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T Simon

Publications and source records attributed to T Simon.

At least 19 recordsLinked to original sources

Why is cardiovascular health important in menopausal women?

Since endogenous estrogen shows some preventative benefits against cardiovascular risk factors in premenopausal women, cardiovascular disease (CVD) is often considered a male disease. However, CVD is the biggest cause of death in women, especially after menopause when endogenous estrogen withdrawal has detrimental effects on cardiovascular physiology and whole-body metabolism. Despite this, awareness of the risk of CVD is low in both women and in doctors; this needs rectifying. Women are under-represented in most clinical studies of CVD. Following diagnosis of CVD, the prognosis for women is not systematically similar to that for men. Furthermore, from the few comparisons conducted, gender differences in response to pharmacological interventions are evident, so that results obtained in wholly or largely male-based studies cannot be systematically extrapolated to women. Women with CVD should be afforded equivalent investigations and treatment to men, and it is vital that women be included in clinical trials in sufficient numbers to allow sub-group analyses and subsequent development of appropriate therapies. Since CVD is usually advanced by the time symptoms appear, prevention is the key; health management advice might include smoking cessation, adoption of a healthy diet, and incorporation of physical activity into the lifestyle.

Anti-Arrhythmia Agents↗

Culture medium and protein supplementation in the generation and maturation of dendritic cells.

Dendritic cells (DC) are powerful antigen-presenting cells that have drawn many attentions due to the recent development of anti-cancer vaccines. Clinical grade production of monocyte-derived DC (Mo-DC) is extensively studied, and many efforts are made to develop and improve clinical standard operating procedures. Most of the parameters involved, such as the cytokines and maturation agents, have been widely assessed. However, very few are investigated about how culture medium and additional protein components affect DC yield, viability and maturation. Thus, our study aimed to compare the impact of standard culture medium on Mo-DC differentiation and maturation. Commercially available media for hematopoietic cell culture as well as different protein supplementations, that is foetal calf serum (FCS), autologous plasma (AP), human serum (HS) and human serum albumin (HSA) were tested. Culture yields, cell viability and DC maturation were investigated. Differentiation yields were similar between the conditions used. However, we evidenced significant differences in terms of cytotoxicity and DC maturation (phenotypic and functional). This underscores the importance of defining culture medium composition in clinical standard operating procedures to insure quality control, and also when preparing DC for experimental uses.

Cell Culture Techniques↗

Indicators of lifetime endogenous estrogen exposure and risk of venous thromboembolism.

BACKGROUND: Lifetime estrogen exposure has been related to breast cancer risk, osteoporosis, and cardiovascular disease but data on venous thromboembolism (VTE) risk are limited. METHODS: Data from a hospital-based case-control study among 608 postmenopausal women (191 with a first episode of idiopathic VTE and 417 age-matched controls) were used to determine whether estrogen exposure, as assessed by age at menopause [classified as early (< or = 45 years), normal (46-54 years) and late menopause (> or = 55 years)] and parity, was associated with the risk of VTE. RESULTS: After adjustment for potential confounding variables, the risk of VTE was increased with each year's delay in the menopause [odds ratio (OR) = 1.06, 95% confidence interval (CI) = 1.02-1.10, P < 0.0075]. When compared with women with normal menopause used as a reference, the adjusted OR for VTE was 0.59 (95% CI = 0.36-0.97) and 2.53 (95% CI = 1.28-4.99) for women with early menopause and late menopause, respectively (P = 0.001). Adjusted OR for VTE was also higher for women with more than two children when compared with those with less than or equal to two children (1.56, 95% CI = 1.03-2.34, P = 0.03). The lowest risk of VTE was observed in women with early menopause and lower parity (adjusted OR = 0.60, 95% CI = 0.30-1.24), the highest risk was among women with late menopause who have had more than two children (adjusted OR = 3.41, 95% CI = 1.46-9.25). CONCLUSION: These results show that the longer exposure to endogenous estrogen is associated with an increased VTE risk.

