-
1.
Interventions to Improve Statin Tolerance and Adherence in Patients at Risk for Cardiovascular Disease : A Systematic Review for the 2020 U.S. Department of Veterans Affairs and U.S. Department of Defense Guidelines for Management of Dyslipidemia.
Reston, JT, Buelt, A, Donahue, MP, Neubauer, B, Vagichev, E, McShea, K
Annals of internal medicine. 2020;(10):806-812
Abstract
BACKGROUND Strategies to improve patients' tolerance of and adherence to statins may enhance the effectiveness of dyslipidemia treatment in those at risk for cardiovascular disease (CVD). PURPOSE To assess the benefits and harms of interventions to improve statin adherence in patients at risk for CVD. DATA SOURCES MEDLINE, EMBASE, PubMed, and the Cochrane Library from December 2013 through May 2019 (English language only). STUDY SELECTION Systematic reviews (SRs), randomized controlled trials (RCTs), and cohort studies that addressed interventions for improving statin tolerance and adherence. DATA EXTRACTION One investigator abstracted data and assessed study quality, and a second investigator checked abstractions and assessments for accuracy. DATA SYNTHESIS One SR, 1 RCT, and 4 cohort studies were included. The SR found that intensified patient care improved adherence and decreased levels of total serum cholesterol and low-density lipoprotein cholesterol (LDL-C) at 6 months or more of follow-up. Compared with statin treatment discontinuation, nondaily statin dosing lowered total cholesterol and LDL-C levels. One large cohort study suggested that more than 90% of patients who discontinued statin treatment could be rechallenged with the same or a different statin and be adherent 1 year after a statin-related adverse event led to discontinuation. Two small cohort studies reported that more than 90% of patients who were previously intolerant to statins and who had low baseline levels of vitamin D were able to adhere to statins 1 year after vitamin D supplementation. LIMITATION This is a qualitative synthesis of new evidence with existing meta-analyses, and studies had several methodological shortcomings. CONCLUSION Although the strength of evidence for most interventions was low or very low, intensified patient care and rechallenge with the same or a different statin (or a lower dose) seem to be favorable options for improving statin adherence. PRIMARY FUNDING SOURCE U.S. Department of Veterans Affairs.
-
2.
Effect of green tea extract on lipid profile in patients with type 2 diabetes mellitus: A systematic review and meta-analysis.
Asbaghi, O, Fouladvand, F, Moradi, S, Ashtary-Larky, D, Choghakhori, R, Abbasnezhad, A
Diabetes & metabolic syndrome. 2020;(4):293-301
Abstract
BACKGROUND Previous studies have indicated controversial results regarding the efficacy of green tea extract (GTE) in improving the lipid profile of type 2 diabetes mellitus (T2DM) patients. We aimed to conduct a systematic review and meta-analysis to pool data from randomized controlled trials (RCTs). METHODS A systematic search was performed in Web of Science, PubMed, and Scopus databases, without any language and time restriction until August 2019, to retrieve the RCTs which examined the effects of GTE on serum concentrations of high-density lipoprotein (HDL), low-density lipoprotein (LDL), triglyceride (TG) or total cholesterol (TC) in T2DM patients. Meta-analyses were carried out using a random effects model. I2 index was used to evaluate the heterogeneity. RESULTS Initial search yielded 780 publications. Of these, seven studies were eligible. The supplementary intake of GTE improved lipid profile by reducing serum TG concentrations in patients with T2DM. Meanwhile, subgroup analyses based on duration of interventions (≤8 and > 8 weeks) and intervention dosage (≤800 and > 800 mg/day) showed that the GTE supplementation longer than 8 weeks and in doses >800 mg/day resulted in a significant decrease in serum TG concentrations. Furthermore, intervention longer than 8 weeks with doses lower than 800 mg/day resulted in a significant reduction in serum TC concentrations. CONCLUSION In conclusion, present systematic review and meta-analysis revealed that the supplementary intake of GTE may improve lipid profile by reducing serum concentrations of TG in patients with T2DM. Furthermore, the results of our stratified analyses suggested that long-term GTE intervention may reduce serum concentrations of TG and TC.
-
3.
The effect of saffron supplementation on blood glucose and lipid profile: A systematic review and meta-analysis of randomized controlled trials.
