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1.
Evaluating the safety and efficacy of a polyherbal Unani formulation in dyslipidaemia-a prospective randomized controlled trial.
Ain, Q, Nawab, M, Ahmad, T, Kazmi, MH, Naikodi, MAR
Journal of ethnopharmacology. 2022;:115036
Abstract
ETHNOPHARMACOLOGICAL RELEVANCE Unani System of Medicine offers treatment for obesity and dyslipidaemia. Jawarish Falafili (JF) is a Unani polyherbal pharmacopoeial preparation. It has been used in the treatment of obesity for a long time. Dyslipidaemia is a recognised modifiable risk factor for hypertension, ischemic heart disease and stroke. Limitations of the current conventional therapy have provided scope for research of a potential drug in this medical condition. It was hypothesised that JF may ameliorate dyslipidaemia in human participants. AIM OF THE STUDY The main objective of this study was to evaluate the safety and efficacy of the JF. MATERIALS AND METHODS This was a prospective randomized, active-controlled, open-label and parallel-group study. We randomized 74 participants of dyslipidaemia into treatment (n = 38) and control (n = 36) groups. Of them, 30 participants in each group completed the trial. The participants of any sex aged between 30 and 60 years, with serum total cholesterol (TC) ≥200 mg/dl and/or serum triglycerides (TG) ≥150 mg/dl and/or low-density lipoprotein cholesterol (LDL-C) level ≥130 mg/dl and/or high-density lipoprotein cholesterol (HDL-C) level <40 mg/dl were enrolled in this study. The participants of the treatment group were treated with JF (10 gm/day) once and atorvastatin (20 mg/day) was given to the control group for 90 days once at night daily. RESULTS We observed a significant reduction (treatment group versus control group) in mean serum TC by 22.89% versus 19.36%, TG by 29.90% versus 23.26% and LDL-C by 29.16% versus 27.92% from baseline (p < 0.05). But the change in mean serum HDL-C levels post-treatment was insignificant in both groups (p > 0.05). On intergroup comparison, the magnitude of the difference of mean TC, TG, LDL-C and HDL-C levels between the groups was not statistically significant (p > 0.00.05). CONCLUSIONS This study concluded that JF and atorvastatin were equally effective in controlling dyslipidaemia. They were tolerated well by all participants and found safe during the course of treatment.
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2.
Efficacy and Tolerability of Pitavastatin Versus Pitavastatin/Fenofibrate in High-risk Korean Patients with Mixed Dyslipidemia: A Multicenter, Randomized, Double-blinded, Parallel, Therapeutic Confirmatory Clinical Trial.
Ihm, SH, Chung, WB, Lee, JM, Hwang, BH, Yoo, KD, Her, SH, Song, WH, Chae, IH, Park, TH, Kim, JH, et al
Clinical therapeutics. 2020;(10):2021-2035.e3
Abstract
PURPOSE Dyslipidemia is an important risk factor for cardiovascular disease (CVD). Statins are known to effectively reduce not only low-density lipoprotein cholesterol (LDL-C) level but also death and nonfatal myocardial infarction due to coronary heart disease. The risk for CVD from atherogenic dyslipidemia persists when elevated triglyceride (TG) and reduced high-density lipoprotein cholesterol (HDL-C) levels are not controlled with statin therapy. Therefore, statin/fenofibrate combination therapy is more effective in reducing CVD risk. Here, we assessed the efficacy and tolerability of pitavastatin/fenofibrate combination therapy in patients with mixed dyslipidemia and a high risk for CVD. METHODS This multicenter, randomized, double-blind, parallel-group, therapeutic-confirmatory clinical trial evaluated the efficacy and tolerability of fixed-dose combination therapy with pitavastatin/fenofibrate 2/160 mg in Korean patients with a high risk for CVD and a controlled LDL-C level (<100 mg/dL) and a TG level of 150-500 mg/dL after a run-in period with pitavastatin 