Bempedoic acid for high-risk patients with CVD as adjunct lipid-lowering therapy: A cost-effectiveness analysis.

BACKGROUND: Bempedoic acid is a novel adenosine triphosphate citrate lyase inhibitor shown to reduce low density lipoprotein cholesterol when used as an adjunct lipid-lowering therapy in patients with high cardiovascular disease (CVD) risk. OBJECTIVE: Our analysis aimed to determine the price at which bempedoic acid would be cost-effective from the Australian health care perspective. METHODS: A Markov model was designed using data from the Cholesterol Lowering via Bempedoic Acid, an ACL-Inhibiting Regimen (CLEAR) Harmony trial, to model the clinical outcomes and costs of 1000 patients treated with bempedoic acid over a lifetime horizon. Relevant health states were "Alive with CVD," "Alive with recurrent CVD," and "Dead." With annual cycles, patients were at risk of a nonfatal myocardial infarction, coronary revascularization, and death from CVD or non-CVD causes. Costs and utilities were obtained from published sources. Outcomes of interest were the incremental cost-effectiveness ratios in terms of cost per quality-adjusted life year (QALY) gained and cost per year of life saved. Outcomes were discounted at 5% per annum. RESULTS: Among 1000 individuals, bempedoic acid in addition to statin therapy was estimated to save 122 (discounted) years of life and 103 (discounted) QALYs compared with statin therapy alone. At an acquisition cost of AU$584.40 per year (USD$397.01), bempedoic acid would be considered cost-effective within the Australian setting, with an incremental cost-effectiveness ratio of AU$49,890 per QALY gained (USD$33,893) and AU$42,433 per year of life saved (USD$28,827). CONCLUSIONS: Bempedoic acid may be cost-effective within the Australian health care setting at an annual acquisition price less than $600.

A cost minimization analysis of olive oil vs. hyperoxygenated fatty acid treatment for the prevention of pressure ulcers in primary healthcare: A randomized controlled trial.

Pressure ulcers represent a major current health problem and cause an important economic impact on the healthcare system. Most studies on the prevention of pressure ulcers have been carried out in hospital contexts, with respect to the use of hyperoxygenated fatty acids (HOFA), and to date no studies have specifically examined the use of olive oil-based treatments. AIM: To evaluate the cost of using extra virgin olive oil, rather than HOFA, in the prevention of pressure ulcers among persons with impaired mobility and receiving home care. STUDY DESIGN: Cost minimization analysis of the results obtained from a noninferiority, triple-blind, parallel, multicenter, randomized clinical trial. Population attending primary healthcare centers in Andalusia (Spain). STUDY SAMPLE: 831 immobilized patients at risk of suffering pressure ulcers. These persons were included in the study and randomly assigned as follows: 437 to the olive oil group and 394 to the HOFA group. At the end of the follow-up period, the results obtained by the olive oil group were not inferior to those of the HOFA group, and did not exceed the 10% delta limit. The total treatment cost for 16 weeks was €19,758 with HOFAs and €9,566 with olive oil. Overall, the olive oil treatment was €10,192 less costly. It has been concluded the noninferiority of olive oil makes this product an effective alternative for the prevention of pressure ulcers in patients who are immobilized and in a domestic environment. This treatment enables considerable savings in direct costs. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01595347. Date: 2011-2013.

The rise and fall of the world's first fat tax.

In 2011, Denmark introduced the world's first tax on saturated fat, but only 15 months later the fat tax was abolished. The aim of this article is to investigate the political processes surrounding the implementation and rapid abolition of the fat tax. Our findings suggest that industry and trade associations were heavily involved in the political process of formulating the fat tax. Industry representatives used certain tactics to oppose the fat tax: threatening lawsuits, predicting welfare losses, casting doubt on evidence, diverting focus and requesting postponement. After the fat tax was implemented, the food industry continued their opposition through intensified lobbyism and juridical actions at EU level. However, other factors seem to have contributed to the fall of the fat tax. The tax received criticism for being poorly designed and gradually lost popularity among health professionals, politicians and the public. In the end, the fat tax was abolished for financial reasons. This study demonstrates how politicians considered the fat tax as a funding source rather than a public health initiative, which resulted in significant shortcomings. Furthermore, we demonstrate that the massive influence by industry stakeholders was not balanced with inputs from public health professionals, who should assume a more proactive role in policy-making.

