgerungen: Für die meisten EOP-Patienten die regelmäßig an der parodontalen Erhaltungstherapie teilnahmen war diese hinsichtlich der Aufrechterhaltung der nach der aktiven Parodontaltherapie erzielten klinischen und mikrobiologischen Verbesserungen erfolgreich. Jedoch wurde bei 20 Patienten ein geringer Prozentsatz von Taschen als fortschreitend identifiziert. Die Variablen, von denen gefunden wurde, dass sie eine Beziehung zur Progression haben waren: sowohl Vorhandensein von P. gingivalis, T. denticola als auch hohe Bakterienzahl von P. gingivalis, T. denticola und die bakterielle Gesamtbelastung, Anzahl der akuten Episoden, Anzahl verlorener Zähne, Rauchen und Stress. Résumé Suivi en maintenance sur 5 ans de patients atteints de parodontites d'apparition précoce. Objectifs: Cette étude se propose d'évaluer l'état clinique et microbiologique de patients atteints de parodontites d'apparition précoce ou agressive (EOP) qui furent suivis en maintenance (SPC) tous les 3-6 mois pendant une période de 5 ans après un traitement parodontal actif. Matériel & Méthodes: La population étudiée consistait en 25 individus atteints de parodontites d'apparition précoce. L'examen clinique et l'enregistrement des profondeurs de poche (PPD) et du niveau d'attache (CAL) furent réalisés avant le traitement (T0), 3 mois après la fin du traitement actif (T1) et chaque année aux rendez vous de maintenance (T2,T3,T4,T5). Des échantillons microbiologiques furent prélevés lors de la maintenance à 5 ans (T5). La plaque sous-gingivale de chaque patient fut prélevée d'une poche profonde (>5mm), sur la base des examens initiaux, choisis au hasard dans chaque quadrant. Les niveaux d' Actinobacillus actinomycetemcomitans, Bacteroides forsythus, Porphyromonas gingivalis et Treponema denticola furent déterminés par hybridation par sonde d'oligonucleotides. Résultats: pendant la période d'examination de 5 ans, la moyenne des SPC par patient fut de 12.7 sessions. Une amélioration significative fut observée pour PPD, CAL, l'indice de saignement gingival et la suppuration suite au traitement. Cependant, entre T1 et T5, 134 sites chez 20 patients connurent une détérioration avec une perte d'attache de 2 mm. De ces 134 sites qui présentaient une progression de la maladie, des échantillons microbiologiques furent obtenus aléatoirement dans 13 sites (9.7%) chez 8 patients. Parmi d'autres facteurs, le tabagisme et le stress furent reconnus comme ayant une significative valeur prédictive pour de futures pertes d'attache. P. gingivalis, T. denticola et la charge bactérienne totale étaient de façon statistiquement significatif plus importants chez les patients chez qui la maladie progressait au cours des 5 ans de maintenance. Conclusions: pour la plupart des patients atteints d' EOP, des soins parodontaux de soutien réguliers sont efficaces pour maintenir les améliorations cliniques et microbiologiques obtenus par le traitement actif. Cependant, un petit pourcentage de sites progressait chez 20 patients. Les variables en ralation avec cette progression étaient la présence et aussi un comptage important de P. gingivalis, T. denticola et la charge bactérienne totale, le nombre d'épisodes aigus le nombre de dents perdues le tabagisme et le stress. [source]

Autoimmune liver diseases in a paediatric population with coeliac disease , a 10-year single-centre experience

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 2 2010
A. R. DI BIASE
Summary Backgroud, Coeliac disease (CD) can be associated with liver disease. Gluten-free diet (GFD) normalizes cryptogenic forms, but most likely not autoimmune hepatitis (AIH). For this condition, immunosuppressants represent the treatment. However, when these are stopped, AIH generally relapses. Aim, To determine in CD children liver test abnormality frequency, the effect of GFD alone, or plus prolonged immunosuppressants on AIH course. Methods, Coeliac disease patients with abnormal transaminases were selected; if transaminases <5 × UNL (upper normal limits), GFD alone was administered; if >5 × UNL, liver examinations and biopsy were performed. In AIH, immunosuppressants were administered (5 years). Treatment was stopped only if patients remained in remission during the entire maintenance period and normalized liver histology. Results, A total of 140 out of 350 CD children had hypertransaminaemia: 133 cryptogenic disease, 7 AIH. GFD normalized only cryptogenic hepatitis. During treatment, all AIH persistently normalized clinical and biochemical parameters; after withdrawal, six patients maintained a sustained remission (follow-up range: 12,63 months), while one relapsed. Conclusions, In CD children with AIH, only GFD plus immunosuppressants determines a high remission rate. When clinical remission is reached, a prolonged immunosuppressive regimen induces a high sustained remission rate after treatment withdrawal, indicating that this regimen may prevent early relapse. Aliment Pharmacol Ther,31, 253,260 [source]

