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1.
Definition of terms
Under the term non-alcoholic fatty liver disease (NAFLD) both simple hepatic fat accumulation and non-alcoholic steatohepatitis (NASH) are combined. NASH is associated with liver fibrosis, cirrhosis and hepatocellular carcinoma (HCC).Epidemiological importance
In 2020, NAFLD will be the leading cause for liver transplantation in the USA, with rising financial costs for the healthcare system.Comorbidities, diagnosis, and treatment
Type 2 diabetes (T2D) and metabolic syndrome (MetS) are important risk factors for the development of NAFLD, whereby these three diseases share similar pathophysiologic conditions, e.g., insulin resistance, obesity, and metabolic inflammation. Due to the rising number of patients with T2D and MetS, clinicians should aim to diagnose NAFLD early in this patient population and if necessary start treatment.Goal
The aim of this work is to give an overview over the topic of NAFLD and diagnostic approaches in patients with T2D.2.
Norio Akuta Yusuke Kawamura Fumitaka Suzuki Satoshi Saitoh Yasuji Arase Hideo Kunimoto Yushi Sorin Shunichiro Fujiyama Hitomi Sezaki Tetsuya Hosaka Masahiro Kobayashi Yoshiyuki Suzuki Mariko Kobayashi Kenji Ikeda Hiromitsu Kumada 《Hepatology International》2016,10(4):647-656
Background and aim
Relationships between circulating microRNA-122 (miR-122) and histological features of nonalcoholic fatty liver disease (NAFLD) are unclear.Methods
The impact of serum miR-122 levels for histological features and hepatocellular carcinoma (HCC) was investigated in 305 Japanese patients with histological proven NAFLD. Twenty-three patients were with HCC at the time of diagnosis of NAFLD, and four patients developed HCC during the follow-up. The cross-sectional or longitudinal evaluations were performed to investigate the impact for HCC.Results
Serum miR-122 levels (calibrated relative to the median levels of patients) partly affected severity of steatosis, ballooning, lobular inflammation, and stage. Multivariate analysis identified HCC and/or histological components of NASH as morphological factors that independently influenced serum miR-122 levels at the diagnosis of NAFLD. There was a strong correlation between serum miR-122 levels and AST, ALT levels. In cross-sectional evaluation, serum miR-122 levels of patients without HCC were significantly higher than those with HCC in patients of stage 3 but not stage 4. In longitudinal evaluation of one patient with follow-up time of 25 years, from the diagnosis of NAFLD until HCC, serum miR-122 levels had already tended to decrease before the progression of fibrosis stage.Conclusions
HCC and/or histological components of NASH affected serum miR-122 levels, independently. In longitudinal evaluation of HCC patients, serum miR-122 levels had already tended to decrease before the progression of fibrosis stage. Further prospective studies are needed to investigate the impact of serum miR-122 for histological features and hepatocarcinogenesis of NAFLD.3.
Background
The prevalence of nonalcoholic fatty liver disease (NAFLD) continues to increase. An estimated 25?% of the adult population worldwide and more than 50?% of patients with type 2 diabetes or obesity have NAFLD.Objectives
An overview of the natural history and complications of NAFLD is provided.Materials and methods
Following an extensive literature research, the current guidelines, expert opinions and studies focusing on NAFLD were analyzed.Results
The term NAFLD includes the entities nonalcoholic fatty liver (NAFL) and nonalcoholic steatohepatitis (NASH), which are defined by histological parameters. Importantly, “benign” NAFL may progress towards more aggressive NASH with the development of liver fibrosis. The grade of fibrosis is the most important predictor for overall and liver-related mortality in NAFLD patients and patients suffering from type 2 diabetes mellitus have a higher risk for progressive fibrosis. Progressive NAFLD can develop into liver cirrhosis with the potential of fatal complications of portal hypertension and liver failure. Notably, hepatocellular carcinoma may also develop in noncirrhotic NAFLD. Furthermore, NAFLD is an independent risk factor for cardiovascular disease and extrahepatic malignancy, which represent the two most frequent causes of death in NAFLD patients. To date, a lifestyle intervention aiming at weight reduction and increased physical activity is the first-line therapy for NAFLD.Conclusions
NAFLD is one of the most common liver diseases and is associated with relevant hepatic and extrahepatic morbidity and mortality.4.
