Animal Study Suggests Lorcaserin (Belviq®) May be Useful to Reduce Opioid Intake

MedicalResearch.com Interview with:
Christina R. Merritt and Kathryn A. Cunningham
Center for Addiction Research
University of Texas Medical Branch
Galveston, TX 77555

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Opioid use disorder (OUD) is one of the top public health problems in the United States. Overdoses on prescription opioids, heroin and fentanyl accounted for 33,091 deaths in the U.S. in 2015 (https://www.cdc.gov/mmwr/volumes/65/wr/mm655051e1.htm); each day, 91 Americans die from an opioid overdose (https://www.cdc.gov/drugoverdose/epidemic/). The first-ever Surgeon General’s Report on Alcohol, Drugs and Health (https://addiction.surgeongeneral.gov/ ) observed that more people used prescription opioids than tobacco in 2015. Furthermore, individuals with OUD, the most problematic pattern of opioid abuse, often relapse, particularly in environments associated with past drug use, and new means to help maintain abstinence are needed.

Serotonin (5-hydroxytryptamine; 5-HT) function in the brain, particularly through its cognate 5-HT2C receptor, is an important regulator of the abuse liability of cocaine and other psychostimulants. Previous studies suggested that the weight loss medication and selective 5-HT2C receptor agonist lorcaserin (Belviq®) can curb cocaine- and nicotine-seeking in preclinical models, even when tested in tempting environments. We administered lorcaserin to rats who were trained to take the powerful painkiller oxycodone (OxyContin®), a prescription opioid currently approved for treatment of acute and chronic pain with characteristically high abuse potential. Lorcaserin suppressed oxycodone intake as well as the drug-seeking behaviors observed when rats were exposed to cues such as the lights and sounds previously associated with drug intake. Taken together, these findings highlights the therapeutic potential for lorcaserin to extend abstinence and enhance recovery from OUD.

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Thyroid Hormone Medication Should Not Be Taken With Cow’s Milk

MedicalResearch.com Interview with:
Deborah Chon MD
Endocrinology fellow
UCLA David Geffen School of Medicine 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Our study shows that drinking cow’s milk concurrently with oral levothyroxine significantly reduces the absorption of the medication.

Levothyroxine is used for the physiologic replacement of thyroid hormone in patients with hypothyroidism and for serum TSH suppression in patients with thyroid cancer. It is the mostly commonly prescribed medication in the United States as of 2014. Frequent dose adjustments of levothyroxine have been shown to be a costly burden to the national healthcare system.

Previous studies have shown that certain foods and medication, such as calcium supplements, can interfere with levothyroxine absorption. However, this is the first study to demonstrate that ingesting cow?s milk, a common breakfast staple, affects oral levothyroxine absorption.

To determine the possible effect of cow’s milk ingestion, we measured levothyroxine absorption in humans with and without concurrent milk consumption. Pharmacokinetic studies were conducted in healthy adults without allergies to milk or levothyroxine, and who were not pregnant nor using oral contraceptives. All subjects had no history of known thyroid disease and normal thyroid hormone function at baseline. Following an overnight fast, serum total thyroxine T4 (TT4) concentrations were measured at baseline and at 1, 2, 4, and 6 hours after ingestion of 1,000 ?g of oral levothyroxine alone or when co-administered with 12 oz. of milk (2% fat). There was a four-week washout period between the two study visits.

Ten subjects (mean age 33.7?10.2 years, 60% male) completed the study. The serum total T4 absorption over six hours, calculated as area under the curve (AUC), was significantly lower when taking cow?s milk concurrently with levothyroxine compared levothyroxine alone (mean?SD: 67.26?12.13 vs. 73.48?16.96; p = 0.02). Also, peak serum TT4 concentrations were significantly lower in those who ingested levothyroxine concurrently with milk, compared to taking levothyroxine alone (p=0.04).
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NSAIDS Diclofenac and Ibuprofen Associated with Increased Risk of Cardiac Arrest

MedicalResearch.com Interview with:

Kathrine Bach Søndergaard MD, Research Fellow Gentofte University Hospital Department of Cardiology Hellerup

Dr. Søndergaard

Kathrine Bach Søndergaard MD, Research Fellow
Gentofte University Hospital
Department of Cardiology
Hellerup 

MedicalResearch.com: What is the background for this study?

Response: Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used and have in previous studies been associated with an increased risk of cardiovascular adverse events, such as myocardial infarction and heart failure. Cardiac arrest is the ultimate adverse event; however, no research exists of the association between cardiac arrest and use of NSAIDs, which we aimed to assess in this study.