Quality of life in acute and maintenance treatment of non-erosive and mild erosive gastro-oesophageal reflux disease

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 4 2005
F. PACE
Summary Background:, Quality of life has been assessed in a large, multicentre randomized, open label study. Aim:, To evaluate the economic and clinical consequences of two different maintenance treatment modalities, administered to 6017 gastro-oesophageal reflux disease patients at 451 gastroenterological centres in Italy. Methods:, Adult gastro-oesophageal reflux disease patients received, at enrolment, an acute treatment of esomeprazole 40 mg/day for 4 weeks and, if successfully treated, were randomized into two maintenance treatment strategies: esomeprazole 20 mg/day or esomeprazole on demand for 6 months. A baseline endoscopy allowed the exclusion of grade II,IV oesophagitis according to Savary,Miller's classification. Burden of gastro-oesophageal reflux disease was measured at baseline by the generic questionnaire Short-Form 36 and by a disease specific instrument, quality of life in reflux and dyspepsia (QOLRAD), also administered at start and conclusion of maintenance period. Investigators were required to collect patient judgement about the degree of satisfaction with treatment effect on heartburn, with a 7-point scale. Results:, A comparison between Short-Form 36 scores and the normative source of the Italian general population suggested that symptomatic gastro-oesophageal reflux disease patients experience a worse quality of life than the general population. At the end of the 4-week treatment with esomeprazole 40 mg all (QOLRAD) dimensions showed a statistically significant (P < 0.0001) and clinically meaningful improvement. Satisfaction level towards treatment was reported high in the total enrolled population after acute treatment with esomeprazole 40 mg/day (96.2% satisfied and 64.4% very satisfied). A statistically significant difference in (QOLRAD) scores was registered at the end of maintenance phase in favour of the continuous regimen, nevertheless the size of this difference was very small in all dimensions; similarly, the proportion of patients very satisfied was slightly higher in the continuous treatment arm (64.5%) than in the on-demand arm (59.7%). Conclusions:, Gastro-oesophageal reflux disease can significantly impair health-related quality of life and esomeprazole therapy allows immediate relief in the acute phase of the disease. Quality of life improvement was maintained during the 6-month follow-up with a slight difference in term of quality of life in reflux and dyspepsia scores and patients' satisfaction in favour of the continuous treatment strategy. [source]

Long-term study of fluticasone propionate aqueous nasal spray in acute and maintenance therapy of nasal polyposis

ALLERGY, Issue 6 2009
R. Jankowski
Background:, Topical steroids are first-line medication to control nasal polyposis (NP), a disease with long-term clinical course. Objective:, The aim of this study was to evaluate the efficacy and safety of fluticasone propionate aqueous nasal spray (FPANS) 200 ,g twice a day (bd) after 1 month of treatment, and to compare FPANS 200 ,g bd and FPANS 200 ,g once a day (od) in maintenance and long-term treatment. Methods:, Double-blind, placebo-controlled, 8-month study with three treatment periods (1-month acute period followed with 1-month maintenance period and 6-month follow-up period) was carried out. Group 1 received FPANS 200 ,g bd, during acute, maintenance and follow-up periods, Group 2 received FPANS 200 ,g bd during acute period and FPANS 200 ,g od during maintenance and follow-up periods, and Group 3 received placebo during acute and maintenance periods and FPANS 200 ,g bd during follow-up period. Endpoints were change from baseline in clinic peak nasal inspiratory flow (PNIF), domiciliary evening PNIF, intensity of symptoms and polyposis grade. Results:, After acute period and maintenance periods, FPANS 200 ,g bd was significantly more effective than placebo on all endpoints and more effective than FPANS 200 ,g od after 1-month maintenance period on clinic PNIF, evening PNIF, obstruction, percentage of days with no sense of smell and percentage of nights with no disturbances. The two doses were similar on other endpoints. After the 6-month follow-up period, there was no difference between the two doses of FPANS at all efficacy endpoints. The safety profile of FPANS did not highlight any new or unanticipated adverse events. Conclusion:, The study demonstrated the efficacy of FPANS 200 ,g bd in acute treatment and FPANS 200 ,g od as a sufficient dose to maintain a long-term efficacy in the treatment for NP. [source]

