Effect of soy on metabolic syndrome and cardiovascular risk factors: a randomized controlled trial.

BACKGROUND: Cardiovascular diseases are currently the commonest cause of death worldwide. Different strategies for their primary prevention have been planned, taking into account the main known risk factors, which include an atherogenic lipid profile and visceral fat excess. METHODS: The study was designed as a randomized, parallel, single-center study with a nutritional intervention duration of 12 weeks. Whole soy foods corresponding to 30 g/day soy protein were given in substitution of animal foods containing the same protein amount. RESULTS: Soy nutritional intervention resulted in a reduction in the number of MetS features in 13/26 subjects. Moreover, in the soy group we observed a significant improvement of median percentage changes for body weight (-1.5 %) and BMI (-1.5 %), as well as for atherogenic lipid markers, namely TC (-4.85 %), LDL-C (-5.25 %), non-HDL-C (-7.14 %) and apoB (-14.8 %). Since the majority of the studied variables were strongly correlated, three factors were identified which explained the majority (52 %) of the total variance in the whole data set. Among them, factor 1, which loaded lipid and adipose variables, explained the 22 % of total variance, showing a statistically significant difference between treatment arms (p = 0.002). CONCLUSIONS: The inclusion of whole soy foods (corresponding to 30 g/day protein) in a lipid-lowering diet significantly improved a relevant set of biomarkers associated with cardiovascular risk.

Risk identification and possible countermeasures for muscle adverse effects during statin therapy.

The use of statins for cardiovascular disease prevention is clearly supported by clinical evidence. However, in January 2014 the U.S. Food and Drug Administration released an advice on statin risk reporting that "statin benefit is indisputable, but they need to be taken with care and knowledge of their side effects". Among them the by far most common complication is myopathy, ranging from common but clinically benign myalgia to rare but life-threatening rhabdomyolysis. This class side effect appears to be dose dependent, with more lipophilic statin (i.e., simvastatin) carrying a higher overall risk. Hence, to minimize statin-associated myopathy, clinicians should take into consideration a series of factors that potentially increase this risk (i.e., drug-drug interactions, female gender, advanced age, diabetes mellitus, hypothyroidism and vitamin D deficiency). Whenever it is appropriate to stop statin treatment, the recommendations are to stay off statin until resolution of symptoms or normalization of creatine kinase values. Afterwards, clinicians have several options to treat dyslipidemia, including the use of a lower dose of the same statin, intermittent non-daily dosing of statin, initiation of a different statin, alone or in combination with nonstatin lipid-lowering agents, and substitution with red yeast rice.

Statin therapy and related risk of new-onset type 2 diabetes mellitus.

The use of statins for cardiovascular disease (CVD) prevention is clearly supported by clinical evidence. Although statin therapy is rather well tolerated, recent data from prospective and retrospective clinical trials and related meta-analyses suggest an increased incidence of new-onset type 2 diabetes mellitus (T2DM) in association with such treatment. The incidence of this adverse effect is not negligible, especially for specific subsets of patients, such as women, elderly, presence of familial history of T2DM and Asian ethnicity. Statin-driven T2DM appears to be a medication class-effect, mostly not related to potency nor to individual statin, as well as to be independent of previous history of CVD. Therefore, implementation of strategies for identification of patients using statins and at specific risk of incident T2DM, as well as of different therapeutic options is important and is discussed in this article. As most authors emphasized that benefits of CVD reduction by statin therapy seem to far exceed the risk of T2DM development itself, these medications remain the cornerstone for primary and secondary CVD prevention, although a specific attention to glucose metabolism and metabolic syndrome features should be payed before and during statin treatment, especially in cohorts at greater risk.