Risk factors for bacterial vaginosis.

OBJECTIVE: To analyse risk factors for bacterial vaginosis (BV). STUDY DESIGN: We conducted a case-control study on risk factors for BV, in several first-level gynecological centers in Italy. Cases were women aged 18-70 years with confirmed diagnosis of BV (using test for proline iminopeptidase (PIP) activity). Control were the first patients observed in the same center without any symptom suggesting vaginal infection, and a negative PIP activity test. A total of 476 cases and 450 controls entered the study. RESULTS: The number of sexual partners in the month before interview, but not the number of intercourses, was associated with an increased risk of BV. The risk of BV with vaginal douching or tight jeans/trousers once or more a week was 2.0 (95% CI 1.0-3.9) and 1.5 (95% CI 1.0-2.2), respectively, compared to never users. CONCLUSION: The findings are consistent with previous data and suggest that daily habits play an important role in risk of BV.

Current drug use as risk factor for erectile dysfunction: results from an Italian epidemiological study.

Several drugs have been associated with an increased risk of erectile dysfunction (ED). We analysed the role of pharmacological treatments on the risk of ED using data from a cross-sectional study on prevalence and risk factors for ED in the general population in Italy. A total of 2450 men aged more than 18 years were randomly identified by 143 general practioners (GP) among their registered patients and invited to a confidential interview by their GP. 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. Out of the 2450 men identified, 440 (18%) refused to participate. The present analysis therefore includes information on 2010 men. After adjustment for related pathologies, anxiolytics and antidepressants showed insignificantly higher odds ratio (ORs, respectively, 1.7 and 2.1); antipsychotic drug use significantly increased the risk of ED (OR 9.0, 95% confidence interval, CI 1.8-44.4). Diuretics (OR 3.1, 95% CI 1.4-6.9) and anticholinergic drugs (OR 12.8, 95% CI 2.7-60.1) were associated with ED risk. No association emerged between ED and H2 antagonists, anticholesterolemic or hypoglycemic drugs. In conclusion, after taking account of related pathologies, our results suggest that men treated with antipsychotic, diuretic and anticholinergic drugs are at greater risk of ED.

Cigarette smoking: a risk factor for erectile dysfunction in diabetics.

OBJECTIVES: Diabetes is one of the systemic disorders most frequently associated with erectile dysfunction (ED). An extensive literature documents well the relationship between ED and several factors related to diabetic pathology, but the role of risk factors mainly related to life-style, e.g. cigarette smoking, is still not defined. METHODS: Eligible for the study were men aged 20-70 years with a diagnosis of insulin-dependent (type 1---IDDM) or non-insulin-dependent (type 2--NIDDM) diabetes who were observed on randomly selected days in 178 diabetes centers in Italy. ED was defined as a failure to achieve and maintain an erection sufficient for satisfactory sexual performance. RESULTS: The study population consisted of 9,670 diabetic men. Of these 2,962 (30%) were never smokers, 2,877 (30%) current smokers and 3,831 (40%) ex-smokers. After taking into account the effect of age, the odds ratios of ED in comparison with never smokers was 1.4 (95% confidence interval 1.3-1.6) for smokers and 1.5 (95% confidence interval 1.3-1.6) for ex-smokers. Duration and intensity of the smoking habit was associated with an increased risk of ED. Among ex-smokers, the risk of ED significantly decreased; with increase in the number of years since the patient quit smoking. CONCLUSION: The study offers an assessment of the association between smoking habit and ED and its potential interaction with other risk factors in diabetic men.

Incidence of erectile dysfunction in Italian men with diabetes.