2 mg alone. In the 8-week main study, 347 eligible patients were randomly assigned to receive pitavastatin 2 mg with or without fenofibrate 160 mg after a run-in period. In the extension study, patients with controlled LDL-C and non-HDL-C (<130 mg/dL) levels were included after the completion of the main study. All participants in the extension study received the pitavastatin/fenofibrate combination therapy for 16 weeks for the assessment of the tolerability of long-term treatment. FINDINGS The difference in the mean percentage change in non-HDL-C from baseline to week 8 between the combination therapy and monotherapy groups was -12.45% (95% CI, -17.18 to -7.72), and the combination therapy was associated with a greater reduction in non-HDL-C. The changes in lipid profile, including apolipoproteins, fibrinogen, and high-sensitivity C-reactive protein from baseline to weeks 4 and 8 were statistically significant with combination therapy compared to monotherapy at all time points. Furthermore, the rates of achievement of non-HDL-C and apolipoprotein B targets at week 8 in the combination therapy and monotherapy groups were 88.30% versus 77.98% (P = 0.0110) and 78.94% versus 68.45% (P = 0.0021), respectively. The combination therapy was well tolerated, with a safety profile similar to that of statin monotherapy. IMPLICATIONS In these Korean patients with mixed dyslipidemia and a high risk for CVD, combination therapy with pitavastatin/fenofibrate was associated with a greater reduction in non-HDL-C compared with that with pitavastatin monotherapy, and a significantly improvement in other lipid levels. Moreover, the combination therapy was well tolerated, with a safety profile similar to that of statin monotherapy. Therefore, pitavastatin/fenofibrate combination therapy could be effective and well tolerated in patients with mixed dyslipidemia. ClinicalTrials.gov identifier: NCT03618797.
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3.
Prevalence of dyslipidemia among the diabetic patients in southern Bangladesh: A cross-sectional study.
Das, H, Banik, S
Diabetes & metabolic syndrome. 2019;(1):252-257
Abstract
AIM: Diabetic dyslipidemia is one of the major risk factors for cardiovascular disease which has a vast mortality rate throughout the world. Early detection and treatment of dyslipidemia can avoid risk for cardiovascular disorder in diabetic patients. This study was conducted to determine the prevalence of and pattern of dyslipidemia in diabetic patients. MATERIALS AND METHODS This cross sectional study was performed in several specialized diabetic hospital of Noakhali, a southern district of Bangladesh. All known cases of diabetes mellitus were evaluated for their lipid profile. A total number of 1008 patients were included in the study having 683 (67.8%) female and 325 (32.2%) male subjects. RESULTS The prevalence of dyslipidemia among the male subjects was 73% while among female subjects 71%. Among diabetic males the percentage of high serum Cholesterol, high serum TG (Triglyceride), low HDL (High density cholesterol) and high LDL (Low density cholesterol) was 35.69%, 44.31%, 50.15% and 72.92% respectively, whereas the female had the percentage at 35.29%, 40.85%, 49.49% and 70.57% respectively. CONCLUSION Majority portion of the study subjects were dyslipidemic. The most prevalent pattern among both male and female was high level of LDL and low level of HDL. The prevalence of dyslipidemia in Bangladesh is significantly high, which indicates the urgency of lifestyle intervention strategies to prevent and manage this important health problem and risk factor.
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4.
Three-arm, placebo-controlled, randomized clinical trial evaluating the metabolic effect of a combined nutraceutical containing a bergamot standardized flavonoid extract in dyslipidemic overweight subjects.