Age Factors↗

[Flecainide controlled-release for prevention of atrial fibrillation relapse].

UNLABELLED: Flecainide acetate instant release (LI) has been prescribed for years in the prevention of atrial fibrillation (AF) relapse after sinus rate conversion. A new controlled-release (LP) formulation of flecainide was recently introduced. The objectives of this observational study were to evaluate the benefit/risk ratio of LI or LP flecainide treatment for prevention of AF relapse. METHODS: EPIFLEC study was an open, prospective, observational study conducted by 151 cardiologists who had prescribed either flecainide LI (group 1) to 838 patients or flecainide LP (group 2) to 214 patients or flecainide LI before LP (group 3) to 242 patients. In these patients, AF was either paroxystic (35%) or persistant (65%). Concomitant pathologies were observed in 80% of these patients (mean age 68 years) with a high incidence (50%) of hypertension. The mean duration of treatment was 6.9 +/- 6.7 months in group 1 (LI), 6.2 +/- 3.1 months in group 2 (LP) and 12.7 +/- 5.4 months in group 3 (LI-LP). RESULTS: mean daily dosages of flecainide were similar among the 3 groups. Antithrombotic drugs were prescribed in 74% (group 1) to 83% (group 2) of the patients and another antiarrhythmic drug was associated to flecainide among 12 to 21% of the patients. AF relapse was observed in 171 patients in group 1 (LI), 38 patients in group 2 (LP) and 39 patients in group 3 (LI-LP). The incidence of AF relapse was compared in groups 1 and 2 at 10 months of follow-up and AF relapse probability was not significantly different between flecainide LI and LP :26 +/- 2% and 23 +/- 4% respectively (OR = 0.99, CI 95%:0.69-1.4; p = 0.96). A multivariate analysis showed that previous multiples episodes of AF, electrical shock rate conversion and history of flutter and hypertension were independent predictors of AF relapse. Among 11 deaths observed during follow-up, only 2 were cardiovascular. The most frequent non lethal cardiovascular adverse events were arrhythmias or cardiac conduction disorders and were limited to less than 5% of the patients. Only 5 supraventricular transient pro arrhythmias episodes were recorded. CONCLUSION: this pharmaco-epidemiological study in private practice confirms that flecainide is able to prevent AF relapse in 75% of patients at 10 months and that the tolerance of the treatment is acceptable in these patients.

Aged↗

Is there a benefit of 131 I-MIBG therapy in the treatment of children with stage 4 neuroblastoma? A retrospective evaluation of The German Neuroblastoma Trial NB97 and implications for The German Neuroblastoma Trial NB2004.

AIM: (131)I-meta-iodobenzylguanidine ((131)I-MIBG) therapy has been used in neuroblastoma treatment for many years but its value in high intensive first line treatment protocols is not exactly known. PATIENTS, METHODS: Stage 4 neuroblastoma patients >1 year with (123)I-MIBG positive residual disease (primary tumour and/or metastasis) after complete induction chemotherapy according to the German neuroblastoma trial NB97 were retrospectively analyzed. RESULTS: One-hundred-eleven patients had (123)I-MIBG positive residual disease after complete induction chemotherapy. Forty patients received (131)I-MIBG therapy using a median activity of 0.44 GBq/kg body weight. By univariate analysis, patients who underwent (131)I-MIBG therapy had a better 3-year event free survival (3-y-EFS 46 +/- 8%) and 3-year overall survival (3-y-OS 58 +/- 9%) than 71 patients without (131)I-MIBG therapy (3-y-EFS 19 +/- 5%, p = 0.003; 3-y-OS 43 +/- 6%, p = 0.037). However, subgroup analysis of 66 patients who underwent high dose chemotherapy with autologous stem cell transplantation (ASCT) during treatment found a very similar outcome with (131)I-MIBG therapy (3-y-EFS 49 +/- 9%, 3-y-OS 59 +/- 10%) and without (131)I-MIBG therapy (3-y-EFS 33 +/- 9%, p = 0.171; 3-y-OS 59 +/- 9%, p = 0.285) due to the dominating effect of ASCT. By multivariate analysis, (131)I-MIBG therapy had no impact on EFS (p = 0.494) and OS (p = 0.891). Only ASCT, external beam radiation therapy and MYCN amplification were important for EFS and OS. CONCLUSIONS: An independent advantage of I-131-MIBG therapy could not be proven in this retrospective analysis. The ongoing German Neuroblastoma Trial NB2004 will address the influence of (131)I-MIBG therapy with emphasis on tumour dosimetry.