Background
Administrative databases that include diagnostic codes are valuable sources of information for research purposes.Aim
To validate diagnostic codes for hepatocellular carcinoma (HCC) in chronic hepatitis B patients.Methods
We conducted a retrospective study of patients with chronic HBV seen in the national Veterans Administration (VA). HCC cases were identified by the presence of ICD-9 code 155.0. We randomly selected 200 HBV controls without this code as controls. We manually reviewed the electronic medical record (EMR) of all cases and controls to determine HCC status. We calculated the positive predictive value (PPV), negative predictive value (NPV), sensitivity, and specificity for the HCC code. We conducted an implicit review of the false-positive cases to determine possible reasons for the miscoding.Results
Of the 8350 patients with HBV, 416 had an ICD-9 code for HCC. Of these 416, 332 patients had confirmed HCC and 61 did not; HCC status was indeterminate for 23 patients. Of the 200 controls, none had HCC confirmed in the EMR. The PPV ranged from 85.3 to 80.0% and specificity ranged from 99.2 to 99.0% based on classification of indeterminate cases as true versus false positives, respectively. The NPV, sensitivity, and specificity were 100%. Two-thirds of false-positive cases were diagnosed with HCC prematurely as a workup of liver mass and latter imaging and/or biopsy were not diagnostic for HCC.Conclusion
The diagnostic code of HCC in chronic HBV patients in the VHA data is predictive of the presence of HCC in medical records and can be used for epidemiological and clinical research.5.
6.
Purpose
To determine the predictive value of qSOFA (quick Sequential Organ Failure Assessment) in Malawian patients with suspected infection.Methods
Prospective observational study in a tertiary referral hospital in Malawi.Results
Predictive ability of qSOFA was reasonable [AUROC 0.73 (95% CI 0.68–0.78)], increasing to 0.77 (95% CI 0.72–0.82) when classifying all patients with altered mental status as high risk. Adding HIV status as a variable to the qSOFA score did not improve predictive value.Conclusion
qSOFA is a simple tool that can aid risk stratification in resource-limited settings.7.
Susumu Eguchi Shigehiro Matsumoto Koji Hamasaki Mitsuhisa Takatsuki Masaaki Hidaka Yoshitsugu Tajima Ichiro Sakamoto Takashi Kanematsu 《Journal of hepato-biliary-pancreatic sciences》2008,15(6):627-633
Background/Purpose
While lipiodolized transarterial chemoembolization (lip-TACE) is effective for treating unresectable hepatocellular carcinoma (HCC), its effect for treating recurrent HCC after curative liver resection needs to be clarified.Methods
Of 163 patients who had undergone curative liver resection between 1992 and December 2003, 65 patients (39.8%) had recurrent HCC in the liver without extrahepatic recurrence and were indicated for lip-TACE. The overall survival rate after lip-TACE was calculated, and its correlation with factors such as the histology of the primary HCC and background noncancerous tissue were analyzed.Results
The overall survival rates after lip-TACE after the detection of the first recurrent HCC were 82.6%, 44.5%, and 24.8% at 1, 3, and 5 years, respectively. The factors affecting patient survival after lip-TACE were microscopic portal venous involvement of HCC at liver resection, grade of inflammation in the noncancerous liver parenchyma, and recurrence within 1 year after the initial liver resection. Multivariate analysis showed that the period between the resection and first recurrence had the highest hazard ratio.Conclusions
Lip-TACE is a reasonable procedure for treating recurrent HCC in selected patients who are not eligible for hepatic re-resection. When HCC recurred within 1 year from the primary liver resection, the effect of lip-TACE on patient survival was limited.8.
