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1.
J Sci Food Agric ; 96(9): 3063-8, 2016 Jul.
Article in English | MEDLINE | ID: mdl-26415675

ABSTRACT

BACKGROUND: Atherosclerosis-induced coronary heart disease - caused by elevated levels of low-density lipoproteins (LDL) and inflammation - is one of the most prevalent diseases. Monounsaturated fatty acids are reported to prevent atherosclerosis; emu oil is a rich source of monounsaturated fatty acid, and we hypothesize that emu oil supplementation could lower inflammation and prevent atherosclerosis in diet-induced obese (DIO) animals. Male Wistar rats were randomly divided into five groups (n = 6), and fed with normal diet (chow pellet; ND), or with cafeteria diet (CD), or with CD along with emu oil supplementation at three different doses: ED1 (2 mL), ED2 (4 mL) and ED3 (8 mL) kg(-1) body weight (BW), respectively. RESULTS: After 12 weeks, the animals were sacrificed and serum was analysed for measuring lipid profile, C-reactive proteins, testosterone and luteinizing hormone. Histopathological studies were performed to observe atherogenic changes in thoracic aorta. Restoration of altered lipid and hormonal profiles, and inhibition of atherogenic changes in thoracic aorta, were observed with supplementation of emu oil, confirming its anti-atherosclerotic activity. CONCLUSION: The high content of oleic acid in emu oil could have orchestrated - either solely or in combination with linoleic and linolenic acids - causing the upregulation of testosterone biosynthesis and inhibition of atheromatous plaque formation in diet-induced obese animals. © 2015 Society of Chemical Industry.


Subject(s)
Atherosclerosis/prevention & control , Dietary Supplements , Disease Models, Animal , Fatty Acids, Monounsaturated/therapeutic use , Hypolipidemic Agents/therapeutic use , Obesity/physiopathology , Oils/therapeutic use , Animals , Aorta, Thoracic/immunology , Aorta, Thoracic/pathology , Atherosclerosis/etiology , Biomarkers/blood , C-Reactive Protein/analysis , Diet, Atherogenic/adverse effects , Dietary Supplements/economics , Fatty Acids, Monounsaturated/administration & dosage , Fatty Acids, Monounsaturated/economics , Hypolipidemic Agents/administration & dosage , Hypolipidemic Agents/economics , India , Lipids/blood , Luteinizing Hormone/blood , Male , Obesity/etiology , Obesity/immunology , Obesity/pathology , Oils/administration & dosage , Oils/economics , Oleic Acid/administration & dosage , Oleic Acid/economics , Oleic Acid/therapeutic use , Pilot Projects , Plaque, Atherosclerotic/etiology , Plaque, Atherosclerotic/prevention & control , Random Allocation , Rats, Wistar , Testosterone/blood
2.
Article in English | MEDLINE | ID: mdl-25896944

ABSTRACT

The determination of phthalates in edible oils (virgin olive oil, olive oil, canola oil, hazelnut oil, sunflower oil, corn oil) sold in Turkish markets was carried out using gas chromatography-mass spectrometry. Mean phthalate concentrations were between 0.102 and 3.863 mg L(-1) in virgin olive oil; 0.172 and 6.486 mg L(-1) in olive oil; 0.501 and 3.651 mg L(-1) in hazelnut oil; 0.457 and 3.415 mg L(-1) in canola oil; 2.227 and 6.673 mg L(-1) in sunflower oil; and 1.585 and 6.248 mg L(-1) in corn oil. Furthermore, the influence of the types of oil and container to the phthalate migration was investigated. The highest phthalate levels were measured in sunflower oil. The lowest phthalate levels were determined in virgin olive oil and hazelnut oil. The highest phthalate levels were determined in oil samples contained in polyethylene terephthalate.


Subject(s)
Dietary Fats, Unsaturated/analysis , Endocrine Disruptors/analysis , Food Contamination , Food Packaging , Phthalic Acids/analysis , Plant Oils/chemistry , Plasticizers/analysis , Corn Oil/adverse effects , Corn Oil/chemistry , Corn Oil/economics , Corylus/chemistry , Dietary Fats, Unsaturated/adverse effects , Dietary Fats, Unsaturated/economics , Endocrine Disruptors/toxicity , Fatty Acids, Monounsaturated/adverse effects , Fatty Acids, Monounsaturated/chemistry , Fatty Acids, Monounsaturated/economics , Food Inspection , Gas Chromatography-Mass Spectrometry , Humans , Limit of Detection , Nuts/chemistry , Olive Oil/adverse effects , Olive Oil/chemistry , Olive Oil/economics , Olive Oil/standards , Phthalic Acids/toxicity , Plant Oils/adverse effects , Plant Oils/economics , Plasticizers/toxicity , Polyethylene Terephthalates/chemistry , Polyethylene Terephthalates/toxicity , Rapeseed Oil , Risk Assessment , Sunflower Oil , Turkey
3.
Bioresour Technol ; 102(1): 50-6, 2011 Jan.
Article in English | MEDLINE | ID: mdl-20594828

ABSTRACT

This paper analyses the potential environmental impacts and economic viability of producing biodiesel from microalgae grown in ponds. A comparative Life Cycle Assessment (LCA) study of a notional production system designed for Australian conditions was conducted to compare biodiesel production from algae (with three different scenarios for carbon dioxide supplementation and two different production rates) with canola and ULS (ultra-low sulfur) diesel. Comparisons of GHG (greenhouse gas) emissions (g CO(2)-e/tkm) and costs (¢/tkm) are given. Algae GHG emissions (-27.6 to 18.2) compare very favourably with canola (35.9) and ULS diesel (81.2). Costs are not so favourable, with algae ranging from 2.2 to 4.8, compared with canola (4.2) and ULS diesel (3.8). This highlights the need for a high production rate to make algal biodiesel economically attractive.


