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https://www.readbyqxmd.com/read/29779195/efficacy-and-safety-of-alirocumab-in-individuals-with-diabetes-mellitus-pooled-analyses-from-five-placebo-controlled-phase-3-studies
#1
Henry N Ginsberg, Michel Farnier, Jennifer G Robinson, Christopher P Cannon, Naveed Sattar, Marie T Baccara-Dinet, Alexia Letierce, Maja Bujas-Bobanovic, Michael J Louie, Helen M Colhoun
INTRODUCTION: Diabetes mellitus (DM) carries an elevated risk for cardiovascular disease. Here, we assessed alirocumab efficacy and safety in people with/without DM from five placebo-controlled phase 3 studies. METHODS: Data from up to 78 weeks were analyzed in individuals on maximally tolerated background statin. In three studies, alirocumab 75 mg every 2 weeks (Q2W) was increased to 150 mg Q2W at week 12 if week 8 low-density lipoprotein cholesterol (LDL-C) was ≥ 70 mg/dL; two studies used alirocumab 150 mg Q2W throughout...
May 19, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/29779170/histological-improvement-of-non-alcoholic-steatohepatitis-with-a-prebiotic-a-pilot-clinical-trial
#2
Marc R Bomhof, Jill A Parnell, Hena R Ramay, Pam Crotty, Kevin P Rioux, Chris S Probert, Saumya Jayakumar, Maitreyi Raman, Raylene A Reimer
PURPOSE: In obesity and diabetes the liver is highly susceptible to abnormal uptake and storage of fat. In certain individuals hepatic steatosis predisposes to the development of non-alcoholic steatohepatitis (NASH), a disease marked by hepatic inflammation and fibrosis. Although the precise pathophysiology of NASH is unknown, it is believed that the gut microbiota-liver axis influences the development of this disease. With few treatment strategies available for NASH, exploration of gut microbiota-targeted interventions is warranted...
May 19, 2018: European Journal of Nutrition
https://www.readbyqxmd.com/read/29779024/a-randomized-clinical-trial-of-metformin-to-treat-autosomal-dominant-polycystic-kidney-disease
#3
Stephen L Seliger, Kaleab Z Abebe, Kenneth R Hallows, Dana C Miskulin, Ronald D Perrone, Terry Watnick, Kyongtae Tae Bae
BACKGROUND: Metformin inhibits cyclic AMP generation and activates AMP-activated protein kinase (AMPK), which inhibits the cystic fibrosis transmembrane conductance regulator and Mammalian Target of Rapamycin pathways. Together these effects may reduce cyst growth in autosomal dominant polycystic kidney disease (ADPKD). METHODS: A phase II, double-blinded randomized placebo-controlled trial of 26 months duration. Participants will include nondiabetic adults (n = 96) aged 18-60 years, with an estimated glomerular filtration rate (eGFR) ≥50 mL/min/1...
May 18, 2018: American Journal of Nephrology
https://www.readbyqxmd.com/read/29778606/avatrombopag-before-procedures-reduces-need-for-platelet-transfusion-in-patients-with-chronic-liver-disease-and-thrombocytopenia
#4
Norah Terrault, Yi-Cheng Chen, Namiki Izumi, Zeid Kayali, Paul Mitrut, Won Young Tak, Lee F Allen, Tarek Hassanein
BACKGROUND & AIMS: Patients with thrombocytopenia and chronic liver disease (CLD) may require platelet transfusions before scheduled procedures to decrease risk of bleeding. We performed 2 randomized, placebo-controlled, phase 3 trials in patients with thrombocytopenia and CLD undergoing scheduled procedures to evaluate the safety and efficacy of avatrombopag in increasing platelet counts in this patient population METHODS: In the ADAPT-1 and ADAPT-2 studies, adults with thrombocytopenia and CLD (n=231 and n= 204, respectively) were in 1 of 2 cohorts according to their baseline platelet count (below 40x109 /L or 40-50x109 /L) and within each cohort randomized (2:1) to 5 daily doses of avatrombopag (60 mg if baseline platelet count below 40x109 /L or 40 mg if 40-50x109 /L) or placebo...