Rotigotine improves restless legs syndrome: A 6-month randomized, double-blind, placebo-controlled trial in the United States,,§

MOVEMENT DISORDERS, Issue 11 2010
Wayne A. Hening MD
Abstract This randomized, double-blinded, placebo-controlled trial (NCT00135993) assessed efficacy and safety of the dopamine agonist rotigotine in the treatment of idiopathic restless legs syndrome (RLS) over a 6-month maintenance period. A total of 505 eligible participants with moderate to severe RLS (IRLS sum score , 15) were randomly assigned to five groups to receive either placebo or rotigotine (0.5, 1, 2, or 3 mg/24 hr) delivered by once-daily transdermal patch (fixed-dose regimen). The two co-primary efficacy parameters decreased from baseline to end of maintenance in IRLS sum score and in clinical global impressions (CGI-1) score. On both primary measures, 2 and 3 mg/24 hr rotigotine was superior to placebo (P < 0.001). Adjusted treatment differences to placebo for the IRLS sum score were ,4.5 (95% CI: ,6.9, ,2.2) for 2 mg/24 hr rotigotine, ,5.2 (95% CI: ,7.5, ,2.9) for 3 mg/24 hr rotigotine, and for CGI item 1 ,0.65 (95% CI: ,1.0, ,0.3) and ,0.9 (95% CI: ,1.3, ,0.5) for the 2 and 3 mg/24 hr doses, respectively. Skin reactions (27%) and known dopaminergic side effects such as nausea (18.1%) and headache (11.6%) were mostly mild or moderate in rotigotine subjects. Rotigotine transdermal patches releasing 2 to 3 mg/24 hr significantly reduced the severity of RLS symptoms. Treatment efficacy was maintained throughout the 6-month double-blind period. © 2010 Movement Disorder Society [source]

Comparison of chronic renal failure rats and modification of the preparation protocol as a hyperphosphataemia model

NEPHROLOGY, Issue 2 2008
KAZUHIRO TERAI
SUMMARY: Background: Several animal models with chronic renal failure have been established and used for demonstrating complications including hyperphosphataemia. Although long-time feeding is required to cause hyperphosphataemia in animals, a few modifications have been reported to provide more useful models for research. Methods: Three separate experiments were carried out in the present study. First, characteristics of commonly used subnephrectomized (5/6Nx) rats and rats fed an adenine diet (0.75% adenine in normal diet) were compared as hyperphosphataemia models. Next, using adenine-diet rats, the inhibitory effect of sevelamer hydrochloride (Sev) on serum phosphorus elevation was examined. Third, oral adenine dosing for induction of hyperphosphataemia and validation as a model using Sev were examined. Results: Serum phosphorus in 5/6Nx rats became elevated in 8,17 weeks, but the levels and time points of elevation differed among animals. In adenine-fed rats, the elevation was more clearly demonstrated with less diversity at 4 weeks. The data revealed a potential shorter model preparation period and the importance of controlling feeding amounts. Oral adenine dosing induced hyperphosphataemia by 12 days, and Sev treatment was inhibitory. After a maintenance period of over a month (no treatments), Sev-treated rats showed hyperphosphataemia as did oral adenine-dosed control rats. The serum phosphorus levels significantly decreased on further Sev treatment. Conclusion: Oral dosing with adenine made the model preparation period definitely shorter, and its usefulness as a hyperphosphataemia model was revealed using Sev. [source]

Titration with Oxymorphone Extended Release to Achieve Effective Long-Term Pain Relief and Improve Tolerability in Opioid-Naive Patients with Moderate to Severe Pain

