Prevention of postcoronary angioplasty restenosis by omega-3 fatty acids: main results of the Esapent for Prevention of Restenosis ITalian Study (ESPRIT).

BACKGROUND AND OBJECTIVE: Previous trials of omega-3 fatty acids (omega-3 FA) for restenosis prevention after percutaneous transluminal coronary angioplasty (PTCA) have yielded conflicting results. We tested the hypothesis that long-term administration of omega-3 FA before PTCA may have significant effects on restenosis. METHODS: We randomized 339 patients in a double-blind, placebo-controlled study of omega-3 FA (as an ethyl ester preparation given as 6 1-g capsules providing 3 g eicosapentaenoic acid and 2.1 g docosahexaenoic acid/d started 1 month before PTCA and given for 1 month thereafter, then continued at half-dose for 6 months) versus an olive oil placebo. Of these, 257 patients (125 on omega-3 FA, 132 on placebo) well matched for risk factors underwent successful balloon-only PTCA (280 total lesions) and were evaluable at 6 months with repeat angiography. Restenosis was defined at quantitative angiography as a recurrence of >50% diameter stenosis in the dilated vessel (Definition I) and as >50% loss of the short-term gain immediately after PTCA (Definition II). RESULTS: Restenosis rates per vessel were 29.4% and 31.6% in the omega-3 FA group, and 39.6% and 35.4% in the placebo group according to Definitions I (P =.04) and II (P = not significant), respectively. Restenosis rates per patient were 31.2% and 33.6% in the omega-3 FA group, and 40.9% and 37.1% in the placebo group according to Definitions I (P =.05) and II (P = not significant), respectively. CONCLUSIONS: With a long treatment before PTCA, omega-3 FA produced a small but significant decrease in the restenosis rate compared with placebo.

Pregnancy outcome after cabergoline treatment in early weeks of gestation.

We collected information on 61 pregnancies in 50 women treated with cabergoline. These pregnancies resulted in 12 (19.7%) early terminations (five induced abortions, six spontaneous abortions, one hydatidiform mole) and 49 (80.3%) live births. In one case, malformations were suspected by a gynecologist based on ultrasound at 12 gestational weeks and the pregnancy was terminated; additional information was not available. There was one case of trisomy 18. The frequency of spontaneous and induced abortions and major congenital malformations was comparable with rates in the general population. The data did not indicate any potential adverse effect of the drug on pregnancy. The data from this study in combination with previous reports can exclude a congenital malformation risk greater than 10% associated with pregnancy exposure to cabergoline.

Prevalence of overactive bladder and urinary incontinence.

We conducted a cross-sectional study in Italy among men at least 50 years old and women at least 40 years old who consecutively visited their general practitioners. Patients were asked about the frequency of symptoms of overactive bladder and urinary incontinence. A total of 9613 men (mean age, 64.8 years; range, 50-98 years) and 13,365 women (mean age, 60.3 years; range, 40-98 years) were identified by 774 general practitioners. The frequencies of overactive bladder were 3.0% (95% confidence interval, 2.7-3.5) in men and 1.1% (95% confidence interval, 0.9-1.3) in women. The corresponding frequencies for urinary incontinence were 8.3% (95% confidence interval, 7.7-8.9) in men and 10.2% (95% confidence interval, 9.6-10.8) in women.

Impact of urinary incontinence and overactive bladder on quality of life.

OBJECTIVE: To assess the quality of life (QOL) of women with urinary incontinence (UI) or overactive bladder (OB) compared with women without UI. METHODS: A case-control study conducted in Italy on risk factors for UI and OB. Information on QOL were collected using the SF-12 questionnaire, validated for Italian women. RESULTS: A total of 1062 cases (258 had stress, 195 urge, 486 mixed UI and 123 OB without incontinence) and 1143 controls were interviewed. QOL, as assessed by the SF-12, was significantly impaired in cases compared with controls (p=0.0001); the mean SF-12 physical health score was 48.3 for controls, but 45.6, 42.0, 44.5 and 40.0 for cases with OB, urge, stress and mixed incontinence, respectively. Women with OB had significantly higher physical health scores than women with urge and mixed UI (p<0.005) (44.6 versus 41.7 and 41.3). Physical and mental health dimensions of cases significantly decreased with increasing severity of symptoms. CONCLUSIONS: QOL was significantly impaired in women with UI or OB compared to controls. Physical and mental functioning tended to be more impaired in patients than in controls.