PURPOSE: We determined the incidence of erectile dysfunction in Italian men with diabetes. MATERIALS AND METHODS: We estimated the incidence of erectile dysfunction, defined as failure to achieve and maintain erection sufficient for satisfactory sexual performance, after 2.8 years of followup in 1,010 men enrolled for a prevalence study of erectile dysfunction in diabetes. RESULTS: Of the 1,010 men 192 (19%) complained of erectile dysfunction. The crude incidence rate of erectile dysfunction was 68 cases per 1,000 person-years (95% confidence interval 59 to 77). The incidence of erectile dysfunction increased with increasing age (10-fold higher for ages 70 to 79 than for 19 to 29 years), duration of diabetes (1.6-fold higher a history of 11 years or greater than for less than 5) and deteriorating metabolic control (1.7-fold higher for hemoglobin A1c greater than 9% than less than 7.5%). Moreover, it was higher in type 2 than in type 1 diabetes (74 versus 45 cases per 1,000 person-years). The relative risk was 1.75, 2.02, 1.97, 1.16, 1.86, 3.79 and 1.52 for associated obliterative arterial disease of the lower legs, ischemic heart disease, renal disease, autonomic neuropathy, sensitive and motor neuropathy, diabetic foot and retinal disease, respectively. Of the characteristics at study enrollment patient age, duration of diabetes, renal disease and hypertension were multivariate predictors of the erectile dysfunction 2.8 years later. CONCLUSIONS: The incidence of erectile dysfunction in Italian men with diabetes at a mean followup of 2.8 years was 68 cases per 1,000 person-years, more than 2-fold that in the Massachusetts Male Aging Study of the general population. The knowledge of this incidence should promote specific preventive and therapeutic interventions for erectile dysfunction in men with diabetes.

Management of erectile dysfunction in diabetic subjects: results from a survey of 400 diabetes centres in Italy.

We report the results of a survey on erectile dysfunction (ED) conducted in 400 Italian Diabetes Centres in 1998. A questionnaire consisting of 10 items was sent to the Centres recorded by the Italian Association of Diabetologists and the Italian Society of Diabetology; 400 Centres returned the completed questionnaire (58%). Forty-nine percent of the Centres declared that they investigated ED systematically but less than half of them (46%) had done it autonomously. The percentage of Centres performing intracavernous injection (ICI) was 84%. This maneuvre was most commonly performed by diabetologists (61%), followed by urologists (29%) and andrologists (18%) (categories are not mutually exclusive). ICI was also the most common type of treatment (85%), followed by oral (32%) and topic (7%) therapies (categories are not mutually exclusive). Slightly more than half of the interviewed Centres (51%) did not investigate ED routinely, attributing this to structural problems, lack of specific training and the availability of more specialised Centres as the main reasons for this. However, the majority of Centres expressed interest in managing ED. Among the available tests for ED, ICI was the most frequently employed. While most Centres seek the collaboration of external specialists to diagnose ED, the diabetologist is the physician who most frequently performs ICI. We conclude that Italian diabetologists need specific training to reach a greater degree of autonomy in the management of ED in their patients.

[Urinary incontinence: frequency and diagnostic and therapeutic approach in general practice in Italy]. / Incontinenza urinaria: frequenza ed approccio diagnostico e terapeutico nella pratica di Medicina Generale in Italia.

OBJECTIVE: A large observational study was conducted to assess the frequency of urinary incontinence (UI) and overactive bladder (OAB) and to describe the diagnostic and therapeutic approach in General Medical Practice in Italy. MATERIALS AND METHODS: Subjects eligible for the study were men aged > 50 years and women aged > 40 years, observed consecutively by their own General Practitioner (GP) for a check-up or medical prescription examination during the recruitment period, who agreed to participate in the study. All the subjects included in the study were interviewed by their GP using a common questionnaire that included information about their general characteristics and a specific medical history. The subject was also asked: "Have you had involuntary loss of urine during the last 3 months?"; "Do you urinate more than 8 times a day on average and/or Do you have to get up more than once a night?"; "Have you urgency problems?". If the subject answered yes to the first question or to both the second and third, a urinary problem was diagnosed, in particular UI if the anser was yes to the first and OAB if to the second and third. In these subjects the interview was continued in order to define the type of UI, using the diagnostic flow chart proposed by Wean. RESULTS: On the whole, 9613 men (average age 64.8, range 50-98) and 13,365 women (average age 60.3 years, range 40-98) were interviewed by 774 GPs. A diagnosis of urinary problems was made in 1084 men (11.3%) and 1507 women (11.3%). Among the men the GP was already aware of the condition in 603 cases (55.6%) and a new diagnosis was made in 481 cases (44.4%). The corresponding figures for women were 560 (37.2%) and 947 (62.8%). The proportion of new diagnosis out of all the subjects with micturition problems tended to be greater in the younger age (chi square for trend p < 0.05). The presence of OAB without UI was found in 3.0% [95% Confidence Interval (CI) 1.7-3.5] of the men and 1.1% (95% CI 0.9-1.3) of the women. Over all, 8.3% (95% CI 7.7-8.9) of the men and 10.2% (95% CI 9.6-10.8) of the women reported UI. The frequency of OAB and UI conditions increased with age in both men and women. On the whole, a urine test was requested in 71.9% of the subjects with a new diagnosis of UI or OAB and the frequency of haematuria was equal to 15.7% of the cases, without marked differences by type of diagnosis of micturition problem. A urine culture was done in 60.7% of the cases and was positive in 17.7%. Further diagnostic investigations were prescribed in the majority of cases, 76.6%. This was observed in particular among the men (86.2% of the cases compared to 71.7% of the women) but with no substantial differences between the different diagnoses of UI. Pharmacological treatment was suggested to 68% of the men and 44.9% of the women. The condition for which pharmacological treatment was less often prescribed was stress UI, where it was suggested in 54.5% of the men and 27.3% of the women. For men, alpha-lytics were the drugs most often prescribed for all urinary problems, regardless of the type. For women, anticholinergics were the most commonly advised type of drug, followed by anti-infectives.