Bats and zoonotic viruses: can we confidently link bats with emerging deadly viruses?

An increasingly asked question is 'can we confidently link bats with emerging viruses?'. No, or not yet, is the qualified answer based on the evidence available. Although more than 200 viruses - some of them deadly zoonotic viruses - have been isolated from or otherwise detected in bats, the supposed connections between bats, bat viruses and human diseases have been raised more on speculation than on evidence supporting their direct or indirect roles in the epidemiology of diseases (except for rabies). However, we are convinced that the evidence points in that direction and that at some point it will be proved that bats are competent hosts for at least a few zoonotic viruses. In this review, we cover aspects of bat biology, ecology and evolution that might be relevant in medical investigations and we provide a historical synthesis of some disease outbreaks causally linked to bats. We provide evolutionary-based hypotheses to tentatively explain the viral transmission route through mammalian intermediate hosts and to explain the geographic concentration of most outbreaks, but both are no more than speculations that still require formal assessment.

Fatty acid composition, physicochemical properties, antioxidant and cytotoxic activity of apple seed oil obtained from apple pomace.

BACKGROUND: Apple pomace is generated in huge quantities in juice-processing industries the world over and continuous efforts are being made for its inclusive utilization. In this study, apple seeds separated from industrial pomace were used for extraction of oil. The fatty acid composition, physicochemical and antioxidant as well as in vitro anticancer properties of extracted oil were studied to assess its suitability in food and therapeutic applications. RESULTS: The fatty acid composition of seed oil revealed the dominance of oleic (46.50%) and linoleic acid (43.81%). It had high iodine (121.8 g I 100 g⁻¹) and saponification value (184.91 mg KOH g⁻¹ oil). The acid value, refractive index and relative density were 4.28 mg KOH g⁻¹, 1.47 and 0.97 mg mL⁻¹, respectively. The antioxidant potential (IC50) of apple seed oil was 40.06 µg mL⁻¹. Cytotoxicity of apple seed oil against CHOK1, SiHa and A549 cancer cell lines ranged between 0.5 ± 0.06% and 88.6 ± 0.3%. CONCLUSION: The physicochemical properties of apple seed oil were comparable with edible food oil, indicating its better stability and broad application in the food and pharmaceutical industries. Apple seed oil could be a good source of natural antioxidants. Also, the in vitro cytotoxic activity against specific cell lines exhibited its potential as an anticancer agent.

Effectiveness of olive oil for the prevention of pressure ulcers caused in immobilized patients within the scope of primary health care: study protocol for a randomized controlled trial.

BACKGROUND: Pressure ulcers are considered an important issue, mainly affecting immobilized older patients. These pressure ulcers increase the care burden for the professional health service staff as well as pharmaceutical expenditure. There are a number of studies on the effectiveness of different products used for the prevention of pressure ulcers; however, most of these studies were carried out at a hospital level, basically using hyperoxygenated fatty acids (HOFA). There are no studies focused specifically on the use of olive-oil-based products and therefore this research is intended to find the most cost-effective treatment and achieve an alternative treatment. METHODS/DESIGN: The main objective is to assess the effectiveness of olive oil, comparing it with HOFA, to treat immobilized patients at home who are at risk of pressure ulcers. As a secondary objective, the cost-effectiveness balance of this new application with regard to the HOFA will be assessed. The study is designed as a noninferiority, triple-blinded, parallel, multi-center, randomized clinical trial. The scope of the study is the population attending primary health centers in Andalucía (Spain) in the regional areas of Malaga, Granada, Seville, and Cadiz. Immobilized patients at risk of pressure ulcers will be targeted. The target group will be treated by application of an olive-oil-based formula whereas the control group will be treated by application of HOFA to the control group. The follow-up period will be 16 weeks. The main variable will be the presence of pressure ulcers in the patient. Secondary variables include sociodemographic and clinical information, caregiver information, and whether technical support exists. Statistical analysis will include the Kolmogorov-Smirnov test, symmetry and kurtosis analysis, bivariate analysis using the Student's t and chi-squared tests as well as the Wilcoxon and the Man-Whitney U tests, ANOVA and multivariate logistic regression analysis. DISCUSSION: The regular use of olive-oil-based formulas should be effective in preventing pressure ulcers in immobilized patients, thus leading to a more cost-effective product and an alternative treatment. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01595347.

