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Endoscopic Sleeve Gastroplasty safe, Effective for obesity over 5 years

Endoscopic sleeve gastroplasty (ESG) was safe and effective for weight loss, during a single-centre five-year follow-up study.

“It is a great procedure, patients are satisfied, and it achieves good results,” Dr. Reem Sharaiha of Weill Cornell Medicine in New York City told Reuters Health by email. “ESG has been gaining momentum among the patient population. Many were interested in the long-term results of endoscopic approaches, including insurances/bariatric surgeons, as most (studies) have not shown durability in the past.”

Dr Sharaiha and colleagues studied 216 patients who underwent ESG at Weill Cornell from 2013-2019 (mean age, 46; 68% women). During the procedure, the endoscopist inserts a suturing device through the mouth and into the stomach, which is sutured to make it smaller.

Study participants had a body mass index of >30 kg/m2 (or >27 with comorbidities) and had failed to achieve a total body weight loss (TBWL) of at least 5% with noninvasive measures such as drugs.

Source: Medscape

FDA approves Somapacitan-beco for Adult Growth Hormone Deficiency treatment

FDA approves Sogroya (somapacitan-beco) a 0nce-weekly treatment for Adult Growth Hormone Deficiency.

Sogroya (somapacitan-beco) injection 10 mg/1.5 mL (6.7 mg/mL) is a human growth hormone analog taken once a week by subcutaneous injection. The FDA’s decision is based on a comprehensive clinical program, including the REAL 1 study, a 35-week, double-blind, placebo-controlled study, in treatment-naïve adult patients with GHD.

Sogroya may cause serious side effects, including:

  • High risk of death in people who have critical illnesses because of heart or stomach surgery, trauma or serious breathing problems
  • Increased risk of growth of cancer or a tumor that is already present and increased risk of the return of cancer
  • New or worsening high blood sugar or diabetes
  • Odema
  • Decrease in a hormone called cortisol
  • Decrease in thyroid hormone levels.
  • Severe and constant abdominal pain. This could be a sign of pancreatitis
  • Loss of fat and tissue weakness in the area of skin you inject.
  • Increase in phosphorus, alkaline phosphatase and parathyroid hormone levels in your blood

The most common side effects of Sogroya may include back pain, joint pain, indigestion, sleep problems, dizziness, swelling of the tonsils, vomiting, high blood  pressure, increase creatine phosphokinase, weight gain, and low red blood cells

 

Source: FDA

Antihypertensive drugs that reduces risk for Depression

The risk of depression is elevated in patients with cardiovascular diseases, but several specific antihypertensive therapies are associated with reduced risk, and none appear to increase the risk, according to a population-based study that evaluated 10 years of data in nearly 4 million subjects.

Agents associated with a reduced risk of depression were: two angiotensin agents, enalapril and ramipril; three calcium antagonists, amlodipine, verapamil, and verapamil combinations; and four beta-blockers, propranolol, atenolol, bisoprolol, and carvedilol.

Source: Medscape

FDA approves saliva test to detect COVID-19

FDA approves emergency use of Saliva Test to detect COVID-19

Rutgers University-based RUCDR Infinite Biologics developed a saliva collection method in partnership with Spectrum Solutions and Accurate Diagnostic Labs.

The document states that the collection of saliva specimens is limited to patients with symptoms of COVID-19 and should be performed in a health care setting under the supervision of a trained health care clinician. Samples are transported for RNA extraction and are tested within 48 hours of collection. In saliva samples obtained from 60 patients evaluated by the researchers, all were in agreement with the presence of COVID-19.

Source: Medscape

CO-RADS classification

The CO-RADS classification is a standardized reporting system for patients with suspected COVID-19 infection developed for a moderate to high prevalence setting.

CO-RADS 1

  • COVID-19 is highly unlikely.
  • The CT is normal or there are findings that indicate a non-infectious disease like congestive heart failure, sarcoid, histoplasmosis, malignancy, UIP or fibrotic NSIP (if unchanged to prior examination).
  • An exemption has to be made for the first few days of a mild infection when the CT can be normal.

CO-RADS 2

  • Level of suspicion of COVID-19 infection is low.
  • Findings are consistent with other infections like typical bronchiolitis with tree-in-bud and thickened bronchus walls.
  • No typical signs of COVID-19.

CO-RADS 3

  • COVID-19 unsure or indeterminate.
  • CT abnormalities indicating infection, but unsure whether COVID-19 is involved, like widespread bronchopneumonia, lobar pneumonia, septic emboli with ground glass opacities.

CO-RADS 4

  • In CO-RADS 4 the level of suspicion is high.
  • Mostly these are suspicious CT findings but not extremely typical:
  • Unilateral ground glass
  • Multifocal consolidations without any other typical finding
  • Findings are suspicious of COVID-19 in underlying pulmonary disease.

