Combined treatment with Dif1stat and diet reduce plasma lipid indicators of moderate hypercholesterolemia more effectively than diet alone: a randomized trial in parallel groups.

An open-labeled randomized trial with parallel groups was carried out to study the effects of Dif1stat (Monascus purpureus-Linear aliphatic alcohols-Niacin) in the treatment of primary moderate hypercholesterolemia. The trial lasted 8 months. The patients, males and females, were assigned to two groups: A (#130), treated with diet, and B (#110) submitted to diet + Dif1stat. After 4 months, group A did not show significant changes in Total cholesterol (TC), LDL-cholesterol (LDLC), HDL-cholesterol (HDLC) or non-HDL-cholesterol (non-HDLC). The same group, showed a reduction in TC (-22%), LDLC (-30%) and non-HDLC (-27%) after 8 months (P < or = 0.001). After 4 months, TC (-21.3%), LDLC (-29%), and non-HDLC (-26%) were significantly lowered in group B (P < or = 0.001). In group B, TC, LDLC and non-HDLC showed a further reduction after 8 months: -29.4, -38 and -37%, respectively (P < or = 0.001). Even triglycerides (TG) decreased significantly (-33%) (P < or = 0.001). After 8 months, group B showed a significant reduction of TG (-33%) (P < or = 0.001), when compared to group A. Some safety parameters were significantly reduced in both groups: AST and gamma-GT in group A after 4 and 8 months, as well as ALT, AST and gamma-GT in group B after 8 months (P < or = 0.001). Dif1stat, given with a suitable diet, was well tolerated in the long-term and induced an anti-atherogenic plasma lipid and lipoprotein profile, in patients with moderate hypercholesterolemia.

Effects of low-dose atorvastatin and rosuvastatin on plasma lipid profiles: a long-term, randomized, open-label study in patients with primary hypercholesterolemia.

BACKGROUND AND OBJECTIVE: Despite the favorable effects of reduction of low-density lipoprotein-cholesterol (LDL-C) levels in decreasing the risk of coronary heart disease, many patients treated with lipid-lowering HMG-CoA reductase inhibitors (statins) do not achieve goal LDL-C levels. This may be due to high doses of statins prescribed that could potentially induce adverse effects and compromise patient safety and compliance with considerable expense in the long-term. We compared the actions of rosuvastatin and atorvastatin, administered at the low dosages of 10 and 20 mg/day, respectively, in reducing plasma LDL-C levels and their effects on other components of the atherogenic lipid profile in patients with primary hypercholesterolemia. METHODS: In this randomized, parallel group, open-label clinical study, 106 patients with LDL-C >200 mg/dL were treated with rosuvastatin 10 mg/day (group A; n = 52), or atorvastatin 20 mg/day (group B; n = 54) for 48 weeks. RESULTS: At 48 weeks, rosuvastatin 10 mg/day was associated with a significantly greater reduction in plasma LDL-C levels compared with atorvastatin 20 mg/day (-44.32% vs -30%; p < 0.005). Compared with atorvastatin, rosuvastatin also produced a greater reduction in plasma total cholesterol, triglycerides, and non-high-density lipoprotein-cholesterol (non-HDL-C) levels (p < 0.005). Plasma HDL-C levels were not affected significantly, independent of the drug used. CONCLUSION: In high-risk patients with primary hypercholesterolemia, rosuvastatin 10 mg/day was more efficacious than atorvastatin 20 mg/day in reducing plasma LDL-C levels, enabling goal LDL-C levels to be achieved and improving other lipid parameters. Both treatments were well tolerated over 48 weeks.

Modifications of metabolic and cardiovascular risk factors after weight loss induced by laparoscopic gastric banding.

BACKGROUND: The well-known inverse relation between life expectancy and BMI, particularly in morbid obesity, is presumably in large part due to multiple cardiovascular and metabolic comorbidities. Severely obese patients treated with laparoscopic adjustable silicone gastric banding (LASGB) were evaluated for such risk factors before and 1 year after LASGB. METHODS: 130 individuals (age 20-66, BMI 34-59 kg/m2) who underwent LASGB between 1996 and 2000 were studied; 50 of them were available for reevaluation 12 months after surgery. The presence and severity of diabetes (DM), hypertension (HTN), hypercholesterolemia (HC) and hypertriglyceridemia (HT) were assessed before and after surgery. In 18 of them erythrocyte sedimentation rate (ESR) were also measured. RESULTS: Comorbidities were highly prevalent at the initial evaluation: DM 10%, HTN 32%, HC 37%, HT 27%. In the subgroup reevaluated after surgery, prevalence of DM decreased from 15% to 6%, HTN from 37% to 25%, HC from 36% to 25%, and HT from 29% to 13%, with an average BMI loss from 44.1 to 35.9. ESR decreased from a preoperative value of 36.7 +/- 22.6 mm/hr to 18.3 +/- 11.9 mm/hr at 1 year (p < 0.001). CONCLUSION: Morbidly obese subjects respond to LASGB with an impressive reduction of comorbidities which is sustained for at least 1 year, well after the initial acute negative energy balance and when weight tends to stabilize. The high prevalence of elevated ESR, which has been considered a strong predictor of coronary mortality, confirms previous reports of its association with obesity, and the clear tendency to normalization with weight loss may represent a further element contributing to lower morbidity.