Subject(s)
Biofuels , Environmental Monitoring , Microalgae/growth & development , Animals , Australia , Carbon Dioxide/analysis , Carbon Dioxide/economics , Fatty Acids, Monounsaturated/analysis , Fatty Acids, Monounsaturated/economics , Greenhouse Effect , Life Cycle Stages , Rapeseed Oil , Sulfur/analysis , Sulfur/economics
4.
Med Clin (Barc) ; 137(3): 119-25, 2011 Jun 25.
Article in Spanish | MEDLINE | ID: mdl-21074814

ABSTRACT

Current guidelines for the management of hypercholesterolemia identify LDL cholesterol (LDL-c) reduction as the primary therapeutic target and have highlighted the need to use statins to achieve it. There are six statins with four different doses and with different power-reducing LDL-c. By adding ezetimibe, there are 48 therapeutic possibilities. This extensive offer provides pharmaceutical treatment, but it is difficult to choose the most cost-effective statin because it is very difficult to remember all the powers and costs of treatment options. This paper offers a method to prioritize the best cost-effective lipid lowering, and chooses the cheapest statin that achieves the desired therapeutic goal of LDL-c.


Subject(s)
Hydroxymethylglutaryl-CoA Reductase Inhibitors/economics , Hypercholesterolemia/economics , Atorvastatin , Cholesterol, LDL/blood , Cost-Benefit Analysis , Fatty Acids, Monounsaturated/economics , Fatty Acids, Monounsaturated/therapeutic use , Fluorobenzenes/economics , Fluorobenzenes/therapeutic use , Fluvastatin , Goals , Heptanoic Acids/economics , Heptanoic Acids/therapeutic use , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Hypercholesterolemia/blood , Hypercholesterolemia/drug therapy , Indoles/economics , Indoles/therapeutic use , Lovastatin/economics , Lovastatin/therapeutic use , Practice Guidelines as Topic , Pravastatin/economics , Pravastatin/therapeutic use , Pyrimidines/economics , Pyrimidines/therapeutic use , Pyrroles/economics , Pyrroles/therapeutic use , Rosuvastatin Calcium , Simvastatin/economics , Simvastatin/therapeutic use , Spain , Sulfonamides/economics , Sulfonamides/therapeutic use
5.
Public Health Nutr ; 12(8): 1270-5, 2009 Aug.
Article in English | MEDLINE | ID: mdl-18986592

ABSTRACT

OBJECTIVE: To examine the effect of the new Canadian labelling regulations on the fat composition and prices of margarines. STUDY DESIGN: A survey of all margarines sold in major supermarkets in the Greater Toronto area was conducted in 2006, and results were compared with those of a similar survey conducted in 2002. Average fat composition, proportion of 'trans fat-free' margarines and average prices of margarines were compared. A general linear model procedure was used to compare the relationship between price and fat composition in 2002 and 2006. RESULTS: Average amounts of trans fatty acids (TFA) and MUFA decreased, while average amounts of PUFA increased significantly from 2002 to 2006. The proportion of margarines with less than 0.2 g TFA/10 g serving rose significantly from 31 % in 2002 to 69 % in 2006. Margarines lower in TFA on average cost significantly more than margarines with greater amounts of these fats, and this relationship appeared stronger in 2006 relative to 2002. CONCLUSIONS: There is evidence of reductions in TFA in margarines since new labelling regulations came into effect in Canada; however, TFA reductions appeared to be restricted to higher-priced margarines. Results suggest that voluntary approaches (i.e. manufacturer incentives via labelling) to reduce population intakes of TFA will yield little changes in TFA content of low-cost products and thus may have limited benefit for lower-income groups, who are at higher risk of heart disease.


Subject(s)
Dietary Fats/analysis , Fatty Acids, Monounsaturated/analysis , Food Labeling/legislation & jurisprudence , Margarine/analysis , Trans Fatty Acids/analysis , Canada , Commerce , Costs and Cost Analysis , Data Collection , Dietary Fats/economics , Fatty Acids, Monounsaturated/economics , Food Labeling/economics , History, 21st Century , Humans , Margarine/economics , Trans Fatty Acids/economics
7.
Am J Cardiovasc Drugs ; 6(3): 177-88, 2006.
Article in English | MEDLINE | ID: mdl-16780391

