A comparison of budesonide/formoterol maintenance and reliever therapy vs. conventional best practice in asthma management.

Objective: To study the effectiveness and safety of budesonide/formoterol (Symbicort) Maintenance And Reliever Therapy (Symbicort SMART, AstraZeneca, Södertalje, Sweden), a simplified management approach with one inhaler compared with conventional best practice (CBP) with multiple inhalers in patients with persistent asthma.

Design: Open-label randomised controlled parallel group trial, 6-month treatment.

Participants: A total of 908 patients > or = 12 years of age, with persistent asthma receiving treatment with inhaled corticosteroids (ICS), either alone or in conjunction with long-acting beta(2)-agonist.

Safety, tolerability and efficacy of a rapid dose escalation of quetiapine in bipolar I mania: the FATIMA study.

Objective: The FATIMA study (FAst TItration of quetiapine fumarate in bipolar I MAnia) evaluated the safety, tolerability and efficacy of a rapid dose escalation of quetiapine in acutely ill bipolar I patients experiencing a manic episode.

Methods: In an open-label, phase II pilot study, 29 patients aged 18 years or older, hospitalised with a bipolar I manic episode, received quetiapine twice daily for 21 days. Quetiapine was administered at 200, 400, 600, then 800 mg/day on the first 4 days, with flexible dosing (400-800 mg/day) subsequently.

Centralized Pan-European survey on the undertreatment of hypercholesterolaemia (CEPHEUS).

The CEntralized Pan-European survey on tHE Under-treatment of hypercholeSterolaemia (CEPHEUS) was initiated to quantify the degree of under-treatment of hypercholesterolaemia in Europe. Its primary objective was to establish the proportion of treated patients reaching the LDL-C goals according to the Third Joint European Task Force guidelines. Secondary objectives targeted subgroups of primary or secondary prevention patients and those with a metabolic syndrome.

Evaluation of the GERD Impact Scale, an international, validated patient questionnaire, in daily practice. Results of the ALEGRIA study.

Background And Study Aims: Gastroesophageal reflux disease (GERD) is a common chronic disease that is primarily diagnosed based on symptom severity and frequency. This study gathered epidemiological data in a population of GERD patients and evaluated the added-value of the GERD Impact Scale (GIS), a novel, validated patient questionnaire, as a tool for initial and long-term patient management.

Patients And Methods: This observational study recruited patients (296 study centers) with symptomatic GERD and a history of erosive, or reflux, esophagitis.

Discovery Belux: comparison of rosuvastatin with atorvastatin in hypercholesterolaemia.

Methods: Discovery Belux is an open-label, multicentre, randomised, phase IIIb, parallel group study comparing the efficacy of rosuvastatin (RSV) and atorvastatin (ATV) on changes in lipid levels and the achievement of European Atherosclerosis Society (EAS) lipid goals. Patients (> or = 18 years) with primary hypercholesterolaemia, with a low-density lipoprotein (LDL-C) level > 120 mg/dl (on treatment) or > 135 mg/dl (naive subjects), and with a statin indication, were randomised to receive RSV 10 mg/day or ATV 10 mg/day for 12 weeks. Patients not at goal after 12 weeks and receiving ATV 10 were further switched to RSV 10 mg for another 12 weeks.

An open multicentre pilot study examining the safety, efficacy and tolerability of fast titrated (800 mg/day by day 4) quetiapine in the treatment of schizophrenia/schizoaffective disorder.

Objective. Rapid dose escalation of quetiapine could offer prompt and effective therapy to patients requiring hospitalization for schizophrenia or schizoaffective disorder. This study evaluated the safety, tolerability, and efficacy of a rapid dose escalation of quetiapine to 800 mg/day over 4 days in patients with severe psychotic symptoms diagnosed as schizophrenia or schizoaffective disorder.

Fulvestrant (Faslodex) in advanced breast cancer: clinical experience from a Belgian cooperative study.

Fulvestrant (Faslodex) is a new estrogen receptor (ER) antagonist with no agonist effects that is licensed for the treatment of postmenopausal women with hormone-sensitive advanced breast cancer (ABC) who have progressed/recurred on prior antiestrogen therapy. The Faslodex Compassionate Use Program (CUP) provides expanded access to fulvestrant in countries where it is not yet available for patients who are not eligible to enter clinical trials. This analysis pools data from 402 patients who received fulvestrant as part of the CUP in Belgium, predominantly as 3rd- to 5th-line endocrine therapy for ABC.