PAIN MEDICINE, Issue 7 2008
Richard Rauck MD
ABSTRACT Objective., Assess the effectiveness and tolerability of a program of gradual dose titration with oxymorphone extended release (ER) for treatment of moderate to severe chronic pain in opioid-naive patients. Design., Open-label, nonrandomized 6-month study with a titration/stabilization period of ,1 month followed by a 5-month maintenance period. Setting., Multidisciplinary pain centers in the United States. Patients., Adult opioid-naive patients with moderate to severe chronic pain. Interventions., Patients were gradually titrated from a 5-mg dose of oxymorphone ER (taken every 12 hours) to a stabilized dose that provided effective pain relief and was well tolerated. Outcome Measures., Brief Pain Inventory Short Form questions 5 and 9, patient and physician global assessments of pain relief, adverse events (AEs), and discontinuations. Results., The majority (94/126; 75%) of patients were stabilized on a dose of oxymorphone ER that provided effective pain relief with tolerable AEs. Most (81/94; 86%) required <24 days to reach a stable dose. Sixteen percent of patients in the titration period and 17% of patients in the maintenance period discontinued because of AEs possibly or probably related to oxymorphone ER. Patients completing the entire 5-month maintenance period experienced effective pain relief with significant (>50%) reductions of pain interference with quality-of-life measures. There was minimal dose escalation over the 5 months and low use of rescue medication. Conclusions., Oxymorphone ER provided effective pain relief from moderate to severe chronic pain in opioid-naive patients. Gradual titration was well tolerated, with a low rate of discontinuations caused by AEs. [source]

Assessing the clinical or pharmaco-economical benefit of target controlled desflurane delivery in surgical patients using the Zeus® anaesthesia machine,

ANAESTHESIA, Issue 11 2009
B. Lortat-Jacob
Summary The Zeus® anaesthesia machine includes an auto-control mode which allows targeting of end-tidal volatile and inspired oxygen concentrations. We assessed the clinical benefits and economic impact of this target-controlled anaesthesia compared with conventional manually controlled anaesthesia. Eighty patients were randomly assigned to receive desflurane either with a fresh gas flow set by the anaesthetist or in auto-control mode. Drug delivery was adjusted to maintain bispectral index between 40,60 units and systolic arterial pressure under 15 mmHg above its pre-induction value (upper limit) and over 90 mmHg (lower limit). Blood pressure was maintained in the desired range for 89% and 91% of the maintenance period for auto-control and manual control respectively (p = 0.49). Bispectral index was in the desired range for 82% and 79% of the maintenance period, for auto-control and manual control respectively (p = 0.46). Oxygen consumption was more than halved by the use of auto-control mode, and mean (SD) desflurane consumption during surgery was 0.07 (0.04) vs 0.2 (0.07) ml.min,1 in auto-control and manual control respectively (p < 0.0001). The number of drug delivery adjustments per hour was significantly lower in auto-control mode (mean (SD) 7 (2) vs 15 (12); p < 0.0001). Thus, the auto-control mode provided similar haemodynamic stability and bispectral control as did conventional manually controlled anaesthesia, but led to a reduction in gas and vapour consumption with a more clinically acceptable workload. [source]

Stimulation and microswitch-based programs for enhancing indices of happiness: a maintenance assessment

BEHAVIORAL INTERVENTIONS, Issue 1 2003
Giulio E. Lancioni
This study assessed whether stimulation and microswitch-based programs maintained their positive impact on indices of happiness over time. Three people with multiple disabilities, who had participated in a study comparing these programs, continued to be exposed to them over a maintenance period of 5 or 6 months. Maintenance data showed that the frequencies of indices of happiness increased or remained unchanged for two participants and declined for the third. The frequencies of microswitch activations were higher for two of the participants and largely unchanged for the other. Procedural aspects of the study, implications of the findings, and relevant issues for new research are discussed. Copyright © 2003 John Wiley & Sons, Ltd. [source]

Health-related utility among adults with atopic dermatitis treated with 0·1% tacrolimus ointment as maintenance therapy over the long term: findings from the Protopic® CONTROL study