ABSTRACT

OBJECTIVE: To assess the cost efficacy of atorvastatin, simvastatin, lovastatin, fluvastatin, pravastatin, and colestyramine in the reduction of low-density lipoprotein-cholesterol (LDL-C) levels and the cost per patient to achieve the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) therapeutic objectives in Spain. METHOD: The following treatments were evaluated: atorvastatin, simvastatin, and pravastatin 10-40 mg/day; lovastatin and fluvastatin 20-80 mg/day; and colestyramine 12-24 g/day. The cost effectiveness of these treatments was evaluated, in terms of cost per percentage of LDL-C reduction, by comparing annual treatment costs versus the efficacy of LDL-C reduction. Treatment costs included medication costs (2003 wholesale prices), control measures, and the treatment of adverse affects. The efficacy of HMG-CoA reductase inhibitors (statins) was obtained from a meta-analysis of results obtained from clinical trials published between 1993 and 2003 that met the following criteria: monotherapy; >16 weeks of treatment; randomized allocation of individuals to the intervention and comparator groups; dietary treatment for > or =3 months before administration of medication; and double-blind measurement of outcomes. Average and incremental cost-effectiveness ratios were calculated to assess the efficiency of cholesterol-lowering treatments. RESULTS: Efficacy, in terms of percentage of LDL-C reduction, ranged from 10% for colestyramine 12 g/day to 49% for atorvastatin 40 mg/day. Total annual treatment costs ranged from euro 321 for fluvastatin 20 mg/day to euro 1151 for atorvastatin 40 mg/day. Cost-effectiveness ratios, in terms of cost per percentage of LDL-C reduced, were: euro 11-23 for atorvastatin; euro 12-21 for simvastatin; euro 14-22 for lovastatin; euro 15-24 for fluvastatin; euro 21-42 for pravastatin; and euro 35-46 for colestyramine. Atorvastatin 10 mg/day was the most cost-effective treatment, followed by simvastatin 10 mg/day, lovastatin 20 mg/day, and fluvastatin 20 mg/day. Atorvastatin was the most cost-effective treatment in the achievement of the NCEP ATP III LDL-C reduction objectives in patients with high (<100 mg/dL) and moderate (<130 mg/dL) risk of coronary heart disease (CHD), with a cost per patient of euro 747 and euro 405 per year, respectively. Fluvastatin was the most cost-effective treatment in the achievement of the NCEP ATPIII therapeutic objective in patients with low-risk of CHD (LDL-C <160 mg/dL), with a cost per patient of euro 321. CONCLUSION: Atorvastatin 10 mg/day was the most cost-effective cholesterol-lowering drug, followed by simvastatin 10 mg/day, lovastatin 20 mg/day, and fluvastatin 20 mg/day. The preferred statin should be atorvastatin in patients with moderate-to-high CHD risk and fluvastatin in patients with low risk for CHD.


Subject(s)
Anticholesteremic Agents/economics , Anticholesteremic Agents/therapeutic use , Cholesterol, LDL/blood , Hypercholesterolemia/drug therapy , Hypercholesterolemia/economics , Anticholesteremic Agents/administration & dosage , Atorvastatin , Cholesterol, LDL/drug effects , Cholestyramine Resin/economics , Cholestyramine Resin/therapeutic use , Clinical Trials as Topic , Coronary Disease/blood , Coronary Disease/etiology , Cost-Benefit Analysis , Fatty Acids, Monounsaturated/economics , Fatty Acids, Monounsaturated/therapeutic use , Fluvastatin , Heptanoic Acids/economics , Heptanoic Acids/therapeutic use , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/economics , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Hypercholesterolemia/blood , Hypercholesterolemia/complications , Indoles/economics , Indoles/therapeutic use , Lovastatin/economics , Lovastatin/therapeutic use , Meta-Analysis as Topic , Pravastatin/economics , Pravastatin/therapeutic use , Pyrroles/economics , Pyrroles/therapeutic use , Risk Factors , Simvastatin/economics , Simvastatin/therapeutic use , Spain
8.
Cardiovasc Drugs Ther ; 20(4): 309-17, 2006 Aug.
Article in English | MEDLINE | ID: mdl-16779529

ABSTRACT

BACKGROUND: The Lescol Intervention Prevention Study (LIPS) showed substantial gains in health outcomes from statins following PCI. That study was a randomized double-blind placebo-controlled trial undertaken in 77 centres, predominantly in Europe, of patients with moderate hypercholesterolemia who had undergone their first PCI. The evidence on cost-effectiveness has been established for the UK, USA and the Netherlands, but due to different health system cost structures, the results may not be applicable to other European countries. The aim of this study was to estimate the cost-effectiveness of fluvastatin used following first PCI in Hungary. MATERIALS AND METHODS: A deterministic Markov model was used to estimate the incremental costs per quality-adjusted life year gained, with cost data drawn from the Hungarian National Health Insurance Fund. Effectiveness data on fluvastatin was derived directly from LIPS and utility weights from previous studies on heart disease. Sensitivity analyses were conducted around key parameters and analyses were conducted for subgroups identified in LIPS. RESULTS: Treatment with fluvastatin cost an additional 1,704 euro and resulted in an additional 0.107 QALYs per patient discounted over 10-years compared with controls. The incremental cost per quality-adjusted life year gained was 15,910 euro. The key determinants of cost-effectiveness were the effectiveness of fluvastatin, utility weights, cost of fluvastatin, and the time horizon evaluated. Fluvastatin was substantially more cost-effective in patients with diabetes, renal disease, multi-vessel disease or LDL-cholesterol >3.4 mmol/l. CONCLUSIONS: Fluvastatin is an economically efficient pharmaceutical for reducing heart disease in Hungary and other European countries in patients following PCI.


Subject(s)
Angioplasty, Balloon, Coronary , Anticholesteremic Agents/economics , Coronary Disease/therapy , Fatty Acids, Monounsaturated/economics , Hydroxymethylglutaryl-CoA Reductase Inhibitors/economics , Indoles/economics , Angioplasty, Balloon, Coronary/economics , Anticholesteremic Agents/therapeutic use , Coronary Disease/economics , Cost-Benefit Analysis , Fatty Acids, Monounsaturated/therapeutic use , Fluvastatin , Humans , Hungary , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Indoles/therapeutic use , Models, Economic , Myocardial Infarction/prevention & control , Survival Analysis
9.
Clin Ther ; 27(9): 1467-77, 2005 Sep.
Article in English | MEDLINE | ID: mdl-16291420