Erectile dysfunction in type 1 and type 2 diabetics in Italy. On behalf of Gruppo Italiano Studio Deficit Erettile nei Diabetici.

BACKGROUND: Several studies reported data on the increased risk of erectile dysfunction (ED) in populations of diabetic men, but few presented data separately for Type 1 and Type 2 subjects. No comparison data for these diabetic subgroups are available with regard to risk factors for ED. METHODS: Eligible for the study were men aged 20-69 years with a diagnosis of insulin-dependent (Type 1) or non-insulin-dependent (Type 2) diabetes who were observed on randomly selected days in 178 diabetes centres in Italy. Erectile dysfunction was defined as a failure to achieve and maintain an erection sufficient for satisfactory sexual performance. RESULTS: The study population consisted of 1383 Type 1 and 8373 Type 2 men. The prevalence of ED increased with age for both groups. After taking into account the effect of age Type 2 men (37/100 men) tend to report ED less frequently than Type 1 men (51/100 men). A significant positive relationship was reported between ED and poor metabolic control and smoking for both Type 1 and Type 2 men, whereas high body mass index (BMI) increased only the risk of ED in Type 1 cases. CONCLUSIONS: The study offers a quantitative estimate of the prevalence of ED and its main risk factors in Type 1 and Type 2 diabetic subgroups.

Prevalence and risk factors for urinary incontinence in Italy.

OBJECTIVES: To analyze the frequency and risk factors for urinary incontinence (UI) in Italy. METHODS: Eligible for this cross-sectional study were men aged >/=50 years and women aged >/=40, randomly identified among registered subjects of a network of general practitioners during the period March-October 1997. All subjects were invited by telephonic interview to determine the presence of UI, reported by the subjects as loss of urine in the last year. The subjects with UI were further questioned at home for evaluation of the type, degree and frequency of UI episodes. RESULTS: Of the 5,488 subjects interviewed (2,767 women and 2,721 men), 92 (3%) men and 316 (11%) women reported at least one episode of UI during the year before the interview. The frequence of UI increased with age both in men and women, being 2 and 11% in men and women, respectively, aged 50-60 years and 7 and 16% in those aged >/=70. Of the subjects with UI identified, 229 women and 64 men and a group of 289 subjects without UI were questionned at home using a detailed questionnaire. Six and 55% of men and women, respectively, reported stress incontinence, 20 and 12% urge incontinence and 20 and 24% mixed incontinence. The risk of UI increased with body mass index in women. A history of recurrent urinary infection was associated with UI in men and less markedly in women. No association emerged between education, smoking and alcohol or coffee consumption and risk of UI. Parity was directly associated with the risk of UI in women. CONCLUSIONS: The study offers a quantitative estimate of the prevalence of UI and its main risk factors in this Italian population.

Frequency and determinants of erectile dysfunction in Italy.

