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THE ROLE OF THE OCCUPATIONAL PHISICIAN IN DISABLED RETURN TO WORK. Workers, former workers or unemployed workers with disabilities of various kinds often come to the Occupational Health Hospital Department (UOOML), requiring a report on their fitness for work that often is generic or not suitable for specific situations: a detailed knowledge of both working and health conditions, mainly disabilities and job items are needed. The UOOML was never directly involved in the proceedings of targeted fitting-up of the disabled people, while some Doctors of the Department of Prevention of ASL have an advisory role partecipating in the Technical Committee under Law 68 and the 'Disabled Commission'. INAIL (the National Insurance Institute for Occupational Accidents and Diseases), in case of allocation of percentages of disability higher than 33% (necessary requirement for the targeted employment) provides an assessment of the 'residual capacity'. The Company Occupational Physician cooperates and intervenes in the management of the employment of the disabled worker in very different ways and at several stages of the path of integration or reintegration. Considering the prolonged and effective cooperation among the Doctors of the UOOML and the Psysiatrists of our Hospital, we are developing a specific out-patients' department where a report on the fitness for job, as close as possible to the patient/work-task compliance, is provided to the disabled. [ABSTRACT FROM AUTHOR]

Objective: Patients with peripheral artery disease (PAD) are at increased risk of major adverse limb events (MALE). Furthermore, MALE have several clinical implications and a poor prognosis, so prevention is a fundamental issue. The main objective of the present meta-analysis of randomized clinical trials is to evaluate the effect of different lipid-lowering therapies on MALE incidence in patients with PAD., Methods: A meta-analysis of randomized studies that evaluated the use of lipid-lowering therapy in patients with PAD and reported MALE was performed, after searching the PubMed/MEDLINE, Embase, ScieLO, Google Scholar, and Cochrane Controlled Trials databases. A fixed- or random-effects model was used., Results: Five randomized clinical trials including 11,603 patients were identified and considered eligible for the analyses (5903 subjects were allocated to receive lipid-lowering therapy, while 5700 subjects were allocated to the respective placebo/control arms). The present meta-analysis revealed that lipid-lowering therapy was associated with a lower incidence of MALE (OR: 0.76, 95% confidence interval: 0.66-0.87; I2: 28%) compared to placebo/control groups. The sensitivity analysis shows that the results are robust., Conclusion: This study demonstrated that the use of lipid-lowering therapy compared with the placebo/control arms was associated with a marked reduction in the risk of MALE. Physicians involved in the monitoring and treatment of patients with PAD must work hard to ensure adequate lipid-lowering medication in these patients.

Background: Despite strong association of elevated lipoprotein (a) (Lp(a)) levels with incident coronary and cerebrovascular disease, data for incident peripheral artery disease (PAD) are less robust. The main objective of the present systematic review was to analyze the association between elevated Lp(a) levels and PAD outcomes., Methods: This systematic review was performed according to PRISMA guidelines. A literature search was performed to detect randomized clinical trials or observational studies with a cohort design that evaluated the association between Lp(a) levels and PAD outcomes., Results: Fifteen studies including 493,650 subjects were identified and considered eligible for this systematic review. This systematic review showed that the vast majority of the studies reported a significant association between elevated Lp(a) levels and the risk of PAD outcomes. The elevated Lp(a) levels were associated with a higher risk of incident claudication (RR: 1.20), PAD progression (HR: 1.41), restenosis (HR: 6.10), death and hospitalization related to PAD (HR: 1.37), limb amputation (HR: 22.75), and lower limb revascularization (HR: 1.29 and 2.90). In addition, the presence of elevated Lp(a) values were associated with a higher risk of combined PAD outcomes, with HRs in a range between 1.14 and 2.80, despite adjusting for traditional risk factors. Heterogeneity of results can be explained by different patient populations studied and varying Lp(a) cut-off points of Lp(a) analyzed., Conclusion: This systematic review suggests that evidence is available to support an independent positive association between Lp(a) levels and the risk of future PAD outcomes. PROSPERO Registration No.: 289253.

