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Cardiometabolic and Mental Health in Women With Early Gestational Diabetes Mellitus: A Prospective Cohort Study.
Quansah, DY, Gross, J, Gilbert, L, Pauchet, A, Horsch, A, Benhalima, K, Cosson, E, Puder, JJ
The Journal of clinical endocrinology and metabolism. 2022;(3):e996-e1008
Abstract
CONTEXT Early diagnosis and treatment of gestational diabetes (GDM) may reduce adverse obstetric and neonatal outcomes, especially in high-risk women. However, there is a lack of data for other outcomes. OBJECTIVE We compared cardiometabolic and mental health outcomes in women with early (eGDM) and classical (cGDM) GDM. METHODS This prospective cohort included 1185 All women with cGDM and 76 women with eGDM. The eGDM group had GDM risk factors (BMI >30 kg/m2, family history of diabetes, history of GDM, ethnicity), were tested at <20 weeks gestational age, and diagnosed using American Diabetes Association prediabetes criteria. All women underwent lifestyle adaptations. Obstetric, neonatal, mental, and cardiometabolic outcomes were assessed during pregnancy and postpartum. RESULTS The eGDM group had lower gestational weight gain than cGDM (10.7 ± 6.2 vs 12.6 ± 6.4; P = 0.03) but needed more medical treatment (66% vs 42%; P < 0.001). They had similar rates of adverse maternal and neonatal outcomes, except for increased large-for-gestational-age infants (25% vs 15%; P = 0.02). Mental health during pregnancy and postpartum did not differ between groups. eGDM had more atherogenic postpartum lipid profile than cGDM (P ≤ 0.001). In eGDM, the postpartum prevalence of the metabolic syndrome (MetS) was 1.8-fold, prediabetes was 3.1-fold, and diabetes was 7.4-fold higher than cGDM (waist circumference-based MetS: 62% vs 34%/BMI-based MetS: 46% vs 24%; prediabetes: 47.5% vs 15.3%; diabetes: 11.9% vs 1.6%, all P < 0.001). These differences remained unchanged after adjusting for GDM risk factors. CONCLUSION Compared with cGDM, eGDM was not associated with differences in mental health, but with increased adverse cardiometabolic outcomes, independent of GDM risk factors and gestational weight gain. This hints to a preexisting risk profile in eGDM.
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Berberine and lycopene as alternative or add-on therapy to metformin and statins, a review.
Hedayati, N, Oskouei, Z, Tabeshpour, J, Naeini, MB
European journal of pharmacology. 2021;:174590
Abstract
Nutraceuticals are principally extracted from natural products that are frequently safe and well-tolerated. Lycopene and berberine are natural plants with a wide range of beneficial effects including protective activities against metabolic disorders such as diabetes and cardiovascular diseases. These compounds might be considered technically more as a drug than a nutraceutical and could be prescribed as a product. However, further studies are needed to understand if these supplements could affect metabolic syndrome outcomes. Even if nutraceuticals exert a prophylactic activity within the body, their bioactivity and bioavailability have high interindividual variation, and precise assessment of biological function of these bioactive compounds in randomized clinical trials is critical. However, these reports must be interpreted with more considerations due to the low quality of the trials. The aim of this paper is to bring evidence about the management of cardiovascular diseases and diabetes through the use of nutraceuticals with particular attention to lycopene and berberine effectiveness.
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Efficacy and Safety of PCSK9 Inhibition With Evolocumab in Reducing Cardiovascular Events in Patients With Metabolic Syndrome Receiving Statin Therapy: Secondary Analysis From the FOURIER Randomized Clinical Trial.