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Psoriasis: Efficacy and Safety of Guselkumab vs Humira for Moderate to Severe Disease

MedicalResearch.com Interview with:

Andrew Blauvelt, M.D., M.B.A. President and Investigator Oregon Medical Research Center

Dr. Blauvelt

Andrew Blauvelt, M.D., M.B.A.
President and Investigator
Oregon Medical Research Center

 MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Findings from the Phase 3 VOYAGE 1 study showed that patients with moderate to severe plaque psoriasis receiving guselkumab, an human anti-interleukin (IL)-23 monoclonal antibody, achieved significant improvement in skin clearance and in comparison with Humira® (adalimumab), a TNF blocker.  The Phase 3 study and head-to-head analysis of guselkumab vs. adalimumab showed the significant and durable efficacy of guselkumab as maintained through one year when compared with adalimumab, and the robust efficacy of this novel IL-23 targeted therapy in meeting all primary and major secondary endpoints.

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Regional Variation in Chemotherapy Prescriptions For Metastatic Prostate Cancer

MedicalResearch.com Interview with:

Megan Elizabeth Veresh Caram MD Clinical Lecturer Internal Medicine, Hematology & Oncology University of Michigan

Dr. Caram

Megan Elizabeth Veresh Caram MD
Clinical Lecturer
Internal Medicine, Hematology & Oncology
University of Michigan

 

MedicalResearch.com: What is the background for this study?

Response: Abiraterone and enzalutamide are oral medications that were approved by the Food & Drug Administration in 2011 and 2012 to treat men with metastatic castration-resistant prostate cancer. Most men with advanced prostate cancer are over age 65 and thus eligible for Medicare Part D. We conducted a study to better understand the early dissemination of these drugs across the United States using national Medicare Part D and Dartmouth Atlas data.

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Flu Treatment With Neuraminidase Inhibitors During Pregnancy Not Linked To Birth Defects

MedicalResearch.com Interview with:

Dr. Sophie Graner Department of Women's and Childrens Health Karolinska Institute, Stockholm, Sweden

Dr. Graner

Dr. Sophie Graner
Department of Women’s and Childrens Health
Karolinska Institute, Stockholm, Sweden

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Pregnant women are at increased risks of severe disease and death due to influensa infection, as well as hospitalization. Also influenza and fever increase the risk of adverse pregnancy outcomes for their infants such as intrauterine death and preterm birth. Due to this, the regulatory agencies in Europe and the US recommended post exposure prophylaxis and treatment for pregnant women with neuraminidase inhibitors during the last influenza pandemic 2009-10. Despite the recommendations, the knowledge on the effect of neuraminidase inhibitors on the infant has been limited. Previously published studies have not shown any increased risk, but they have had limited power to assess specific neonatal outcomes such as stillbirth, neonatal mortality, preterm birth, low Agar score, neonatal morbidity and congenital malformations.
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mGlu2 receptor Agonist ADX71149 Plus Levetiracetam May Reduce Seizures With Fewer Side Effects

MedicalResearch.com Interview with:

Robert Lutjens, PhD Head of Discovery at Addex Therapeutics Geneva, Switzerland

Dr. Lutjens

Robert Lutjens, PhD
Head of Discovery at Addex Therapeutics
Geneva, Switzerland

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Metabotropic glutamate receptors represent an attractive therapeutic target for various neurologic conditions. In particular, the metabotropic glutamate receptor subtype 2 (mGlu2) can affect excitatory synaptic transmission by decreasing glutamate release. As excess gluatamate is observed in epilepsy, targeting mGlu2 could lead to new avenues of therapy. Positive allosteric modulators (PAMs) of mGlu2 could be valuable candidate drugs as they do not directly activate receptors. Therefore, they may avoid tachyphylaxis and side effects emerging from direct receptor agonism. 

The publication summarizes the effects obtained when the mGlu2 receptor is activated using an agonist or PAM, such as ADX71149, in the 6Hz psychomotor seizure test, considered to be the most relevant model of pharmacoresistant limbic seizures. The data show that while seizures are reduced when mGlu2-acting compounds are administered alone, their combination with the antiseizure drug levetiracetam (LEV) result in a potent reduction of doses required to produce full efficacy, which is important because higher doses of LEV are associated with dose-limiting side effects, such as aggression, nervousness/anxiety, somnolence and fatigue. In this study, a fixed dose of ADX71149 was seen to increase the potency of LEV, leading to an approximate 35-fold increase in its potency. Conversely, using a fixed dose of LEV with varying doses of ADX71149 resulted in an approximate 14-fold increase in ADX71149 potency.