Cicero, AFG, Fogacci, F, Bove, M, Giovannini, M, Borghi, C
Phytotherapy research : PTR. 2019;(8):2094-2101
Abstract
Our double-blind, placebo-controlled, parallel-group, dose-escalation, clinical trial aimed to test the effect of a combined nutraceutical containing bergamot extract (120-mg flavonoids), phytosterols, vitamin C, and chlorogenic acid from dry artichoke extract on 90 overweight dyslipidemic subjects. Participants were randomly allocated to treatment with two pills of either active treatment or placebo, or a combination of both (a pill per treatment). After 8 weeks, all active-treated groups experienced a significant improvement in triglycerides (TG) versus placebo and in low-density lipoprotein cholesterol (LDL-C) versus baseline and placebo treatments. In the high-dose-treated group, also total cholesterol (TC), nonhigh-density lipoprotein cholesterol (non-HDL-C), γ-glutamil transpeptidasi, high-sensitivity C-reactive protein (hs-CRP), and tumor necrosis factor-α (TNF-α) significantly decreased. At 24-week follow-up, TG levels maintained lower than baseline in all groups. All patients allocated to either low-dose or high-dose active treatment experienced a significant decrease in TG, LDL-C, and homeostatin model assessment of insulin resistance. In subjects taking high-dose active treatment, adiponectin significantly increased, whereas TC, non-HDL-C, insulin (fasting plasma insulin), leptin, leptin/adiponectin ratio, hs-CRP, and TNF-α were significantly reduced. The tested nutraceutical showed to improve lipid and glucose metabolism, adipokines pattern, and systemic inflammation in dyslipidemic overweight subjects.
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5.
Ascophyllum nodosum and Fucus vesiculosus on glycemic status and on endothelial damage markers in dysglicemic patients.
Derosa, G, Cicero, AFG, D'Angelo, A, Maffioli, P
Phytotherapy research : PTR. 2019;(3):791-797
Abstract
The aim of this study was to evaluate a nutraceutical combination containing polyphenols extracted from Ascophyllum nodosum and Fucus vesiculosus and chromium picolinate on glyemic status; secondary outcomes were considered the changes on endothelial markers. We randomized 65 dysglycemic patients to placebo or the nutraceutical agent for 6 months. We evaluated fasting plasma glucose (FPG), postprandial plasma glucose (PPG), HbA1c , fasting plasma insulin, homeostatic model assessment (HOMA) index, high sensitivity C-reactive protein (Hs-CRP), tumor necrosis factor-α (TNF-α), and adhesion molecules. At baseline and at 3 and 6 months, all patients underwent an oral glucose tolerance test. We recorded a reduction of HbA1c , FPG, PPG, and HOMA-IR compared with placebo (p < 0.05). After 6 months, 18.2% of patients retuned to a normal glycemic status in the nutraceutical group versus 0 patients in placebo group (p < 0.05); 69.7% were classified as impaired fasting glycemia and 12.1% as impaired glucose tolerance in the nutraceutical group versus 17.2% and 82.8 in placebo group (p < 0.01) for both. A reduction of Hs-CRP and TNF-α was recorded with the nutraceutical. The administration of a nutraceutical combination containing A. nodosum and F. vesiculosus can be helpful in improving insulin sensitivity and glycemic status. Larger randomized studies are required to confirm the positive effects of these agents.
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6.
Efficacy and Safety of Triple Therapy With Telmisartan, Amlodipine, and Rosuvastatin in Patients With Dyslipidemia and Hypertension: The Jeil Telmisartan, Amlodipine, and Rosuvastatin Randomized Clinical Trial.
