[Contribution of centralized reading of intima media thickness in an IMMEDIAT study conducted in hypertensive patients followed up in general medicine]. / Apport de la lecture centralisée de la mesure de l'épaisseur intima-média dans l'étude IMMEDIAT menée chez des hypertendus suivis en médecine générale.

OBJECTIVE: To compare the results of two readings of Intima Media thickness (EIM): one performed during measurement by the cardiologist, the other by a technician in a reading unit. To evaluate the consequences of these readings on the principal criterion of a study conducted into cardiovascular risk (RCV) for hypertensives followed up in ordinary medical practice. METHODS: The EIM was measured in 991 hypertensives with the aid of the M'Ath program by cardiologists specially trained in the technique, within the framework of a study aimed at evaluating the RCV according to the WHO/ISH classification. The re-reading of source data by a reference centre was performed with the same program. RESULTS: The analysis was performed in 973 patients after eliminating duplicates and missing values (2%). The average cardiologist value of EIM was 0.761 +/- 0.168 mm, after centralised reading it was 0.743 +/- 0.128 mm. The difference between the measurements was -0.020 +/- 0.150 (p < 0.0001). According to the OMS/ISH classification, the presence of a vascular condition categorizes a hypertensive as being at "high risk" of a cardiovascular complication occurring. The calculation of RCV was performed by taking a value of EIM > 0.7 mm and/or presence of a plaque to define a vascular condition. The appreciation of risk was identical for the subjects at low risk and at very high risk. There was a shift from medium risk towards high risk: General Medicine 15%, Cardio 49%, after re-reading 68%. CONCLUSION: Despite the simplicity and the good inter observer reproducibility of the measurement of EIM by the M'Ath program, centralization of the reading is recommended during clinical trials.

[Study of the effect of season on the frequency of side effects or antihypertensive agents]. / Etude de l'influence de la saison sur la fréquence des effets indésirables chez des hypertendus sous traitements antihypertenseurs.

OBJECTIVES: To evaluate the influence of season on side effects of antihypertensive treatments in hypertensive patients followed by cardiologists. METHODS: In 12,071 hypertensive subjects, referred to cardiologists, a questionnaire with 14 possible side effects due to antihypertensive treatment was administered during the consultation. Details on antihypertensive treatment and cardiovascular characteristics were obtained from medical records. This evaluation was obtained in patients recruited during summer (7,438 patients) and during winter (4,633 patients). RESULTS: In this population of treated hypertensives, blood pressure level was < 140/90 mmHg in 28%, and 50% were treated with a monotherapy. At least one side effect was declared by 40% of cases, and it was observed dyspnea (10%), dizziness (8%), fatigue (8%), palpitations (6%), ankle oedema (5%), headaches (5%). The higher rate was observed in patients on monotherapy, most frequent side effects were fatigue (9%) on beta-blockers, cough (9%) on ACEI, oedema (18%) on calcium antagonists, dyspnea (9%) on diuretics, dizziness on ARB (8%) and central acting agents (18%). Regression analysis indicates that female patient, uncontrolled BP, age less than 50, and greater number of antihypertensive tablets were independent determinants for at least one side effects under antihypertensive treatments. Season was not a significant determinant of side effect appearance. CONCLUSION: This study indicates that during hypertensive treatments, at least one side effect is declared by 40% of patients. A female patient, uncontrolled for BP, aged less of 50 and treated with a multiple therapy is more prone to complain of side effects, but season was not a significant determinant of its appearance.

Azelastine reduces allergen-induced nasal response: a clinical and rhinomanometric assessment.