Introduction: Obesity and its co-morbidities, including type 2 diabetes (T2DM) and dyslipidemia, are accompanied by excess cardiovascular morbi-mortality. Aside from excess low density lipoprotein-cholesterol (LDL-C), atherogenic dyslipidemia (AD), mainly characterized by elevated triglycerides and decreased high density lipoprotein-cholesterol (HDL-C) levels, is often present in T2DM obese patients. Bariatric surgery, such as Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG), has become a reference treatment in that population. However, the respective effects of RYGB vs SG on lipid metabolism in T2DM patients have been rarely studied., Methods: A meta-analysis of randomized controlled trials, comparing the effects of RGYBG vs SG on lipid metabolism 12 months after surgery in T2DM patients, was performed., Results: Four studies including a total of 298 patients (151 patients in the RYGB and 147 patients in the SG group) were examined. Despite a greater decrease in body mass index and greater improvement in glycemic control in RYGB compared to SG. RYGB vs SG was more effective in reducing total cholesterol, LDL-C, and non-HDL-C levels (mean difference [MD] -26.10 mg/dL, 95 % CI -38.88 to -13.50, p<0.00001; [MD] -20.10 mg/dL, 95 % CI -27.90 to -12.20, p<0.00001 and MD 31.90 mg/dl, 95 % CI -46.90 to -16.80, p<0.00001, respectively)., Conclusions: The superiority of RYGB vs SG in reducing LDL-C, with an effect comparable to a moderate-intensity statin, suggests RYBG should be favored in hypercholesterolemic T2DM patients in order to further reduce cardiovascular risk., (© 2022. The Society for Surgery of the Alimentary Tract.)

Background: Given the complex aetiology and a limited amount of evidence, the medical treatment (including statin use) of myocardial infarction with non-obstructive coronary artery disease (MINOCA) remains uncertain. The objective of the present study was to evaluate the effect of statin therapy on major cardiovascular events (MACE) and mortality in MINOCA patients., Methods: A systematic review and meta-analysis of time-to-event outcomes were performed of studies of statin therapy on MINOCA patients, reporting data from MACE or mortality, after searching the PubMed/MEDLINE, Embase, Science Direct, Scopus, Google Scholar, and Cochrane databases. A fixed-effects meta-analysis model was then applied., Results: Six observational studies of statin therapy on MINOCA, involving a total of 11,171 patients, were identified and considered eligible for analysis (9129 subjects received statin therapy while 2042 patients were part of the respective control arms). Quantitative analysis (5 studies were included) showed that statin use was associated with lower mortality (HR: 0.65; 95% CI: 0.56-0.75, I 2 : 0%). Also, the meta-analysis showed that statin therapy was associated with a lower incidence of MACE (HR: 0.78; 95% CI: 0.69-0.88, I 2 :27%)., Conclusion: Our data suggest that in a population with MINOCA, the use of statin therapy results in significant reduction on MACE and mortality. These results must be confirmed in future clinical trials.

Background: Due to their anti-inflammatory properties, it has been suggested that the use of statins could influence the evolution of influenza virus infection., Aim: To evaluate the effect of statin therapy on mortality from influenza., Methods: A meta-analysis that included studies evaluating the use of statins in patients with influenza and reporting data on mortality, after searching the PubMed/MEDLINE, Embase, and Cochrane Controlled Trials databases, was performed. A random effects model was applied. The risk of bias was analyzed and a sensitivity analysis was performed., Results: Eight studies (10 independent cohorts), which included a total of 2,390,730 patients, were identified and eligible for analysis. A total of 1,146,995 subjects analyzed received statins, while 1,243,735 subjects were part of the control group. Statin therapy was associated with lower mortality (OR: 0.66; 95% CI: 0.51-0.85). The sensitivity analysis showed that the results were robust., Conclusion: Our data suggest that, in a population with influenza, the use of statins was associated with a significant reduction in mortality. These results must be confirmed in future clinical trials.

Cadmium (Cd) is a toxic metal and an important environmental contaminant. We analyzed its effects on oligoelements, oxidative stress, cell death, Hsp expression and the histoarchitecture of rat lung under different diets, using animal models of subchronic cadmium intoxication. We found that Cd lung content augmented in intoxicated groups: Zn, Mn and Se levels showed modifications among the different diets, while Cu showed no differences. Lipoperoxidation was higher in both intoxicated groups. Expression of Nrf-2 and SOD-2 increased only in SoCd. GPx levels showed a trend to increase in Cd groups. CAT activity was higher in intoxicated groups, and it was higher in Soy groups vs. Casein. LDH activity in BAL increased in CasCd and decreased in both soy-fed groups. BAX/Bcl-2 semiquantitative ratio showed similar results than LDH activity, confirmed by Caspase 3 immunofluorescence. The histological analysis revealed an infiltration process in CasCd lungs, with increased connective tissue, fused alveoli and capillary fragility. Histoarchitectural changes were less severe in soy groups. Hsp27 expression increased in both intoxicated groups, while Hsp70 only augmented in SoCd. This show that a soy-diet has a positive impact upon oxidative unbalance, cell death and morphological changes induced by Cd and it could be a good alternative strategy against Cd exposure., (© 2022. The Author(s), under exclusive licence to Springer Nature B.V.)