OBJECTIVE: To analyze the prevalence and risk factors for erectile dysfunction (ED) in Italy in a cross-sectional study. METHODS: Eligible for the study were men aged 18 years or more, randomly identified by 143 general practitioners among their registered patients during the period January 1996 to February 1997. ED was defined as the impossibility to achieve and maintain an erection sufficient for satisfactory sexual performance. RESULTS: Of the 2, 010 men interviewed, 257 (12.8%) reported ED. The prevalence increased with age, from 2% in men aged 18-39 to 48% in those >70 years (tested for trend, p = 0.0001). A history of cardiopathy, diabetes, hypertension, neuropathy, thrombotic/hemorrhagic stroke, peripheral vascular disorders, pelvic/medullary injury and pelvic surgery/radiation all increased the risk of ED. The association of hypertension and diabetes tends to increase the risk of ED. In comparison with nondiabetic and nonhypertensive men, the odds ratio (OR) was 1.4 (95% confidence interval (CI), 0.7-3.2) for hypertensive men without diabetes, 4.6 (95% CI, 1.6-13.7) for diabetic men without hypertension and 8.1 (95% CI, 1.2-55.0) for men with diabetes and hypertension. In comparison with never smokers, the OR of ED was 1.7 (95% CI, 1.2-2.4) for current smokers and 1.6 (95% CI, 1.1-2.3) for ex-smokers and increased with duration of the habit. CONCLUSIONS: The study offers a quantitative estimate of the prevalence of ED and of its main risk factors in Italian men.

Indobufen compared with aspirin and dipyridamole on graft patency after coronary artery bypass surgery: results of a combined analysis.

BACKGROUND: Two prospective, randomized, double-blind clinical trials, performed in the UK and Italy, showed that indobufen, a reversible cyclo-oxygenase inhibitor, is as effective as, and safer than, a combination of aspirin with dipyridamole in preventing occlusion of saphenous vein coronary artery bypass grafts (CABG) 1 year after surgery. OBJECTIVE: To obtain, in a larger patient population, a more precise estimate of the possible differences in efficacy and safety between the two treatments. METHODS: We performed a combined analysis of the results of the two studies, based on the 1-year angiography data, on a total of 934 patients with 2258 saphenous vein distal anastomoses. RESULTS: Patients in the UK and Italy had similar baseline clinical characteristics. The analysis confirmed that there were no significant differences between the two treatment groups in the proportion of patients with one or more occluded grafts and in the proportion of occluded distal anastomoses. The combined analysis showed that the difference in response frequency (indobufen compared with aspirin and dipyridamole) was close to 0: 2.0% (95% confidence interval (CI) -4.2 to 8.2) in terms of patients, and 0.8% (95% CI -2.5 to 4.2) in terms of distal anastomoses. The 1-year incidence of postoperative major cardiovascular events was not statistically different between the treatment groups (19/694 indobufen compared with 25/678 aspirin and dipyridamole). CONCLUSIONS: Two multicentre CABG studies performed in different countries in patients with similar characteristics showed similar results in terms of graft patency. On the basis of the combined analysis, the two treatments can reasonably be considered to be equally effective in the prevention of graft occlusion.

Indobufen versus warfarin in the secondary prevention of major vascular events in nonrheumatic atrial fibrillation. SIFA (Studio Italiano Fibrillazione Atriale) Investigators.

BACKGROUND AND PURPOSE: The results of a large prospective randomized trial have shown the efficacy of oral anticoagulation in the secondary prevention of major vascular events in patients with nonrheumatic atrial fibrillation (NRAF); less well established is the role of antiplatelet agents. The present study compared the effects of indobufen, a reversible inhibitor of platelet cyclooxygenase, with those of warfarin in this setting. METHODS: A total of 916 patients with NRAF and a recent (< or = 15 days) cerebral ischemic episode were admitted to this multicenter, randomized study, during which they were treated with either indobufen (100 or 200 mg BID) or warfarin (to obtain an international normalized ratio of 2.0 to 3.5) for 12 months. The two groups (462 on indobufen and 454 on warfarin) were well balanced in terms of their main baseline characteristics. The primary outcome of the study was the combined incidence of nonfatal stroke (including intracerebral bleeding), pulmonary or systemic embolism, nonfatal myocardial infarction, and vascular death. RESULTS: At the end of follow-up, the incidence of primary outcome events was 10.6% in the indobufen group (95% confidence interval, 7.7% to 13.5%) and 9.0% in the warfarin group (95% confidence interval, 6.3% to 11.8%), with no statistically significant difference between treatments. The frequency of noncerebral major bleeding complications was low: only four cases (0.9%) of gastrointestinal bleeding were observed, all of them in the warfarin group. CONCLUSIONS: We conclude that, within the limitations of its design, this study may help the medical community in devising appropriate antithrombotic strategies for NRAF patients for whom oral anticoagulants are contraindicated or do not represent a feasible approach to treatment.