The effect of azelastine 2 mg b.d. p.o. for 10 days on grass pollen-induced nasal responses in 16 patients with grass pollen allergic rhinitis has been assessed. The study was a double blind, randomized, placebo controlled, crossover trial, with a 10-14 day wash-out period. Patients were challenged with grass pollen before and after placebo and azelastine. The response was assessed by measurement of nasal resistance using active posterior rhinomanometry, by weighing nasal secretions, and by counting sneezes. The sensation of nasal obstruction was assessed with a visual analogue scale. After measurement of baseline total nasal resistance, doubling doses of allergen were sprayed into both nostrils at 15 min intervals until the nasal resistance was doubled. Cumulative doses of allergen that doubled prechallenge nasal resistance, numbers of sneezes and the amounts of nasal secretions were similar before azelastine as well as before and after placebo (cumulative dose, mean, (microgram): 2.3, 4.2 and 2.1 respectively, N.S.). After azelastine, the cumulative dose of allergen was increased (7.3 micrograms), and nasal secretions and the number of sneezes were decreased. The visual analogue scores were similar before and after azelastine as well as before and after the placebo. It is concluded that azelastine reduced the allergen-induced nasal responses.

[Iodized polyvidone (betadine) and prevention of postoperative infection. A multicenter study]. / Polyvidone iodée (bétadine) et prévention de l'infection postopératoire. Etude multicentrique.

A multicentre study of a new preparation of povidone iodine (5% betadine) was carried out on 150 patients undergoing cataract surgery. Pre-operatively the eye was prepared by daubing the peri-ocular skin and a two-minute instillation into the conjunctival fornices. No other antiseptic was applied. Tolerance to the product was evaluated in all the patients: clinical evaluation postoperatively and during a 60-day follow-up period confirmed that the preparation was harmless to the eye. Microbiological investigations (comprising conjunctival swabbing, bacterial culture and count of the bacterial species isolated, before and after application of the product) performed on 60 patients showed a significant fall in the number of colonies after treatment.

Effect of arginine aspartate on the exercise-induced hyperammoniemia in humans: a two periods cross-over trial.

To investigate the effect of the ingestion of arginine aspartate (AA) in the decrease of the exercise-induced accumulation of ammonia in plasma, 11 voluntary subjects took part in a cross-over study where AA effect was tested against placebo. Both treatments were randomly administered in a double-blind procedure. To ensure the subjects would be able to present reproducible exercise-testing results during repetitive sessions, they were involved before the experiment in a cycle ergometer training program during 8 weeks. This training determined a significant 14% increase (P less than 0.001) in maximal oxygen uptake (VO2 max). The treatments were administered during 10 days and the two treatments were separated by a 10 day-wash-out period. A 45 min-cycle ergometer test was performed at 80% VO2 max during the 10th day of each treatment to measure plasma ammonia (p[NH4+]) and total blood lactate (b[lact]) concentrations at rest and at the 15th, 30th and 45th min of exercise (determinations of changes from rest; delta p[NH4+] and delta b[lact]). Both concentrations were unchanged between AA and placebo at rest but a significant lesser delta p[NH4+] was found under AA at the 15th min of exercise only (P less than 0.05). On the other hand, an order effect was found for delta p[NH4+] between the two periods of randomized treatment that was interpreted as a remaining training effect. This effect was highly significant at the 30th and 45th min of exercise (P less than 0.001). It was concluded that AA effect was minor with regard to the training effect. As it was not located at the same time of exercise, AA effect would not consequently have the same functional origin (postulated increase in the peripheral clearance of ammonia) than those of training (decrease in muscle production of ammonia).

Electrophysiologic properties of falipamil (AQA-39)--a new bradycardiac agent.

Falipamil hydrochloride (AQA 39) is a new antiarrhythmic agent structurally related to verapamil. We evaluated the electrophysiologic properties of intravenous falipamil (1.5 mg kg-1 within 20 minutes) in 12 patients. The spontaneous cycle length was significantly (P less than 0.001) prolonged (+79 +/- 59 ms). Atrioventricular conduction was significantly (P less than 0.001) shorter due to AH interval shortening (-17 +/- 14 ms), most probably related to an anticholinergic effect. Similarly, the anterograde Wenckebach point occurred at a significantly (P less than 0.06) higher rate after falipamil (+10 +/- 7 beats min-1). No statistically significant effect was noted on the refractory periods of the AV node, although there was a trend to shortening. The refractoriness of the right atrium and ventricle was significantly prolonged. It is concluded that falipamil is a bradycardiac agent with electrophysiologic properties quite different from those of verapamil and similar to those of class IA antiarrhythmic agents.