3-Iodobenzylguanidine↗

[Dosimetry for therapeutic treatment of neuroblastoma by 131I-mIBG].

AIM: Targeted radiotherapies using iodine-131 meta-iodobenzylguanidin have long been in use for treatment of stage IV neuroblastoma but reliable dosimetric data are scarce. METHOD: This work presents an approach to determine the whole body exposure and tumour doses delivered during therapy. Dosimetric data are reported and discussed for six treatments carried out according to the trial protocol NB2004 as it is in use in our study in the last two years. RESULTS: Whole body exposures are found to be in the range of 1.75 to 2.5 Gy whereas tumour doses vary between 15 and 55 Gy. CONCLUSION: The course of action prescribed by the trial protocol allows whole body exposure as well as tumour doses to be determined routinely.

3-Iodobenzylguanidine↗

[Neuroblastoma].

Neuroblastoma is an embryonal tumour of childhood. Primary tumours are localized retroperitoneally or abdominally. Neuroblastoma produce catecholamine metabolites which are used as tumour markers. MIBG scintigraphy in addition to ultrasound and nuclear magnetic resonance tomography allow specific imaging of the tumour tissue. In young patients, spontaneous remissions are not uncommon, whereas the outcome in older children is poor despite intensive treatment. Therefore, the treatment of neuroblastoma must be risk adapted. The 5 year overall survival rates in the German NB97 trial were 96+/-1% in the observation group, 89+/-3% in the median risk group, and 50+/-3% in the high risk group.

Abdominal Neoplasms↗

Comparison of cardiac output measurements by arterial trans-cardiopulmonary and pulmonary arterial thermodilution with direct Fick in septic shock.

BACKGROUND AND OBJECTIVE: The aim of this study was to compare cardiac output (CO) measurements by arterial trans-cardiopulmonary thermodilution (ATD) and pulmonary arterial thermodilution (PATD) with CO estimated on the basis of the Fick calculation via a metabolic monitor in septic shock. METHODS: In a prospective animal study 20 anaesthetized, ventilated pigs (20.9 +/- 1.9 kg) were investigated. Septic shock was induced with faecal peritonitis. A pulmonary artery catheter was used for conventional measurement of CO. Simultaneously ATD was measured with a thermistor tipped catheter inserted into right carotid artery. Whole body oxygen consumption was measured by indirect calorimetry. Eighty data pairs of simultaneous CO measurements were analysed. RESULTS: CO measured with Fick and that measured with PATD were significantly correlated (r = 0.94, r = 0.87, P < 0.001). Mean CO measured by PATD was 94.3 +/- 40.1 mL min(-1) kg(-1). Bias was 10.1 mL min(-1) kg(-1) (95% confidence interval (CI): 6.0-14.2 mL min(-1) kg(-1)) with limits of agreement of -26.8 to 47.0 mL min(-1) kg(-1). Correlation between Fick derived CO estimation and ATD CO was similar (r = 0.91, r2 = 0.83, P < 0.001). Mean CO measured by trans-cardiopulmonary thermodilution was 104.3 +/- 43.2 mL min(-1) kg(-1). Bias was 0.75 mL min(-1) kg(-1) (95% CI: -3.8 to 5.3 mL min(-1) kg(-1)) with limits of agreement of -39.7 to 41.2 mL min(-1) kg(-1). CONCLUSIONS: Even during haemodynamic instability in septic shock the correlation of arterial trans-cardiopulmonary thermodilution and PATD derived CO with direct Fick was good. As arterial trans-cardiopulmonary thermodilution is less invasive than PATD, the former may offer practical advantages.