Winnie Y. Zou Hashem B. El-Serag Yvonne H. Sada Sarah L. Temple Shubhada Sansgiry Fasiha Kanwal Jessica A. Davila 《Digestive diseases and sciences》2018,63(5):1173-1181
Background
Hospice provides integrative palliative care for advance-staged hepatocellular carcinoma (HCC) patients, but hospice utilization in HCC patients in the USA is not clearly understood.Aims
We examined hospice use and subsequent clinical course in advance-staged HCC patients.Methods
We conducted a retrospective study on a national, Veterans Affairs cohort with stage C or D HCC. We evaluated demographics, clinical factors, treatment, and clinical course in relation to hospice use.Results
We identified 814 patients with advanced HCC, of whom 597 (73.3%) used hospice. Oncologist management consistently predicted hospice use, irrespective of HCC treatment [no treatment: OR 2.25 (1.18–4.3), treatment: OR 1.80 (1.10–2.95)]. Among patients who received HCC treatment, hospice users were less likely to have insurance beyond VA benefits (47.2 vs. 60.0%, p = 0.01). Among patients without HCC treatment, hospice users were older (62.2 [17.2] vs. 60.2 [14.0] years, p = 0.05), white (62.1 vs. 52.9%, p = 0.01), resided in the Southern USA (39.5 vs. 31.8%, p = 0.05), and had a performance score ≥ 3 (41.9 vs. 31.8%, p = 0.01). The median time from hospice entry to death or end of study was 1.05 [2.96] months for stage C and 0.53 [1.18] months for stage D patients.Conclusions
26.7% advance-staged HCC patients never entered hospice, representing potential missed opportunities for improving end-of-life care. Age, race, location, performance, insurance, and managing specialty can predict hospice use. Differences in managing specialty and short-term hospice use suggest that interventions to optimize early palliative care are necessary.9.
Huang-Wei Xu Yung-Chien Hsu Chia-Hao Chang Kuo-Liang Wei Chun-Liang Lin 《Hepatology International》2016,10(2):340-346
Background
Growing evidence suggests that non-alcoholic fatty liver disease (NAFLD) is linked to an increased risk for chronic kidney disease (CKD); liver fibrosis with biopsy-proven NAFLD has also been shown to associate with an increased risk of CKD. This study compares the diagnostic performance of simple noninvasive tests in identifying prevalent CKD among individuals with ultrasonography-diagnosed NAFLD.Methods
A total of 755 with ultrasonography-diagnosed NAFLD were included. Estimated glomerular filtration rate and noninvasive markers for hepatic fibrosis: aspartate transaminase to alanine transaminase ratio (AAR), aspartate transaminase to platelet ratio index (APRI), FIB-4 score, NAFLD fibrosis score (NFS) and BARD score were assessed.Results
Binary logistic regression to generate a propensity score and receiver operating characteristic curves were developed for each of the noninvasive markers for predicting CKD, and the area under the receiver operating characteristic curve was greatest for FIB-4 score (0.750), followed by NFS (0.710), AAR (0.594), APRI (0.587), and BARD score (0.561). A cut-off value of 1.100 for FIB-4 score gave a sensitivity of 68.85 % and a specificity of 71.07 % for predicting CKD. The positive predictive value and negative predictive value were 37.50 and 90.05 %, respectively. In multiple logistic regression analysis, only FIB-4 score ≧1.100 (OR 2.660, 95 % CI 1.201–5.889; p = .016), older age, higher diastolic blood pressure and higher uric acid were independent predictors of CKD.Conclusions
High noninvasive fibrosis score is associated with an increased risk of prevalent CKD; the FIB-4 is the better predictor. With a cut-off value of 1.100 for FIB-4, it is useful in excluding the presence of CKD in patients with NAFLD.10.