Hong, SJ, Jeong, HS, Cho, JM, Chang, K, Pyun, WB, Ahn, Y, Hyon, MS, Kang, WC, Lee, JH, Kim, HS
Clinical therapeutics. 2019;(2):233-248.e9
Abstract
PURPOSE Fixed-dose combination therapy with telmisartan, amlodipine, and rosuvastatin is needed in patients with hypertension and dyslipidemia for better adherence and cost-effectiveness than free-equivalent combination therapies. This study aimed to compare the efficacy and safety of combination therapy with telmisartan, amlodipine, and rosuvastatin versus telmisartan plus amlodipine or telmisartan plus rosuvastatin in patients with hypertension and dyslipidemia. METHODS The Jeil Telmisartan, Amlodipine, and Rosuvastatin Randomized Clinical Trial (J-TAROS-RCT) was an 8-week, multicenter, randomized, double-blind, parallel, Phase III clinical trial conducted at 9 hospitals in Korea. After a run-in period of >4 weeks, patients who fulfilled the criteria of the National Cholesterol Education Program Adult Treatment Panel III guidelines were eligible for randomization to receive 1 of 3 treatments for 8 weeks: (1) telmisartan/amlodipine 80 mg/10 mg plus rosuvastatin 20 mg, (2) telmisartan/amlodipine 80 mg/10 mg, or (3) telmisartan 80 mg plus rosuvastatin 20 mg. The primary end point was efficacy evaluation of combination therapy with telmisartan/amlodipine/rosuvastatin by comparing the change in mean sitting systolic blood pressure (msSBP) and mean percentage change in LDL-C from baseline after 8 weeks of treatment. Adverse events (AEs), clinical laboratory data, and vital signs were assessed in all patients. FINDINGS Among 148 patients, the changes in msSBP from baseline after 8 weeks of treatment were a mean (SD) of -24.41 (2.38) versus -9.31 (2.36) mm Hg in the telmisartan/amlodipine/rosuvastatin and telmisartan/rosuvastatin groups, respectively. Significantly more participants achieved the target BP at week 8 in the telmisartan/amlodipine/rosuvastatin group (41 patients [87.2%]) than in the telmisartan/rosuvastatin group (24 [50.0%], P < 0.001). The changes in mean (SD) LDL-C at 8 weeks compared with baseline values were -57.59% (11.59%) versus 6.08% (20.98%) in the telmisartan/amlodipine/rosuvastatin and telmisartan/amlodipine groups, respectively. The percentages of patients who achieved the target LDL-C according to their risk factors after 8 weeks of treatment were 97.87% vs 6.12% in the telmisartan/amlodipine/rosuvastatin and the telmisartan/amlodipine groups (P < 0.0001), respectively. No significant differences were found in the incidence of overall AEs and adverse drug reactions, and serious AEs were comparable among 3 groups. IMPLICATIONS Fixed-dose combinations of telmisartan, amlodipine, and rosuvastatin decreased BP and LDL-C in patients with hypertension and dyslipidemia. The safety and tolerability profiles of fixed-dose telmisartan, amlodipine, and rosuvastatin combination therapy were comparable with those of telmisartan plus amlodipine or telmisartan plus rosuvastatin. ClinicalTrials.gov identifier: NCT03088254.
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7.
The effect of apple vinegar consumption on glycemic indices, blood pressure, oxidative stress, and homocysteine in patients with type 2 diabetes and dyslipidemia: A randomized controlled clinical trial.
Gheflati, A, Bashiri, R, Ghadiri-Anari, A, Reza, JZ, Kord, MT, Nadjarzadeh, A
Clinical nutrition ESPEN. 2019;:132-138
Abstract
BACKGROUND Some foods and drinks contain special ingredients, causing impressive effects on human health. The aim of the current study was to assess the health effects of apple vinegar in patients with diabetes and dyslipidemia. METHOD Seventy participants with type 2 diabetes and hyperlipidemia were randomly assigned into an intervention and control group in order to assess the effect of 20 ml apple vinegar per day using an 8-week parallel study. Fasting blood sugar (FBS), homeostasis model assessment for insulin resistance (HOMA-IR), homeostasis model assessment for b-cell function (HOMA-B), quantitative insulin sensitivity checks index (QUICKI), insulin, malondialdehyde (MDA), 2,20-Diphenyl-1- picrylhydrazyl (DPPH), homocysteine, systolic blood pressure (SBP), and diastolic blood pressure (DBP) were measured at the beginning and end of the study. RESULTS The intervention with apple vinegar could significantly improve FBS (mean change: -10.16 ± 19.48 mg/dl, p = 0.006) and DPPH (mean change: 16.58 ± 11.56, p < 0.001) within intervention group and in comparison with control group (p < 0.001). Additionally, the significant increase of MDA in control group (p < 0.05) caused a considerable difference between two groups. Glycemic indices containing insulin, HOMA-IR, HOMA-B, and QUICKI decrease significantly in both groups (p < 0.05). No considerable effect was observed on blood pressure and homocysteine in intervention group as well as control group. CONCLUSION This trial provided some evidences that apple vinegar consumption may cause beneficial effects on glycemic indices and oxidative stress in individuals with diabetes and dyslipidemia. This randomized clinical trial was registered in the Iranian Registry of Clinical Trials (https://www.irct.ir/) as 2013070710826N5.
