ESSENS dyslipidemia: A placebo-controlled, randomized study of a nutritional supplement containing red yeast rice in subjects with newly diagnosed dyslipidemia

AbstractObjectiveEvidence suggests prolonged exposure to lower levels of low-density lipoprotein cholesterol (LDL-C), starting at a younger age, substantially lowers cardiovascular (CV) risk. Accordingly, the CV pandemic affecting younger population in low- to low-middle-income countries, where statin usage is poor even in secondary prevention, may benefit from lipid-lowering nutritional products, as nutritional intervention is generally preferred in these cultures. However, the safety and efficacy of such preparations have not been systematically tested.MethodsIn this multicenter, double-blind study, 191 statin-free subjects with newly-diagnosed hyperlipidemia (LDL-C >120 mg/dL, 3.11 mmol/L) and no evidence of CV disease were randomized to one capsule of a proprietary bioactive phytonutrient formulation containing red yeast rice, grape-seed, niacinamide, and folic acid (RYR-NS) or matched placebo twice daily, along with lifestyle modification, for 12 wk.ResultsMean baseline LDL-C levels were 148.5 ± 24.0 mg/dL (3.85 ± 0.62 mmol/L) and 148.6 ± 21.9 mg/dL (3.85 ± 0.57 mmol/L) in the RYR-NS and placebo groups respectively. Compared with placebo, RYR-NS resulted in a significant reduction in LDL-C (−29.4% versus −3.5%, P < 0.0001) and non–high-density lipoprotein cholesterol (non-HDL-C; −29.8% versus −10.3%, P < 0.0001) at 12 wk. With RYR-NS, 43.4% individuals attained desirable LDL-C levels and 55.4% desirable non-HDL-C levels by week 12, compared to only 0% and 1.1%, respectively, at baseline. No safety issues were observed.ConclusionThis study demonstrates the efficacy and safety of RYR-NS in lowering LDL-C and non-HDL-C after 12 wk, with magnitude of LDL-C reduction being comparable to that seen with moderate-intensity statin therapy. Further long-term studies are required to determine the impact of RYR-NS on treatment adherence and clinical outcomes

Isolation and characterization of Escherichia coli serotype O157:H7 and other verotoxin-producing E. coli in healthy Indian cattle

Background and Aim: Cattle are the main reservoir of Escherichia coli O157:H7 and other verotoxigenic E. coli (VTEC); therefore, there is an increased risk of infection to humans by either direct or indirect mode of transmissions. However, the prevalence of E. coli O157:H7 in the healthy cattle population of India is yet to be ascertained. This study aimed to screen the dairy cattle in and around Pune, Maharashtra, India, for verotoxin-producing E. coli O157:H7. Materials and Methods: A total of 257 rectal swabs were collected from 15 different organized and unorganized dairy farms of Pune during the period, January-March 2015. The screening involved enrichment in EC broth followed by differential identification on MacConkey sorbitol agar. The presumptive positive isolates were further confirmed by multiplex polymerase chain reaction (PCR) using primers specific to rfbE (O157), fliC (H7), VT1 (MK1), and VT2 (MK2). Vero-toxicity and antibiotic sensitivity were examined in PCR confirmed isolates. Results: Out of the 257 samples analyzed, 1.9% (2/105) were positive for O157:H7 and 39% (41/105) were positive for VTEC. Two PCR confirmed positive O157:H7 strains and two randomly selected PCR-positive VT strains exhibited in vitro cytopathic effect on Vero cells on day-7 post-inoculation. Antibiotic sensitivity profiling of O157:H7 strains exhibited resistance against penicillin G, kanamycin, ampicillin, tetracycline, gentamycin, cefotaxime, streptomycin, and piperacillin. Conclusion: These findings reveal the presence of pathogenic E. coli O157:H7 in the healthy cattle of Pune; in a situation, wherein regular surveillance for O157:H7 is not a norm. Therefore, the findings presented herein warrant routine surveillance and public awareness to prevent the transfer of such pathogens and manage health risks to the public

Multifunctional Photoactive Nanomaterials for Photodynamic Therapy against Tumor: Recent Advancements and Perspectives

Numerous treatments are available for cancer, including chemotherapy, immunotherapy, radiation therapy, hormone therapy, biomarker testing, surgery, photodynamic therapy, etc. Photodynamic therapy (PDT) is an effective, non-invasive, novel, and clinically approved strategy to treat cancer. In PDT, three main agents are utilized, i.e., photosensitizer (PS) drug, oxygen, and light. At first, the photosensitizer is injected into blood circulation or applied topically, where it quickly becomes absorbed or accumulated at the tumor site passively or actively. Afterward, the tumor is irradiated with light which leads to the activation of the photosensitizing molecule. PS produces the reactive oxygen species (ROS), resulting in the death of the tumor cell. However, the effectiveness of PDT for tumor destruction is mainly dependent on the cellular uptake and water solubility of photosensitizer molecules. Therefore, the delivery of photosensitizer molecules to the tumor cell is essential in PDT against cancer. The non-specific distribution of photosensitizer results in unwanted side effects and unsuccessful therapeutic outcomes. Therefore, to improve PDT clinical outcomes, the current research is mostly focused on developing actively targeted photosensitizer molecules, which provide a high cellular uptake and high absorption capacity to the tumor site by overcoming the problem associated with conventional PDT. Therefore, this review aims to provide current knowledge on various types of actively and passively targeted organic and inorganic nanocarriers for different cancers

Nanoemulgel: A Novel Nano Carrier as a Tool for Topical Drug Delivery

Nano-emulgel is an emerging drug delivery system intended to enhance the therapeutic profile of lipophilic drugs. Lipophilic formulations have a variety of limitations, which includes poor solubility, unpredictable absorption, and low oral bioavailability. Nano-emulgel, an amalgamated preparation of different systems aims to deal with these limitations. The novel system prepared by the incorporation of nano-emulsion into gel improves stability and enables drug delivery for both immediate and controlled release. The focus on nano-emulgel has also increased due to its ability to achieve targeted delivery, ease of application, absence of gastrointestinal degradation or the first pass metabolism, and safety profile. This review focuses on the formulation components of nano-emulgel for topical drug delivery, pharmacokinetics and safety profiles