LDL-cholesterol control in the primary prevention of cardiovascular diseases: An expert opinion for clinicians and health professionals.

AIMS: Although adequate clinical management of patients with hypercholesterolemia without a history of known cardiovascular disease is essential for prevention, these subjects are often disregarded. Furthermore, the scientific literature on primary cardiovascular prevention is not as rich as that on secondary prevention; finally, physicians often lack adequate tools for the effective management of subjects in primary prevention and have to face some unsolved relevant issues. This document aims to discuss and review the evidence available on this topic and provide practical guidance. DATA SYNTHESIS: Available algorithms and risk charts represent the main tool for the assessment of cardiovascular risk in patients in primary prevention. The accuracy of such an estimate can be substantially improved considering the potential contribution of some additional risk factors (C-reactive protein, lipoprotein(a), family history of cardiovascular disease) and conditions (environmental pollution, sleep quality, socioeconomic status, educational level) whose impact on the cardiovascular risk has been better understood in recent years. The availability of non-invasive procedures to evaluate subclinical atherosclerosis may help to identify subjects needing an earlier intervention. Unveiling the presence of these conditions will improve cardiovascular risk estimation, granting a more appropriate intervention. CONCLUSIONS: The accurate assessment of cardiovascular risk in subjects in primary prevention with the use of algorithms and risk charts together with the evaluation of additional factors will allow physicians to approach each patient with personalized strategies, which should translate into an increased adherence to therapy and, as a consequence, a reduced cardiovascular risk.

Clinical effectiveness of a highly standardized and bioavailable mixture of flavonoids and triterpenes in the management of acute hemorroidal crisis.

BACKGROUND AND AIM OF THE WORK: Patients with acute haemorrhoidal crisis often need of an immediate and effective pharmacological approach to alleviate their pain, bleeding and swelling or have to be referred by the general practitioner to the surgeon for a definitive treatment. Effective and not invasive treatment control of the acute crisis could be of practical use in order to avoid or to delay invasive procedures to a time more convenient for the patient and/or for the surgeon. METHODS: After enrolling, according to the group treatment, every patient starts taking 1 tablet every 8 hours for 7 days of Emospid or 2 tablets every 8 hours for 7 days of MMDH tablets. According to a simplified PATE 2000 classification, the following parameters were evaluated: haemorrhoidal grade, internal and external haemorrhoids, internal and external oedema, internal and external thrombosis, bleeding, bleeding intensity, pain, itching, defecation problems and urgency, tenesm, mucus in stools and sphinterial tone. RESULTS: In the Emospid group, within the considered period, 35 patients out 40 shift downwards of 1 grade of the haemorrhoidal scale (from III to II and from II to I); 22 out of 29 stop bleeding; bleeding intensity drops by about 90%; pain ceased in 33 out of38; pain intensity drops by about 75%; itching ceased in 25 out 35; tenesm ceased in 32 out of 33; sphinterial tone reduced from hypertonic to normal in 19 out 24; mucus in the stools was found in 3 out of 12; 12 out 35 still presented defecation disorders; defecation urgency was found in 2 out of 14; need to defecate in 2 times was found in 1 out of 17; acute events (external and/or internal oedema, external and/or internal thrombosis) was found in 10 out of 36. In the MDHH group results were, in terms of global evaluation, inferior of about 25-50% according to the considered parameter when compared with the one got by the Emospid treatment. CONCLUSIONS: Patients with acute haemorrhoidal crisis may be successfully treated with Emospid in order to avoid or to delay, if acute crisis relapsed, invasive procedures. Moreover, the treatment with Emospid shows to be more effective, if compared with MMDH, in counteracting acute haemorrhoidal crisis. (www.actabiomedica.it)

Interaction between ticlopidine or warfarin or cardioaspirin with a highly standardized deterpened Ginkgo biloba extract (VR456) in rat and human.

Ginkgo biloba is available in Europe as an over-the-counter drug and it is reported to cause hemorrhage when co-administered with other anti-platelet agents. We set out to study the interactions of ticlopidine with Ginkgo biloba extract or VR456, a new highly standardized deterpened extract from Ginkgo biloba leaves. Male Wistar rats were used to study the effects of ticlopidine (50-100 mg/kg/day), given alone and in combination for 5 days with Ginkgo biloba extract (50 mg/kg/day) or VR456 (50 mg/kg/day), on bleeding time and ex vivo ADP-induced platelet aggregation measurements. In addition, human studies were performed with the compounds under investigation. Combined treatment of ticlopidine and undeterpened Ginkgo biloba extract increased anti-platelet effect and prolonged the bleeding time in the rat. On the contrary, the combination treatment of ticlopidine and VR456 increased anti-platelet effect but did not prolong bleeding time. Moreover, daily administration of 360 mg of VR456 for 14 days to ticlopidine-treated humans did not highlight any unwanted effect and did not alter PT/INR and PTT parameters. Same results have been also obtained in warfarin or in cardioaspirin-treated patients. These data point out the clear role played by the terpenoid, PAF-antagonist fraction of Ginkgo biloba extract in affecting bleeding risk in anticoagulant-treated subjects and suggest VR456 as a possible option treatment in geriatric people subjected to anticoagulant treatment where the use of standard Ginkgo biloba extracts are discouraged.

Greenselect Phytosome as an adjunct to a low-calorie diet for treatment of obesity: a clinical trial.

A recently developed oral formulation in the form of coated tablets (Monoselect Camellia) (MonCam) containing highly bioavailable green tea extract (GreenSelect Phytosome) was tested in obese subjects (n=100) of both genders on a hypocaloric diet. Fifty subjects were assigned to the green tea extract plus hypocaloric diet, while the other 50 subjects followed the hypocaloric diet only. After 90 days of treatment, significant weight loss and decreased body mass index (BMI) were observed in the group taking the herbal extract (14-kg loss in the green tea group compared to a 5-kg loss in the diet-only group); waistline was reduced only in male subjects. Besides the effect on weight and BMI, biochemical parameters (LDL-, HDL-, and total cholesterol, triglycerides, growth hormone, insulin-like growth factor-1, insulin, and cortisol) were improved in both groups. Leptin, not tested in the diet-only group, was reduced in patients taking MonCam. Taking into consideration the high safety profile of the product and the total absence of adverse effects observed during and after the trial, MonCam appears to be a safe and effective tool for weight loss.