May 17, 2018: Gastroenterology
https://www.readbyqxmd.com/read/29778325/tranexamic-acid-for-hyperacute-primary-intracerebral-haemorrhage-tich-2-an-international-randomised-placebo-controlled-phase-3-superiority-trial
#5
Nikola Sprigg, Katie Flaherty, Jason P Appleton, Rustam Al-Shahi Salman, Daniel Bereczki, Maia Beridze, Hanne Christensen, Alfonso Ciccone, Ronan Collins, Anna Czlonkowska, Robert A Dineen, Lelia Duley, Juan Jose Egea-Guerrero, Timothy J England, Kailash Krishnan, Ann Charlotte Laska, Zhe Kang Law, Serefnur Ozturk, Stuart J Pocock, Ian Roberts, Thompson G Robinson, Christine Roffe, David Seiffge, Polly Scutt, Jegan Thanabalan, David Werring, David Whynes, Philip M Bath
BACKGROUND: Tranexamic acid can prevent death due to bleeding after trauma and post-partum haemorrhage. We aimed to assess whether tranexamic acid reduces haematoma expansion and improves outcome in adults with stroke due to intracerebral haemorrhage. METHODS: We did an international, randomised placebo-controlled trial in adults with intracerebral haemorrhage from acute stroke units at 124 hospital sites in 12 countries. Participants were randomly assigned (1:1) to receive 1 g intravenous tranexamic acid bolus followed by an 8 h infusion of 1 g tranexamic acid or a matching placebo, within 8 h of symptom onset...
May 15, 2018: Lancet
https://www.readbyqxmd.com/read/29778041/the-efficacy-of-vitamin-d-in-multiple-sclerosis-a-meta-analysis
#6
REVIEW
Chao Zheng, Liang He, Lingling Liu, Jie Zhu, Tao Jin
BACKGROUND: Multiple sclerosis (MS) is a chronic inflammatory demyelination disorder in the central nervous system (CNS) leading to a high level of neurological disability. The pathogenesis of MS remains largely unknown, which explains the lack of significant efficacy of therapy in MS. Vitamin D deficiency is widely considered to be an environmental risk factor for MS. Many studies investigating the therapeutic effects of vitamin D on MS have been applied. The objective of this systematic review and meta-analysis was to evaluate the effectiveness of vitamin D in MS patients...
May 12, 2018: Multiple Sclerosis and related Disorders
https://www.readbyqxmd.com/read/29777744/omalizumab-can-inhibit-respiratory-reaction-during-aspirin-desensitization
#7
David M Lang, Mark A Aronica, Elizabeth S Maierson, Xiao-Feng Wang, Dorothy C Vasas, Stanley L Hazen
BACKGROUND: Aspirin desensitization has been associated with benefit in management of aspirin exacerbated respiratory disease (AERD). An intervention that would encourage aspirin desensitization to be performed more frequently has substantial potential for improving outcomes and quality of life in patients with AERD. OBJECTIVE: We investigated whether omalizumab administration would be associated with attenuation of aspirin-provoked bronchospasm in patients with AERD undergoing aspirin desensitization...
May 16, 2018: Annals of Allergy, Asthma & Immunology
https://www.readbyqxmd.com/read/29777264/empagliflozin-reduces-cardiovascular-events-mortality-and-renal-events-in-participants-with-type-2-diabetes-after-coronary-artery-bypass-graft-surgery-subanalysis-of-the-empa-reg-outcome%C3%A2-randomised-trial
#8
Subodh Verma, C David Mazer, David Fitchett, Silvio E Inzucchi, Egon Pfarr, Jyothis T George, Bernard Zinman
AIMS/HYPOTHESIS: After coronary artery bypass graft (CABG) surgery in individuals with type 2 diabetes, there remains a considerable residual cardiovascular risk. In the EMPA-REG OUTCOME® trial in participants with type 2 diabetes and established cardiovascular disease, empagliflozin reduced the risk of cardiovascular death by 38%, all-cause mortality by 32%, hospitalisation for heart failure by 35% and incident or worsening nephropathy by 39% vs placebo when given in addition to standard of care...
