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At the request of French Regulatory Authorities, a new formulation of Levothyrox® was licensed in France in 2017, with the objective of avoiding the stability deficiencies of an existing licensed formulation. Before launching the new formulation, an average bioequivalence (ABE) trial was conducted, having enrolled 204 subjects and selected for interpretation a narrow a priori bioequivalence range of 0.90-1.11. Bioequivalence was concluded. In a previous publication, we questioned the ability of an ABE trial to guarantee the switchability within patients of the new and old levothyroxine formulations. It was suggested that the two formulations should be compared using the conceptual framework of individual bioequivalence. The present paper is a response to those claiming that, despite the fact that ABE analysis does not formally address the switchability of the two formulations, future patients will nevertheless be fully protected. The basis for this claim is that the ABE study was established in a large trial and analyzed using a stringent a priori acceptance interval of equivalence. These claims are questionable, because the use of a very large number of subjects nullifies the implicit precautionary intention of the European guideline when, for a Narrow Therapeutic Index drug, it recommends shortening the a priori acceptance interval from 0.80-1.25 to 0.90-1.11. [ABSTRACT FROM AUTHOR]

In this paper we question whether prior cross-national differences in food attitudes still exist and if so, to what extent. Due to societal evolutions such as sedentarism and globalization, international variations in food attitudes may not be as pronounced as currently believed. A cross-sectional web-based survey was carried out in the United States, the United Kingdom, France and Belgium. A total of 2167 respondents (52% women; mean age = 39.0 years, SD = 11.4) participated. To successfully combat obesity, a joint approach focusing on food choice and physical activity is required; therefore we included behavioral measures by means of choice tasks for these two important drivers. Further, the extent to which respondents subscribe to the unhealthy = tasty intuition, together with health and taste interest were investigated. Socio-demographic information and self-reported heights and weights were also incorporated. Logistic regressions were fitted with weight status as the dependent variable and the attitudinal and behavioral measures as independent variables. Our findings indicate that having a higher interest in healthy eating decreases the chance of being overweight (odds = 0.88) and believing that unhealthy food is tasty significantly increases the chance of being obese by 1.18 times. Overall, we find that food attitudes have largely converged across the countries we investigated. [ABSTRACT FROM AUTHOR]

Background: The Seven Countries Study in the 1960s showed very low mortality from coronary heart disease (CHD) in Japan, which was attributed to very low levels of total cholesterol. Studies of migrant Japanese to the USA in the 1970s documented increase in CHD rates, thus CHD mortality in Japan was expected to increase as their lifestyle became Westernized, yet CHD mortality has continued to decline since 1970. This study describes trends in CHD mortality and its risk factors since 1980 in Japan, contrasting those in other selected developed countries.Methods: We selected Australia, Canada, France, Japan, Spain, Sweden, the UK and the USA. CHD mortality between 1980 and 2007 was obtained from WHO Statistical Information System. National data on traditional risk factors during the same period were obtained from literature and national surveys.Results: Age-adjusted CHD mortality continuously declined between 1980 and 2007 in all these countries. The decline was accompanied by a constant fall in total cholesterol except Japan where total cholesterol continuously rose. In the birth cohort of individuals currently aged 50-69 years, levels of total cholesterol have been higher in Japan than in the USA, yet CHD mortality in Japan remained the lowest: >67% lower in men and > 75% lower in women compared with the USA. The direction and magnitude of changes in other risk factors were generally similar between Japan and the other countries.Conclusions: Decline in CHD mortality despite a continuous rise in total cholesterol is unique. The observation may suggest some protective factors unique to Japanese. [ABSTRACT FROM AUTHOR]