Introduction: Several studies have evaluated the relation between variables of cardiopulmonary exercise testing (CPET) and major clinical events in pulmonary hypertension (PH) patients, although the results were conflicting. The main objective of this study was to investigate the prognostic value of the CPET derived parameters on all-cause mortality or urgent transplantation in PH patients., Material and Methods: A meta-analysis of time-to-event outcomes were performed from observational studies that evaluated the predictive value of CEPT-related variables [peak oxygen uptake (VO₂) and the ventilation to CO₂ production slope (VE/VCO₂)] in PH patients, reporting data from mortality or urgent transplantation, after searching the PubMed/MEDLINE, Embase, Science Direct, Scopus, Google Scholar, and Cochrane databases. A random-effects meta-analysis model was then applied., Results: Nine eligible studies, including 986 patients, were identified and considered eligible for the quantitative analyses. This meta-analysis showed that high peak VO₂ was associated with a lower mortality or transplant occurrence (HR: 0.81; 95% CI: 0.78-0.85, I2 = 29%). In addition, high VE/VCO₂ slope was associated with a higher incidence of the primary endpoint (HR: 1.04; 95% CI: 1.02-1.06, I2 = 78%). The sensitivity analysis showed that the results were robust., Conclusions: Our data suggest that in a population with PH the CPET-related variables have predictive capacity regarding mortality and the risk of transplantation. Future studies should establish the best cut-off points for these CPET-related variables.

Introduction: Sodium Glucose Co-transporter 2 inhibitors and glucagon-like peptide 1 receptor agonists (GLP-1RAs) were associated with a reduction in cardiovascular disease events in cardiovascular outcomes trials (CVOTs) in type 2 diabetes. Most of the patients included in these trials received metformin as background therapy., Aim: To evaluate the effect of glucagon-like peptide 1 receptor agonists on major cardiovascular events (MACE) and mortality in metformin-naïve patients with type 2 diabetes., Methods: A systematic review and meta-analysis of randomized controlled clinical trials of GLP-1RAs on type 2 diabetes population was performed, after searching the PubMed/MEDLINE, Embase, Scielo, Google Scholar and Cochrane Controlled Trials databases. The primary endpoint was MACE. The secondary endpoints were cardiovascular death and all-cause mortality. A meta-analysis of time-to-event outcomes was performed. This meta-analysis was registered in PROSPERO (CRD42021260040) RESULTS: Seven trials, including 11510 patients, were identified and considered eligible for the analyses. GLP-1RAs were associated with a significant reduction in MACE incidence (HR: 0.86, 95% confidence interval: 0.79-0.94; I 2 : 0%). The secondary endpoints analysis showed a non-significant reduction in all-cause mortality (HR: 0.86, 95% confidence interval: 0.73-1.00 I 2 : 0%) and cardiovascular mortality (HR: 0.81, 95% confidence interval: 0.63-1.05; I 2 : 0%)., Conclusions: In this meta-analysis, GLP-1RAs reduced the incidence of MACE in patients with type 2 diabetes without metformin at baseline, without significant reduction in all-cause mortality and cardiovascular mortality. These results support the fact that when a GLP-1RAs is administered, the benefit on cardiovascular outcomes is independent of the use of metformin., (© 2021. Italian Society of Hypertension.)

Background: In patients with coronary artery disease anti-inflammatory drugs have been shown to be effective in reducing cardiovascular events. The effect of this intervention in the population with type 2 diabetes mellitus (T2DM) is poorly explored. The main objective of this study was to evaluate the effect of anti-inflammatory therapy on the incidence of major cardiovascular events (MACE) in patients with T2DM., Methods: A meta-analysis of randomized studies that evaluated the use of anti-inflammatory therapy in patients with T2DM and reported MACE was performed, after searching the PubMed/MEDLINE, Embase, Scielo, Google Scholar and Cochrane Controlled Trials databases. A fixed or random effects models were used., Results: Five studies were selected for the analysis (2075 subjects in the anti-inflammatory therapy arm and 2490 patients in the placebo/control arm). All studies included patients with T2DM and history of coronary artery disease. Four studies evaluated the use of colchicine and one of them canakinumab. The use of anti-inflammatory therapy was associated with a lower risk of MACE (HR: 0.80; 95% CI, 0.69-0.93; I 2  = 24%). The sensitivity analysis shows that the results are robust., Conclusion: This meta-analysis demonstrated that the use of anti-inflammatory therapy in patients with T2DM and atherosclerotic cardiovascular disease was associated with reduced risk of MACE. These results suggest the need to consider the inflammatory pathway as a potential therapeutic target in patients with T2DM., Competing Interests: Declaration of competing interest The authors declare that they have no conflict of interest., (Copyright © 2021 Diabetes India. Published by Elsevier Ltd. All rights reserved.)