May 19, 2018: Diabetologia
https://www.readbyqxmd.com/read/29777228/effects-of-clomiphene-citrate-on-male-obesity-associated-hypogonadism-a-randomized-double-blind-placebo-controlled-study
#9
Andressa Heimbecher Soares, Nidia Celeste Horie, Lucas Augusto Piccinin Chiang, Bruno Caramelli, Mariana Gomes Matheus, Alexandre Holthausen Campos, Luciana Cavalheiro Marti, Fernanda Agostini Rocha, Marcio C Mancini, Elaine Maria Frade Costa, Cintia Cercato
BACKGROUND: Obesity causes secondary hypogonadism (HG) in men. Standard testosterone (T) replacement therapy improves metabolic parameters but leads to infertility. OBJECTIVE: To evaluate clomiphene citrate (CC) treatment of adult men with male obesity-associated secondary hypogonadism (MOSH). DESIGN: Single-center, randomized, double-blind, placebo-controlled trial. PARTICIPANTS: Seventy-eight men aged 36.5 ± 7...
May 17, 2018: International Journal of Obesity: Journal of the International Association for the Study of Obesity
https://www.readbyqxmd.com/read/29776990/effect-of-2-psoriasis-treatments-on-vascular-inflammation-and-novel-inflammatory-cardiovascular-biomarkers-a-randomized-placebo-controlled-trial
#10
Nehal N Mehta, Daniel B Shin, Aditya A Joshi, Amit K Dey, April W Armstrong, Kristina Callis Duffin, Zelma Chiesa Fuxench, Charlotte L Harrington, Rebecca A Hubbard, Robert E Kalb, Alan Menter, Daniel J Rader, Muredach P Reilly, Eric L Simpson, Junko Takeshita, Drew A Torigian, Thomas J Werner, Andrea B Troxel, Stephen K Tyring, Suzette Baez Vanderbeek, Abby S Van Voorhees, Martin P Playford, Mark A Ahlman, Abass Alavi, Joel M Gelfand
BACKGROUND: Psoriasis is a chronic inflammatory disease associated with dyslipidemia, cardiovascular events, and mortality. We aimed to assess and compare the effect of treatment of moderate-to-severe psoriasis with adalimumab or phototherapy on vascular inflammation and cardiovascular biomarkers. METHODS AND RESULTS: Randomized, double-blind, trial of adalimumab, phototherapy, and placebo (1:1:1) for 12 weeks, with crossover to adalimumab for 52 weeks total. Outcomes included vascular inflammation by 18 F-fluorodeoxyglucose positron emission tomography/computed tomography and biomarkers of inflammation, insulin resistance, and lipoproteins...
June 2018: Circulation. Cardiovascular Imaging
https://www.readbyqxmd.com/read/29776960/effect-of-combined-treatment-with-folic-acid-vitamin-b-6-and-vitamin-b-12-on-plasma-biomarkers-of-inflammation-and-endothelial-dysfunction-in-women
#11
William G Christen, Nancy R Cook, Martin Van Denburgh, Elaine Zaharris, Christine M Albert, JoAnn E Manson
BACKGROUND: The aim of this study was to determine whether reducing plasma homocysteine concentrations with long-term, combined treatment with folic acid, vitamin B6 , and vitamin B12 alters plasma biomarkers of inflammation and endothelial dysfunction in women at increased risk of cardiovascular disease. METHODS AND RESULTS: We conducted a blood substudy of 300 treatment-adherent participants (150 in the active treatment group, 150 in the placebo group) in the WAFACS (Women's Antioxidant and Folic Acid Cardiovascular Study), a randomized, double-blind, placebo-controlled trial testing a daily combination of folic acid (2...
May 18, 2018: Journal of the American Heart Association
https://www.readbyqxmd.com/read/29776349/randomised-controlled-trial-rct-of-cannabinoid-replacement-therapy-nabiximols-for-the-management-of-treatment-resistant-cannabis-dependent-patients-a-study-protocol
#12
Anjali K Bhardwaj, David J Allsop, Jan Copeland, Iain S McGregor, Adrian Dunlop, Marian Shanahan, Raimondo Bruno, Nghi Phung, Mark Montebello, Craig Sadler, Jessica Gugusheff, Melissa Jackson, Jennifer Luksza, Nicholas Lintzeris
BACKGROUND: The cannabis extract nabiximols (Sativex®) effectively supresses withdrawal symptoms and cravings in treatment resistant cannabis dependent individuals, who have high relapse rates following conventional withdrawal treatments. This study examines the efficacy, safety and cost-effectiveness of longer-term nabiximols treatment for outpatient cannabis dependent patients who have not responded to previous conventional treatment approaches. METHODS/DESIGN: A phase III multi-site outpatient, randomised, double-blinded, placebo controlled parallel design, comparing a 12-week course of nabiximols to placebo, with follow up at 24 weeks after enrolment...