ABSTRACT

BACKGROUND: The Lescol Intervention Prevention Study (LIPS) was a multinational randomized controlled trial that showed a 47% reduction in the relative risk of cardiac death and a 22% reduction in major adverse cardiac events (MACEs) from the routine use of fluvastatin, compared with controls, in patients undergoing percutaneous coronary intervention (PCI, defined as angioplasty with or without stents). In this study, MACEs included cardiac death, nonfatal myocardial infarction, and subsequent PCI and coronary artery bypass graft. Diabetes was the greatest risk factor for MACEs. OBJECTIVE: This study estimated the cost-effectiveness of fluvastatin when used for secondary prevention of MACEs after PCI in people with diabetes. METHODS: A post hoc subgroup analysis of patients with diabetes from the LIPS was used to estimate the effectiveness of fluvastatin in reducing myocardial infarction, revascularization, and cardiac death. A probabilistic Markov model was developed using United Kingdom resource and cost data to estimate the additional costs and quality-adjusted life-years (QALYs) gained over 10 years from the perspective of the British National Health Service. The model contained 6 health states, and the transition probabilities were derived from the LIPS data. Crossover from fluvastatin to other lipid-lowering drugs, withdrawal from fluvastatin, and the use of lipid-lowering drugs in the control group were included. RESULTS: In the subgroup of 202 patients with diabetes in the LIPS trial, 18 (15.0%) of 120 fluastatin patients and 21 (25.6%) of 82 control participants were insulin dependent (P = NS). Compared with the control group, patients treated with fluvastatin can expect to gain an additional mean (SD) of 0.196 (0.139) QALY per patient over 10 years (P < 0.001) and will cost the health service an additional mean (SD) of 10 pounds ( 448 pounds) (P = NS) (mean [SD] US $16 [$689]). The additional cost per QALY gained was 51 pounds (US $78). The key determinants of cost-effectiveness included the probabilities of repeat interventions, cardiac death, the cost of fluvastatin, and the time horizon used for the evaluation. CONCLUSION: Fluvastatin was an economically efficient treatment to prevent MACEs in these patients with diabetes undergoing PCI.


Subject(s)
Angioplasty, Balloon, Coronary , Diabetes Complications/economics , Fatty Acids, Monounsaturated/economics , Heart Diseases/economics , Hydroxymethylglutaryl-CoA Reductase Inhibitors/economics , Indoles/economics , Cost-Benefit Analysis , Diabetes Complications/prevention & control , Diabetes Complications/therapy , Fatty Acids, Monounsaturated/therapeutic use , Fluvastatin , Heart Diseases/prevention & control , Heart Diseases/therapy , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Indoles/therapeutic use , Markov Chains , Models, Economic , Multicenter Studies as Topic , Multivariate Analysis , Quality-Adjusted Life Years , Randomized Controlled Trials as Topic , United Kingdom
10.
Ann Pharmacother ; 39(4): 610-6, 2005 Apr.
Article in English | MEDLINE | ID: mdl-15741421

ABSTRACT

BACKGROUND: In the LIPS (Lescol Intervention Prevention Study), fluvastatin 80 mg/day reduced the risk of major adverse cardiac events (MACE) by 22% versus placebo (p = 0.01) following successful first percutaneous coronary intervention (PCI) in patients with stable or unstable angina or silent ischemia. The cost-effectiveness of such therapy is unknown. OBJECTIVE: To evaluate the cost-effectiveness of fluvastatin following successful first PCI from a US healthcare system perspective. METHODS: We used a Markov model to estimate expected outcomes and costs of 2 alternative treatment strategies following successful first PCI in patients with stable or unstable angina or silent ischemia: (1) diet/lifestyle counseling plus immediate fluvastatin 80 mg/day; and (2) diet/lifestyle counseling only, with initiation of fluvastatin 80 mg/day following occurrence of future nonfatal MACE. The model was estimated with data from LIPS and other published sources. Cost-effectiveness was calculated as the ratio of the difference in expected medical-care costs to the expected difference in life-years (LYs) and quality-adjusted life-years (QALYs) alternatively. RESULTS: Treatment with fluvastatin following successful first PCI was found to increase life expectancy by 0.78 years (QALYs 0.68). Cost-effectiveness of fluvastatin following successful first PCI is 13 505 dollars per LY (15 454 dollar per QALY) saved. Ratios are lower for patients with diabetes (9396 dollar per LY; 10 718 dollar per QALY) and those with multivessel disease (9662 dollar per LY; 11 076 dollar per QALY). Findings were robust with respect to changes in key model parameters and assumptions. CONCLUSIONS: Fluvastatin therapy following PCI is cost-effective compared with other generally accepted medical interventions.


Subject(s)
Atherectomy, Coronary/economics , Fatty Acids, Monounsaturated/economics , Fatty Acids, Monounsaturated/therapeutic use , Indoles/economics , Indoles/therapeutic use , Aged , Angina, Unstable/drug therapy , Angina, Unstable/economics , Atherectomy, Coronary/statistics & numerical data , Cost-Benefit Analysis/economics , Cost-Benefit Analysis/statistics & numerical data , Fluvastatin , Humans , Markov Chains , Middle Aged , Quality of Life , Risk Reduction Behavior
11.
Clin Ther ; 26(10): 1599-607, 2004 Oct.
Article in English | MEDLINE | ID: mdl-15598476

