Clinical management of heterozygous familial hypercholesterolemia in a Polish outpatient metabolic clinic: a retrospective observational study.

INTRODUCTION: There are currently no reports available from a Polish clinical practice on heterozygous familial hypercholesterolemia (HeFH) management. The aim of this study was to test the efficacy of HeFH hypolipidemic treatment in a Polish outpatient metabolic clinic according to treatment targets outlined in the European Atherosclerosis Society (EAS) and European Society of Cardiology (ESC) guidelines. MATERIAL AND METHODS: This retrospective, observational study was performed on HeFH patients who attended their routine follow-up visits in the metabolic outpatient clinic in the period between April and September 2016. According to EAS/ESC guidelines, the goal and intensity of therapy were assigned individually for every patient based on cardiovascular (CV) risk (high or very high). The treatment target was achievement of low-density lipoprotein cholesterol (LDL-C) levels < 1.8 mmol/l for very high CV risk patients and < 2.6 mmol/l for high CV risk patients. A ≥ 50% decrease in LDL-C over the observation period was an additional outcome measure. RESULTS: In the overall group of 222 HeFH patients (mean age: 55.2 ±16.2 years, 72% women), LDL-C levels decreased on average by 52.6% (p < 0.001). More than half of the patients were treated with the maximum tolerated dose of statins. A total of 25.2% of patients attained target levels of LDL-C and 55.9% attained a ≥ 50% reduction in its concentration. Despite therapy, significantly elevated post-follow-up levels of LDL-C (> 4.1 mmol/l) remained in 14% of all patients. CONCLUSIONS: Hypolipidemic therapy according to EAS/ESC guidelines was suboptimal for a significant number of HeFH patients. Additional clinical management should be considered.

Prospective randomized clinical trial of laparoscopic sleeve gastrectomy versus open Roux-en-Y gastric bypass for the management of patients with morbid obesity.

INTRODUCTION: Roux-en-Y gastric bypass (RYGB) is considered the gold standard bariatric procedure with documented safety and effectiveness. Laparoscopic sleeve gastrectomy (LSG) is a newer procedure being done with increasing frequency. Randomized comparisons of LSG and other bariatric procedures are limited. We present the results of the first prospective randomized trial comparing LSG and RYGB in the Polish population. AIM: To assess the efficacy and safety of LSG versus RYGB in the treatment of morbid obesity and obesity-related comorbidities. MATERIAL AND METHODS: Seventy-two morbidly obese patients were randomized to RYGB (36 patients) or LSG (36 patients). Both groups were comparable regarding age, gender, body mass index (BMI) and comorbidities. The follow-up period was at least 12 months. Baseline and 6 and 12 month outcomes were analyzed including assessment of percent excess weight lost (%EWL), reduction in BMI, morbidity (minor, major, early and late complications), mortality, reoperations, comorbidities and nutritional deficiencies. RESULTS: There was no 30-day mortality and no significant difference in major complication rate (0% after RYGB and 8.3% after LSG, p > 0.05) or minor complication rate (16.6% after RYGB and 10.1% after LSG, p > 0.05). There were no early reoperations after RYGB and 2 after LSG (5.5%) (p > 0.05). Weight loss was significant after RYGB and LSG but there was no difference between both groups at 6 and 12 months of follow-up. At 12 months %EWL in RYGB and LSG groups reached 64.2% and 67.6% respectively (p > 0.05). There was no significant difference in the overall prevalence of comorbidities and nutritional deficiencies. CONCLUSIONS: Both LSG and RYGB produce significant weight loss at 6 and 12 months after surgery. The procedures are equally effective with regard to %EWL, reduction in BMI and amelioration of comorbidities at 6 and 12 months of follow-up. Laparoscopic sleeve gastrectomy and RYGB are comparably safe techniques with no significant differences in minor and major complication rates at 6 and 12 months.

Comparison of combined statin-fibrate treatment to monotherapy in patients with mixed hyperlipidemia.

BACKGROUND: Statins are the preferred drugs for the treatment of hypercholesterolemia, and fibrates for hypertriglyceridemia. In patients with mixed hyperlipidemia, monotherapy with one of these agents may not be effective and combined treatment may be preferable. AIM: To compare retrospectively the efficacy and safety of combined statin-fibrate treatment in patients with mixed hyperlipidemia in whom previous monotherapy with one of these agents occurred ineffective. METHODS AND RESULTS: The initial study group consisted of 327 patients who received micronised fenofibrate and 93 patients who received simvastatin for 12 months. Both agents caused significant changes in lipid profile. Following fibrate therapy, total cholesterol (TC), LDL-cholesterol (LDL-C) and triglyceride (TG) levels decreased by 27.9%, 28.2% and 58%, respectively, and following simvastatin therapy by 33.6%, 42.8% and 37.5%, respectively. The HDL-cholesterol (HDL-C) level increased after fenofibrate by 14.8% and remained unchanged following simvastatin therapy. The TC/HDL-C ratio decreased following fenofibrate by 35.6%, and following simvastatin by 35.3%. In some patients the required reduction in lipid parameters was not achieved fenofibrate or simvastatin. Subsequently, 93 patients underwent combined therapy by adding a second agent (simvastatin in a dose of 20 mg/day or fenofibrate in a dose of 200 mg per day) which was continued for another 12 months. The addition of simvastatin to fenofibrate decreased TC, LDL-C and TG levels by 35.5%, 42.1% and 59.6%, respectively in comparison to before treatment volumes. HDL-C level was increased by 11.1%, and TC/HDL-C ratio decreased by 45.3%. The addition of fenofibrate to simvastatin decreased TC, LDL-C and TG levels by 39.3%, 48.9% and 51,6%, respectively. HDL-C level was increased by 13.4%, and TC/HDL-C ratio decreased by 49.3%. No clinical side effects nor an increase in the transaminase levels, requiring termination of the treatment, were observed. CONCLUSIONS: Combined therapy with 20 mg of simvastatin and 200 mg of micronised fenofibrate is highly effective and safe in patients with mixed hyperlipidemia.