Jason M. Glanz Komal J. Narwaney Shane R. Mueller Edward M. Gardner Susan L. Calcaterra Stanley Xu Kristin Breslin Ingrid A. Binswanger 《Journal of general internal medicine》2018,33(10):1646-1653
Background
Naloxone is a life-saving opioid antagonist. Chronic pain guidelines recommend that physicians co-prescribe naloxone to patients at high risk for opioid overdose. However, clinical tools to efficiently identify patients who could benefit from naloxone are lacking.Objective
To develop and validate an overdose predictive model which could be used in primary care settings to assess the need for naloxone.Design
Retrospective cohort.Setting
Derivation site was an integrated health system in Colorado; validation site was a safety-net health system in Colorado.Participants
We developed a predictive model in a cohort of 42,828 patients taking chronic opioid therapy and externally validated the model in 10,708 patients.Main Measures
Potential predictors and outcomes (nonfatal pharmaceutical and heroin overdoses) were extracted from electronic health records. Fatal overdose outcomes were identified from state vital records. To match the approximate shelf-life of naloxone, we used Cox proportional hazards regression to model the 2-year risk of overdose. Calibration and discrimination were assessed.Key Results
A five-variable predictive model showed good calibration and discrimination (bootstrap-corrected c-statistic?=?0.73, 95% confidence interval [CI] 0.69–0.78) in the derivation site, with sensitivity of 66.1% and specificity of 66.6%. In the validation site, the model showed good discrimination (c-statistic?=?0.75, 95% CI 0.70–0.80) and less than ideal calibration, with sensitivity and specificity of 82.2% and 49.5%, respectively.Conclusions
Among patients on chronic opioid therapy, the predictive model identified 66–82% of all subsequent opioid overdoses. This model is an efficient screening tool to identify patients who could benefit from naloxone to prevent overdose deaths. Population differences across the two sites limited calibration in the validation site.11.
Narendra S. Choudhary Rajesh Puri Sanjiv Saigal Prashant Bhangui Neeraj Saraf Vinit Shah Mukesh Nasa Haimanti Sarin Mridula Guleria Randhir Sud Arvinder S. Soin 《Indian journal of gastroenterology》2016,35(6):465-468
Background
Diagnosis of metastatic disease is important in patients with cirrhosis and hepatocellular carcinoma (HCC) to prevent futile liver transplantation. Some of these patients have metastatic lymphadenopathy; however, it is difficult to perform percutaneous fine-needle aspiration due to presence of collateral and anatomic location. Endoscopic ultrasound (EUS)-guided fine-needle aspiration (FNA) of lymph nodes offers several advantages like real-time vision, proximity to target, and avoidance of collaterals.Aim
The aim of this study was to look for metastatic lymphadenopathy by EUS-guided FNA (EUS-FNA) in prospective liver transplant recipients with HCC.Methods
A prospective study was conducted from January 2013 to January 2016 at a tertiary care center. All prospective liver transplant recipients with HCC had PET-CT and bone scan to look for metastatic disease. EUS-FNA was done in patients with abdominal or mediastinal lymphadenopathy and no evidence of extrahepatic disease. Data is shown as median (25–75 interquartile range).Results
EUS-guided FNA was done for 50 patients (42 abdominal and 8 mediastinal lymph nodes), age 57 (53–62) years, Child-Turcotte-Pugh 7 (6–9), and model for end-stage liver disease 10 (7–16). FNA material was adequate in 92% patients, metastasis in 15 (30%), granulomatous lymphadenopathy in 4 (8%), and reactive change in 27 patients (54%). The material was inadequate for diagnosis in 4 (8%) patients. Thus, EUS-guided FNA precluded transplantation in 30% of patients with lymphadenopathy, and 4 (8%) patients received anti-tubercular therapy before liver transplantation.Conclusion
In patients with HCC and lymphadenopathy, EUS-guided FNA detected metastatic disease and precluded liver transplantation in approximately one third of patients.12.