Algorithms↗

Interlaboratory comparison of red-cell ATP, 2,3-diphosphoglycerate and haemolysis measurements.

BACKGROUND AND OBJECTIVES: Red blood cell (RBC) storage systems are licensed based on their ability to prevent haemolysis and maintain RBC 24-h in vivo recovery. Preclinical testing includes measurement of RBC ATP as a surrogate for recovery, 2,3-diphosphoglycerate (DPG) as a surrogate for oxygen affinity, and free haemoglobin, which is indicative of red cell lysis. The reproducibility of RBC ATP, DPG and haemolysis measurements between centres was investigated. MATERIALS AND METHODS: Five, 4-day-old leucoreduced AS-1 RBC units were pooled, aliquotted and shipped on ice to 14 laboratories in the USA and European Union (EU). Each laboratory was to sample the bag twice on day 7 and measure RBC ATP, DPG, haemoglobin and haemolysis levels in triplicate on each sample. The variability of results was assessed by using coefficients of variation (CV) and analysis of variance. RESULTS: Measurements were highly reproducible at the individual sites. Between sites, the CV was 16% for ATP, 35% for DPG, 2% for total haemoglobin and 54% for haemolysis. For ATP and total haemoglobin, 94 and 80% of the variance in measurements was contributed by differences between sites, and more than 80% of the variance for DPG and haemolysis measurements came from markedly discordant results from three sites and one site, respectively. In descending order, mathematical errors, unvalidated analytical methods, a lack of shared standards and fluid handling errors contributed to the variability in measurements from different sites. CONCLUSIONS: While the methods used by laboratories engaged in RBC storage system clinical trials demonstrated good precision, differences in results between laboratories may hinder comparative analysis. Efforts to improve performance should focus on developing robust methods, especially for measuring RBC ATP.

2,3-Diphosphoglycerate↗

An X-ray outburst from the rapidly accreting young star that illuminates McNeil's nebula.

Young, low-mass stars are luminous X-ray sources whose powerful X-ray flares may exert a profound influence over the process of planet formation. The origin of the X-ray emission is uncertain. Although many (or perhaps most) recently formed, low-mass stars emit X-rays as a consequence of solar-like coronal activity, it has also been suggested that X-ray emission may be a direct result of mass accretion onto the forming star. Here we report X-ray imaging spectroscopy observations which reveal a factor approximately 50 increase in the X-ray flux from a young star that is at present undergoing a spectacular optical/infrared outburst (this star illuminates McNeil's nebula). The outburst seems to be due to the sudden onset of a phase of rapid accretion. The coincidence of a surge in X-ray brightness with the optical/infrared eruption demonstrates that strongly enhanced high-energy emission from young stars can occur as a consequence of high accretion rates. We suggest that such accretion-enhanced X-ray emission from erupting young stars may be short-lived, because intense star-disk magnetospheric interactions are quenched rapidly by the subsequent flood of new material onto the star.

Journal Article↗

Long-term results and risk profiles of patients in five consecutive trials (1979-1997) with stage 4 neuroblastoma over 1 year of age.

During the last two decades new diagnostic and therapeutic tools have been utilized to improve the poor survival chances of children with stage 4 neuroblastoma. This study reviews the risk profiles and the long-term outcome of patients from five consecutive German neuroblastoma trials. A total of 96% of all German patients registered at the German childhood cancer registry with neuroblastoma stage 4 over 1 year of age at diagnosis entered one of the trials during 1979-2001. Eight hundred and twenty-eight consecutive children were analyzed retrospectively. In spite of having significantly improved diagnostic tools like bone marrow superstaging and mIBG scintigraphy the stage 4 incidence did not increase after reaching completeness of the registry (5.4 cases/100,000 children at 1-14 years of age; P=0.52). The distribution of the primary tumors and of metastases was constant over the periods. The amount of bone marrow infiltration did not change with time. The risk factors lactate dehydrogenase, ferritin and MYCN, and the clinical risk groups 4A, 4B, 4C also remained constant over the trials with a few exceptions for NB97. The 5-year event free survival increased from 0.01+/-0.01 (NB79) to 0.14+/-0.03 (NB85), 0.16+/-0.04 (NB82), 0.27+/-0.02 (NB90), and 0.33+/-0.04 (NB97). The overall survival rates improved similarly from 0.04 (NB79) to 0.44 (NB97). In conclusion, the improved survival was associated with better treatment and not caused by lower risk profiles in stage 4 neuroblastoma patients.

