Browsing by Subject "Hyperlipidemias"

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    Open Access
    A 52-Week Placebo-Controlled Trial of Evolocumab in Hyperlipidemia
    (2014) Blom, Dirk J; Hala, Tomas; Bolognese, Michael; Lillestol, Michael J; Toth, Phillip D; Burgess, Lesley; Ceska, Richard; Roth, Eli; Koren, Michael J; Ballantyne, Christie M; Monsalvo, Maria Laura; Tsirtsonis, Kate; Kim, Jae B; Scott, Rob; Wasserman, Scott M; Stein, Evan A
    BACKGROUND Evolocumab, a monoclonal antibody that inhibits proprotein convertase subtilisin/ kexin type 9 (PCSK9), significantly reduced low-density lipoprotein (LDL) cholesterol levels in phase 2 studies. We conducted a phase 3 trial to evaluate the safety and efficacy of 52 weeks of treatment with evolocumab. METHODS We stratified patients with hyperlipidemia according to the risk categories outlined by the Adult Treatment Panel III of the National Cholesterol Education Program. On the basis of this classification, patients were started on background lipid-lowering therapy with diet alone or diet plus atorvastatin at a dose of 10 mg daily, atorvastatin at a dose of 80 mg daily, or atorvastatin at a dose of 80 mg daily plus ezetimibe at a dose of 10 mg daily, for a run-in period of 4 to 12 weeks. Patients with an LDL cholesterol level of 75 mg per deciliter (1.9 mmol per liter) or higher were then randomly assigned in a 2:1 ratio to receive either evolocumab (420 mg) or placebo every 4 weeks. The primary end point was the percent change from baseline in LDL cholesterol, as measured by means of ultracentrifugation, at week 52. RESULTS Among the 901 patients included in the primary analysis, the overall least-squares mean (±SE) reduction in LDL cholesterol from baseline in the evolocumab group, taking into account the change in the placebo group, was 57.0±2.1% (P<0.001). The mean reduction was 55.7±4.2% among patients who underwent background therapy with diet alone, 61.6±2.6% among those who received 10 mg of atorvastatin, 56.8±5.3% among those who received 80 mg of atorvastatin, and 48.5±5.2% among those who received a combination of 80 mg of atorvastatin and 10 mg of ezetimibe (P<0.001 for all comparisons). Evolocumab treatment also significantly reduced levels of apolipoprotein B, non-high-density lipoprotein cholesterol, lipoprotein(a), and triglycerides. The most common adverse events were nasopharyngitis, upper respiratory tract infection, influenza, and back pain. CONCLUSIONS At 52 weeks, evolocumab added to diet alone, to low-dose atorvastatin, or to high-dose atorvastatin with or without ezetimibe significantly reduced LDL cholesterol levels in patients with a range of cardiovascular risks.
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    Open Access
    Dietary intake and barriers to dietary compliance in black type 2 diabetic patients attending primary health-care services
    (2002) Nthangeni, Gladys; Steyn, Nelia P; Alberts, Marianne; Steyn, Krisela; Levitt, Naomi S; Laubscher, Ria; Bourne, Lesley; Dick, Judy; Temple, Norman
    OBJECTIVE: To determine the dietary intake, practices, knowledge and barriers to dietary compliance of black South African type 2 diabetic patients attending primary health-care services in urban and rural areas. DESIGN: A cross-sectional survey. Dietary intake was assessed by three 24-hour recalls, and knowledge and practices by means of a structured questionnaire (n = 133 men, 155 women). In-depth interviews were then conducted with 25 of the patients to explore their underlying beliefs and feelings with respect to their disease. Trained interviewers measured weight, height and blood pressure. A fasting venous blood sample was collected from each participant in order to evaluate glycaemic control. SETTING: An urban area (Sheshego) and rural areas near Pietersburg in the Northern Province of South Africa. SUBJECTS: The sample comprised 59 men and 75 women from urban areas and 74 men and 80 women from rural areas. All were over 40 years of age, diagnosed with type 2 diabetes for at least one year, and attended primary health-care services in the study area over a 3-month period in 1998. RESULTS: Reported dietary results indicate that mean energy intakes were low (< 70% of Recommended Dietary Allowance), 8086-8450 kJ day(-1) and 6967-7382 kJ day(-1) in men and women, respectively. Urban subjects had higher (P < 0.05) intakes of animal protein and lower ratios of polyunsaturated fat to saturated fat than rural subjects. The energy distribution of macronutrients was in line with the recommendations for a prudent diet, with fat intake less than 30%, saturated fat less than 10% and carbohydrate intake greater than 55% of total energy intake. In most respects, nutrient intakes resembled a traditional African diet, although fibre intake was low in terms of the recommended 3-6 g/1000 kJ. More than 90% of patients ate three meals a day, yet only 32-47% had a morning snack and 19-27% had a late evening snack. The majority of patients indicated that they followed a special diet, which had been given to them by a doctor or a nurse. Only 3.4-6.1% were treated by diet alone. Poor glycaemic control was found in both urban and rural participants, with more than half of subjects having fasting plasma glucose above 8 mmol l(-1) and more than 35% having plasma glycosylated haemoglobin level above 8.6%. High triglyceride levels were found in 24 to 25% of men and in 17 to 18% of women. Obesity (body mass index > or = 30 kg m(-2)) was prevalent in 15 to 16% of men compared with 35 to 47% of women; elevated blood pressure (> or = 160/95 mmHg) was least prevalent in rural women (25.9%) and most prevalent in urban men (42.4%). CONCLUSIONS: The majority of black, type 2 diabetic patients studied showed poor glycaemic control. Additionally, many had dyslipidaemia, were obese and/or had an elevated blood pressure. Quantitative and qualitative findings indicated that these patients frequently received incorrect and inappropriate dietary advice from health educators.