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Guselkumab Potentially Increases Treatment Choices For Psoriasis

MedicalResearch.com Interview with:

Prof. Dr. med. Kristian Reich Dermatologie, Allergologie Psoriasis- und Neurodermitis-Trainer Hamburg

Prof.  Kristian Reich

Prof. Dr. med. Kristian Reich
Dermatologie, Allergologie
Psoriasis- und Neurodermitis-Trainer
Hamburg

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Ustekinumab is an antibody against the p40 molecule shared by IL-12 and IL-23. The antibody shows a favorable benfit-risk profile in the treatment of psoriasis. IL-23 is regarded a key driver in psoriasis pathology. It is speculated that antibodies against the IL-23-specific subunit p19 may produce even higher levels of clinical response than ustekinumab or the anti-TNF antagonist adalimumab. Guselkumab is the first IL-23p19 antibody to publish phase III data in psoriasis.   
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Antidepressants Have Variable Effects On Symptom Clusters

MedicalResearch.com Interview with:

Adam Chekroud PhD Candidate Human Neuroscience Lab

Adam Chekroud

Adam Chekroud
PhD Candidate
Human Neuroscience Lab
Department of Psychology
Yale University

MedicalResearch.com: What is the background for this study?

Response: We know that depression includes a wide range of symptoms, from low mood and feeling worthless, to problems sleeping, slowed thinking, and suicidal ideation.

We wanted to know whether antidepressants work well in treating all of these symptoms, or whether they are primarily effective on certain kinds of symptoms.

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SWORD Study Demonstrates Two-Drug Control of HIV

MedicalResearch.com Interview with:

Kati Vandermeulen Senior Director, Global Regulatory Leader and Compound Development Team Lead IDV Janssen

Kati Vandermeulen

Kati Vandermeulen
Senior Director, Global Regulatory Leader and Compound Development Team Lead
IDV Janssen

MedicalResearch.com: What is the background for this study? What are the main findings?

Response:  SWORD is the first large trial program specifically conducted to look at the combination of dolutegravir and rilpivirine as a complete, two-drug antiretroviral regimen. Results of the two identical Phase III SWORD studies have been positive and demonstrate that the two-drug regimen of dolutegravir and rilpivirine is as effective, with comparable tolerability, to traditional three- or four-drug (integrase inhibitor-, non-nucleoside reverse transcriptase inhibitor-, or boosted protease inhibitor-based) antiretroviral regimens for the maintenance treatment of HIV.
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5-alpha reductase inhibitors For BPH Linked to Higher, Not Lower, PSA Levels

MedicalResearch.com Interview with:
Teemu J Murtola, MD, PhD, adjunct professor
University of Tampere, Faculty of Medicine and Life Sciences
Tampere University Hospital, Department of Urology
Tampere, Finland

MedicalResearch.com: What is the background for this study?

Response: A previous study called Prostate Cancer Prevention Trial
(PCPT) showed that finasteride, which belongs to a drug group called
5alpha-reductase inhibitors lowers serum PSA and increases sensitivity
of PSA to detect high-grade prostate cancer in men who had little or
no symptoms of the lower urinary tract. We postulated that this effect
would increase the accuracy and benefits of PSA-based prostate cancer
screening.

Finnish Randomized Study of Screening for Prostate Cancer was a large
trial of over 80,000 men randomized either to be screened for prostate
cancer with a PSA test at 4-year intervals or to be followed for
prostate cancer incidence and mortality via national registries. Three
consecutive screening rounds were commenced between 1996-2008. In the
current study we compared the effects of PSA-based screening on
prostate cancer risk and mortality separately among men who were using
5alpha-reductase inhibitors finasteride or dutasteride and among men
who were not.

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Roles of Angiotensin Peptides and Recombinant Human ACE2 in Heart Failure

MedicalResearch.com Interview with:

Gavin Y Oudit, MD, PhD, FRCPC Associate Professor, Department of Medicine, University of Alberta Clinician-Scientist, Mazankowski Alberta Heart Institute Canada Research Chair in Heart Failure Division of Cardiology, 2C2 Walter Mackenzie Health Sciences Centre Edmonton, Alberta

Dr. Gavin Oudit

Gavin Y Oudit, MD, PhD, FRCPC
Associate Professor, Department of Medicine, University of Alberta
Clinician-Scientist
Mazankowski Alberta Heart Institute
Canada Research Chair in Heart Failure
Division of Cardiology
Edmonton, Alberta

Heart specialist Gavin Oudit and his research team discovered a molecule — angiotensin converting enzyme 2 (ACE2)—that works to restore balance to the pathways responsible for chronic and acute heart failure, including in hearts from patients with advanced heart failure who underwent heart transplants.

In developing the new drug, Oudit and his team discovered to an extent not seen before how the renin-angiotensin system (RAS), which regulates the body’s sodium balance, fluid volume, and blood pressure, is at play in both acute and chronic heart failure. In collaboration with Dr. Oudit, recombinant human ACE2 was made by Apeiron Biologics, purchased by GlaxoSmithKline, and has recently completed phase II clinical trial.

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