Regional pathologies and globalization of clinical trials: has the time for regional trials arrived?
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Biomedical subjects
Publications and source records attributed to Carlos A Morillo.
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OBJECTIVE: A cut-off value for waist circumference (WC) of 94 cm associated with cardiovascular risk factors (CVRF) has been recommended in Caucasian populations. However, it is unclear if recommendations derived from Western studies should be extrapolated to populations from developing countries. The present study evaluated a group of Colombian subjects to determine and evaluate the level of WC capable of identifying subjects with CVRF. RESEARCH DESIGN AND METHODS: (Study 1) A cross-sectional study in 145 healthy men, to determine the level of WC associated with the following lipid profile (triglycerides 2.25 mmol/L and total-cholesterol/HDL-cholesterol ratio >5) was performed. (Study 2) Two hundred and thirty-eight unrelated male adults were recruited to test whether the new WC cut-off point would identify subjects with CVRF. RESULTS: (Study 1) A WC cut-off point of 88 cm identified subjects with the pre-established lipid profile with a sensitivity of 80.6% and specificity of 80.1%, while the WC of 94 cm had a low sensitivity (48.3%) and a high specificity (93.3%). Additionally, the values of C-reactive protein, fasting glucose and insulin levels in subjects with a WC 88 cm were significantly higher compared to subjects with WC <88 cm. (Study 2) The diagnostic accuracy of the new WC cut-off point (88 cm) to identify subjects with two or more CVRF remained acceptable in the new sample studied (sensitivity: 83.7% and specificity: 84.8%); while the WC value of 94 cm suggested in Caucasians showed a very low sensitivity (43.2%) and a high specificity (93.9%). CONCLUSIONS: This study demonstrates a higher prevalence of CVRF in our population at lower levels of WC than those suggested previously in Caucasians, suggesting that ethnic background should be taken into account when using WC as a screener for CVRF.
In recent years increased interest has focused on the nature and pathophysiology of orthostatic intolerance and syndromes associated with autonomic disorders. Understanding the pathophysiology underlying these syndromes has led to the recognition of several distinct clinical entities with overlapping features and the associated need to reclassify many of the previously unrecognized syndromes. Among the clinical manifestations, syncope and near syncope are frequently associated with orthostatic intolerance. In addition, however, a wide spectrum of symptoms have been described ranging from chronic fatigue to recurrent neurally mediated vasodepressor reactions. The present review focuses on the pathophysiology and classification of syndromes of autonomic dysfunction associated with orthostatic intolerance. Primary and secondary causes of dysautonomia as well as therapeutic approach to these frequently unrecognized syndromes is presented.
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