Aims: Clinical trials showed that statin therapy decreased cardiovascular events without significantly raising the level of transaminases. However, the information in subjects with altered liver test at baseline is more limited. The objectives of this meta-analysis were to analyze the liver safety and cardiovascular benefit when using a statin-based lipid-lowering treatment compared to a less intensive treatment or placebo, in subjects with abnormal liver tests at baseline., Data Synthesis: We performed a meta-analysis including randomized trials of statin-based lipid-lowering therapy versus less intensive lipid-lowering therapy or placebo, reporting worsening hepatic test (>3 ULN) and cardiovascular events in patients with abnormal liver tests at baseline. The random-effects model was performed. This meta-analysis was performed according to PRISMA guidelines. Five eligible trials, including 2548 patients were identified and considered eligible for the analyses. A more intensive statin-based lipid-lowering therapy were associated with a similar occurrence of serious alteration of liver tests (OR: 0.90, 95% confidence interval: 0.21-3.99; I 2 : 64%) compared to less intensive or placebo treatments. Likewise, more intensive lipid-lowering strategies were associated with a significant reduction in major cardiovascular events (OR: 0.34, 95% confidence interval: 0.17-0.70; I 2 : 66%)., Conclusions: In this study, a more intensive statin-based lipid-lowering treatment, compared with less intensive treatment or placebo, showed a similar incidence of worsening transaminases levels in patients with abnormal liver tests at baseline. Also, a reduction in cardiovascular events was observed when a more intensive lipid-lowering therapy was used., (Copyright © 2021 The Italian Diabetes Society, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.)

Background: Bempedoic acid is a novel non-statin drug that was developed to treat hyperlipidemia in combination with other lipid-lowering drugs in those patients who need additional lipid lowering., Objectives: (1) To investigate the lipid efficacy of bempedoic acid; (2) to analyze the anti-inflammatory effects of bempedoic acid estimated through high sensitivity C-reactive protein (hsCRP)., Methods: We performed a meta-analysis including randomized trials of bempedoic acid therapy, reporting low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B and hsCRP with a minimum of 4 weeks of follow-up. The primary endpoint was defined as the percentage change in lipids and hsCRP levels measured from baseline to follow-up, comparing groups of subjects on bempedoic acid versus placebo., Results: Seven eligible trials of bempedoic acid (3892 patients) were included. The bempedoic acid therapy was associated with a significant reduction in LDL-C levels [-20.3% (CI 95% -23.5 to -17.1)]; I 2 =43%]. Similarly, a significant percentage reduction in the apolipoprotein B levels [-14.3% (CI 95% -16.4 to -12.1)]; p<0.05; I 2 =46%], non-HDL-C levels [-15.5% (CI 95% -18.1 to -13.0)]; p<0.05; I 2 =53%] and hsCRP [-23.4% (CI 95% -32.6 to -14.2)]; p<0.05; I 2 =69%] was demonstrated with the bempedoic acid use. The sensitivity analysis showed that the results were robust., Conclusion: Our data suggests that the use of bempedoic acid significantly reduces the levels of all atherogenic lipid markers, including LDL-C, non-HDL-C and apolipoprotein B. Furthermore, considering hsCRP levels, the drug produces an anti-inflammatory effect., (Copyright © 2020 Sociedad Española de Arteriosclerosis. Publicado por Elsevier España, S.L.U. All rights reserved.)