ABSTRACT

BACKGROUND: Diabetes risk is often complicated by a mixed hyperlipoproteinemia not sufficiently controlled by a single antihyperlipidemic drug; however, there are some concerns about the safety of combined statin and fibrate treatments. OBJECTIVE: The aim of this study was to compare the efficacy and safety profile of fluvastatin + fenofibrate combination therapy and those of fluvastatin monotherapy in the treatment of combined hyperlipidemia, type 2 diabetes mellitus (DM), and coronary heart disease (CHD) (ie, high risk for cardiovascular disease [CVD]). METHODS: This 12-month, randomized, double-blind, controlled trial was conducted at the University of Pavia, Pavia, Italy. Patients aged 18 to 80 years with combined hyperlipidemia, type 2 DM, and CHD were randomly assigned to receive combination therapy with extended-release fluvastatin 80 mg + micronized fenofibrate 200 mg or monotherapy with extended-release fluvastatin 80 mg. All treatments were given in tablet form, once daily with the evening meal, for 12 months. Lipid variables (low-density lipoprotein cholesterol [LDL-C], high-density lipoprotein cholesterol [HDL-C], total cholesterol [TC], and triglycerides [TG]) at 6 and 12 months were the primary efficacy variables, and glycemic status (glycosylated hemoglobin [HbA(1c)], fasting plasma glucose, and postprandial plasma glucose levels) at 6 and 12 months was the secondary efficacy variable. Tolerability was assessed using physical examination, including vital-sign assessment, body-weight measurement, electrocardiography, adverse events, and laboratory tests. A pharmacoeconomic analysis of both treatment regimens was also carried out using the incremental cost-effectiveness ratio (ICER). RESULTS: A total of 48 patients (24 men, 24 women; mean [SD] age, 60 [5] years) were enrolled. After 6 months, all primary efficacy variables, except for TG level, showed significant improvements from baseline only in the combination-therapy group (changes: LDL-C, -25%; HDL-C, +12%; and TC, -19%; all, P < 0.05 vs baseline). After 12 months, lipid variables showed significant improvements over baseline in both groups (all, P < 0.05), except for TG in the monotherapy group. Significant changes in LDL-C, HDL-C, and TG were found in the combination-therapy group (-35%, +34%, -32%, respectively) versus the monotherapy group (-25%, +14%, -17%, respectively; all, P < 0.05 between groups). The change from baseline in HbA(1c) level was significant with combination therapy (-12% vs -7%; P < 0.05). Both treatments were well tolerated, with no significant differences in the incidences of adverse events between the 2 groups. The ICER showed that each 1% decrease in LDL-C level achieved with the fenofibrate + fluvastatin combination added a cost of 14.97 Euros/y (US 12.25 US dollars/y), and each 1% increase in HDL-C level added a cost of 7.48 Euros/y (6.12/y US dollars), over the cost of monotherapy. CONCLUSIONS: In this selected sample of patients with combined hyperlipidemia, type 2 DM, and CHD, the combination of extended-release fluvastatin + micronized fenofibrate was associated with a more improved lipid profile than fluvastatin monotherapy, and was a well-tolerated and cost-effective therapeutic choice to treat these patients at high risk for CVD.


Subject(s)
Coronary Disease/drug therapy , Diabetes Mellitus, Type 2/drug therapy , Fatty Acids, Monounsaturated/administration & dosage , Fenofibrate/administration & dosage , Hyperlipidemias/drug therapy , Hypolipidemic Agents/administration & dosage , Indoles/administration & dosage , Adolescent , Adult , Aged , Aged, 80 and over , Blood Glucose/analysis , Coronary Disease/complications , Delayed-Action Preparations/administration & dosage , Diabetes Mellitus, Type 2/complications , Double-Blind Method , Drug Administration Schedule , Drug Therapy, Combination , Fatty Acids, Monounsaturated/economics , Female , Fenofibrate/economics , Fluvastatin , Hemoglobins, Abnormal/analysis , Humans , Hyperlipidemias/complications , Hypolipidemic Agents/economics , Indoles/economics , Lipids/blood , Male , Middle Aged , Treatment Outcome
12.
Pharmacoeconomics ; 22(8): 525-35, 2004.
Article in English | MEDLINE | ID: mdl-15217308

ABSTRACT

AIMS: To estimate the costs, benefits and cost effectiveness, from the UK NHS perspective, of fluvastatin (relative to no HMG-CoA reductase inhibitor [statin]) for the secondary prevention of major adverse cardiac events following a successful first percutaneous coronary intervention (PCI). METHODS: A cost-effectiveness analysis was undertaken using efficacy data from the Lescol Intervention Prevention Study (LIPS). LIPS was a randomised, double-blind, placebo-controlled trial undertaken in 77 centres (predominantly in Europe). Patients included in the trial had moderate hypercholesterolaemia and had successfully undergone their first PCI. Fluvastatin (Lescol) 40 mg twice daily plus dietary counselling was given to the intervention group for up to 4 years; the control group received dietary counselling only. A Markov model was used to estimate the incremental costs per QALY gained over a 10-year period, with cost data drawn from the UK NHS (2002 values). Monte Carlo simulations and multivariate analysis were used to assess uncertainty. Costs were discounted at 6% per annum, and health outcomes at 1.5% per annum. RESULTS: On average, treatment with fluvastatin cost an additional pound 300 (SD pound 303) [euro 423; SD euro 428] per patient and resulted in an additional 0.092 (SD 0.06) QALYs per patient over 10 years compared with controls. The incremental cost per QALY gained with fluvastatin versus the control group was pound 3207 (SD pound 5,497) [euro 4,527; SD euro 7,759]. Fluvastatin was dominant (better outcomes and lower costs) in 15.9% of the simulations and was dominated in 2.9%. The key determinants of cost effectiveness were: the effectiveness of fluvastatin in reducing acute myocardial infarction, subsequent PCI, coronary artery bypass graft and cardiac deaths; the utility weight associated with a subsequent post-PCI state; the cost of fluvastatin; and the time horizon evaluated. CONCLUSIONS: Fluvastatin is the only statin which has proven effective in preventing major coronary adverse events in new PCI patients; other statins lack this evidence. This Markov model, with its underlying assumptions and data, suggests that fluvastatin is a viable and economically efficient pharmaceutical (relative to no statin) to reduce heart disease in the UK when given routinely to all patients following PCI.


