Search

This is a multicenter cross-sectional survey of 2,500 Bulgarian adult patients taking lipid-lowering drugs (LLDs) for at least 3 months with no dose change for a minimum of 6 weeks. The primary objective was to establish the proportion of patients who are on LDL-C target, according to the Fourth Joint European Task Force (FJETF) guidelines. The secondary objectives were to define the proportion of patients at target: according to the 2001 National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III and the 2004 NCEP ATP III guidelines. The patients’ demographics, current LLD treatment, cardiovascular medical history were recorded. Next the lipid profile, glucose level and HbA1c were obtained from these patients. The investigators and patients completed questionnaires related to the LLD therapy. Gender, BMI, history of CHD, therapy compliance, risk category, lack of patient’s awareness of LDL-C targets were all studied as determinants of the undertreatment. Despite the satisfactory awareness of guidelines for management of hypercholesterolaemia, their implementation in clinical practice is still poor. Only 43.10% of patients reached the FJETF-recommended LDL-C goal, 45.24% achieved the 2001 NCEP ATP III recommended LDL-C goal, and only 21.51% — reached the 2004 NCEP ATP III recommended target. Males, CHD patients and those who were aware of LDL-C targets had more chance of reaching their desired LDL-C target.

Results expressed as n (%) except where indicated by an asterisk (*) where reported as mean (standard deviation) CVD: cardiovascular disease, BMI: body mass index, SBP: systolic blood pressure, DBP: diastolic blood pressure, age (years): calculated relative to the subject’s date of visit, percentages are calculated relative to the total number of subjects with data.

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. The primary endpoint was the proportion of patient dropouts because of adverse drug reactions during the first 7 days. Secondary safety assessments included incidences of adverse drug reactions and significant changes in vital signs. Efficacy assessments included Young Mania Rating Scale (YMRS) and Clinical Global Impressions Severity of Illness (CGI-S) score changes from day 1 to day 21.Results:Twenty patients (69%) completed the study. No patients withdrew as a result of drug-related adverse events (AEs) during the first 7 days. Twenty-three patients reported 58 adverse events, and most of the adverse events were mild or moderate. No clinically relevant abnormalities in vital signs were reported. Mean YMRS and CGI-S scores decreased significantly from baseline to day 21 (p < 0.001). Response and remission rates were 78 and 70%, respectively, at the end of the study.Conclusion:Rapid dose escalation of quetiapine to 800 mg/day over 4 days was well tolerated and effective in reducing symptoms within 5 days in acutely ill bipolar I patients with a manic episode.

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. Further-more, CEPHEUS also aimed at the identification of determinants for under-treatment. Among the patients available for evaluation in Belgium (n=6276), 58.5% reached LDL-C goals as recommended by the 2003 European guidelines, 59.8% in primary prevention, 55.8% in secondary prevention, and 55.8% of those with a metabolic syndrome. The majority of patients (82.5%) was treated with statins. The univariate significant (P < 0.10) predictors of attaining LDL-C goal were the following: (a) nonsmoker, (b) no history of PAD or CAD, (c) absence of metabolic syndrome, (d) lower CV risk category, (e) absence of patient's concerns about treatment changes, (f) no withdrawal of lipid-lowering therapy when on target, (g) optimal. treatment adherence, (h) no patient's frustrations, (i) lipid-monitoring frequency, (j) physician being a specialist and (k) physicians finding it stressful to get patients on target. In an adjusted multi-level model, achievement of the LDL-C goals was significantly associated with: (a) type of lipid-lowering therapy, (b) risk category the patient fell into, (c) LDL-C level before initiating treatment, (d) patient's feelings about the treatment, (e) patient's acknowledgement about current cholesterol level and (f) self-reported drug compliance.

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.In 247 untreated patients, we compared the white-coat effects obtained by HBP and ABP. The thresholds to diagnose hypertension wereor = 140/or = 90 mmHg for conventional blood pressure (CBP) andor = 135/or = 85 mmHg for daytime ABP and HBP.Mean systolic/diastolic CBP, HBP and ABP were 155.4/100.0, 143.1/91.5 and 148.1/95.0 mmHg, respectively. The white-coat effect was 5.0/3.5 mmHg larger on HBP compared with ABP (12.3/8.6 versus 7.2/5.0 mmHg; P0.001). The correlation coefficients between the white-coat effects based on HBP and ABP were 0.74 systolic and 0.60 diastolic (P0.001). With ABP as a reference, the specificity of HBP to detect white-coat hypertension was 88.6%, and the sensitivity was 68.4%.Our findings are in line with the recommendations of the ASH Ad Hoc Panel that recommends HBP for screening while ABP has a better prognostic accuracy.