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8.
Coenzyme q10 liquid supplementation in dyslipidemic subjects with statin-related clinical symptoms: a double-blind, randomized, placebo-controlled study.
Derosa, G, D'Angelo, A, Maffioli, P
Drug design, development and therapy. 2019;:3647-3655
Abstract
INTRODUCTION Statin-associated myalgia occurs in about 1-3% of patients in the medical literature. Plasma CoQ10 levels are reduced in patients undergoing statin. OBJECTIVE The primary outcome was the detection of clinical symptoms and the perception of pain evaluated throughout specific questionnaires. The secondary outcome was the variation in lipid profile and the variation in safety parameters. METHODS We enrolled 60 Caucasian patients, intolerant to statins. During the run-in period, patients underwent a 1-month wash-out period during which statins were stopped. At the end of the wash-out period, if CPK and/or transaminases returned within an acceptable range, statins were re-introduced at half of the previously taken dose. After one month, patients were randomized to take either a liquid CoQ10 supplement or a placebo for three months at 100 mg/day. RESULTS The Clinical Index Score for myalgia assessment was lower after 3 months with CoQ10, while it did not change with the placebo. The VAS score was lower after 3 months of CoQ10 supplementation, while no variation was recorded with the placebo. In the group treated with the dietary supplement, CoQ10 plasma concentrations were inversely correlated with CPK levels, Clinical Index Score absolute values, and VAS. CONCLUSION The addition of CoQ10 with half dosage statin in patients with previous intolerance to statins improves the perception of clinical symptoms such as asthenia, myalgia or pain.
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9.
Changes of renal sinus fat and renal parenchymal fat during an 18-month randomized weight loss trial.
Zelicha, H, Schwarzfuchs, D, Shelef, I, Gepner, Y, Tsaban, G, Tene, L, Yaskolka Meir, A, Bilitzky, A, Komy, O, Cohen, N, et al
Clinical nutrition (Edinburgh, Scotland). 2018;(4):1145-1153
Abstract
BACKGROUND & AIMS Data regarding the role of kidney adiposity, its clinical implications, and its dynamics during weight-loss are sparse. We investigated the effect of long-term weight-loss induced intervention diets on dynamics of renal-sinus-fat, an ectopic fat depot, and %renal-parenchymal-fat, lipid accumulation within the renal parenchyma. METHODS We randomized 278 participants with abdominal obesity/dyslipidemia to low-fat or Mediterranean/low-carbohydrate diets, with or without exercise. We quantified renal-sinus-fat and %renal-parenchymal-fat by whole body magnetic-resonance-imaging. RESULTS Participants (age = 48 years; 89% men; body-mass-index = 31 kg/m2) had 86% retention to the trial after 18 months. Both increased renal-sinus-fat and %renal-parenchymal-fat were directly associated with hypertension, and with higher abdominal deep-subcutaneous-adipose-tissue and visceral-adipose-tissue (p of trend < 0.05 for all) after adjustment for body weight. Higher renal-sinus-fat was associated with lower estimated-glomerular-filtration-rate and with higher microalbuminuria and %HbA1C beyond body weight. After 18 months of intervention, overall renal-sinus-fat (-9%; p < 0.05 vs. baseline) but not %renal-parenchymal-fat (-1.7%; p = 0.13 