Subject(s)
Angioplasty, Balloon, Coronary , Coronary Disease/prevention & control , Fatty Acids, Monounsaturated/economics , Hydroxymethylglutaryl-CoA Reductase Inhibitors/economics , Indoles/economics , Coronary Disease/economics , Coronary Disease/therapy , Cost-Benefit Analysis , Fatty Acids, Monounsaturated/therapeutic use , Fluvastatin , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Hypercholesterolemia/drug therapy , Hypercholesterolemia/economics , Indoles/therapeutic use , Markov Chains , Models, Economic , Multicenter Studies as Topic , Multivariate Analysis , Quality-Adjusted Life Years , Randomized Controlled Trials as Topic , Treatment Outcome , United Kingdom
13.
Diabetes Care ; 26(6): 1796-801, 2003 Jun.
Article in English | MEDLINE | ID: mdl-12766112

ABSTRACT

OBJECTIVE: To assess the cost and cost effectiveness of hydroxymethylglutaryl (HMG)-CoA reductase inhibitor (statin) therapy for the primary prevention of major coronary events in the U.S. population with diabetes and LDL cholesterol levels > or =100 mg/dl, especially in the population with LDL cholesterol levels 100-129 mg/dl. RESEARCH DESIGN AND METHODS: Analyses were performed using population estimates from National Health and Nutrition Examination Survey (NHANES)-III, cost estimates from a health system perspective, statin LDL-lowering effectiveness from pivotal clinical trials, and treatment effectiveness from the diabetic subgroup analysis of the Heart Protection Study. RESULTS: -There are approximately 8.2 million Americans with diabetes, LDL cholesterol levels > or =100 mg/dl, and no clinical evidence of cardiovascular disease. Each year, statin therapy could prevent approximately 71,000 major coronary events in this population. In the subgroup with LDL cholesterol levels 100-129 mg/dl, the annual cost of statin treatment ranges from 600 to 1,000 US dollars per subject. In the population with LDL cholesterol levels > or =130 mg/dl, the annual cost ranges from 700 to 2,100 US dollars. Annual incremental cost per subject, defined as the cost of statin treatment plus the cost of major coronary events with statin treatment minus the cost of major coronary events without statin treatment, ranges from 480 to 950 US dollars in the subgroup with LDL cholesterol levels 100-129 mg/dl and from 590 to 1,920 US dollars in the population with LDL cholesterol levels > or =130 mg/dl. CONCLUSIONS: Statin therapy for the primary prevention of major coronary events in subjects with type 2 diabetes and LDL cholesterol levels 100-129 mg/dl is affordable and cost effective relative to statin therapy in subjects with higher LDL cholesterol levels.


Subject(s)
Coronary Disease/prevention & control , Diabetes Mellitus, Type 2/complications , Diabetic Angiopathies/prevention & control , Hydroxymethylglutaryl-CoA Reductase Inhibitors/economics , Atorvastatin , Cholesterol, LDL/blood , Cholesterol, LDL/drug effects , Cost-Benefit Analysis , Fatty Acids, Monounsaturated/economics , Fatty Acids, Monounsaturated/therapeutic use , Fluvastatin , Heptanoic Acids/economics , Heptanoic Acids/therapeutic use , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Indoles/economics , Indoles/therapeutic use , Lovastatin/economics , Lovastatin/therapeutic use , Pravastatin/economics , Pravastatin/therapeutic use , Pyrroles/economics , Pyrroles/therapeutic use , Randomized Controlled Trials as Topic , Reproducibility of Results , Sensitivity and Specificity , Simvastatin/economics , Simvastatin/therapeutic use , United States
14.
Pharmacoeconomics ; 21 Suppl 1: 1-11, 2003.
Article in English | MEDLINE | ID: mdl-12648030

ABSTRACT

BACKGROUND: Coronary heart disease (CHD) is a public health priority in the UK. The National Service Framework (NSF) has set standards for the prevention, diagnosis and treatment of CHD, which include the use of cholesterol-lowering agents aimed at achieving targets of blood total cholesterol (TC) < 5.0 mmol/L and low density lipoprotein-cholesterol (LDL-C) < 3.0 mmol/L. In order to achieve these targets cost effectively, prescribers need to make an informed choice from the range of statins available. AIM: To estimate the average and relative cost effectiveness of atorvastatin, fluvastatin, pravastatin and simvastatin in achieving the NSF LDL-C and TC targets. DESIGN: Model-based economic evaluation. METHODS: An economic model was constructed to estimate the number of patients achieving the NSF targets for LDL-C and TC at each dose of statin, and to calculate the average drug cost and incremental drug cost per patient achieving the target levels. The population baseline LDL-C and TC, and drug efficacy and drug costs were taken from previously published data. Estimates of the distribution of patients receiving each dose of statin were derived from the UK national DIN-LINK database. RESULTS: The estimated annual drug cost per 1000 patients treated with atorvastatin was pound 289000, with simvastatin pound 315000, with pravastatin pound 333000 and with fluvastatin pound 167000. The percentages of patients achieving target are 74.4%, 46.4%, 28.4% and 13.2% for atorvastatin, simvastatin, pravastatin and fluvastatin, respectively. Incremental drug cost per extra patient treated to LDL-C and TC targets compared with fluvastatin were pound 198 and pound 226 for atorvastatin, pound 443 and pound 567 for simvastatin and pound 1089 and pound 2298 for pravastatin, using 2002 drug costs. CONCLUSIONS: As a result of its superior efficacy, atorvastatin generates a favourable cost-effectiveness profile as measured by drug cost per patient treated to LDL-C and TC targets. For a given drug budget, more patients would achieve NSF LDL-C and TC targets with atorvastatin than with any of the other statins examined.