Asbaghi, O, Soltani, S, Norouzi, N, Milajerdi, A, Choobkar, S, Asemi, Z
Complementary therapies in medicine. 2019;:102158
Abstract
BACKGROUND Despite several studies about the effects of saffron supplementation on serum concentrations of lipid and glucose profiles, no systematic study had summarized the findings. Therefore, we conduct current study to systematically summarize findings from studies about the effect of saffron supplementation on serum levels of glucose and lipid profiles and to do a meta-analysis, if possible. METHODS A systematic literature search was conducted for clinical trials published in PubMed, SCOPUS, EMBASE, Cochrane's Library and ISI Web of Science from the beginning to 22 February 2019. All randomized clinical trials on the effect of saffron supplementation on serum concentrations of lipid and glucose profiles were included. RESULTS In overall, six studies were included in the current study. Pooled analysis of six studies for the effect of saffron on serum TG, TC and FBG concentrations and of five studies for LDL and HDL, showed a significant reduction in TG (WMD: -8.93 mg/dl; 95% CI: -16.49 to -1.37, P = 0.02) and TC levels (WMD: -5.72 mg/dl; 95% CI: -11.10 to -0.34, P = 0.03), a significant increase in HDL levels (WMD: 2.7 mg/dl; 95% CI: 0.22 to 5.18, P = 0.03), and no significant effect on LDL (WMD: -2.30 mg/dl; 95% CI: -11.73 to 7.13, P = 0.63) and FBG levels (WMD: -5.30 mg/dl; 95% CI: -14.20 to 3.60, P = 0.51). CONCLUSION We found a significant reduction in serum concentrations of TC and TG and a significant increase in serum levels of HDL following supplementation with saffron. Saffron supplementation had no significant influence on serum FPG and LDL concentrations.
-
4.
Effects of products designed to modulate the gut microbiota on hyperlipidaemia.
Deng, X, Ma, J, Song, M, Jin, Y, Ji, C, Ge, W, Guo, C
European journal of nutrition. 2019;(7):2713-2729
Abstract
PURPOSE Fatalities due to heart and cerebrovascular diseases caused by uncontrolled hyperlipidaemia increase every year; on the other hand, lipid-lowering drugs are known to cause side effects. The gut microbiota has been thoroughly investigated by researchers and consumers, because they have unique functional properties and littler side effects. However, the effects of the gut microbiota remain controversial. We conducted a meta-analysis to assess the effects of products designed to modulate the gut microbiota on various hyperlipidaemias. METHODS We systematically searched PubMed, Embase, Cochrane Library (Central), and Web of Science for randomized controlled trials (published before June 2017, and those only in English) to compare treatment (products designed to modulate the gut microbiota) versus placebo. Our main endpoints were total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) in serum. We assessed pooled data using a fixed effects model. RESULTS Of 1337 identified studies, 21 were eligible and included in our analysis (n = 1436 participants). The combined estimate of effect size for the impact of products designed to modulate the gut microbiota on serum TC (WMD - 11.07 mg/dL, 95% CI - 13.72 to - 8.43, p < 0.001), LDL-C (WMD - 10.96 mg/dL, 95% CI - 13.37 to - 8.56, p < 0.001), and HDL-C (WMD 0.72 mg/dL, 95% CI 0.06-1.38, p = 0.032) were statistically significant, while no significant effect was found on TG concentrations (WMD - 0.56 mg/dL, 95% CI - 5.59 to 4.47, p = 0.828). Subgroup analysis showed parallel trials, probiotics, and long-term intervention had better effects on lowering blood lipid levels. CONCLUSION Products designed to modulate the gut microbiota results in changes of the plasma lipid concentrations and these changes may protect against cardiovascular disease.
-
5.
Effects of probiotic supplementation on the regulation of blood lipid levels in overweight or obese subjects: a meta-analysis.
Yan, S, Tian, Z, Li, M, Li, B, Cui, W
Food & function. 2019;(3):1747-1759
Abstract
BACKGROUND Obesity is a risk factor for many deadly diseases. Meanwhile, the prevalence of obesity has been continuously increasing in many countries. Probiotics are defined as live microorganisms that confer health benefits on hosts. Probiotic supplementation could reduce body weight, body mass index (BMI) and fat percentage. However, it is unclear whether supplementation with probiotics is beneficial to lower blood lipid levels for obese or overweight people. METHODS In this study, a comprehensive search across multiple databases was performed to identify studies that focused on the effects of probiotics on blood lipid levels in overweight or obese subjects. The meta-analysis included studies that compared the variations in blood lipid (total cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL) and triglyceride (TG)) concentrations between overweight and obese subjects who were supplemented with probiotics versus the controls who were not supplemented with probiotics. RESULTS Our findings indicated that probiotic supplementation in obese or overweight people was associated with significantly larger reductions in TC and LDL levels compared to a lack of probiotic supplementation in the control subjects. However, there was no significant difference in the variations between HDL and TG concentrations. CONCLUSION Probiotic supplementation reduced TC and LDL concentrations in obese or overweight people. Additional data from large clinical trials are required to confirm the efficacy and safety of probiotics in the regulation of blood lipid levels in obese or overweight people.