Sugar composition of French royal jelly for comparison with commercial and artificial sugar samples.

A gas chromatographic method was developed to quantify the major and minor sugars of 400 Royal Jellies (RJs). Their contents were compared in relation to the geographical origins and different production methods. A reliable database was established from the analysis of 290 RJs harvested in different French areas that took into account the diversity of geographical origin, harvesting season, forage sources available in the environment corresponding to natural food of the bees: pollen and nectar. Around 30 RJ samples produced by Italian beekeepers, about sixty-ones from French market, and around thirty-ones derived from feeding experiments were analysed and compared with our database. Fructose and glucose contents are in the range 2.3-7.8% and 3.4-7.7%, respectively, whatever the RJ's origin. On the contrary, differences in minor sugar composition are observed. Indeed sucrose and erlose contents in French RJs are lesser than 1.7% and 0.3%, respectively, whereas they reach 3.9% and 2.0% in some commercial samples and 5.1% and 1.7% in RJs produced from feeding experiments. This study could be used to discriminate different production methods and provide an additional tool for identifying unknown commercial RJs.

An over-the-counter moisturizer is as clinically effective as, and more cost-effective than, prescription barrier creams in the treatment of children with mild-to-moderate atopic dermatitis: a randomized, controlled trial.

BACKGROUND: Atopic dermatitis (AD) is a prevalent skin disorder with significant cost of treatment. Several prescription device moisturizers have been approved by the FDA to treat AD but are significantly more expensive than well-crafted over-the-counter (OTC) moisturizers. No studies have been performed to compare both the clinical efficacy and cost-efficacy of these prescription devices to OTC moisturizers. PURPOSE: The purpose of this study is to compare the clinical efficacy and cost-efficacy of a glycyrrhetinic acid-containing barrier repair cream (BRC-Gly, Atopiclair®), a ceramide-dominant barrier repair cream (BRC-Cer, EpiCeram®) and an OTC petroleum-based skin protectant moisturizer (OTC-Pet, Aquaphor Healing Ointment®) as monotherapy for mild-to-moderate AD in children. METHODS: Thirty-nine patients, age 2-17 years, with mild-to-moderate AD were randomized 1:1:1 to receive one of three treatments-BRC-Gly, BRC-Cer or OTC-Pet-with instructions to apply the treatment three times daily for three weeks. Disease severity and improvement was assessed at baseline and on days 7 and 21. RESULTS: No statistically significant difference for any efficacy assessment was found between the three groups at each time point. The OTC-Pet was found to be at least 47 times more cost-effective than BRC-Gly or BRC-Cer. LIMITATIONS: The relatively small sample size of 39 subjects was not sufficient to establish OTC-Pet as superior treatment in AD. CONCLUSIONS: OTC-Pet is as effective in treating mild-to-moderate AD as both BRC-Gly and BRC-Cer and is at least 47 times more cost-effective. NAME OF REGISTRY: II-AF-ATD-Aquaphor, Comparing the Efficacy and Cost-Effectiveness of Aquaphor to Atopiclair and EpiCeram in Children with Mild to Moderate Atopic Dermatitis. REGISTRATION IDENTIFIER: NCT01093469.

Effects of price discounts and tailored nutrition education on supermarket purchases: a randomized controlled trial.