Adolescent↗

Bisoprolol dose-response relationship in patients with congestive heart failure: a subgroup analysis in the cardiac insufficiency bisoprolol study(CIBIS II).

AIMS: Whether all patients with congestive heart failure (CHF) need to reach the target dose of beta-blocker to obtain a benefit in terms of survival remains uncertain. METHODS AND RESULTS: We classified by tertile the 2647 patients enrolled in CIBIS II according to the last tolerated dose: low dose (LD: 1.25, 2.5 or 3.75mg/day, n=434), moderate dose (MD: 5 or 7.5mg/day, n=328) and high dose (HD: 10mg/day, n=565) of bisoprolol or placebo (LD=234, MD=278 and HD=808). In both groups, patients tolerating only low doses were significantly older with more severe New York Heart Association (NYHA) functional class and higher frequency of co-morbidities. Treatment withdrawal was associated with a significant increase of mortality in the bisoprolol group (relative hazard (RH)=2.13, 95% confidence interval (CI)=1.43-3.17, p=0.0002). After adjustment, all-cause mortality was significantly reduced in the bisoprolol group compared to placebo regardless of the dose level considered: LD (RH=0.66, 95% CI=0.48-0.92), MD (RH=0.33, 95% CI=0.21-0.51) or HD (RH=0.59, 95% CI=0.40-0.89). CONCLUSIONS: Bisoprolol reduces mortality in CHF patients at all tolerated dose levels and its withdrawal increases the risk of mortality. Efforts should be made to maintain bisoprolol therapy based on the individual patient's tolerability.

Adrenergic beta-Antagonists↗

Tumour markers are poor predictors for relapse or progression in neuroblastoma.

The value of the tumour markers vanillylmandelic acid (VMA) and homovanillic acid (HVA) in urine (u) and serum (s), neurone-specific enolase (NSE), and lactate dehydrogenase (LDH) in the early prediction of relapse/progression in neuroblastoma is not known. We analysed the data of neuroblastoma patients who had successfully completed first-line treatment and had laboratory results available from their initial diagnosis and from relapse/progression (n=196). Patients' overall survival from relapse or progression was 21.5+/-4.2% (mean+/-standard deviation). At diagnosis, we found abnormal results in 75% for VMA and/or HVA (s), 92% for VMA and/or HVA (u), 90% for NSE, and 81% for LDH. We found a lower incidence of abnormal results at relapse or progression with 40% for VMA and/or HVA (s), 54% for HVA and/or VMA (u), 61% for NSE, and 48% for LDH. Sensitivity of all markers was higher for metastatic compared with local recurrence. NSE was the best, being able to detect 42% of the localised relapses, 77% of the combined local/metastatic relapses, and 69% of the metastatic recurrences. Relapse or progression in neuroblastoma cannot be detected reliably by monitoring tumour markers alone. Therefore, follow-up of neuroblastoma patients must include clinical assessment and imaging studies.

Adolescent↗

Incidence of gastroduodenal ulcers in patients with rheumatoid arthritis after 12 weeks of rofecoxib, naproxen, or placebo: a multicentre, randomised, double blind study.