A prostacyclin-sparing effect of indobufen vs. aspirin.

Indobufen ((+/-)-2-[p-(1-oxo-2-insoindolinyl)-phenyl]-butyric acid, indo) is a drug inhibiting platelet function by a reversible block of the arachidonic acid metabolism at the level of cyclooxygenase. Since tolerability profile of such drugs is mostly linked to extra-platelet cyclooxygenase inhibition, we prospectively evaluated the extent of platelet and extra-platelet cyclooxygenase inhibition by in vivo administration of indo in comparison with ASA. We assessed the effects of the two drugs on the ex vivo generation of TXB2 and 6-keto-PGF1 alpha in whole blood, as indices of the production of TXA2 and PGI2 (prostacyclin), respectively, either after spontaneous clotting at 37 degrees C for 1 h (Study 1) or after the addition of 2 micrograms/ml collagen (Study 2). Generation of 6-keto-PGF1 alpha in whole blood is a mixed index of platelet and extra-platelet cyclooxygenase activity, deriving from both platelet and white blood cell arachidonic acid metabolization. Fifteen patients with ischemic heart disease and baseline serum TXB2 levels > 300 ng/ml were allocated to receiving one single administration of either indobufen 200 mg (n = 6) or aspirin 500 mg (n = 9). Whole blood prostanoid generation was assessed at 0, 1, 2, 4, 6, 8, 12 and 24 h after drug administration (Study I). Ten healthy male volunteers were allocated to a double-blind, randomized crossover comparison of indo 200 mg b.i.d. vs. ASA 300 mg/d for 7 days (Study 2). Prostanoid generation and whole blood platelet aggregation were performed before and at the end of each study period (Day 0 and Day 7). At each time-point after single dose administration (Study 1), indobufen caused less % inhibition of whole blood 6-keto-PGF1 alpha than of TXB2. At 2 h, TXB2 was reduced to a similar extent after ASA (98 +/- 4%) and indo (97 +/- 6%) (p = N.S.), while inhibition of 6-keto-PGF1 alpha was clearly different ( > 98% after ASA, 81 +/- 2.5% after indo, p < 0.01). After one week of ASA or indo (Study 2) the maximum extent of whole blood platelet aggregation was similarly inhibited (from 17.2 +/- 1.4 ohms to 3.6 +/- 1.3 ohms with ASA; from 18.3 +/- 1.0 ohms to 1.6 +/- 0.7 ohms with indo (p ASA vs. indo = N.S.). Despite equal inhibition of whole blood TX production after collagen (from 49.0 +/- 4.3 ng/ml to 1.1 +/- 0.6 ng/ml with ASA, from 49.8 +/- 1.3 ng/ml to 1.4 +/- 0.6 ng/ml with indo), again, however, 6-keto-PGF1 alpha production was less affected by indo than by ASA (from 409 +/- 30 pg/ml to 37 +/- 13 pg/ml with ASA, inhibition = 91%; from 396 +/- 35 to 318 +/- 40 with indo, inhibition = 20%). These differential effects of indo and ASA might lead to a better platelet selectivity, tolerability and benefit/risk profile of indo vs. ASA, which are worthy of further assessment.

[Italian Study on Atrial Fibrillation (SIFA): status report]. / Studio Italiano Fibrillazione Atriale (SIFA): stato della ricerca.