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 9.1/6.7 mmHg if based on ambulatory blood pressure and 12.2/8.7 mmHg if based on self-measured blood pressure. The ambulatory WCE was significantly higher in women, in older subjects (65+), in obese subjects, in non-smokers and in patients on antihypertensive drug treatment. The self-measured WCE was significantly higher in women and in non-smokers. Ambulatory WCH was present in 6.6% of the untreated patients and 14.2% had self-measured WCH. The proportion of ambulatory WCH was significantly higher in obese subjects; the proportion of self-measured WCH did not differ by gender, age, body mass index, or smoking habits. CONCLUSIONS: The ambulatory white-coat syndrome was determined by gender, age, body mass index, smoking habits, and treatment status. The self-measured white-coat syndrome was greater than the ambulatory white-coat syndrome but depended less on the determinants under study. ispartof: pages:37-40 ispartof: Blood pressure monitoring vol:8 issue:1 pages:37-40 ispartof: 19th Meeting of the International-Society-for-Hypertension/12th European-Society-of-Hypertension Meeting location:CZECH REPUBLIC, PRAGUE date:23 Jun - 27 Jun 2002 status: published

We characterized the anti-inflammatory effects of budesonide on the expression of adhesion molecules involving Lewisa (Lea) epitope, its sialylated derivative (sLea), 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 Lea 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. The present data show that budesonide significantly modified the levels of expression of ICAM-1 and VCAM-1, and to a lesser extent that of P-selectin, in the surface and glandular epithelia. Budesonide markedly decreased the levels of expression of the binding sites for both Lea and sLea, while those of Lea and sLea remained globally unchanged. In conclusion, the present study documents that glucocorticoid-induced effects can encompass receptors for Lea epitopes different from E- and P-selectins on epithelial cells of human nasal polyps.

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., Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, SCOPUS: ar.j, FLWOA, info:eu-repo/semantics/published

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 (≥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. Patients not at goal with RSV 10 mg were further titrated to RSV 20 mg. Results - 938 patients were randomised to the two treatment groups. After 12 weeks of treatment, a significantly greater percentage of patients receiving RSV 10 compared with ATV 10 achieved EAS LDL-C target goal (< 115 mg/dl) (85% vs. 67%). LDL-C was reduced by 47% and total cholesterol (TC) by 33% with RSV 10. This was 38% and 27% for ATV 10, respectively. After 24 weeks, an additional 57% of patients initially taking RSV 10 and uncontrolled, reached the target with RSV 20. In the patient group, initially taking ATV 10 and uncontrolled, 65% reached the target with RSV 10 after 24 weeks. Both treatments were well tolerated with a similar incidence of adverse events. In addition, a health economic analysis was performed. As RSV 10 is available at a lower cost in Belgium and as it is more effective, compared to ATV 10, it appeared to be the option of choice from a cost-effectiveness perspective. Conclusions - Rosuvastatin 10 mg treatment is significantly more effective than atorvastatin 10 mg at achieving European LDL-C goals, at lowering LDL-C and TC. These results were obtained with a similar safety profile. From a cost-effectiveness perspective RSV 10 is the preferred therapeutic option in comparison with ATV 10. Uptitration of uncontrolled patients to RSV 20 mg and switch from ATV 10 to RSV 10 allowed significantly more patients to reach the LDL-C and TC target goal.

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.day(-1) until disease progression, death or unacceptable toxicity, were analysed. The median (range) duration of gefitinib treatment was 2.3 months (0.0-32.7). Its use was predominantly in second- or third-line treatment. The overall response and disease control rates were 8.9 and 41.2%, respectively. In univariate analysis, response was more common in females and never-smokers. In multivariate analysis, female sex was the only significant predictive factor (odds ratio (OR) (95% confidence interval (CI)) 0.329 (0.129-0.839)). Symptom improvement was reported in 108 patients of whom 32 (29.6%) had an objective response, 66 (61.1%) experienced disease stabilisation and 10 (9.3%) progressed. Gefitinib was well tolerated; only 7.8% of the patients reported grade 3 or 4 toxicity. The overall median survival was 4.7 months, with a 1-yr survival rate of 21%. Survival was strongly influenced by a better performance status (PS) (good PS: hazard ratio (HR) (95%CI) 0.110 (0.077-0.157)) and adenocarcinoma with bronchioloalveolar carcinoma features histology (HR (95%CI) 0.483 (0.279-0.834)). In conclusion, the activity of gefitinib was confirmed in the present large Western community implementation study. Response, present in a small subgroup, led to a rewarding survival and could be predicted by sex only. Baseline performance status and adenocarcinoma with bronchioloalveolar carcinoma features histology were significant factors for survival.