-
6.
Optimising treatment of hyperlipidaemia: Quantitative evaluation of UK, USA and European guidelines taking account of both LDL cholesterol levels and cardiovascular disease risk.
Soran, H, Adam, S, Durrington, PN
Atherosclerosis. 2018;:135-142
Abstract
BACKGROUND AND AIMS Guidelines for cholesterol-lowering medication either advocate fixed dose statin treatment without low density lipoprotein (LDL) cholesterol targets or treatment aimed at LDL cholesterol goals. The decrease in LDL cholesterol concentration determines the reduction in atherosclerotic cardiovascular disease (CVD) risk. METHODS As indices of the effectiveness of reductions in LDL cholesterol concentration achieved by the various guidelines, the number of CVD events prevented in 100 people during 10 years of treatment (N100) and the number of people, who must be treated for 10 years to prevent one CVD event (NNT), were calculated taking into account both CVD risk and pretreatment LDL cholesterol concentration. That our method of calculating NNT and N100, could be extended to statin regimens of different intensity or of statin combined with adjunctive cholesterol-lowering medication was demonstrated by meta-analysis. RESULTS Reductions in LDL-cholesterol concentration are determined by the choice and dose of medication and by the pre-treatment LDL-cholesterol concentration. At similar CVD risk, whatever cholesterol-lowering strategy is adopted, people with higher pre-treatment LDL cholesterol benefit more than those with lower levels. Fixed dose statin regimens are less effective than target LDL cholesterol levels of 1.8 or 1.4 mmol/l when pre-treatment LDL-cholesterol levels exceed 4 mmol/l. However, fixed dose statin is more effective in people with lower initial LDL cholesterol. The predicted NNT and N100 were closely related to the observed reduction in CVD risk in our meta-analysis. CONCLUSIONS In hypercholesterolaemia, aiming for LDL cholesterol targets with statin dose titration (and when necessary adjunctive medication) is essential to optimise benefit.
-
7.
Comparative Effectiveness of Inclisiran 100, 300, and 500 mg in a Population with Hyperlipidemia: A Network Meta-Analysis of Randomized Controlled Trials.
Wang, Y, Wang, J, Wang, S
American journal of cardiovascular drugs : drugs, devices, and other interventions. 2018;(4):271-282
Abstract
BACKGROUND To our knowledge, inclisiran was the first agent composed of small interfering RNAs (siRNAs) to be preliminarily used to reduce proatherogenic lipoprotein cholesterol levels. Inclisiran was evaluated in large clinical trials but did not receive government approval. The ability of inclisiran to reduce low-density lipoprotein cholesterol (LDL-C) greatly improved its chances of becoming a novel therapeutic option for patients with hyperlipidemia. OBJECTIVE Our goal was to summarize the preliminary effectiveness and safety data for inclisiran. METHODS We conducted a comprehensive search of PubMed, Scopus, Web of Science, the OVID EMB Reviews database, and Clinical Trials with the keyword "inclisiran" to find all related randomized controlled trials (RCTs). Five recently published RCTs involving 583 adults aged 18-65 years with hyperlipidemia were included in the analysis. RESULTS Subgroup analysis suggested that inclisiran 100 mg (standard mean difference [SMD] - 2.09; 95% confidence interval [CI] - 2.51 to - 1.66; p < 0.05), 300 mg (SMD - 2.74; 95% CI - 3.61 to - 1.87; p < 0.05), and 500 mg (SMD - 2.21; 95% CI - 2.62 to - 1.80; p < 0.05) significantly (p < 0.05) reduced LDL-C and total cholesterol even though pooled analysis showed no LDL-C-lowering effect (SMD 0.15; 95% CI - 0.34 to 0.04; p = 0.116). Compared with patients receiving placebo, pooled and subgroup analysis of patients receiving inclisiran showed no favorable changes in triglycerides or high-density lipoprotein cholesterol (p > 0.05). The most commonly reported adverse events were musculoskeletal pain, nasopharyngitis, headache, and elevated C-reactive protein (CRP), none of which were significant (p > 0.05). CONCLUSIONS To date, inclisiran has been effective in treating hyperlipidemia. Major adverse events were not identified, although other possible adverse events may be discovered with more RCTs and extensive long-term follow-up.