BRITISH JOURNAL OF DERMATOLOGY, Issue 6 2009
C.D. Poole
Summary Background, Long-term maintenance treatment with 0·1% tacrolimus ointment for the prevention of flares has been demonstrated to be well tolerated and effective in adults for the treatment of atopic dermatitis (AD) but its impact on health-related utility has not been reported. Objectives, The purpose of this study was to estimate utility changes associated with the use of tacrolimus ointment in the maintenance treatment of adults with AD. Methods, Data were collected from a clinical trial investigating long-term maintenance treatment with 0·1% tacrolimus ointment in adults with AD. All patients were treated with twice-daily tacrolimus ointment during an open-label period (OLP) of up to 6 weeks, with subsequent randomization to a double-blind disease-control period (DCP) of 12 months comparing tacrolimus ointment, used twice weekly as maintenance treatment, vs. the emollient vehicle as standard treatment. Health-related utility (EQ-5Dindex) was estimated by Monte Carlo simulation from SF-12 responses by application of a published response mapping algorithm and the U.K. tariff for EQ-5D responses and SF-6D responses, respectively. Results, Evaluable data were available for 257 patients stratified into mild, moderate or severe AD with a median age at screening of 28 years [interquartile range (IQR) 22,38] and 40% male. At screening the median EQ-5Dindex across the strata was 0·848 units (IQR 0·704,0·882) for mild cases, 0·796 (0·737,0·876) for moderate cases, and 0·760 (0·661,0·823, P < 0·001) for those with severe disease. At the end of the OLP, mean utility improvement across all strata was 0·027 [95% confidence interval (CI) ,0·011 to 0·065, P = 0·165] for mild cases, 0·046 (95% CI 0·015,0·064, P = 0·002) for moderate cases and 0·076 (95% CI 0·035,0·118, P < 0·001) for those with severe disease. At the end of the blinded DCP, repeated measures analysis showed an age- and sex-adjusted mean change of 0·045 units (P < 0·001) for subjects treated with tacrolimus ointment over those treated with emollient vehicle. Conclusions, Patients with AD of all severities showed considerable decrements in health-related utility. However, treatment with 0·1% tacrolimus ointment was associated with clinically significant improvement in health-related utility for patients with moderate and severe AD, which was sustained over a 12-month maintenance period compared with those using standard treatment with an emollient vehicle. [source]

Efficacy and safety of 800 and 1200 mg eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures

ACTA NEUROLOGICA SCANDINAVICA, Issue 5 2009
A. Gil-Nagel
Objectives ,,, To evaluate the efficacy and safety of eslicarbazepine acetate (ESL) as adjunctive therapy in adults with partial-onset seizures. Material and methods ,,, Double-blind, placebo-controlled, parallel-group, multicenter study consisting of an 8-week baseline period, after which patients were randomized to placebo (n = 87) or once-daily ESL 800 mg (n = 85) or 1200 mg (n = 80). Patients received half dose during 2 weeks preceding a 12-week maintenance period. Results ,,, Seizure frequency over the maintenance period was significantly (P < 0.05) lower than placebo in both ESL groups. Responder rate was 23% (placebo), 35% (800 mg), and 38% (1200 mg). Median relative reduction in seizure frequency was 17% (placebo), 38% (800 mg), and 42% (1200 mg). The most common adverse events (AEs) (>10%) were dizziness, somnolence, headache, and nausea. The majority of AEs were of mild or moderate severity. Conclusions ,,, Once-daily treatment with ESL 800 and 1200 mg was effective and generally well tolerated. [source]

Dynamic links between theta executive functions and alpha storage buffers in auditory and visual working memory

EUROPEAN JOURNAL OF NEUROSCIENCE, Issue 9 2010
Masahiro Kawasaki
Abstract Working memory (WM) tasks require not only distinct functions such as a storage buffer and central executive functions, but also coordination among these functions. Neuroimaging studies have revealed the contributions of different brain regions to different functional roles in WM tasks; however, little is known about the neural mechanism governing their coordination. Electroencephalographic (EEG) rhythms, especially theta and alpha, are known to appear over distributed brain regions during WM tasks, but the rhythms associated with task-relevant regional coupling have not been obtained thus far. In this study, we conducted time,frequency analyses for EEG data in WM tasks that include manipulation periods and memory storage buffer periods. We used both auditory WM tasks and visual WM tasks. The results successfully demonstrated function-specific EEG activities. The frontal theta amplitudes increased during the manipulation periods of both tasks. The alpha amplitudes increased during not only the manipulation but also the maintenance periods in the temporal area for the auditory WM and the parietal area for the visual WM. The phase synchronization analyses indicated that, under the relevant task conditions, the temporal and parietal regions show enhanced phase synchronization in the theta bands with the frontal region, whereas phase synchronization between theta and alpha is significantly enhanced only within the individual areas. Our results suggest that WM task-relevant brain regions are coordinated by distant theta synchronization for central executive functions, by local alpha synchronization for the memory storage buffer, and by theta,alpha coupling for inter-functional integration. [source]