Relationship between obstructive sleep apnea and nonalcoholic fatty liver disease in nonobese adults
Jia-Chao Qi Jian-Chai Huang Qi-Chang Lin Jian-Ming Zhao Xin Lin Li-Da Chen Jie-Feng Huang Xiao Chen 《Sleep & breathing》2016,20(2):529-535
Purpose
Obstructive sleep apnea (OSA) is closely related to nonalcoholic fatty liver disease (NAFLD), though the mechanism is not conclusive as obesity is a confounder. The objective of this observational study was to investigate the correlation between these disorders in nonobese subjects.Methods
We consecutively enrolled nonobese individuals undergoing polysomnography and abdominal ultrasonography and analyzed differences in NAFLD patients grouped by the apnea–hypopnea index (AHI) and in OSA patients according to the presence or absence of NAFLD. Multivariate regression analysis was used to evaluate the independent risks of NAFLD in OSA patients.Results
A total of 175 participants were included. The 106 ultrasound-diagnosed NAFLD patients were classified into four groups by AHI. There were no significant differences in triglycerides (TG), serum aminotransferase levels of alanine aminotransferase and aspartate aminotransferase, high-sensitivity C-reactive protein, and homeostasis model assessment of insulin resistance (HOMA-IR) with worsening OSA. In both OSA patients with NAFLD and those without NAFLD, body mass index (BMI), the lowest oxygen saturation (LaSO2), HOMA-IR, and TG were significantly associated. Additionally, BMI, LaSO2, and TG independently predicted the development of NAFLD after adjustments (odds ratio [OR]?=?1.562, p?=?0.003; OR?=?0.960, p?=?0.03; OR?=?3.410, p?<?0.001, respectively).Conclusions
In nonobese subjects, OSA itself does not appear to induce significant changes in liver enzymes. With reference to lipid metabolism, weight control and OSA-related hypoxemia are key factors in reducing the risk of NAFLD in OSA patients. Additional large-scale, prospective studies are warranted to investigate the impact of OSA on liver injury in nonobese adults.13.
Purpose of Review
Liver-directed SABR (stereotactic ablative body radiotherapy) is emerging as an effective local therapy option for HCC (hepatocellular carcinoma). This review summarizes recent clinical progresses and proposes future directions.Recent Findings
SABR is an effective and safe, non-invasive local therapy option for HCC in the primary and salvage treatment settings, as well as a bridge to liver transplantation in selected patients. Randomized trials comparing SABR with other locoregional modalities are currently ongoing.Summary
Research efforts are being made toward better predicting normal tissue toxicity and tumor radiosensitivity for a tailored maximal safe treatment in HCC SABR. More recently, potential synergy with immunotherapies is of increasing interest in HCC.14.
Joseph J. Gallo Seungyoung Hwang Jin Hui Joo Hillary R. Bogner Knashawn H. Morales Martha L. Bruce Charles F. ReynoldsIII 《Journal of general internal medicine》2016,31(4):380-386
Background
Two-thirds of older adults have two or more medical conditions that often take precedence over depression in primary care.Objective
We evaluated whether evidence-based depression care management would improve the long-term mortality risk among older adults with increasing levels of medical comorbidity.Design
Longitudinal analyses of the practice-randomized Prevention of Suicide in Primary Care Elderly: Collaborative Trial (PROSPECT). Twenty primary care practices randomized to intervention or usual care.Patients
The sample included 1204 older primary care patients completing the Charlson Comorbidity Index (CCI) and other interview questions at baseline.Intervention
For 2 years, a depression care manager worked with primary care physicians to provide algorithm-based care for depression, offering psychotherapy, increasing the antidepressant dose if indicated, and monitoring symptoms, medication adverse effects, and treatment adherence.Main Measures
Depression status based on clinical interview, CCI to evaluate medical comorbidity, and vital status at 8 years (National Death Index).Key Results
In the usual care condition, patients with the highest levels of medical comorbidity and depression were at increased risk of mortality over the course of the follow-up compared to depressed patients with minimal medical comorbidity [hazard ratio 3.02 (95 % CI, 1.32 to 8.72)]. In contrast, in intervention practices, patients with the highest level of medical comorbidity and depression compared to depressed patients with minimal medical comorbidity were not at significantly increased risk [hazard ratio 1.73 (95 % CI, 0.86 to 3.96)]. Nondepressed patients in intervention and usual care practices had similar mortality risk.Conclusions
Depression management mitigated the combined effect of multimorbidity and depression on mortality. Depression management should be integral to optimal patient care, not a secondary focus.15.