May 18, 2018: BMC Psychiatry
https://www.readbyqxmd.com/read/29775957/how-treatment-improvement-in-adhd-and-cocaine-dependence-are-related-to-one-another-a-secondary-analysis
#13
Frances R Levin, C Jean Choi, Martina Pavlicova, John J Mariani, Amy Mahony, Daniel J Brooks, Edward V Nunes, John Grabowski
BACKGROUND: Attention-deficit hyperactivity disorder (ADHD) is overrepresented among individuals seeking treatment for substance use disorders. We previously reported that treatment with extended release mixed amphetamine salts (MAS-XR) increased abstinence, compared to placebo, among patients with co-occurring ADHD and cocaine dependence. This secondary analysis investigates the temporal relationship between ADHD improvement and cocaine abstinence in the first six weeks of the trial...
May 1, 2018: Drug and Alcohol Dependence
https://www.readbyqxmd.com/read/29775547/acute-dietary-nitrate-supplementation-does-not-attenuate-oxidative-stress-or-the-hemodynamic-response-during-submaximal-exercise-in-hypobaric-hypoxia
#14
Colin R Carriker, Paige Rombach, Brooke M Stevens, Roger A Vaughan, Ann L Gibson
PURPOSE: To investigate changes in oxidative stress, arterial oxygen saturation (SaO2), blood pressure (BP), and heart rate (HR) while exercising in hypobaric hypoxia following acute dietary nitrate supplementation. METHODS: Nine well-trained (60.8±7.8 ml/kg/min) males (29±7 years) visited the lab on 3 occasions, each separated by 1 week. Visit 1 included a maximal aerobic cycling test (VO2max) and 5 five-minute increasing intensity exercise bouts in a normobaric environment (1600m)...
May 18, 2018: Applied Physiology, Nutrition, and Metabolism, Physiologie Appliquée, Nutrition et Métabolisme
https://www.readbyqxmd.com/read/29775087/does-armodafinil-improve-driving-task-performance-and-weight-loss-in-sleep-apnea-a-randomized-trial
#15
Julia Louise Chapman, Elizabeth Anne Cayanan, Camilla Miranda Hoyos, Yasmina Serinel, Maria Comas, Brendon John Yee, Keith Keat Huat Wong, Ronald Robert Grunstein, Nathaniel Stuart Marshall
RATIONALE Obstructive sleep apnea (OSA) patients unable to tolerate standard treatments have few alternatives. They may benefit from weight loss, but the major symptom of daytime performance impairment may remain during weight loss programs. OBJECTIVES We hypothesized that wakefulness-promoter armodafinil would improve driving task performance over placebo in patients undergoing weight loss. METHODS Placebo-controlled, double-blind, randomized trial of Armodafinil vs Placebo daily for 6 months in patients who were also randomized to one of two diets for six months with follow-up at one year in overweight, adult, OSA patients who had rejected standard treatment and suffered daytime sleepiness...
May 18, 2018: American Journal of Respiratory and Critical Care Medicine
https://www.readbyqxmd.com/read/29774768/the-effects-of-boswellia-serrata-gum-resin-on-the-blood-glucose-and-lipid-profile-of-diabetic-patients-a-double-blind-randomized-placebo-controlled-clinical-trial
#16
Saeed Mehrzadi, Bahreh Tavakolifar, Hasan Fallah Huseini, Seyed Hamdollah Mosavat, Mojtaba Heydari
Regarding preclinical evidence for antidiabetic effects of Boswellia serrata, we evaluated antihyperglycemic and lipid-lowering effects of Boswellia serrata gum resin in type 2 diabetic patients. Fifty-six diabetic patients were randomly allocated to 2 groups to receive 250 mg of the Boswellia serrata gum resin or placebo twice daily for 8 weeks in addition to their routine antidiabetic treatments. Although there was a considerable reduction after the intervention in the field of fasting blood sugar, glycosylated hemoglobin, and triglyceride in the Boswellia serrata gum resin group, no significant difference was observed in all outcome measures between the 2 groups at the end of the study...