BACKGROUND: Previous studies in patients with osteoarthritis have suggested that the selective cyclooxygenase (COX)-2 inhibitor rofecoxib results in less gastrointestinal damage than non-selective non-steroidal antiinflammatory drugs (NSAIDs). This study compared the incidence of endoscopically detected gastroduodenal ulcers in rheumatoid arthritis patients treated with rofecoxib or a non-selective NSAID. METHODS: In this multicentre, randomised, double blind, 12 week study, patients with rheumatoid arthritis were allocated to rofecoxib 50 mg once daily (n=219), naproxen 500 mg twice daily (n=220), or placebo (n=221). Endoscopy was performed at baseline and at six and 12 weeks. Lifetable analysis and log rank tests were used to analyse the incidence of gastroduodenal ulcers > or =3 mm. Gastric or duodenal ulcers > or =5 mm and erosions were also evaluated as secondary end points. Tolerability was assessed by adverse events. RESULTS: The cumulative incidence of ulcers > or =3 mm at 12 weeks was significantly higher in patients on naproxen (25.5%) than in patients receiving rofecoxib (6.8%; difference 18.7% (95% confidence interval (CI) 11.7%, 25.7%); p<0.001) or placebo (2.9%; difference 22.6% (95% CI 16.1%, 29.1%); p<0.001). The difference between rofecoxib (6.8%) and placebo (2.9%) did not reach statistical significance (p=0.066). Results were similar for ulcers > or =5 mm and for mean changes from baseline in the number of gastroduodenal erosions. The overall incidence of clinical adverse events was similar among treatment groups (61% of patients on placebo, 62% in patients on rofecoxib, and 66% in patients on naproxen). CONCLUSIONS: Rofecoxib 50 mg daily (twice the dose recommended for this patient population) resulted in a lower incidence of endoscopically detected gastroduodenal ulcers and erosions than treatment with naproxen 500 mg twice daily.

Adult↗

Influence of tamoxifen on carotid intima-media thickness in postmenopausal women.

BACKGROUND: Intima-media thickness of the common carotid artery (IMT-CCA) is an early marker of atherosclerosis. Tamoxifen is a selective estrogen-receptor modulator with estrogen-like effects on cardiovascular risk factors but as-yet unexplored effects on carotid artery structure. The goal of this study was to determine the influence of tamoxifen on IMT-CCA in menopausal women. METHODS AND RESULTS: With a predefined calculation of the sample size, 67 menopausal women with cancer who were treated with tamoxifen for > or =1 year and 37 menopausal women with cancer who were never treated with tamoxifen were enrolled. IMT-CCA, internal diameter, and pulse pressure were determined with a high-definition echotracking device and applanation tonometry in a central core laboratory that was blinded to treatment. Both groups were similar for clinical characteristics, including cardiovascular risk factors. IMT and internal diameter were significantly lower in the tamoxifen group (mean duration of treatment, 2.4+/-0.9 years) than in the control group (609+/-117 microm versus 662+/-147 microm, P=0.04, and 4.89+/-0.60 mm versus 5.12+/-0.58 mm, P=0.03, respectively). Pulse pressure was not influenced by the use of tamoxifen. After adjustment for age, cardiovascular risk factors, carotid pulse pressure, duration of menopause, and previous use of hormone replacement therapy, IMT remained significantly lower among tamoxifen users (P<0.00001), with an impact on IMT (-70 microm) equivalent to spontaneous evolution with 12 years of aging (5 microm/y). CONCLUSION: The use of tamoxifen was associated with a significantly lower carotid IMT in menopausal women with cancer. Randomized trials are needed to confirm the cardioprotective effect of selective estrogen-receptor modulators in terms of prevention of atherosclerosis.

Antineoplastic Agents, Hormonal↗

Establishment of standardised SLA/LP immunoassays: specificity for autoimmune hepatitis, worldwide occurrence, and clinical characteristics.