-
8.
Acupuncture for hyperlipidemia: Protocol for a systematic review and meta-analysis.
Peng, Q, Yao, X, Xiang, J, Wang, Y, Lin, X
Medicine. 2018;(50):e13041
-
-
Free full text
-
Abstract
BACKGROUND Hyperlipidemia is a major risk factor for cardiovascular and cerebrovascular diseases. Acupuncture has been widely applied in the treatment of hyperlipidemia. But its efficacy has not been evaluated scientifically and systematically. Therefore, we provide a protocol of systematic evaluation to assess the effectiveness and safety of acupuncture treatment on patient with hyperlipidemia. METHODS We will search the following databases electronically, including 3 English literature databases (i.e., PubMed, Embase, and Cochrane Library) and 4 Chinese literature databases (i.e., Chinese Biological and Medical database, China National Knowledge Infrastructure, VIP, and Wanfang Database). We will also search randomized-controlled trials about acupuncture treatment for hyperlipidemia and the search time limit is from its establishment to October 2018. The primary outcome is lipid-lowering efficacy. Secondary outcomes are total cholesterol, low-density lipoprotein cholesterol, triglyceride, and high-density lipoprotein cholesterol levels. We will use RevMan V.5.3 software as well to compute the data synthesis carefully when a meta-analysis is allowed. RESULTS This study will provide a high-quality synthesis to assess the effectiveness and safety of acupuncture treatment on patient with hyperlipidemia. CONCLUSION The conclusion of our systematic review will provide evidence to judge whether acupuncture is an effective intervention for patient with hyperlipidemia.
-
9.
Chronotherapy versus conventional statins therapy for the treatment of hyperlipidaemia.
Izquierdo-Palomares, JM, Fernandez-Tabera, JM, Plana, MN, Añino Alba, A, Gómez Álvarez, P, Fernandez-Esteban, I, Saiz, LC, Martin-Carrillo, P, Pinar López, Ó
The Cochrane database of systematic reviews. 2016;(11):CD009462
-
-
Free full text
-
Abstract
BACKGROUND Elevated levels of total cholesterol and low-density lipoprotein play an important role in the development of atheromas and, therefore, in cardiovascular diseases. Cholesterol biosynthesis follows a circadian rhythm and is principally produced at night (between 12:00 am and 6:00 am). The adjustment of hypolipaemic therapy to biologic rhythms is known as chronotherapy. Chronotherapy is based on the idea that medication can have different effects depending on the hour at which it is taken. Statins are one of the most widely used drugs for the prevention of cardiovascular events. In usual clinical practice, statins are administered once per day without specifying the time when they should be taken. It is unknown whether the timing of statin administration is important for clinical outcomes. OBJECTIVES To critically evaluate and analyse the evidence available from randomised controlled trials regarding the effects of chronotherapy on the effectiveness and safety of treating hyperlipidaemia with statins. SEARCH METHODS We searched the CENTRAL, MEDLINE, Embase, LILACS, ProQuest Health & Medical Complete, OpenSIGLE, Web of Science Conference Proceedings, and various other resources including clinical trials registers up to November 2015. We also searched the reference lists of relevant reviews for eligible studies. SELECTION CRITERIA We included randomised controlled trials (RCTs), enrolling people with primary or secondary hyperlipidaemia. To be included, trials must have compared any chronotherapeutic lipid-lowering regimen with statins and any other statin lipid-lowering regimen not based on chronotherapy. We considered any type and dosage of statin as eligible, as long as the control and experimental arms differed only in the timing of the administration of the same statin. Quasi-randomised studies were excluded. DATA COLLECTION AND ANALYSIS We used the standard methodological procedures expected by Cochrane. We extracted the key data from studies in relation to participants, interventions, and outcomes for safety and efficacy. We calculated odds ratios (OR) for dichotomous data and mean differences (MD) for continuous data with 95% confidence intervals (CI). Using the GRADE approach, we assessed the quality of the evidence and we used the GRADEpro Guideline Development Tool to import data from Review Manager to create 'Summary of findings' tables. MAIN RESULTS This review includes eight RCTs (767 participants analysed in morning and evening arms). The trials used different lipid-lowering regimens with statins (lovastatin: two trials; simvastatin: three trials; fluvastatin: two trials; pravastatin: one trial). All trials compared the effects between morning and evening statin administration. Trial length ranged from four to 14 weeks. We found a high risk of bias in the domain of selective reporting in three trials and in the domain of incomplete outcome data in one trial of the eight trials included. None of the studies included were judged to be at low risk of bias.None of the included RCTs reported data on cardiovascular mortality, cardiovascular morbidity, incidence of cardiovascular events, or deaths from any cause. Pooled results showed no evidence of a difference in total cholesterol (MD 4.33, 95% CI -1.36 to 10.01), 514 participants, five trials, mean follow-up 9 weeks, low-quality evidence), low-density lipoprotein cholesterol (LDL-C) levels (MD 4.85 mg/dL, 95% CI -0.87 to 10.57, 473 participants, five trials, mean follow-up 9 weeks, low-quality evidence), high-density lipoprotein cholesterol (HDL-C) (MD 0.54, 95% CI -1.08 to 2.17, 514 participants, five trials, mean follow-up 9 weeks, low-quality evidence) or triglycerides (MD -8.91, 95% CI -22 to 4.17, 510 participants, five trials, mean follow-up 9 weeks, low-quality evidence) between morning and evening statin administration.With regard to safety outcomes, five trials (556 participants) reported adverse events. Pooled analysis found no differences in statins adverse events between morning and evening intake (OR 0.71, 95% CI 0.44 to 1.15, 556 participants, five trials, mean follow-up 9 weeks, low-quality evidence). AUTHORS' CONCLUSIONS Limited and low-quality evidence suggested that there were no differences between chronomodulated treatment with statins in people with hyperlipidaemia as compared to conventional treatment with statins, in terms of clinically relevant outcomes. Studies were short term and therefore did not report on our primary outcomes, cardiovascular clinical events or death. The review did not find differences in adverse events associated with statins between both regimens. Taking statins in the evening does not have an effect on the improvement of lipid levels with respect to morning administration. Further high-quality trials with longer-term follow-up are needed to confirm the results of this review.
-
10.
Effect of fenugreek on hyperglycaemia and hyperlipidemia in diabetes and prediabetes: A meta-analysis.
Gong, J, Fang, K, Dong, H, Wang, D, Hu, M, Lu, F
Journal of ethnopharmacology. 2016;:260-268
Abstract
ETHNOPHARMACOLOGICAL RELEVANCE Fenugreek is a widely used herb for the treatment of diabetes mellitus (DM) but the effects in randomized controlled trials (RCTs) were controversial. Therefore, a meta-analysis was conducted to estimate the overall effects of fenugreek on hyperglycaemia and hyperlipidemia in diabetes and prediabetes. MATERIALS AND METHODS PubMed, EMBASE, web of science, Chinese Biomedical Literature database (CBM), the Cochrane library, China Doctor Dissertations Full-text Database (CDFD), Wan Fang medical database, China Proceedings of Conference Full-text Database (CPCD), China national knowledge internet (CNKI) and China Master's Theses Full-text Database (CMFD) were searched to find the available literatures. RCTs with regard to the efficacy and safety of fenugreek on prediabetes or DM were included. The data of fasting blood glucose (FBG), postprandial 2h blood glucose (2hBG), glycosylated hemoglobin (HbA1c), triglyceride (TG), total cholesterol (TC), low density lipoprotein cholesterol (LDL-c) and high density lipoprotein cholesterol (HDL-c) were extracted to appraise the net change with fixed or randomized effect model. RESULTS A total of 10 articles (12 studies) were included in the analysis. Pooled results showed fenugreek significantly decreased the levels of FBG (MD -0.84mmol/L; 95% CI -1.38 to -0.31; p=0.002), 2hBG (MD -1.30mmol/L; 95% CI -1.78 to -0.83; p<0.0001), HbA1c (MD -1.16; 95% CI -1.23 to -1.09; p<0.00001) and TC (MD -0.30mmol/L; 95% CI-0.56 to -0.03; p=0.03). In spite of the reductive trends in the TG or LDL-c levels and incremental trends of HDL-c, these results were not statistically significant or need further verification for fenugreek in the treatment of DM and prediabetes. Some studies were of low quality. No liver and kidney toxicity were found in all included studies, and the main side effects were gastrointestinal discomfort. CONCLUSIONS The results suggest fenugreek has the hypoglycaemic and TC-lowering efficacy; however, the effects on TG, LDL-c and HDL-c need further confirmations.