Deedwania, P, Murphy, SA, Scheen, A, Badariene, J, Pineda, AL, Honarpour, N, Keech, AC, Sever, PS, Pedersen, TR, Sabatine, MS, et al
JAMA cardiology. 2021;(2):139-147
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Abstract
IMPORTANCE The PCSK9 inhibitor evolocumab reduced low-density lipoprotein cholesterol and cardiovascular events in the FOURIER randomized clinical trial. Patients with metabolic syndrome (MetS) are at increased cardiovascular risk. OBJECTIVE To investigate outcomes with evolocumab in patients with and without MetS. DESIGN, SETTING, AND PARTICIPANTS The FOURIER trial randomized patients worldwide with stable atherosclerotic cardiovascular disease receiving statin to evolocumab vs placebo with follow-up for a median of 2.2 years. Data were collected February 2013 to November 2016. For this prespecified analysis, patients with the requisite data were stratified based on the National Cholesterol Education Program Adult Treatment Panel III MetS criteria; in secondary analyses, patients were further substratified by diabetes at baseline. Analysis was intention to treat. Analysis began March 2018 and ended April 2020. INTERVENTIONS Patients were randomized to evolocumab or placebo. MAIN OUTCOMES AND MEASURES The primary end point was cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary end point was cardiovascular death, myocardial infarction, or stroke. RESULTS Of 27 342 patients (mean [SD] age, 63 [9] years; 20 623 men [75.4%]) included in this analysis, 16 361 (59.8%) with baseline MetS were, when compared with patients without MetS, at higher risk of cardiovascular events (adjusted hazard ratio [95% CI], 1.31 [1.18-1.46]; P < .001 for the primary and 1.38 [1.20-1.57]; P < .001 for the key secondary end point). Evolocumab reduced low-density lipoprotein cholesterol similarly in patients with MetS (median [interquartile range], 92 [79-109] mg/dL vs 30 [19-48] mg/dL; P < .001) and without MetS (median [interquartile range], 92 [81-108] mg/dL vs 29 [18-44] mg/dl; P < .001). For the primary end point, the hazard ratios (95% CI) with evolocumab vs placebo were 0.83 (0.76-0.91) and 0.89 (0.79-1.01) in patients with and without MetS (P for interaction = .39). For the key secondary end point, the corresponding hazard ratios (95% CIs) were 0.76 (0.68-0.86) and 0.86 (0.74-1.01) (P for interaction = .23), respectively. Evolocumab did not increase the risk of new-onset diabetes or other major safety outcomes including worsening glycemic control, compared with placebo in patients with MetS. CONCLUSIONS AND RELEVANCE Patients with atherosclerotic cardiovascular disease and MetS have substantial residual risk of cardiovascular events despite statin therapy. Evolocumab significantly reduced low-density lipoprotein cholesterol and cardiovascular risk in patients with MetS without increasing new-onset diabetes, worsening glycemic control, or other major safety events. These data suggest the addition of evolocumab to statin therapy in patients with atherosclerotic cardiovascular disease and MetS is safe and efficacious to reduce residual cardiovascular risk. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT01764633.
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Exercise capacity, cardiovascular and metabolic risk of the sample of German police officers in a descriptive international comparison.
Strauss, M, Foshag, P, Jehn, U, Vollenberg, R, Brzęk, A, Leischik, R
International journal of medical sciences. 2021;(13):2767-2775
Abstract
Background: The police force has the mandate to protect citizens and enforce the law for public safety. Employment in the police force is recognized as a dangerous occupation and characterized by job-related physical hazards. Therefore, good health and adequate physical condition are necessary. This study aimed to determine cardiovascular, cardiorespiratory, and metabolic risk parameters of German police officers (POs) in comparison to POs from other nations. Methods: 55 male police officers from Germany participated in the survey. We examined anthropometric measurements, cardiovascular/metabolic risk factors and blood parameters. Additionally, we calculated 10-year cardiovascular risk using the Framingham Risk Score. The diagnosis of metabolic syndrome bases on the criteria of the International Diabetes Federation. We assessed cardiorespiratory status by exercise spirometry. Results: The analyzed group of POs demonstrated a high prevalence of pre obesity (BMI: 28.0±3.2 kg/m², waist circumference: 97.8±12.4 cm). 61.8 % of POs showed an increased waist circumference. POs showed high prevalence of abnormal values of triglyceride (n: 24, 43,6%), and systolic (n: 29, 52,7%) and diastolic (n: 27, 49%) blood pressure. The average 10-year cardiovascular risk (by Framingham) was classified as moderate (9.6 ± 7.4 %). 32 % (n: 18) of POs in our study group were diagnosed with metabolic syndrome. Maximal relative oxygen uptake of POs was 34.1 ± 8.0 ·ml/kg-1 ·min-1. Conclusions: To our knowledge, this study was one of the first to assess data on cardiovascular health, metabolic syndrome and cardiorespiratory status of police officers in Germany. The results of our study demonstrated an increased cardiovascular and metabolic risk and decreased cardiorespiratory fitness in German police officers. The present study results underline the need to implement health-promoting interventions and concepts like corporate sports activities or nutrition courses to counteract cardiovascular and metabolic risk factors. We have to reduce the subsequent development of cardiovascular and metabolic disease in this occupational group.