Improvement of the eradication rate of Helicobacter pylori gastritis in children is by adjunction of omeprazole to a dual antibiotherapy.

Aim: The possible improvement of efficacy and tolerability of a 7-day dual antibiotherapy amoxicillin-clarithromycin (AC) on the eradication of Helicobacter pylori (H. pylori) gastritis in children by the adjunction of omeprazole (OAC) was studied.

Methods: Forty-six children presenting with H.

Gefitinib monotherapy in advanced nonsmall cell lung cancer: a large Western community implementation study.

Epidermal growth factor receptor tyrosine kinase inhibitors represent a new treatment option for patients with advanced nonsmall cell lung cancer (NSCLC). This retrospective study examined to what extent previous clinical trial experience matches large-scale Western community implementation of this treatment. In the Belgian expanded access programme, the data from 513 patients with advanced or metastatic NSCLC, not suitable for further chemotherapy and receiving oral gefitinib 250 mg.

Regulation of expression of galectin-7 in human nasal polyps by budesonide.

Background: Nasal polyposis is a model for the study of inflammatory processes. We analyzed the expression of galectin-7, a growth regulator, in surface epithelium, glandular epithelium, and connective tissue in human nasal polyps, and examined the effect of the glucocorticoid budesonide on its expression in human nasal polyps ex vivo.

Methods: Using quantitative, computer-assisted microscopy and immunohistochemistry, we measured galectin-7 expression in nine nasal polyps obtained by surgical resection.

Patients' experience of pain and discomfort during instrumentation in the diagnosis and non-surgical treatment of periodontitis.

Background: The present multicenter study aimed to survey the patients' experiences in relation to the diagnosis and non-surgical treatment of periodontitis according to current treatment routine.

Methods: Patients (N = 268) treated for plaque-related periodontitis were enrolled in two groups: group 1 received primary probing of pocket depths (PD 1) and/or primary scaling and root planing (SRP 1); group 2 consisted of patients who were scheduled in the different centers for recall PD/scaling/subgingival instrumentation. Data collection included a full periodontal status, anesthesia employed, procedure time, and patient self-completed questionnaires to assess their previous and current experience of pain and discomfort during anesthesia and periodontal treatment.

Antihypertensive treatment based on home or office blood pressure--the THOP trial.

Objective And Methods: In this randomized clinical trial, conducted in 400 hypertensive patients [sitting diastolic blood pressure (DBP) >95 mmHg], blood pressure-lowering therapy was adjusted in a stepwise manner, either on the basis of the self-measured DBP at home or on the basis of conventional DBP measured at the doctor's office.

Results: Therapy guided by home blood pressure instead of office blood pressure led to less intensive drug treatment and marginally lower costs, but also to less blood pressure control with no differences in left ventricular mass. Self-measurement helped to identify patients with white-coat hypertension.

Budesonide-dependent modulation of expression of macrophage migration inhibitory factor in a polyposis model: evidence for differential regulation in surface and glandular epithelia.

Macrophage migration inhibitory factor (MIF) is a counterregulatory lymphokine for glucocorticoid action within the immune system. To provide further insights into the way expression of pleiotropically acting MIF is modulated by glucocorticoids, we investigated the influence of the glucocorticoid budesonide on the level of expression of MIF in a model of human nasal polyposis by quantitative immunohistochemical analysis. Ten nasal polyps obtained from surgical resection were maintained for 24 hours in the presence of 3 budesonide concentrations: 10, 50, and 250 ng/mL.

Antihypertensive treatment based on blood pressure measurement at home or in the physician's office: a randomized controlled trial.

Context: Self-measurement of blood pressure is increasingly used in clinical practice, but how it affects the treatment of hypertension requires further study.

Objective: To compare use of blood pressure (BP) measurements taken in physicians' offices and at home in the treatment of patients with hypertension.

Design, Setting, And Participants: Blinded randomized controlled trial conducted from March 1997 to April 2002 at 56 primary care practices and 3 hospital-based outpatient clinics in Belgium and 1 specialized hypertension clinic in Dublin, Ireland.

Self-measured versus ambulatory blood pressure in the diagnosis of hypertension.

Objective: We examined to what extent self-measurement of blood pressure at home (HBP) can be an alternative to ambulatory monitoring (ABP) to diagnose white-coat hypertension.