Shahinul Alam Mohammad Shaiful Islam Saiful Islam Golam Mustafa Ahmed Abu Saleh Nooruddin Ahmad 《Indian journal of gastroenterology》2017,36(5):366-372
Background/Purpose
The aim of this study was to determine the association of single nucleotide polymorphism (SNP) in patatin-like phospholipase domain-containing 3 (PNPLA3) at I148 with histological severity of non-alcoholic fatty liver disease (NAFLD).Methods
Patients were selected for the study if they had histological evidence of NAFLD and clinical evidence of non-alcoholic steatohepatits (NASH) cirrhosis. We included 50 NASH cirrhosis, 99 patients of NAFLD including 36 non-NASH fatty liver (NNFL) along with 63 NASH and 75 healthy controls. PNPLA3 genotyping was done by real-time PCR using a Taqman assay for rs738409.Results
CC, CG, and GG frequencies were 45 (60.0%)/27 (36.0%)/3 (4.0%) in healthy control, 19 (52.8%)/14 (38.9%)/ 3 (8.3%) in NNFL, 18 (28.6%)/29 (46.0%)/16 (25.4%) in NASH, and 7 (14.6%), 25 (52.1%), 16 (33.3%) in cirrhosis. The frequency of G allele was significantly higher (62.6%) in NAFLD than in healthy control. The GG genotype had 20.25 times odds of NAFLD. The GG genotype had 6.53 times odds of having NASH. HOMA-IR > 1.6 had 3.81 times odds of having NASH. Regression analysis revealed that G allele odds of having cirrhosis was 3.9 times compared to C. The G allele was also significantly associated with steatosis, lobular inflammation, NAFLD activity score, and fibrosis.Conclusion
PNPLA3 genotype showed an association with NAFLD, NASH, fibrosis, and cirrhosis.16.
Zhang Wei Zhu Li-Qun Huo Xiao-Ling Qin Jian Yuan Guo-Yue 《Hepatology International》2016,10(3):511-517
Purpose
To investigate the association between the single nucleotide polymorphisms (SNPs) of the adiponectin gene and nonalcoholic fatty liver disease (NAFLD) as well as the impact of the interaction of multiple SNPs on NAFLD risk, based on a Chinese population study.Methods
A total of 612 subjects (411 male, 201 female) were selected, including 302 NAFLD patients and 310 controls. Three SNPs were selected for genotyping in the case-control study: rs266729, rs822393, and rs1501299. A logistic regression model was used to examine the interaction between the SNPs and NAFLD. The odds ratio (OR) and 95 % confidence interval (95 % CI) were calculated. Generalized multifactor dimensionality reduction (GMDR) was employed to analyze the interaction among SNPs.Results
Logistic analysis showed a significant association between genotypes of variants in rs266729 and rs822393 and increased NAFLD risk. The carriers of the homozygous mutant of two SNP polymorphisms revealed increased NAFLD risk compared to those with wild-type homozygotes; ORs (95 % CI) were 1.31 (1.14–1.81) (p = 0.001) and 1.18 (1.05–1.71) (p = 0.005), respectively. There was a significant two-locus model (p = 0.0010) involving rs266729 and rs822393, indicating a potential gene-gene interaction between rs266729 and rs822393. Overall, the two-locus models had a cross-validation consistency of 10 and testing accuracy of 62.17 %. Subjects with the CG or GG and CT or TT genotype have the highest NAFLD risk compared to subjects with the CC-CC genotype; the OR (95 % CI) was 2.52 (1.31–3.82), p < 0.001, after covariate adjustment.Conclusions
Our results support an important association of the rs266729 (?11377 G/C) and rs822393 (?4522 C/T) polymorphism with increased risk of NAFLD. The interaction analysis showed a combined effect of rs266729 and rs822393 on NAFLD.17.
Shin E Ryu HS Kim SH Jung H Jang JJ Lee K 《Journal of hepato-biliary-pancreatic sciences》2011,18(4):544-550
Background/purpose
Heat shock protein 70 (HSP70) and glutamine synthetase (GS) have been proposed to be promising markers for the differentiation of malignant and benign hepatocellular lesions. The aim of this study was to investigate the clinicopathological significance of the expression of HSP70 and GS in surgically resected hepatocellular carcinoma (HCC).Methods
The authors collected 412 HCC samples and 120 non-neoplastic hepatic tissue samples and performed an immunohistochemical study.Results
HSP70 staining was observed in 282 of 392 HCC samples (71.9%), and GS immunoreactivity was observed in 212 of 395 HCC cases (53.7%). Of the several clinicopathological parameters examined, microscopic vascular invasion, a large tumor size, and a high Edmonson–Steiner grade were found to be correlated with positive staining for HSP70 (P = 0.032, 0.002, and 0.012, respectively). Survival analysis showed a correlation between HSP70 expression and disease-free survival. GS was not found to be related to clinicopathological parameters.Conclusions
The findings of the present study suggest that HSP70 be viewed as a predictor of prognosis as well as a useful diagnostic marker for HCC.18.