/

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.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.Ninety percent of the patients received infiltration anesthesia during primary SRP, compared to only 2% during recall scaling/instrumentation and none during PD. Many patients (40% in SRP group 1 and 52% in the recall scaling/instrumentation group) were most bothered by the scaling procedure, while others (35% in the primary SRP patients) by the anesthetic injection. Painful experiences during previous primary PD and present SRP were highly correlated (r = 0.6).From these results, it is evident that subgingival instrumentation causes pain and discomfort, an aspect that should be considered in periodontal therapy. Unfortunately, the use of local infiltration anesthesia to reduce pain is in itself a cause of discomfort. Attractive alternatives for anesthetic applications are much needed.

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. CONCLUSIONS: The present findings support a stepwise strategy for the evaluation of blood pressure, in which self-measurement and ambulatory monitoring are complementary to conventional office blood pressure measurement. ispartof: pages:311-4 ispartof: Blood pressure monitoring vol:9 issue:6 pages:311-4 ispartof: Workshop on Whats New in Blood Pressure Measurement location:FRANCE, Paris date:Jun 2004 status: published

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. As quantitatively demonstrated by computer-assisted microscopy, 50 ng/mL induced an increase in MIF expression in the surface epithelium and a decrease in MIF expression in the glandular epithelium. At the 250 ng/mL dose, the inverse effect was induced. Evidently, surface and glandular epithelia react nonuniformly to the glucocorticoid regarding MIF presence, adding dependence on the cell type to the regulatory network.

Self-measurement of blood pressure is increasingly used in clinical practice, but how it affects the treatment of hypertension requires further study.To compare use of blood pressure (BP) measurements taken in physicians' offices and at home in the treatment of patients with hypertension.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. Four hundred participants with a diastolic BP (DBP) of 95 mm Hg or more as measured at physicians' offices were enrolled and followed up for 1 year.Antihypertensive drug treatment was adjusted in a stepwise fashion based on either the self-measured DBP at home (average of 6 measurements per day during 1 week; n = 203) or the average of 3 sitting DBP readings at the physician's office (n = 197). If the DBP guiding treatment was above (89 mm Hg), at (80-89 mm Hg), or below (80 mm Hg) target, a physician blinded to randomization intensified antihypertensive treatment, left it unchanged, or reduced it, respectively.Office and home BP levels, 24-hour ambulatory BP, intensity of drug treatment, electrocardiographic and echocardiographic left ventricular mass, symptoms reported by questionnaire, and costs of treatment.At the end of the study (median follow-up, 350 days; interquartile range, 326-409 days), more home BP than office BP patients had stopped antihypertensive drug treatment (25.6% vs 11.3%; P.001) with no significant difference in the proportions of patients progressing to multiple-drug treatment (38.7% vs 45.1%; P =.14). The final office, home, and 24-hour ambulatory BP measurements were higher (P.001) in the home BP group than in the office BP group. The mean baseline-adjusted systolic/diastolic differences between the home and office BP groups averaged 6.8/3.5 mm Hg, 4.9/2.9 mm Hg, and 4.9/2.9 mm Hg, respectively. Left ventricular mass and reported symptoms were similar in the 2 groups. Costs per 100 patients followed up for 1 month were only slightly lower in the home BP group (3875 vs 3522 [4921 dollars vs 4473 dollars]; P =.04).Adjustment of antihypertensive treatment based on home BP instead of office BP led to less intensive drug treatment and marginally lower costs but also to less BP control, with no differences in general well-being or left ventricular mass. Self-measurement allowed identification of patients with white-coat hypertension. Our findings support a stepwise strategy for the evaluation of BP in which self-measurement and ambulatory monitoring are complementary to conventional office measurement and highlight the need for prospective outcome studies to establish the normal range of home-measured BP.

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. This feature was observed in nasal polyps from allergic patients but not in those from nonallergic patients. Since eosinophils represent the main inflammatory cell population in nasal polyps, we investigated the effect of galectin-1 on their migration levels by means of quantitative phase-contrast computer-assisted videomicroscopy. Our results show that galectin-1 (coated on plastic supports) markedly reduced the migration levels of eosinophils in comparison to P-selectin. On the cellular level, marked modifications in the polymerization/depolymerization dynamics of the actin cytoskeleton (as revealed by means of computer-assisted fluorescence microscopy) and, to a much lesser extent, an increase in the adhesiveness of eosinophils to tested substrata were detectable. The present study therefore reveals a new galectin-1-mediated mechanism of action for glucocorticoid-mediated anti-inflammatory effects.