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Associations of body composition and physical fitness with gestational diabetes and cardiovascular health in pregnancy: Results from the HealthyMoms trial.
Henriksson, P, Sandborg, J, Söderström, E, Leppänen, MH, Snekkenes, V, Blomberg, M, Ortega, FB, Löf, M
Nutrition & diabetes. 2021;(1):16
Abstract
The aim of this study was to examine associations of body composition (fat mass index, % fat mass, fat-free mass index, body mass index) and physical fitness (cardiorespiratory fitness and handgrip strength) with gestational diabetes and cardiovascular health in early pregnancy. This cross-sectional study utilized baseline data (n = 303) collected in early pregnancy from the HealthyMoms trial. Body composition was measured using air-displacement plethysmography, cardiorespiratory fitness was assessed by means of the 6-min walk test and handgrip strength using a dynamometer. Logistic regression was used to estimate odds ratios (ORs) for gestational diabetes as well as high (defined as 1 SD above the mean) blood pressure, homeostatic model assessment for insulin resistance (HOMA-IR), and metabolic syndrome score (MetS score) per 1 SD increase in body composition and fitness variables. Fat mass index, % fat mass and body mass index were all strongly associated with gestational diabetes (ORs: 1.72-2.14, P ≤ 0.003), HOMA-IR (ORs: 3.01-3.80, P < 0.001), blood pressure (ORs: 1.81-2.05, P < 0.001) and MetS score (ORs: 3.29-3.71, P < 0.001). Associations with fat-free mass index were considerably weaker (ORs: 1.26-1.82, P = 0.001-0.15) and were strongly attenuated after adjustments for fat mass index (ORs: 0.88-1.54, P = 0.039-0.68). Finally, greater cardiorespiratory fitness was associated with lower risk of high HOMA-IR and MetS score (ORs: 0.57-0.63, P ≤ 0.004) although these associations were attenuated when accounting for fat mass index (ORs: 1.08-1.11, P ≥ 0.61). In conclusion, accurately measured fat mass index or % fat mass were strongly associated with gestational diabetes risk and markers of cardiovascular health although associations were not stronger than the corresponding ones for body mass index. Fat-free mass index had only weak associations with gestational diabetes and cardiovascular health which support that the focus during clinical care would be on excess fat mass and not fat-free mass.
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Muscular strength and cardiovascular risk factors in adults: a systematic review.
De Lima, TR, Martins, PC, Guerra, PH, Santos Silva, DA
The Physician and sportsmedicine. 2021;(1):18-30
Abstract
OBJECTIVE The purpose of this study was to identify and summarize the relationships between MS and individual components of metabolic syndrome (MetS) [high waist circumference (WC), high blood pressure (BP), high systolic blood pressure (SBP), high diastolic blood pressure (DBP), high triglycerides (TG), fasting blood glucose (GL) and low HDL cholesterol levels (HDL-C)] in adults. METHODS A systematic review was performed on six electronic databases (Lilacs, Pubmed, Scielo, Scopus, Sportdiscus, and Web of Knowledge), with complimentary searches in reference lists. The databases were investigated without restrictions regarding the period of publication. RESULTS Of the 6,833 articles initially identified, 17 were included, with data on 43,343 adults. Higher MS values were associated with lower WC values. Different results in relation to the association between MS and BP, MS and SBP, and MS and DBP were verified. In addition, inconclusive results were verified in the relationship between MS and TG, MS and HDL-C, and MS and GL. CONCLUSION Higher MS values were related with lower WC in adults. More evidence from longitudinal studies with high methodological rigor is needed to elucidate the relationship between MS and CVD among adults.