Non-valvular atrial fibrillation increases the risk of stroke by a factor of 5 and is present in about 15% of patients with acute stroke. Its prevalence in the general population increases from 0.5% at 50-59 years to > 10% at 80-99 years. In patients with non-valvular atrial fibrillation the risk of stroke increases with age, blood pressure and other evidence of cardiac disease. In addition, non-valvular atrial fibrillation is associated with a greater early mortality and a greater risk of recurrent stroke. The anticoagulant therapy to prevent early recurrent embolism is likewise controversial. Anticoagulant therapy appears to reduce this risk, but there is the danger of accentuating hemorrhagic infarction, especially in patients with large strokes. The effectiveness of antiplatelet drugs in patients with cardioembolic stroke is also not defined. The Studio Italiano Fibrillazione Atriale (SIFA) is a multicentric, randomized trial to assess the efficacy and safety of anticoagulant, warfarin, versus antiplatelet treatment, indobufen, a reversible inhibitor of platelet cyclo-oxygenase, in the prevention of recurrent cerebral ischemia and other systemic embolisms in non-valvular atrial fibrillation patients. Patients of both sexes, aged > 30 years with non-valvular atrial fibrillation, who have presented in the last 2 weeks an ischemic cerebral event (transitory ischemic attack or non-disabling stroke) and who have given their informed consent, were eligible. Patients with hemorrhagical diseases or contraindications to anticoagulant therapy were excluded. Patients were randomly given either indobufen (400 mg/die) or oral warfarin to an international normalized ratio of 2.0-3.5. The primary end-points were: recurrence of cerebral ischemia, systemic embolisms, intracranial or fatal hemorrhage, acute myocardial infarction, vascular death.(ABSTRACT TRUNCATED AT 250 WORDS)

Factors influencing 1-year patency of coronary artery saphenous vein grafts. Studio Indobufene nel Bypass Aortocoronarico (SINBA).

BACKGROUND: To evaluate the possible influence of a series of clinical angiographic and surgical variables on the 1-year patency of saphenous vein (SV) coronary graft, data collected prospectively in a multicenter randomized clinical trial were analyzed. METHODS AND RESULTS: The study group included 349 patients--847 SV distal anastomoses--who underwent angiography at a median time of 374 days after surgery. By logistic binomial regression analysis, age, sex, smoking habits, hypertension, high cholesterol, previous myocardial infarction, and angina were not found to be significant factors leading to graft occlusion. Among the angiographic and surgical variables, the following were retained as predictive of higher occlusion risk: (1) vessel diameter (< or = 1.5 mm versus > 1.5 mm, odds ratio (OR) = 2.46); (2) the location of the grafted vessel, namely, the right coronary artery versus the left anterior descending (OR = 2.15); and (3) the wall motion of the vessel-dependent myocardial region (altered versus normal: OR = 2.12). The presence of two or three risk factors multiplied the occlusion risk up to 11-fold. CONCLUSIONS: The study suggests that vessel diameter, wall motion of the vessel-dependent myocardial region, and location of the grafted vessel are the main determinants of SV coronary graft patency during the first postoperative year. Knowledge of these artery-specific factors may provide a basis for estimating the risk of graft occlusion, thereby modifying surgical strategy and postoperative surveillance.

[The use of a synthetic film (Bioprocess) in abrasions and second degree burns. Preliminary study in the emergency room]. / Utilizzo di una pellicola sintetica (Bioprocess) nelle abrasioni e nelle ustioni di secondo grado. Studio preliminare in Pronto Soccorso.

This study analyzes the usage of Bioprocess in abrasions and second degree burns, observing advantages and disadvantages of this treatment. This clinical research shows an important control against pain, a good hemostatic effect, an apparent reduction of healing time, an excellent cicatrization quality.

Indobufen in the prevention of thromboembolic complications in patients with heart disease. A randomized, placebo-controlled, double-blind study.