[Efficacy and safety of combined statin-fenofibrates therapy compared with monotherapy in patients with mixed hyperlipidemia and high risk of coronary heart disease]. / Skutecznosc i bezpieczenstwo terapii skojarzonej statynami i fibratami w porównaniu z monoterapia u chorych z hiperlipidemia mieszana i wysokim ryzykiem choroby niedokrwiennej serca.

UNLABELLED: In most patients with mixed hyperlipidemia and coronary heart disease (CHD) the treatment targeted both at triglyceride and LDL cholesterol levels is very difficult, when one lipid-lowering drug is used. We performed a prospective study evaluating the efficacy and safety of statins (simvastatin 20 mg, fluvastatin 40 mg, lovastatin 20 mg, atorvastatin 10 mg) and fibrates (fenofibrate 200 mg, ciprofibrate 100 mg) used alone, and then compared with statin-fibrate combinations in 180 patients. Each of three periods of therapy lasted 8-12 weeks. All regimens of statins and fibrates normalised the lipid profile more effectively than monotherapy. Monotherapy with statins lowered total cholesterol by 23.8% in relation to the baseline; compared with 13% for fibrates monotherapy and 34.3% for statins plus fibrates combinations. Triglyceride concentration decreased by 25.5% with statins alone, 34.0% with fibrates alone and 44.5% with combined therapy. LDL cholesterol was reduced by 28.1%, 12.7%, 40.3%, respectively. Statins increased HDL cholesterol by 4%, fibrates by 18% and combined therapy by 15.2%. The target levels for LDL cholesterol were achieved in 3.7% patients on statins therapy, in 1.1% on fibrates and 21.7% on the combined therapy. For total cholesterol the changes were 8.3%, 2.2% and 41.7%, respectively and for triglycerides the were 27.7%, 45% and 66.7%, respectively. The safety of the treatment was assessed by recording adverse events and measuring clinical laboratory parameters. No significant increase in CPK or ALT levels was observed. Only 7 patients had a history of moderate ALT increase (< 3 times) and 27 of CPK increase (< 3 times) when receiving combined statins plus fibrates. CONCLUSIONS: We conclude that combined therapy with statins and fibrates can improve lipid abnormalities in mixed hyperlipidaemia more effective then statins or fibrates monotherapy. The combined therapy was well tolerated and safe.

[Risk factors for ischemic heart disease and glycosaminoglycans (GAG's) in plasma in atherosclerosis obliterans]. / Czynniki ryzyka choroby niedokrwiennej serca i glikozoaminoglikany w surowicy w atherosclerosis obliterans.

UNLABELLED: GAGs (glycosoaminoglycans) derive from damaged artery endothelium cells. Theoretically their concentration could be used to measure the level of atherosclerosis process. The aim of the study was to estimate the concentration of glucosamine and galactosamine in plasma in patients with AO in comparison to the main risk factors of CHD: smoking, hyperlipidemia, hypertension. INVESTIGATED GROUP: the subject of the study were 35 men and 26 women suffering from AO. The control group comprised 20 men and 28 women. People from both groups were 36-65 years old. The concentration of glucosamine and galactosamine were determined by automatic amino acid analyzer LC 6001 Biotronic. The lipids in plasma were determined by conventional methods. Results 100% of men and 81% of women with AO were smokers to compare 70% and 17% in the control group. Systolic blood pressure in men with AO was 134 +/- 13 mm Hg and in women 136 +/- 16 mm Hg. In the control groups they were respectively 122 +/- 10 mm Hg and 124 +/- 10 mm Hg. The difference between the groups is statistically significant. Diastolic and systolic pressures in women with AO were higher then in the control group. In men with AO systolic pressure, but not diastolic pressure, was higher than in the control group. It was observed that in women with AO the concentration of total cholesterol, LDL-chol, apo B in serum, apo B in LDL, TG, TC-HDL-chol/HDL-chol, LDL/HDL were higher, HDL-chol was lower in comparison with the control group. In men with AO total cholesterol, LDL-chol/HDL-chol and TC-HDL-chol/HDL-chol were higher then in the control group, HDL-chol was lower. 80% of women and 74% of men with AO suffered from hyperlipidemia compared with 36% and 60% in the control group respectively. Mixed hyperlipidemia was the most important factor differentiating patients with AO and the control group, when compared to other types of hyperlipidemia. The coexistence of risk factors was more frequently observed in patient with AO then in the control group. Differences in concentrations of glucosamine and galactosamine between the patients with AO and the control group were not statistically significant in women and only slightly statistically significant in men. CONCLUSIONS: Classical risk factors of CHD differentiate patients with AO from the healthy people. The concentrations of glucosamine and galactosamine in plasma cannot be used to determine the atherosclerosis process.