Objective: To evaluate the effect of very low levels of LDL-C (< 55 mg/dl) achieved with lipid-lowering therapy on hemorrhagic stroke incidence., Methods: We performed a meta-analysis including randomized trials that achieved LDL-C levels under 55 mg/dl in more intensive lipid-lowering arms, regardless of the lipid-lowering drug used. A fixed-effects model was used. This meta-analysis was performed according to PRISMA guidelines., Results: Eight eligible trials including 122.802 patients, were identified and considered eligible for the analyses. A total of 62.526 subjects were allocated to receive more intensive lipid-lowering therapy while 60.276 subjects were allocated to the respective control arms. There were no differences in the incidence of hemorrhagic stroke between the group that received a more intensive lipid-lowering therapy (achieved LDL-C level <55 mg/dl), and the group that received a less intense scheme (OR, 1.05; 95%CI, 0.85-1.31). The statistical heterogeneity was low (I 2  = 2%). The sensitivity analysis showed that the results were robust., Conclusions: The use of more intensive lipid-lowering therapy that achieved an LDL-C level lower than 55 mg/dl in patients with high cardiovascular risk, is not associated with an increased risk of hemorrhagic stroke. Considering the cardiovascular benefit and safety observed with the achievement of very low LDL-C values, the challenging lipid goals recommended by the new guidelines seem consistent., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Aims: To evaluate the effect of sodium-glucose cotransporter-2 (SGLT-2) inhibitors and glucagon-like peptide-1 receptor agonists (GLP-1RAs) on major cardiovascular events (MACE) in metformin-naïve patients with type 2 diabetes (T2D)., Methods and Results: A meta-analysis was performed of randomized controlled clinical trials of GLP-1RAs and SGLT-2 inhibitors on T2D populations, after searching the PubMed/MEDLINE, Embase, and Cochrane Controlled Trials databases. The primary endpoint was MACE. The secondary endpoint, explored in the subgroup of SGLT-2 inhibitors studies, was cardiovascular death or hospitalization for heart failure. A random-effects meta-analysis model was applied. Six eligible trials (three studies of SGLT-2 inhibitors and three trials of GLP-1RAs), including 13 049 patients, were identified and considered eligible for the analyses. The new antidiabetic drugs were associated with a significant reduction in MACE [odds ratio (OR): 0.80, 95% confidence interval: 0.70-0.93; I2: 53%]. The subgroup analysis showed the following findings: GLP-1RAs group, OR: 0.77 (95% confidence interval 0.67-0.88); SGLT-2 inhibitors, OR: 0.85 (95% confidence interval 0.63-1.15). SGLT-2 inhibitors were associated with a significant reduction in hospitalization for heart failure or cardiovascular mortality incidence (OR: 0.67, 95% confidence interval: 0.47-0.95; I2: 78%)., Conclusion: In this meta-analysis, new antidiabetic drugs reduced the incidence of MACE in metformin-naïve T2D patients. The beneficial effect was especially observed in the GLP-1RAs subgroup. The use of SGLT-2 inhibitors was associated with a reduction in cardiovascular death or hospitalization for heart failure. These results support the fact that metformin would not be indispensable to obtain positive cardiovascular effects when new antidiabetic drugs are administered., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)

Background and Objective: The paper presents a novel procedure based on 3D scanning and 3D modelling to automatically assess linear and volumetric measurements of an arm and to be further applied to patients affected by post breast cancer lymphedema. The aim is the creation of a virtual platform easily usable by medical personnel to get more objective evaluations during the lymphedema treatment., Methods: The procedure is based on the 3D scanning of the arm using the Occipital Structure Sensor and an ad-hoc developed application, named Lym 3DLab. Lym 3DLab emulates the traditional measurement methods, which consist in taking manual circumference measurements or using the water displacement method. These measurements are also used to design the compression stockings, the typical orthopaedic device used for lymphedema treatment. A validation test has been performed to compare the measurements computed by Lym 3DLab with both water displacement and manual circumference measurements. Eight volunteers have been involved who are not affected by lymphedema. Furthermore, a specific usability test has been performed to evaluate the 3D scanning procedure by involving four physiotherapists., Results: The comparison between the volumes has highlighted how all the 3D acquired models have their volumes inside a range of acceptability. This range has been defined by considering the sensitivity error of the tape measure used to measure the water displacement. The comparison between the perimeters of cross sections computed with Lym 3DLab and the circumference measurements has shown results that are very accurate with an average difference of 2 mm. The measure errors have been considered negligible by the medical personnel who have evaluated the proposed procedure more accurate than the traditional ones. The test with physiotherapists has shown a high level of usability of the whole virtual environment, but the 3D scanning procedure requires an appropriate training of the personnel to make the 3D acquisition as fast and efficient as possible., Conclusions: The achieved results and the physiotherapists' feedback allow planning a future test with patients affected by lymphedema in collaboration with the hospital. A further test has been planned to use the computed measurements to design orthopaedic compression stockings., Competing Interests: Declaration of Competing Interest None., (Copyright © 2020 Elsevier B.V. All rights reserved.)