Methods: In 247 untreated patients, we compared the white-coat effects obtained by HBP and ABP. The thresholds to diagnose hypertension were > or = 140/> or = 90 mmHg for conventional blood pressure (CBP) and > or = 135/> or = 85 mmHg for daytime ABP and HBP.

Determinants of white-coat syndrome assessed by ambulatory blood pressure or self-measured home blood pressure.

Background: Gender, age, smoking, race, and body mass index have been reported to determine the ambulatory white-coat effect (WCE) and white-coat hypertension (WCH).

Methods: Baseline conventional, day-time ambulatory and self-measured home blood pressure measurements from the THOP trial were used to study the effect of gender, age, body mass index, smoking habits and treatment status on the white-coat syndrome as assessed by ambulatory monitoring or self-measurement.

Results: The mean systolic/diastolic WCE was 9.

Glucocorticoid-induced differential expression of the sialylated and nonsialylated Lewis(a) epitopes and respective binding sites in human nasal polyps maintained under ex vivo tissue culture conditions.

We characterized the anti-inflammatory effects of budesonide on the expression of adhesion molecules involving Lewis(a) (Le(a)) epitope, its sialylated derivative (sLe(a)), and their respective binding sites in human nasal polyposis. By computer-assisted microscopy, we quantitatively characterized the level of histochemical expression of L- and P-selectins, sialylated and nonsialylated Le(a) epitopes, and their respective binding sites in both surface epithelium and glandular epithelium of human nasal polyps obtained from surgical resection, maintained under ex vivo tissue culture conditions for 24 hours, and treated or not with budesonide. Intercellular adhesion molecule 1 (ICAM-1) and vascular cell adhesion molecule 1 (VCAM-1) were chosen as methodological controls, because data already published in the literature clearly indicated budesonide-mediated effects on ICAM-1 and VCAM-1 levels of expression.

Galectin-1 is overexpressed in nasal polyps under budesonide and inhibits eosinophil migration.

Because of the importance of galectins for various cellular activities, the influence of the glucocorticoid budesonide on the level of expression of galectins-1 and -3 was investigated in human nasal polyposis. Ten nasal polyps obtained from surgical resection were maintained for 24 hours in the presence of various concentrations of budesonide. As quantitatively demonstrated by means of computer-assisted microscopy, 250 ng/ml (the highest dose tested) induced a pronounced increase of galectin-1 expression.

A 15-month evaluation of the effects of repeated subgingival minocycline in chronic adult periodontitis.

Background: A double-blind, randomized, parallel, comparative study was designed to evaluate the long-term safety and efficacy of subgingivally administered minocycline ointment versus a vehicle control.

Methods: One hundred four patients (104) with moderate to severe adult periodontitis (34 to 64 years of age; mean 46 years) were enrolled in the study. Following scaling and root planing, patients were randomized to receive either 2% minocycline ointment or a matched vehicle control.

Comparative activity of piperacillin/tazobactam against 5625 isolates from hospitalised patients. Multicentre Study Group.

The comparative activities of piperacillin/tazobactam and other antibiotics against 5625 Gram-negative and Gram-positive bacteria freshly isolated from hospitalized patients was examined. The percentage of Enterobacteriaceae susceptible to piperacillin/tazobactam, ceftazidime, imipenem and ciprofloxacin was very similar and varied from 81% to 84% in the Enterobacteriaceae with inducible type 1 beta-lactamases and from 93 to 97% in the non-inducible organisms. Piperacillin/tazobactam was similar in activity to ceftazidime against Pseudomonas aeruginosa and more active than imipenem or ciprofloxacin.

Bisoprolol and atenolol in essential hypertension: effects on systemic and renal hemodynamics and on ambulatory blood pressure.

The acute and short-term responses to bisoprolol and to atenolol on systemic and renal hemodynamics and on ambulatory blood pressure (BP) were compared in a randomized double-blind cross-over study including 14 patients with mild to moderate essential hypertension. After a 4-week placebo period, the patients received either bisoprolol (10 mg once daily, o.d.

Determination of leucovorin and 5-fluorouracil in plasma by high-performance liquid chromatography.

A method was developed for the determination of (6R)- and (6S)-leucovorin and 5-fluorouracil in plasma. As leucovorin diastereoisomers cannot be separated on a classical reversed-phase column, it was necessary to use a chiral stationary phase. The method presented is based on the same principle as the method described by Wainer and Stiffin [J.