vs. baseline) significantly decreased, and similarly across the intervention groups. Renal-sinus-fat and %renal-parenchymal-fat changes were correlated with weight-loss per-se (p < 0.05). In a model adjusted for age, sex, and visceral-adipose-tissue changes, 18 months reduction in renal-sinus-fat associated with decreased pancreatic, hepatic and cardiac fats (p < 0.05 for all) and with decreased cholesterol/high-density lipoprotein-cholesterol (HDL-c) (β = 0.13; p = 0.05), triglycerides/HDL-c (β = 0.13; p = 0.05), insulin (β = 0.12; p = 0.05) and gamma glutamyl transpeptidase (β = 0.24; p = 0.001), but not with improved renal function parameters or blood pressure. Decreased intake of sodium was associated with a reduction in %renal-parenchymal-fat, after adjustment for 18 months weight-loss (β = 0.15; p = 0.026) and hypertension (β = 0.14; p = 0.04). CONCLUSIONS Renal-sinus-fat and renal-parenchymal-fat are fairly related to weight-loss. Decreased renal-sinus-fat is associated with improved hepatic parameters, independent of changes in weight or hepatic fat, rather than with improved renal function or blood pressure parameters. CLINICALTRIALS. GOVIDENTIFIER NCT01530724.
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Efficacy and safety of pemafibrate (K-877), a selective peroxisome proliferator-activated receptor α modulator, in patients with dyslipidemia: Results from a 24-week, randomized, double blind, active-controlled, phase 3 trial.
Ishibashi, S, Arai, H, Yokote, K, Araki, E, Suganami, H, Yamashita, S, ,
Journal of clinical lipidology. 2018;(1):173-184
Abstract
BACKGROUND To overcome the concerns associated with the use of fibrates, pemafibrate (K-877), a novel selective peroxisome proliferator-activated receptor modulator, was developed. In a previous phase 2 trial, we showed excellent efficacy and safety of pemafibrate in patients with dyslipidemia. OBJECTIVE The objective of the study was to evaluate the efficacy and safety of pemafibrate over 24 weeks in adults with dyslipidemia in comparison with fenofibrate. METHODS In this multicenter, 24-week, double-blind, clinical study, 225 patients with high triglyceride (TG; ≥150 mg/dL [1.7 mmol/L] and <500 mg/dL [5.7 mmol/L]) and relatively low high-density lipoprotein cholesterol (<50 mg/dL [1.3 mmol/L] in men or 55 mg/dL [1.4 mmol/L] in women) levels were randomized to receive either pemafibrate at 0.2 or 0.4 mg/d or fenofibrate 106.6 mg/d. RESULTS Pemafibrate 0.2, 0.4 mg/d and fenofibrate significantly reduced TG levels from baseline by -46.2%, -45.9%, and -39.7%, respectively. As compared with fenofibrate, the least squares mean differences (95% confidence intervals) in TG were -6.5% (-12.0, -1.1) and -6.2% (-11.6, -0.8) in pemafibrate 0.2 and 0.4 mg/d respectively, which showed the superiority of these doses of pemafibrate to 106.6 mg/d of fenofibrate. The incidence rates of adverse drug reactions in pemafibrate groups (2.7% and 6.8%) were significantly lower than that in the fenofibrate group (23.7%). Pemafibrate significantly decreased alanine aminotransferase and gamma-glutamyltransferase levels, whereas fenofibrate increased both of them. The increments of serum creatinine and cystatin C were smaller in pemafibrate than those in fenofibrate. CONCLUSIONS Pemafibrate was superior to fenofibrate in terms of serum TG-lowering effect and hepatic and renal safety.