January 2018: Journal of evidence-based integrative medicine
https://www.readbyqxmd.com/read/29774628/efficacy-and-safety-of-brexpiprazole-for-the-treatment-of-acute-schizophrenia-in-japan-a-6-week-randomized-double-blind-placebo-controlled-study
#17
Jun Ishigooka, Shuichi Iwashita, Yoshihiro Tadori
AIMS: This study aimed to evaluate the efficacy, safety, and tolerability of brexpiprazole compared to placebo in Japanese patients with acute schizophrenia. METHODS: We conducted a 6-week, multicenter, double-blind, placebo-controlled, phase 2/3 study in Japan. Patients with acute schizophrenia were randomized (1:1:1:1) to receive brexpiprazole 1, 2, or 4 mg or placebo once a day. The primary endpoint was the change from baseline to week 6 in Positive and Negative Syndrome Scale (PANSS) total scores...
May 18, 2018: Psychiatry and Clinical Neurosciences
https://www.readbyqxmd.com/read/29774521/patient-reported-outcomes-of-multiple-myeloma-patients-treated-with-panobinostat-after-%C3%A2-2-lines-of-therapy-based-on-the-international-phase-3-randomized-double-blind-placebo-controlled-panorama-1-trial
#18
Paul G Richardson, Robert L Schlossman, Anuja N Roy, Ashok Panneerselvam, Suddhasatta Acharyya, Monika Sopala, Sagar Lonial
The phase 3 PANORAMA-1 trial led to regulatory approvals of panobinostat (PAN) in combination with bortezomib (BTZ) and dexamethasone (DEX) for the treatment of multiple myeloma after ≥2 prior regimens, including BTZ and an immunomodulatory drug. Patient-reported outcomes (PROs) were assessed in PANORAMA-1, with data available for 73 patients in the PAN + BTZ + DEX arm and 74 patients in the placebo (PBO) + BTZ + DEX arm. Per the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), global health status/quality of life (QoL) scores initially declined with PAN + BTZ + DEX during the first 24 weeks before approaching baseline scores and remaining steady during the next 24 weeks, with no difference between arms at Week 48...
May 17, 2018: British Journal of Haematology
https://www.readbyqxmd.com/read/29773704/effect-of-dietary-omega-3-fatty-acid-supplementation-on-frailty-related-phenotypes-in-older-adults-a-systematic-review-and-meta-analysis-protocol
#19
Joanne Stocks, Ana M Valdes
INTRODUCTION: The beneficial effect of dietary omega-3 supplementation in younger adults or older people with acute or chronic disease is established. Knowledge is now needed about the effect in medically stable older people. The objective of this study is to examine and assess the evidence for a role of dietary omega-3 polyunsaturated fatty acid (PUFA) supplementation in older adults on (1) muscle mass and muscle strength, (2) inflammatory biomarkers and (3) physical activity. METHODS AND ANALYSIS: A systematic review and data synthesis will be conducted of randomised controlled trials in older people not recruited for any given disease diagnosis...
May 17, 2018: BMJ Open
https://www.readbyqxmd.com/read/29773176/effects-of-zinc-magnesium-and-chromium-supplementation-on-cardiometabolic-risk-in-adults-with-metabolic-syndrome-a-double-blind-placebo-controlled-randomised-trial
#20
Ha-Na Kim, Se-Hong Kim, Young-Mi Eun, Sang-Wook Song
The prevalence of metabolic syndrome (MetS) has been increasing rapidly worldwide. The activities of zinc, magnesium and chromium have a potential association with MetS; therefore, we investigated the effects of zinc, magnesium and chromium supplements on metabolic risk factors in adults with MetS. In this double-blind, placebo controlled randomised study, 32 adults with MetS were included in the zinc, magnesium, and chromium-administered group (n = 16) or the placebo group (n = 16) and received either 300 mg magnesium, 600 μg chromium and 36 mg zinc per day or placebo over a 24-week period...
July 2018: Journal of Trace Elements in Medicine and Biology
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