[Flecainide controlled-release for prevention of atrial fibrillation relapse]. / Acétate de flécaïnide a libération prolongée et prévention des récidives de fibrillation auriculaire: etude pharmaco-epidémiologique EPIFLEC dans une cohorte de 1 294 patients.

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.

A double-blind randomized trial comparing the efficacy and safety of a 5-day course of cefotiam hexetil with that of a 10-day course of penicillin V in adult patients with pharyngitis caused by group A beta-haemolytic streptococci.

A 10-day course of penicillin is the antibiotic regimen currently recommended by the American Heart Association (AHA) as treatment for patients with tonsillitis caused by group A beta-haemolytic streptococci (GABHS), with the aim of preventing both the suppurative and non-suppurative complications of this infection. This prospective, multicentre, randomized, double-blind, double-dummy clinical trial was undertaken in order to compare the efficacy of, tolerability of and compliance with a 5-day course of cefotiam hexetil (CTM) 200 mg bd with that of a 10-day course of penicillin V (PEV) 1 megaunit (600 mg) tds, to investigate the significance of recovering GABHS during or after treatment and to evaluate the potential economic advantages of short-term regimens. Two hundred and fifty ambulatory adult patients with a presumptive diagnosis (based on a positive rapid antigen detection test) of GABHS tonsillitis were recruited in 60 centres; the diagnosis was subsequently confirmed by a positive culture of a throat swab. At the time of entry into the trial there was no statistically significant difference between the groups in terms of clinical symptoms. In an intention-to-treat analysis, both the clinical and bacteriological response rates at days 10 and 30 were comparable for each group i.e. 106 of 119 (89.1%) patients and 90 of 109 (82.6%) patients respectively in the CTM group and 103 of 117 (88.0%) patients and 92 of 107 (86.0%) patients respectively in the PEV group. The times until defervescence and resolution of symptoms were also similar. Of the 115 patients in each group who were assessed at day 90, there were three clinical relapses in the CTM group and seven in the PEV group. No non-suppurative complications of GABHS infection were detected. Tolerance was significantly better in the CTM group than in the PEV group, 14 of 119 (11.8%) patients and 26 of 117 (22.2%) patients in the former and latter groups respectively reporting adverse events. In three cases in each group treatment was discontinued prematurely because of adverse events; none of these in the CTM group was serious but one patient in the PEV group experienced a severe allergic reaction. Compliance in both groups was good during the first 5 days of therapy but, by the end of each course, 93.6% of patients in the CTM group had completed treatment, compared with 73.0% in the PEV group.(ABSTRACT TRUNCATED AT 400 WORDS)

Cefotiam concentrations in the sinus fluid of patients with chronic sinusitis after administration of cefotiam hexetil.

Cefotiam hexetil is a prodrug of cefotiam. The concentrations of cefotiam in plasma and sinus secretions were determined in 18 patients (10 males, 8 females, aged 39.3 +/- 13.0 years) with chronic sinusitis. All patients received two 200 mg oral doses of cefotiam hexetil 12 h apart and were divided into four groups according to the time which elapsed between the last dose and collection of secretion samples. The last dose was given 2 h (group I), 3 h (group II), 4 h (group III) or 6 h (group IV) before sinus puncture. Cefotiam concentrations were measured by high-pressure liquid chromatography and microbiological assay, results being very similar with both methods. Mean concentrations of cefotiam with the standard deviation in sinus exudates were 1.04 +/- 0.60 mg/l at 2 h (n = 6), 1.04 +/- 0.33 mg/l at 3 h (n = 4), 0.75 +/- 0.74 mg/l at 4 h (n = 4) and < 0.10 mg/l at 6 h (n = 4). Mean sinus fluid concentrations were higher than mean plasma concentrations in all groups. These results suggest that cefotiam concentrations higher than the MICs for common pathogens are found in sinus secretions up to 4 h after oral administration of cefotiam hexetil.

[Determination of variability factors of arterial pressure using 3843 self-measurements of blood pressure in 34 active hypertensives]. / Approche des facteurs de variabilité de la pression artérielle par 3 843 automesures tensionnelles chez 34 hypertendus actifs.

To assess the role of physical activity, stress and treatment on BP variations in working hypertensives we used repeated self measurements of BP which are cheaper and more simple than ambulatory BP measurements but allow for a smaller number of measurements. 34 working hypertensives self measured daily life BP, at home and at workplace, 7 times a day, for at least one week, before and 6 weeks after beta-blockade with metoprolol 200 to 400 mg daily. They used a Spengler SP9 electronic sphygmometer and specified on 4 grades scales their physical activity and stress just before measurement. The time for self measurement of BP was settled according to occupations more than to clocktime. The equipment was standardized at each visit by measuring BP with a mercury manometer then with the electronic sphygmometer. There were no significant differences neither for SBP nor for DBP and the two measures correlate closely (r = 0.91), P = 0.0001). Analysis of variance on SBP exhibits the role of time (p (0.001) and stress (p (0.0001). Physical activity does not interfere (p = 0.19). There is no difference between work days and sundays (p = 0.17). Treatment effect was very strong (p (0.0001) but there was no interaction neither with physical activity nor stress. Analysis of variance on DBP exhibits similar results except that BP on workdays is significantly higher than on sundays (p = 0.03). We conclude that: Repeated self measurement of BP is able to display variation of BP with occupations and stress. Beta-blockade lowers BP but does not interfere with variability.

[Aeromonas hydrophila septicemia: 3 cases, 1 with mediastinitis]. / Septicémies à Aeromonas hydrophila: trois observations dont une avec médiastinite.

Three cases of Aeromonas hydrophila septicaemia are reported. The first case concerned a 51 years old patient suffering from drowning who had previously been in good health and who died after a few days of refractory hypoxaemia. The second case was an 8 years old child with trisomy 21 operated for a congenital cardiac defect. The portal of entry was a catheter and the septicaemia was complicated by A. hydrophila mediastinitis, a complication which has not been described previously. The third case was a 75 years old man with no previous medical history, whose hobby was gardening. He developed septicaemia after a flu-like illness. A. hydrophila is a mobile Gram negative bacillus whose natural habitat is water. It appears to be an exceptional and temporary contaminant of the human G I tract. Clinical infection is rare and usually focal: gastroenteritis, infection of soft tissues after trauma in aquatic surroundings. In 60 out of 82 cases there was a documented deficiency in the patient's immune defenses. A digestive portal of entry was suspected in 63 cases but only rarely proved. In one of our cases the portal of entry was septic thrombophlebitis induced by an indwelling catheter; this complication has not previously been reported. The clinical picture of A. hydrophila septicaemia is characterised by the relative high incidence of Echtyma gangrenosum. The lethal outcome in 50 p. 100 of cases is often related to the patient's general condition. The sensitivity of the three cultures isolated was tested against third generation cephalosporins: they were effective in each occasion.