BACKGROUND: Traditional methods to improve population diets have largely relied on individual responsibility, but there is growing interest in structural interventions such as pricing policies. OBJECTIVE: The aim was to evaluate the effect of price discounts and tailored nutrition education on supermarket food and nutrient purchases. DESIGN: A 2 x 2 factorial randomized controlled trial was conducted in 8 New Zealand supermarkets. A total of 1104 shoppers were randomly assigned to 1 of the following 4 interventions that were delivered over 6 mo: price discounts (12.5%) on healthier foods, tailored nutrition education, discounts plus education, or control (no intervention). The primary outcome was change in saturated fat purchased at 6 mo. Secondary outcomes were changes in other nutrients and foods purchased at 6 and 12 mo. Outcomes were assessed by using electronic scanner sales data. RESULTS: At 6 mo, the difference in saturated fat purchased for price discounts on healthier foods compared with that purchased for no discount on healthier foods was -0.02% (95% CI: -0.40%, 0.36%; P = 0.91). The corresponding difference for tailored nutrition education compared with that for no education was -0.09% (95% CI: -0.47%, 0.30%; P = 0.66). However, those subjects who were randomly assigned to receive price discounts bought significantly more predefined healthier foods at 6 mo (11% more; mean difference: 0.79 kg/wk; 95% CI: 0.43, 1.16; P < 0.001) and 12 mo (5% more; mean difference: 0.38 kg/wk; 95% CI: 0.01, 0.76; P = 0.045). Education had no effect on food purchases. CONCLUSIONS: Neither price discounts nor tailored nutrition education had a significant effect on nutrients purchased. However, the significant and sustained effect of discounts on food purchases suggests that pricing strategies hold promise as a means to improve population diets.

Production of medium-chain-length polyhydroxyalkanoates by Pseudomonas aeruginosa with fatty acids and alternative carbon sources.

In this study, medium-chain-length polyhydroxyalkanoates (mcl-PHAs) were produced by Pseudomonas aeruginosa using different carbon sources. Decanoic acid induced the highest (9.71% [+/- 0.7]) mcl-PHAs accumulation in bacterial cells at 47 h. The cells preferred to accumulate and degrade the polyhydroxyoctanoate than polyhydroxydecanoate (PHD) during early stage and final stage of the growth, respectively. The production cost of mcl-PHAs can be reduced by using edible oils as the carbon source. The bacteria accumulated 6% (+/- 0.7) of mcl-PHAs in the presence of olive oil. Besides, reused oil was another potential carbon source for the reduction of the production cost of mcl-PHAs. Overall, PHD was the major constituent in the accumulated mcl-PHAs.

Biodiesel production from waste cooking oil: 2. Economic assessment and sensitivity analysis.

The economic feasibilities of four continuous processes to produce biodiesel, including both alkali- and acid-catalyzed processes, using waste cooking oil and the 'standard' process using virgin vegetable oil as the raw material, were assessed. Although the alkali-catalyzed process using virgin vegetable oil had the lowest fixed capital cost, the acid-catalyzed process using waste cooking oil was more economically feasible overall, providing a lower total manufacturing cost, a more attractive after-tax rate of return and a lower biodiesel break-even price. On the basis of these economic calculations, sensitivity analyses for these processes were carried out. Plant capacity and prices of feedstock oils and biodiesel were found to be the most significant factors affecting the economic viability of biodiesel manufacture.

1% or less: a community-based nutrition campaign.

OBJECTIVE: The authors evaluated the effectiveness of a community education campaign to encourage a switch from high-fat (whole and 2%) milk to low-fat (1%, 1/2%, and skim) milk as a way to reduce consumption of saturated fat. METHODS: Milk sales data were collected from supermarkets in the intervention and comparison communities for three one-month time periods: at baseline, immediately following the campaign, and six months after the campaign. In addition, trained volunteers conducted pre- and post-intervention telephone surveys. RESULTS: Overall milk sales increased by 16% in the intervention cities following the campaign and remained high at follow-up. Low-fat milk's market share increased from 18% of overall milk sales at baseline to 41% of overall milk sales in the month following the end of the campaign, an increase in market share that was sustained at the six-month follow-up. In the post-intervention telephone survey, 38.2% of those respondents who reported drinking high-fat milk at baseline reported having switched to low-fat milk. CONCLUSION: A focused message communicated through paid advertising, public relations activities, and community-based education programs increased low-fat and overall milk consumption in one community.