The safety and efficacy of subgingivally-applied 2% minocycline ointment was evaluated in a randomized, double-blind study of 103 adults with moderate to severe periodontitis. Two groups were compared; one received the test minocycline ointment and the other a vehicle control. Both groups had scaling and root planing at baseline, after which the test or control ointments were applied with an applicator into the periodontal pockets at baseline, and at 2, 4, and 6 weeks. Assessment of clinical response was made by measuring probing depth and probing attachment level and gingival bleeding. These measurements were made at baseline prior to scaling and root planing, and at weeks 4 and 12. Microbiological assessment of the subgingival flora was carried out with DNA probes at baseline, and at weeks 2, 4, 6, and 12 to identify and quantify Porphyromonas gingivalis, Prevotella intermedia, and Actinobacillus actinomycetemcomitans. Subgingival minocycline ointment resulted in statistically significantly greater reduction of P. gingivalis at weeks 2, 4, 6, and 12; P. intermedia at weeks 2, 4, 6, and 12; and A. actinomycetemcomitans at weeks 6 and 12. Probing depth reductions were seen for both groups at weeks 4 and 12; however, this reduction was statistically significantly greater in subjects treated with minocycline ointment. Reduction in gingival index and probing attachment gain were seen in both groups, however, the differences between the groups were not statistically significant.(ABSTRACT TRUNCATED AT 250 WORDS)

ContextSelf-measurement of blood pressure is increasingly used in clinical practice, but how it affects the treatment of hypertension requires further study.ObjectiveTo compare use of blood pressure (BP) measurements taken in physicians' offices and at home in the treatment of patients with hypertension.Design, Setting, and ParticipantsBlinded 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. Four hundred participants with a diastolic BP (DBP) of 95 mm Hg or more as measured at physicians' offices were enrolled and followed up for 1 year.InterventionsAntihypertensive drug treatment was adjusted in a stepwise fashion based on either the self-measured DBP at home (average of 6 measurements per day during 1 week; n = 203) or the average of 3 sitting DBP readings at the physician's office (n = 197). If the DBP guiding treatment was above (>89 mm Hg), at (80-89 mm Hg), or below (

Objetivos Comparar la utilidad de la medida de la presion arterial (PA) en la consulta y en el domicilio, en el tratamiento de la hipertension arterial. Diseno, ambito y participantes Ensayo clinico aleatorizado y controlado, realizado entre marzo de 1997 y abril de 2002, en 56 centros de atencion primaria y 3 consultas externas de hospitales de Belgica, y en una clinica especializada en hipertension de Dublin (Irlanda). Se recluto a 400 participantes, con una PA diastolica (PAD), medida en consulta, igual o superior a 95 mmHg, seguidos durante un ano. Intervencion El tratamiento farmacologico antihipertensivo se ajusto, de forma escalonada, segun la automedida domiciliaria de la PAD (media de 6 medidas/dia durante una semana; n = 203) o a la media de 3 determinaciones de la PA medida en la consulta (n = 197). Un medico ciego a la asignacion modificaba el tratamiento (intensificacion, no modificacion o reduccion de este) si la PAD estaba por encima de 89, entre 80-89 o por debajo de 80 mmHg, respectivamente. Medidas principales de resultados Valores de PA en la consulta, domiciliarias y en la monitorizacion ambulatoria de 24 h; intensidad del tratamiento; masa ventricular izquierda por electrocardiograma y ecocardiograma; sintomas referidos a traves de un cuestionario, y costes del tratamiento. Resultados Al final del estudio (mediana de seguimiento, 350 dias), hubo mas pacientes en el grupo de presiones domiciliarias que habian interrumpido el tratamiento farmacologico (el 25,6 frente al 11,3% de los asignados a medidas en consulta; p Conclusiones El ajuste del tratamiento antihipertensivo basado en la medida domiciliaria de la PA, en lugar de la consulta, comporta un tratamiento menos intensivo y, de forma marginal, un coste mas bajo, pero tambien un peor control de la PA, sin diferencias en el estado general ni en la masa ventricular izquierda. La automedida permitio identificar a los pacientes con hipertension de bata blanca. Estos resultados avalan una estrategia escalonada en la evaluacion de la PA, de manera que la automedida y la monitorizacion ambulatoria son tecnicas complementarias a la medida convencional en la consulta, y ponen de manifiesto la necesidad de realizar estudios prospectivos para establecer los valores normales de la presion arterial domiciliaria.

Summary: 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.) or atenolol (100 mg o.d.) for 4 weeks and were switched to the other drug after a new 4-week placebo period. Cardiac output (CO) was measured by Doppler echography, and renal blood flow (RBF) and glomerular filtration rate (GFR) were measured by constant infusion techniques using [123I]iodohippurate and [5lCr]EDTA, respectively. Bisoprolol and atenolol decreased diurnal and nocturnal blood pressure (BP). Both drugs decreased heart rate (HR) and BP both acutely and after 4 weeks. During short-term treatment, CO was maintained with bisoprolol but reduced by atenolol (by 17%). RBF decreased after the first drug intake (by 9 and 12%, respectively) but returned to its baseline value after 4 weeks, so that calculated renal vascular resistance (RVR) was reduced (by 12 and 15%, respectively). Overall, GFR was not affected by treatment. Bisoprolol and atenolol are effective antihypertensive agents that preserve renal hemodynamics during short-term treatment