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The Effect of Gum Arabic (Acacia Senegal) on Cardiovascular Risk Factors and Gastrointestinal Symptoms in Adults at Risk of Metabolic Syndrome: A Randomized Clinical Trial.
Jarrar, AH, Stojanovska, L, Apostolopoulos, V, Feehan, J, Bataineh, MF, Ismail, LC, Al Dhaheri, AS
Nutrients. 2021;(1)
Abstract
Gum Arabic (GA) is a widely-used additive in food processing, but is also historically used in a number of traditional therapies. It has been shown to have a broad range of health benefits, particularly in improving important cardiovascular risk indicators. Metabolic syndrome and its associated cardiac outcomes are a significant burden on modern healthcare systems, and complementary interventions to aid in its management are required. We aimed to examine the effect of GA on those with, or at risk of, metabolic syndrome to identify an effect on improving important disease parameters related to cardiovascular outcomes. A single-blind, randomized, placebo-controlled trial was conducted to identify the effects of daily GA supplementation on metabolic and cardiovascular risk factors. A total of 80 participants were randomized to receive 20 g of GA daily (n = 40) or placebo (1 g pectin, n = 40) for 12 weeks. Key endpoints included body-anthropometric indices, diet and physical activity assessment, and blood chemistry (HbA1c, fasting glucose, and blood lipids). Of the 80 enrolled, 61 completed the study (intervention: 31, control: 30) with 19 dropping out due to poor treatment compliance. After 12 weeks, the participants receiving the GA showed significant decreases in systolic and diastolic blood pressure, fat-free body mass, energy and carbohydrate consumption, and fasting plasma glucose, as well as increased intake of dietary fiber. They also reported improvements in self-perceived bloating and quality of bowel movements, as well as a decreased appetite score following GA consumption. These results suggest that GA could be a safe and beneficial adjunct to other treatments for those with, or at risk of, metabolic syndrome.
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The Type and Amount of Dietary Fat Affect Plasma Factor VIIc, Fibrinogen, and PAI-1 in Healthy Individuals and Individuals at High Cardiovascular Disease Risk: 2 Randomized Controlled Trials.
Kris-Etherton, PM, Stewart, PW, Ginsberg, HN, Tracy, RP, Lefevre, M, Elmer, PJ, Berglund, L, Ershow, AG, Pearson, TA, Ramakrishnan, R, et al
The Journal of nutrition. 2020;(8):2089-2100
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Abstract
BACKGROUND Factor VIIc, fibrinogen, and plasminogen activator inhibitor 1 (PAI-1) are cardiovascular disease (CVD) risk factors and are modulated, in part, by fat type and amount. OBJECTIVE We evaluated fat type and amount on the primary outcomes: factor VIIc, fibrinogen, and PAI-1. METHODS In the Dietary Effects on Lipoproteins and Thrombogenic Activity (DELTA) Trial, 2 controlled crossover feeding studies evaluated substituting carbohydrate or MUFAs for SFAs. Study 1: healthy participants (n = 103) were provided with (8 wk) an average American diet [AAD; designed to provide 37% of energy (%E) as fat, 16% SFA], a Step 1 diet (30%E fat, 9% SFA), and a diet low in SFA (Low-Sat; 26%E fat, 5% SFA). Study 2: participants (n = 85) at risk for CVD and metabolic syndrome (MetSyn) were provided with (7 wk) an AAD, a step 1 diet, and a high-MUFA diet (designed to provide 37%E fat, 8% SFA, 22% MUFA). RESULTS Study 1: compared with AAD, the Step 1 and Low-Sat diets decreased mean factor VIIc by 1.8% and 2.6% (overall P = 0.0001), increased mean fibrinogen by 1.2% and 2.8% (P = 0.0141), and increased mean square root PAI-1 by 0.0% and 6.0% (P = 0.0037), respectively. Study 2: compared with AAD, the Step 1 and high-MUFA diets decreased mean factor VIIc by 4.1% and 3.2% (overall P < 0.0001), increased mean fibrinogen by 3.9% and 1.5% (P = 0.0083), and increased mean square-root PAI-1 by 2.0% and 5.8% (P = 0.1319), respectively. CONCLUSIONS Replacing SFA with carbohydrate decreased factor VIIc and increased fibrinogen in healthy and metabolically unhealthy individuals and also increased PAI-1 in healthy subjects. Replacing SFA with MUFA decreased factor VIIc and increased fibrinogen but less than carbohydrate. Our results indicate an uncertain effect of replacing SFA with carbohydrate or MUFA on cardiometabolic risk because of small changes in hemostatic factors and directionally different responses to decreasing SFA. This trial was registered at https://clinicaltrials.gov/ct2/show/NCT00000538?term=NCT00000538&rank=1 as NCT00000538.