Purpose/introduction
Growing evidence suggests complex interplay between nonalcoholic fatty liver disease (NAFLD) and bone health. The present study’s aim was to examine the impact of metformin treatment on circulating osteoprotegerin (OPG) in patients with NAFLD, a population in which this relationship has not yet been studied.Methods
In a randomized, placebo-controlled study, 63 patients with NAFLD were assigned to one of two groups: Group 1 received daily metformin; Group 2 received a placebo. Metabolic parameters, insulin resistance markers and OPG levels were examined at baseline and at the end of the study.Results
In the placebo group, liver function and OPG levels did not change during the study. Among metformin-treated patients, significant declines in OPG and alkaline phosphatase were observed. CRP and ALT decreased marginally during the 4-month treatment period. While at baseline circulating OPG levels did not differ significantly between the groups, by the end of the study OPG was significantly lower in patients treated with metformin than in the placebo group (p < 0.0001). Delta OPG was significantly greater in the metformin group than the placebo group (p = 0.001). In the general linear model, metformin treatment was the only significant independent predictor of endpoint and delta OPG.Conclusions
Metformin treatment was associated with a significant decrease in OPG levels in patients with NAFLD. The effect on OPG was associated with exposure to metformin per se.Clinical trial registration number
NCT01084486.19.
Jeffrey M. Ashburner Steven J. Atlas Shaan Khurshid Lu-Chen Weng Olivia L. Hulme Yuchiao Chang Daniel E. Singer Patrick T. Ellinor Steven A. Lubitz 《Journal of general internal medicine》2018,33(12):2070-2077
Background
Oral anticoagulants reduce the risk of stroke in patients with atrial fibrillation. However, many patients with atrial fibrillation at elevated stroke risk are not treated with oral anticoagulants.Objective
To test whether electronic notifications sent to primary care physicians increase the proportion of ambulatory patients prescribed oral anticoagulants.Design
Randomized controlled trial conducted from February to May 2017 within 18 practices in an academic primary care network.Participants
Primary care physicians (n?=?175) and their patients with atrial fibrillation, at elevated stroke risk, and not prescribed oral anticoagulants.Intervention
Patients of each physician were randomized to the notification or usual care arm. Physicians received baseline email notifications and up to three reminders with patient information, educational material and primary care guidelines for anticoagulation management, and surveys in the notification arm.Main Measures
The primary outcome was the proportion of patients prescribed oral anticoagulants at 3 months in the notification (n?=?972) vs. usual care (n?=?1364) arms, compared using logistic regression with clustering by physician. Secondary measures included survey-based physician assessment of reasons why patients were not prescribed oral anticoagulants and how primary care physicians might be influenced by the notification.Key Results
Over 3 months, a small proportion of patients were newly prescribed oral anticoagulants with no significant difference in the notification (3.9%, 95% CI 2.8–5.3%) and usual care (3.2%, 95% CI 2.4–4.2%) arms (p?=?0.37). The most common, non-exclusive reasons why patients were not on oral anticoagulants included atrial fibrillation was transient (30%) or paroxysmal (12%), patient/family declined (22%), high bleeding risk (20%), fall risk (19%), and frailty (10%). For 95% of patients, physicians stated they would not change their management after reviewing the alert.Conclusions
Electronic physician notification did not increase anticoagulation in patients with atrial fibrillation at elevated stroke risk. Primary care physicians did not prescribe anticoagulants because they perceived the bleeding risk was too high or stroke risk was too low.Trial Registration
ClinicalTrials.gov identifier NCT0295028520.
M. G. Pramateftakis P. Hatzigianni D. Kanellos G. Vrakas Th. Tsachalis I. Mantzoros I. Kanellos C. Lazaridis 《Techniques in coloproctology》2010,14(1):63-64