BACKGROUND: The purpose of this randomized, double-blind study was to evaluate the efficacy of indobufen, a reversible inhibitor of platelet cyclooxygenase, in the prevention of embolic events of cardiac origin. METHODS AND RESULTS: One hundred ninety-six patients with heart disease and at risk for cardiogenic embolism (90 with atrial fibrillation and 106 in sinus rhythm) were randomly assigned to receive indobufen (100 mg b.i.d.) or placebo. All patients were reexamined every 3 months for the duration of the study. The primary study end points were cerebral ischemic attack (stroke and transient ischemic attack), systemic embolism, pulmonary embolism, and fatal myocardial infarction. The median duration of treatment was 854 days in the indobufen group and 865 days in the placebo group. The frequencies of primary end points (fatal and nonfatal) were 6.1% and 17.3%, respectively, in the indobufen and placebo groups (p < 0.05) for a reduction of 65% in the risk of a primary event (indobufen/placebo relative risk, 0.35; 95% confidence limits, 0.14-0.89). Adverse drug reactions, mostly gastrointestinal or hemostasis disorders, occurred in 9.2% of indobufen-treated patients. CONCLUSIONS: The results of the study indicate that indobufen may reduce the risk of ischemic events in patients with heart disease associated with an increased risk of embolism.

Antiplatelet treatment after carotid endarterectomy: a pilot study.

The present study was undertaken in patients subjected to endarterectomy for extracranial carotid stenosis in order to verify the efficacy and the safety of medical treatment with indobufen (2-[4-(1-oxo-2-isoindolinyl)-phenyl] butyric acid), a drug which has been successfully used in the long-term treatment of cardiovascular ischemic diseases, and which showed a significant antiplatelet effect. One hundred thirty-eight patients entered into the study with previous diagnosis of cerebrovascular ischemic event within 3 months before surgery. Patients were treated after surgery with indobufen 400 mg/die/orally in the first 2 months after discharge and than 200 mg/die/orally. The planned duration of medical treatment was 24 months. Any patient interrupting the medical treatment for a cumulative period greater than 30 days/year was excluded from the analysis; the end points of the study were considered death and the occurrence of disabling stroke. Eleven patients were considered as dropped out because of treatment interruption. The operative (at 1 month after surgery) mortality rate was 0.79%. The cumulative operative mortality and morbidity rate was estimated in 2.37%. The mean follow-up period was 6 months and the cumulative mortality rate at 36 months was estimated in 7.14%. The cumulative risk/year of TIA or ischemic stroke is higher than the risk for myocardial infarction, but the long-term mortality rate mainly depends on the latter complication which occurred later. Treatment with indobufen after carotid surgery seems to be effective as far it was restricted to an homogeneous group of patients presenting symptomatic extracranial carotid disease.

Indobufen versus placebo in the prevention of restenosis after carotid endarterectomy: a double-blind pilot study.

A randomized clinical trial was undertaken to assess the efficacy of indobufen in inhibiting platelet adhesiveness in carotid thromboendarterectomy. The patients were treated under double-blind conditions with indobufen and with placebo, and were then assessed by means of scintigraphy with labelled platelets, ultrasonic tomography and angiography for a minimum follow-up period of 6 months. Haematological and clinical assessments were also performed. The results of the study suggest that platelet accumulation in carotid endarterectomy may be an early sign of restenosis; anti-aggregant treatment with indobufen carried out at an early stage prior to surgery inhibited platelet accumulation. The final result showed that anti-aggregant treatment had a positive influence on the short- and medium-term outcome of carotid endarterectomy.

Results of a phase IV study carried out with acipimox in type II diabetic patients with concomitant hyperlipoproteinaemia.

The aim of this phase IV study was to assess the tolerability and efficacy of acipimox, a lipid-lowering drug, in 3009 type II diabetic out-patients with types II and IV hyperlipoproteinaemia. The study was carried out by 150 Italian diabetes centres. Acipimox was given at the dosage of one capsule (250 mg), two or three times daily for at least 2 months. Acipimox produced a mean fall of 43% in serum triglycerides and of 18% in total serum cholesterol levels compared with baseline. The lipid-lowering effect was present throughout treatment, but was most pronounced at the end of treatment. An increase in the serum concentration of high density lipoprotein cholesterol (15%) was also observed at the end of the trial. Fasting blood glucose and glycosylated haemoglobin levels showed a slight reduction during the study. Adverse events were reported in 263 (8.8%) cases and 165 (5.4%) patients discontinued the treatment. The female trial population showed a nearly two-fold greater incidence of adverse events than the males. In the majority of cases the adverse events experienced by patients were transient episodes of flushing and mild gastro-intestinal disturbances (e.g. gastric pain and pyrexia).