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Cardiometabolic health in offspring of women with PCOS compared to healthy controls: a systematic review and individual participant data meta-analysis.
Gunning, MN, Sir Petermann, T, Crisosto, N, van Rijn, BB, de Wilde, MA, Christ, JP, Uiterwaal, CSPM, de Jager, W, Eijkemans, MJC, Kunselman, AR, et al
Human reproduction update. 2020;(1):103-117
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Abstract
BACKGROUND Women diagnosed with polycystic ovary syndrome (PCOS) suffer from an unfavorable cardiometabolic risk profile, which is already established by child-bearing age. OBJECTIVE AND RATIONALE The aim of this systematic review along with an individual participant data meta-analysis is to evaluate whether cardiometabolic features in the offspring (females and males aged 1-18 years) of women with PCOS (OPCOS) are less favorable compared to the offspring of healthy controls. SEARCH METHODS PubMed, Embase and gray literature databases were searched by three authors independently (M.N.G., M.A.W and J.C.) (last updated on 1 February 2018). Relevant key terms such as 'offspring' and 'PCOS' were combined. Outcomes were age-specific standardized scores of various cardiometabolic parameters: BMI, blood pressure, glucose, insulin, lipid profile and the sum scores of various cardiometabolic features (metabolic sum score). Linear mixed models were used for analyses with standardized beta (β) as outcome. OUTCOMES Nine relevant observational studies could be identified, which jointly included 1367 children: OPCOS and controls, originating from the Netherlands, Chile and the USA. After excluding neonates, duplicate records and follow-up screenings, a total of 885 subjects remained. In adjusted analyses, we observed that OPCOS (n = 298) exhibited increased plasma levels of fasting insulin (β = 0.21(95%CI: 0.01-0.41), P = 0.05), insulin-resistance (β = 0.21(95%CI: 0.01-0.42), P = 0.04), triglycerides (β = 0.19(95%CI: 0.02-0.36), P = 0.03) and high-density lipoprotein (HDL)-cholesterol concentrations (β = 0.31(95%CI: 0.08-0.54), P < 0.01), but a reduced birthweight (β = -116(95%CI: -195 to 38), P < 0.01) compared to controls (n = 587). After correction for multiple testing, however, differences in insulin and triglycerides lost their statistical significance. Interaction tests for sex revealed differences between males and females when comparing OPCOS versus controls. A higher 2-hour fasting insulin was observed among female OPCOS versus female controls (estimated difference for females (βf) = 0.45(95%CI: 0.07 to 0.83)) compared to the estimated difference between males ((βm) = -0.20(95%CI: -0.58 to 0.19)), with interaction-test: P = 0.03. Low-density lipoprotein-cholesterol differences in OPCOS versus controls were lower among females (βf = -0.39(95%CI: -0.62 to 0.16)), but comparable between male OPCOS and male controls (βm = 0.27(95%CI: -0.03 to 0.57)), with interaction-test: P < 0.01. Total cholesterol differences in OPCOS versus controls were also lower in females compared to the difference in male OPCOS and male controls (βf = -0.31(95%CI: -0.57 to 0.06), βm = 0.28(95%CI: -0.01 to 0.56), interaction-test: P = 0.01). The difference in HDL-cholesterol among female OPCOS versus controls (βf = 0.53(95%CI: 0.18-0.88)) was larger compared to the estimated mean difference among OPCOS males and the male controls (βm = 0.13(95%CI: -0.05-0.31), interaction-test: P < 0.01). Interaction test in metabolic sum score revealed a significant difference between females (OPCOS versus controls) and males (OPCOS versus controls); however, sub analyses performed in both sexes separately did not reveal a difference among females (OPCOS versus controls: βf = -0.14(95%CI: -1.05 to 0.77)) or males (OPCOS versus controls: βm = 0.85(95%CI: -0.10 to 1.79)), with P-value < 0.01. WIDER IMPLICATIONS We observed subtle signs of altered cardiometabolic health in OPCOS. Therefore, the unfavorable cardiovascular profile of women with PCOS at childbearing age may-next to a genetic predisposition-influence the health of their offspring. Sensitivity analyses revealed that these differences were predominantly observed among female offspring aged between 1 and 18 years. Moreover, studies with minimal risk of bias should elucidate the influence of a PCOS diagnosis in mothers on both sexes during fetal development and subsequently during childhood.