Subject(s)
Cholesterol/blood , Hydroxymethylglutaryl-CoA Reductase Inhibitors/economics , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Hypercholesterolemia/drug therapy , Hypercholesterolemia/economics , Models, Economic , Atorvastatin , Clinical Trials as Topic , Cost-Benefit Analysis , Fatty Acids, Monounsaturated/economics , Fatty Acids, Monounsaturated/therapeutic use , Fluvastatin , Heptanoic Acids/economics , Heptanoic Acids/therapeutic use , Humans , Indoles/economics , Indoles/therapeutic use , Pravastatin/economics , Pravastatin/therapeutic use , Pyrroles/economics , Pyrroles/therapeutic use , Simvastatin/economics , Simvastatin/therapeutic use , United Kingdom
15.
Pharmacoeconomics ; 21 Suppl 1: 13-23, 2003.
Article in English | MEDLINE | ID: mdl-12648031

ABSTRACT

INTRODUCTION: The objective of the Atorvastatin Comparative Cholesterol Efficacy and Safety Study (ACCESS) was to compare the efficacy and safety of the five 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors in a randomised, controlled, yet large-scale study. ACCESS also produced data that permitted comparative analysis of the cost to achieve National Cholesterol Education Panel (NCEP) II low density lipoprotein-cholesterol (LDL-C) targets. STUDY DESIGN: A 54-week, multicentre, open-label, randomised, parallel-arm, active-control study in men and women with or without documented coronary heart disease or peripheral vascular disease. Data included medication use, clinic visits, adverse events, LDL-C and other laboratory measures. Analyses of resource use and cost are reported from a third-party payer perspective. METHODS: Patients were randomly assigned to receive one of the following treatments: atorvastatin (10-80 mg/day); fluvastatin (20-40 mg/day, or 40 mg twice daily); lovastatin (20-40 mg/day, or 40 mg twice daily); pravastatin (10-40 mg/day); or simvastatin (10-40 mg/day). Patients were started at the lowest available dose and titrated to higher doses at 6-week intervals until they achieved the NCEP II LDL-C target or reached the highest available dose of medication. PATIENTS: A total of 153 centres enrolled 3887 patients: atorvastatin (n = 1944); fluvastatin (n = 493); lovastatin (n = 494); pravastatin (n = 478); and simvastatin (n = 478). Inclusion criteria included LDL-C >or= 30 mg/dL higher than NCEP II LDL-C target (stratified by risk factors), fasting triglyceride values < 400 mg/dL, and a confirmed negative serum pregnancy test. Known hypersensitivity to statins, use of prohibited medications, uncontrolled diabetes, acute liver disease and age > 80 years or < 18 years were among the exclusion criteria. RESULTS: Mean total treatment costs to reach LDL-C targets for patients receiving atorvastatin (US dollars 683.37 in 2001) were significantly less than mean total treatment costs for patients receiving fluvastatin (difference = US dollars 211.35, p < 0.01), lovastatin (US dollars 607.96, p < 0.01), pravastatin (US dollars 424.60, p < 0.01) and simvastatin (US dollars 95.74, p < 0.01). Results were robust to sensitivity analyses using alternative definitions of the patient population (randomised, intent-to-treat, completers) and cost measures (50th percentile charges, 95th percentile charges, Medicare prices). CONCLUSIONS: Compared with the other statins studied, atorvastatin was associated with the lowest resource use and costs when used to treat patients to their NCEP II LDL-C targets. Atorvastatin was also associated with the highest percentage of patients achieving their desired clinical outcomes. Therefore, in cost-effectiveness terms, it dominated the four other statins.


Subject(s)
Heptanoic Acids/economics , Heptanoic Acids/therapeutic use , Hydroxymethylglutaryl-CoA Reductase Inhibitors/economics , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Pyrroles/economics , Pyrroles/therapeutic use , Adult , Aged , Atorvastatin , Cholesterol, LDL/blood , Dose-Response Relationship, Drug , Fatty Acids, Monounsaturated/economics , Fatty Acids, Monounsaturated/therapeutic use , Female , Fluvastatin , Humans , Hypercholesterolemia/drug therapy , Hypercholesterolemia/economics , Indoles/economics , Indoles/therapeutic use , Lovastatin/economics , Lovastatin/therapeutic use , Male , Middle Aged , Pravastatin/economics , Pravastatin/therapeutic use , Risk Factors , Simvastatin/economics , Simvastatin/therapeutic use , Treatment Outcome
18.
Manag Care ; 10(10): 48-50, 53-9, 2001 Oct.
Article in English | MEDLINE | ID: mdl-11688111

ABSTRACT

PURPOSE: HMG-CoA reductase inhibitors ("statins") have become the drug class of choice for the treatment of hyperlipidemia. Six product brands encompassing 20 dosage strengths have been available during the past two years. The objective of this review is to describe dosing trends for the six statin brands and to determine if and how these trends vary among managed care plans as a function of product market share. METHODOLOGY: Utilization of HMG-CoA reductase inhibitors was examined using the NDC Health Information Services (Phoenix, Ariz.) database for the two-year period ending December 2000. This database contains unit dispensing data at the dosage-strength level for 1,079 managed care plans. Trends in market share, mean daily dose, and dosage distribution of the six current statin brands were examined. The relationship of market share to mean dose was also examined for each brand. PRINCIPAL FINDINGS: Market share decreased for all statin brands during the two-year period, except for the two newest entries, atorvastatin (up 9.7 share points) and cerivastatin (up 4.6 share points). The mean dose of all statins increased during the two-year period. A statistically significant negative correlation between market share and mean dose was found for atorvastatin and a positive correlation was found for fluvastatin (P < 0.01). Furthermore, atorvastatin share was significantly correlated to lower mean doses of all other statin brands. That is, higher use of atorvastatin was associated with lower doses of all statin products. CONCLUSION: In developing a cost-management strategy, managed care organizations should take historical and anticipated market-share changes and dose-mix changes into account along with the product's clinical efficacy and total cost of care.