Risk factors for stress, urge or mixed urinary incontinence in Italy.

OBJECTIVE: To assess risk factors for different type of urinary incontinence-stress, urge or mixed-and overactive bladder without urinary incontinence. DESIGN: Case-control study. SETTING: Gynaecology clinics. POPULATION: Women attending first level gynaecological centres. METHODS: Cases were 1062 women with urinary incontinence or overactive bladder aged 40 years or more (mean age 62.3 years, range 40-88) consecutively observed in first level gynaecological centres. Controls were 1143 women (mean age 58 years, range 40-86) observed in the same centre after the identification of the cases, without any symptoms related to urinary incontinence or overactive bladder. MAIN OUTCOME MEASURES: Determinants of different types of urinary incontinence and overactive bladder. RESULTS: The risk of urinary incontinence was lower in more educated patients and increased with body mass index (BMI). The number of vaginal births was associated with the risk of stress and mixed urinary incontinence, but not urge urinary incontinence and overactive bladder. In comparison with nulliparae, the odds ratios (OR) for stress and mixed urinary incontinence were 5.4 (95% confidence interval [CI] 1.9-15.0) and 1.6 (95% CI 1.0-2.6), respectively, for women reporting one or two vaginal birth and 5.1 (95% CI 1.8-14.5) and 2.2 (95% CI 1.3-3.7), respectively, for three or more. A history of operative vaginal delivery was directly associated with the risk of stress and mixed urinary incontinence and increased the risk of urge urinary incontinence and of overactive bladder, but the latter ORs were not statistically significant. When compared with women with no birth, a history of caesarean section increased the risk of stress urinary incontinence. A history of hysterectomy, recurrent urinary infection and perineal trauma increased the risk of all types of urinary incontinence. CONCLUSIONS: Vaginal births increased the risk of stress and mixed urinary incontinence, but not of urge urinary incontinence and overactive bladder. The risk of all types of urinary incontinence was increased in women with higher BMI, with a history of hysterectomy, urinary infection and perineal traumas. These factors were not related to the risk of overactive bladder.

Cigarette smoking as risk factor for erectile dysfunction: results from an Italian epidemiological study.

OBJECTIVES: We analysed the role of smoking on the risk of erectile dysfunction (ED) using data from a cross-sectional study on prevalence and risk factors for ED in the general population in Italy. METHODS: A total of 2010 men aged more than 18 years were randomly identified and interviewed by 143 general practitioners among their registered patients. Patients were asked "about their ability to achieve and maintain an erection sufficient for satisfactory sexual performance." If they were dissatisfied, they were defined as having ED. RESULTS: In comparison with never smokers, current smokers had an odds ratio (OR) of ED of 1.7 (95% confidence interval (CI), 1.2-2.4) and ex-smokers of 1.6 (95% CI, 1.1-2.3). The association between smoking and ED risk was present in subjects without a history of any cardiovascular disease, cardiopathy, hypertension, diabetes and neuropathy, but not in those with a history of these conditions. For example, the ORs of ED in smokers, in comparison with never smokers, were respectively 2.4, 2.0 and 1.7 in men with no history of any cardiovascular disease, diabetes and neuropathy, but respectively 1.0, 1.0 and 1.2 in those with a history of the conditions. CONCLUSIONS: This study shows that the risk of ED is influenced by smoking and that the duration of the habit increases the risk. Further, it highlights the potential interaction of smoking with medical history on ED risk.