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Adverse Effects of Low-Dose Methotrexate: A Randomized Trial.
Solomon, DH, Glynn, RJ, Karlson, EW, Lu, F, Corrigan, C, Colls, J, Xu, C, MacFadyen, J, Barbhaiya, M, Berliner, N, et al
Annals of internal medicine. 2020;(6):369-380
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Abstract
BACKGROUND Low-dose methotrexate (LD-MTX) is the most commonly used drug for systemic rheumatic diseases worldwide and is the recommended first-line agent for rheumatoid arthritis. Despite extensive clinical use for more than 30 years, few data on adverse event (AE) rates derive from randomized, placebo-controlled trials, where both causality and magnitude of risk can be inferred. OBJECTIVE To investigate AE rates, risk, and risk differences comparing LD-MTX versus placebo. DESIGN Prespecified secondary analyses of a double-blind, placebo-controlled, randomized trial. (ClinicalTrials.gov: NCT01594333). SETTING North America. PARTICIPANTS Adults with known cardiovascular disease and diabetes or metabolic syndrome. INTERVENTION Random allocation to LD-MTX (≤20 mg/wk) or placebo. All participants received folic acid, 1 mg/d, 6 days per week. MEASUREMENTS Risks for specific AEs of interest, as well as for all AEs, were compared across treatment groups after blinded adjudication. RESULTS After an active run-in period, 6158 patients were enrolled and 4786 randomly assigned to a group; median follow-up was 23 months and median dosage 15 mg/wk. Among the randomly assigned participants, 81.2% were male, median age was 65.7 years, and median body mass index was 31.5 kg/m2. Of 2391 participants assigned to LD-MTX, 2080 (87.0%) had an AE of interest, compared with 1951 of 2395 (81.5%) assigned to placebo (hazard ratio [HR], 1.17 [95% CI, 1.10 to 1.25]). The relative hazards of gastrointestinal (HR, 1.91 [CI, 1.75 to 2.10]), pulmonary (HR, 1.52 [CI, 1.16 to 1.98]), infectious (HR, 1.15 [CI, 1.01 to 1.30]), and hematologic (HR, 1.15 [CI, 1.07 to 1.23]) AEs were elevated for LD-MTX versus placebo. With the exception of increased risk for skin cancer (HR, 2.05 [CI, 1.28 to 3.28]), the treatment groups did not differ in risk for other cancer or mucocutaneous, neuropsychiatric, or musculoskeletal AEs. Renal AEs were reduced in the LD-MTX group (HR, 0.85 [CI, 0.78 to 0.93]). LIMITATION The trial was done in patients without rheumatic disease who tolerated LD-MTX during an active run-in period. CONCLUSION Use of LD-MTX was associated with small to moderate elevations in risks for skin cancer and gastrointestinal, infectious, pulmonary, and hematologic AEs, whereas renal AEs were decreased. PRIMARY FUNDING SOURCE National Institutes of Health.