In physical rehabilitation, motion capture solutions are well-known but not as widespread as they could be. The main limit to their diffusion is not related to cost or usability but to the fact that the data generated when tracking a person must be elaborated according to the specific context and aim. This paper proposes a solution including customized motion capture and data elaboration with the aim of supporting medical personnel in the assessment of spinal cord-injured (SCI) patients using a wheelchair. The configuration of the full-body motion capturing system is based on an asymmetric 3 Microsoft Kinect v2 sensor layout that provides a path of up to 6 m, which is required to properly track the wheelchair. Data elaboration is focused on the automatic recognition of the pushing cycles and on plotting any kinematic parameter that may be interesting in the assessment. Five movements have been considered to evaluate the wheelchair propulsion: the humeral elevation, the horizontal abduction of the humerus, the humeral rotation, the elbow flexion and the trunk extension along the sagittal plane. More than 60 volunteers with a spinal cord injury were enrolled for testing the solution. To evaluate the reliability of the data computed with SCI APPlication (APP) for the pushing cycle analysis, the patients were subdivided in four groups according to the level of the spinal cord injury (i.e., high paraplegia, low paraplegia, C7 tetraplegia and C6 tetraplegia). For each group, the average value and the standard deviation were computed and a comparison with similar acquisitions performed with a high-end solution is shown. The measurements computed by the SCI-APP show a good reliability for analyzing the movements of SCI patients' propulsion wheelchair.

Introduction: Bempedoic acid is a new agent that reduces low-density lipoprotein cholesterol. Since inhibits cholesterol synthesis through a different mechanism than statins, the adverse effects related to it may also be different. Therefore, the objective of the present meta-analysis was to evaluate the effect of bempedoic acid on new onset or worsening diabetes., Methods: We performed a meta-analysis including randomized trials of bempedoic acid therapy, reporting new onset or worsening diabetes with a minimum of 4 weeks of follow-up. The fixed-effects model was performed. This meta-analysis was performed according to PRISMA guidelines., Results: Five eligible trials of bempedoic acid, including 3629 patients, were identified and considered eligible for the analyses. A total of 2419 subjects were allocated to receive bempedoic acid while 1210 subjects were allocated to the respective control arms. Bempedoic acid therapy is associated with a significant reduction in new onset or worsening diabetes [Odds Ratio: 0.66, 95% confidence interval: 0.48-0.90; I2: 0%]., Conclusion: This data suggests that the use of bempedoic acid significantly reduces the new onset or worsening diabetes risk. This finding should be confirmed with future studies., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background: Several studies have investigated the association between non-statin lipid-lowering therapy and regression of atherosclerosis. However, these studies were mostly small and their results were not always robust. The objectives were: (1) to define if a dual lipid-lowering therapy (statin + non-statin drugs) is associated with coronary atherosclerosis regression, estimated by intravascular ultrasound (IVUS); (2) to assess the association between dual lipid-lowering-induced changes in low density lipoprotein cholesterol (LDL-C) and non-high-density-lipoprotein cholesterol (non-HDL-C) levels and atherosclerosis regression., Methods: A meta-analysis including trials of non-statin lipid-lowering therapy, reporting LDL-C, non-HDL-C and total atheroma volume (TAV) with a minimum of 6 months of follow-up was performed. The primary endpoint was defined as the change in TAV measured from baseline to follow-up, comparing groups of subjects on statins alone versus combination of statin and non-statin drugs. The random-effects model and meta-regression were performed., Results: Eight eligible trials of non-statin lipid-lowering drugs (1759 patients) were included. Overall, the dual lipid-lowering therapy was associated with a significant reduction in TAV [- 4.0 mm 3 (CI 95% -5.4 to - 2.6)]; I 2  = 0%]. The findings were similar in the stratified analysis according to the lipid-lowering drug class (ezetimibe or PCSK9 inhibitors). In the meta-regression, a 10% decrease in LDL-C or non-HDL-C levels, was associated, respectively, with 1.0 mm 3 and 1.1 mm 3 regressions in TAV., Conclusion: These data suggests the addition of ezetimibe or PCSK9 inhibitors to statin therapy results in a significant regression of TAV. Reduction of coronary atherosclerosis observed with non-statin lipid-lowering therapy is associated to the degree of LDL-C and non-HDL-C lowering. Therefore, it seems reasonable to achieve lipid goals according to cardiovascular risk and regardless of the lipid-lowering strategy used (statin monotherapy or dual treatment).