BACKGROUND: Antibodies to soluble liver antigen/liver pancreas (SLA/LP) are specific markers of autoimmune hepatitis. Their target antigen has recently been cloned. AIMS: To establish standardised immunoassays using the recombinant antigen, and to assess the frequency and significance of seropositivity in patients from different countries. METHODS: An enzyme linked immunoassay was developed using purified recombinant antigen and validated by testing sera from 200 healthy blood donors and 1026 patients with various liver and non-liver diseases. The assay was then applied to 454 sera from 419 patients with autoimmune hepatitis from different countries. All sera were also tested by inhibition immunoassay and western blot. RESULTS: Antibodies were reliably detected by the recombinant immunoassay and occurred exclusively in patients with autoimmune liver disease. Twenty three of 149 patients from the USA (15%), 23/132 from Brazil (17%), 21/108 from Germany (19%), and 2/30 from Japan (7%) were seropositive. Clinical features at presentation were similar between seropositive and seronegative patients. However, relapse after corticosteroid withdrawal or during maintenance therapy occurred more commonly in seropositive patients. CONCLUSIONS: Antibodies to SLA/LP can be reliably detected by these standardised immunoassays based on recombinant antigen. Antibodies to SLA/LP occur with similar frequencies in different geographical regions, races, and age groups, and are of exquisite diagnostic specificity. Whether SLA/LP positive patients represent a clinically distinct subgroup remains to be determined; relapse during treatment reduction appeared to be more common in the SLA/LP group.

Adolescent↗

[Efficacy and tolerance of propafenone after correction of atrial fibrillation: PEPS pharmaco-epidemiologic study].

The PEPS study had the objective of documenting the acceptability and efficacy of propafenone in 1366 treated patients, after correction of chronic or paroxysmal AF, and followed up over one year. All the cases were validated by quality controls performed by the 196 participating cardiologists. All the events during follow up were validated by a committee of independent experts. The patients, aged 67 +/- 11 years, were in sinus rhythm on inclusion. Propafenone was prescribed at the initial dose of 600 mg/day in 65% of patients. The proportion of patients without relapse of AF was 64 +/- 1% at 12 months. After adjustment, the significant predictors of AF relapse were male sex, previous history of chronic AF and prescription of associated drugs. Neither patient age nor propafenone dose significantly influenced AF relapse. Seven deaths (0.5%) occurred during the study of which 3 were of unknown cause. A pro-arrhythmic effect was observed in 8 patients (0.59%) of which 6 had underlying heart disease. The overall frequency of pro-arrhythmic effects, including the 3 deaths of unknown cause, was therefore 0.81%. Tolerance of treatment with propafenone after correction of AF is therefore satisfactory and the frequency of pro-arrhythmic effects is less than 1%. The efficacy of the treatment for the maintenance of sinus rhythm is in accordance with previously published results.

Aged↗

Sex differences in the prognosis of congestive heart failure: results from the Cardiac Insufficiency Bisoprolol Study (CIBIS II).

BACKGROUND: Whether female sex is associated with a better prognosis in patients with congestive heart failure (CHF) remains uncertain. The Cardiac Insufficiency Bisoprolol Study (CIBIS) II showed that bisoprolol reduced all-cause mortality and morbidity rates in CHF patients treated with diuretics and ACE inhibitors. We examined whether survival was different in men (n=2132) and women (n=515) enrolled in CIBIS II. METHODS AND RESULTS: Women differed from men with regard to age, NYHA functional classification, primary cause of CHF, and risk factors such as left bundle-branch block. After adjustment for baseline differences, the probability of all-cause mortality was significantly reduced by 36% in women compared with that in men (hazard ratio 0.64, 95% CI 0.47 to 0.86, P:=0.003). Women also had a 39% reduction in cardiovascular deaths (hazard ratio 0.64, 95% CI 0.45 to 0.91, P:=0.01) and a 70% reduction in deaths from pump failure (hazard ratio 0.30, 95% CI 0.13 to 0.70, P:=0.005) compared with men. Kaplan-Meier survival analysis revealed a significant reduction in all-cause mortality among women treated with bisoprolol compared with men (6% versus 12% P:=0.01) but not among women treated with placebo (13% versus 18%, P:=0.10). However, this sex/ss-blocker effect was not significant in multivariate analysis. CONCLUSIONS: These results indicate that regardless of ss-blocker treatment and baseline clinical profile, female sex is a significant independent predictor of survival in patients with CHF.

Adrenergic beta-Antagonists↗