Subject(s)
Anticholesteremic Agents/therapeutic use , Drug Costs/statistics & numerical data , Hydroxymethylglutaryl-CoA Reductase Inhibitors/administration & dosage , Hyperlipidemias/drug therapy , Managed Care Programs/economics , Anticholesteremic Agents/economics , Atorvastatin , Databases, Factual , Drug Utilization Review , Fatty Acids, Monounsaturated/administration & dosage , Fatty Acids, Monounsaturated/economics , Fluvastatin , Health Care Sector , Heptanoic Acids/administration & dosage , Heptanoic Acids/economics , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/economics , Indoles/administration & dosage , Indoles/economics , Lovastatin/administration & dosage , Lovastatin/economics , Pravastatin/administration & dosage , Pravastatin/economics , Pyridines/administration & dosage , Pyridines/economics , Pyrroles/administration & dosage , Pyrroles/economics , Simvastatin/administration & dosage , Simvastatin/economics , United States
19.
Int J Clin Pract ; 55(4): 243-9, 2001 May.
Article in English | MEDLINE | ID: mdl-11406909

ABSTRACT

An economic model was developed to estimate the relative cost-effectiveness of alternative HMG-CoA reductase inhibitors (statins)--atorvastatin, cerivastatin, fluvastatin, pravastatin and simvastatin--to achieve target low-density lipoprotein cholesterol (LDL-C) levels in a population of secondary CHD prevention patients. By using a cholesterol target as the endpoint of interest and a dose titration approach, the model assumes that the statins demonstrate a class effect through cholesterol lowering. The model was used to estimate the proportion of patients achieving target LDL-C levels (< 3 mmol/l) under each scenario tested. Total costs and incremental cost-effectiveness relative to no treatment and to the lowest cost option were estimated for each scenario. Total costs were highest for pravastatin and lowest for cerivastatin. Compared with no treatment, the incremental cost per patient treated to target LDL-C varied between 383 Pounds (atorvastatin) and 1213 Pounds (pravastatin). Incremental cost-effectiveness ratios in comparison with the lowest cost treatment (cerivastatin) were 141 Pounds per additional patient achieving target LDL-C with atorvastatin, and 275 Pounds with simvastatin. Fluvastatin and pravastatin were both less effective and more expensive than the lowest cost therapy. Although cerivastatin was associated with lowest expected costs, therapy with atorvastatin achieved the lowest cost-effectiveness ratios. Hence atorvastatin would allow the largest number of patients to be treated to target LDL-C within a fixed drug budget. Choosing between drug therapies on the basis of price alone may be misleading if the effectiveness of therapies varies.


Subject(s)
Cholesterol, LDL/blood , Coronary Disease/prevention & control , Hydroxymethylglutaryl-CoA Reductase Inhibitors/economics , Atorvastatin , Coronary Disease/blood , Coronary Disease/economics , Cost-Benefit Analysis , Fatty Acids, Monounsaturated/economics , Fatty Acids, Monounsaturated/therapeutic use , Fluvastatin , Heptanoic Acids/economics , Heptanoic Acids/therapeutic use , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Indoles/economics , Indoles/therapeutic use , Models, Economic , Pravastatin/economics , Pravastatin/therapeutic use , Pyridines/economics , Pyridines/therapeutic use , Pyrroles/economics , Pyrroles/therapeutic use , Simvastatin/economics , Simvastatin/therapeutic use
20.
Am Fam Physician ; 63(2): 309-20, 323-4, 2001 Jan 15.
Article in English | MEDLINE | ID: mdl-11201696

ABSTRACT

Primary and secondary prevention trials have shown that use of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (also known as statins) to lower an elevated low-density lipoprotein cholesterol level can substantially reduce coronary events and death from coronary heart disease. In 1987 and 1993, the National Cholesterol Education Program promulgated guidelines for cholesterol screening and treatment. Thus far, however, primary care physicians have inadequately adopted these guidelines in clinical practice. A 1991 study found that cholesterol screening was performed in only 23 percent of patients. Consequently, many patients with elevated low-density lipoprotein levels and a high risk of primary or recurrent ischemic events remain unidentified and untreated. A study published in 1998 found that fewer than 15 percent of patients with known coronary heart disease have low-density lipoprotein levels at the recommended level of below 100 mg per dL (2.60 mmol per L). By identifying patients with elevated low-density lipoprotein levels and instituting appropriate lipid-lowering therapy, family physicians could help prevent cardiovascular events and death in many of their patients.


Subject(s)
Coronary Disease/prevention & control , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Atorvastatin , Cholesterol, LDL/blood , Coronary Disease/blood , Coronary Disease/diet therapy , Coronary Disease/epidemiology , Fatty Acids, Monounsaturated/administration & dosage , Fatty Acids, Monounsaturated/economics , Fatty Acids, Monounsaturated/therapeutic use , Fluvastatin , Heptanoic Acids/administration & dosage , Heptanoic Acids/economics , Heptanoic Acids/therapeutic use , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/administration & dosage , Hydroxymethylglutaryl-CoA Reductase Inhibitors/economics , Indoles/administration & dosage , Indoles/economics , Indoles/therapeutic use , Lovastatin/administration & dosage , Lovastatin/economics , Lovastatin/therapeutic use , Pravastatin/administration & dosage , Pravastatin/economics , Pravastatin/therapeutic use , Pyridines/administration & dosage , Pyridines/economics , Pyridines/therapeutic use , Pyrroles/administration & dosage , Pyrroles/economics , Pyrroles/therapeutic use , Risk Factors , Simvastatin/administration & dosage , Simvastatin/economics , Simvastatin/therapeutic use
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