CO-RADS 5

  • Multifocal GGO and consolidation
  • PCR positive

CO-RADS 6

  • Patient with positive PCR and bilateral GGO.

Sintilimab + Platinum based chemotherapy in Advanced Nonsquamous NCLC

The investigational anti-PD-1 antibody sintilimab has shown that it improves the efficacy of platinum-based chemotherapy in the first-line treatment of patients with advanced non-squamous non-small cell lung cancer (NSCLC) in a Chinese phase 3 trial dubbed ORIENT-11.

Sintilimab is a fully human IgG4 monoclonal antibody that blocks the binding of programmed death (PD)-1 to PD ligand 1 (PD-L1) or PD-L2 with high affinity, and has received market authorization in China for the treatment of Hodgkin’s lymphoma.

For ORIENT-11, almost 400 patients with advanced non-squamous NSCLC were randomly assigned to sintilimab or placebo plus pemetrexed and platinum-based chemotherapy in a 2:1 ratio.

“The addition of sintilimab to pemetrexed and platinum significantly improved PFS [progression-free survival] compared to placebo,” reducing progression rates by 52%, noted lead investigator Li Zhang, MD, professor of medical oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China.

Source: Medscape

BCG vaccination may slow spread of COVID-19

Countries that had compulsory bacillus Calmette-Guérin (BCG) vaccination at least until 2000 appear to have built up a degree of “herd immunity” against COVID-19, a new study suggests.

BCG vaccination is usually given at birth or during childhood to protect against tuberculosis (TB). But there is also evidence that it protects against other respiratory infections and lung cancer. In addition, it is an effective treatment for some forms of bladder cancer.

A study in 2018 found that the vaccine appeared to “reprogram” immune cells to produce more of a particular immune signalling molecule. This, in turn, boosted immunity against viral infection. The studies found that having mandatory BCG vaccination significantly “flattened the curve” of the initial spread of COVID-19 throughout the populations studied.

Source: Medscape

Tenofovir prophylaxis to prevent mother-to-child transmission of HBV

New recommendation: WHO recommends that pregnant women testing positive for HBV infection (HBsAg positive) with an HBV DNA ≥ 5.3 log10 IU/mL (≥ 200,000 IU/mL)1 receive tenofovir prophylaxis from the 28th week of pregnancy until at least birth, to prevent mother-to-child transmission of HBV. This is in addition to three-dose hepatitis B vaccination in all infants, including timely birth dose (conditional recommendation, moderate quality of evidence). Use of HBeAg testing, where HBV DNA testing is not available, to determine treatment eligibility for tenofovir prophylaxis to prevent mother-to-child transmission of HBV.

New recommendation: WHO recommends that in settings in which antenatal HBV DNA testing is not available, HBeAg testing can be used as an alternative to HBV DNA testing to determine eligibility for tenofovir prophylaxis to prevent mother-to-child transmission of HBV2 (conditional
recommendation, moderate quality of evidence).

Source: WHO

Lenvatinib-Pembrolizumab combination in Advanced Gastric Cancer

The combination of the anti-PD-1 antibody pembrolizumab and the multikinase inhibitor lenvatinib provides objective response rates in many patients with advanced gastric cancer, according to results from an early single-arm trial.

Lenvatinib monotherapy was associated with durably stable disease in a phase-1 study of patients with solid tumors, and the combination of lenvatinib plus pembrolizumab has shown promising antitumor activity with manageable safety profiles for several malignancies.

Lenvatinib is a multikinase inhibitor of VEGFR1, VEGFR2, and VEGFR3, and other receptor tyrosine kinases. Pembrolizumab, an antibody targeting PD-1, has also moderate efficacy in biomarker-unselected endometrial cancer.

Source: Medscape

COVID-19 coronavirus vaccine tracker

Researchers worldwide are working around the clock to find a vaccine against SARS-CoV-2, the virus causing the COVID-19 pandemic. Experts estimate that a fast-tracked vaccine development process could speed a successful candidate to market in approximately 12-18 months.

How are vaccines tested?

  • In the pre-clinical stage of testing, researchers give the vaccine to animals to see if it triggers an immune response.
  • In phase 1 of clinical testing, the vaccine is given to a small group of people to determine whether it is safe and to learn more about the immune response it provokes.
  • In phase 2, the vaccine is given to hundreds of people so scientists can learn more about its safety and correct dosage.
  • In phase 3, the vaccine is given to thousands of people to confirm its safety – including rare side effects – and effectiveness. These trials involve a control group which is given a placebo.

Vaccines in clinical trials

  • Sinovac: Chinese company Sinovac is developing a vaccine based on inactivated Covid-19 particles. The vaccine has shown a promising safety profile in the early stages of testing and is now moving into Phase 3 trials in Brazil.
  • The Murdoch Children’s Research Institute in Australia is conducting a phase 3 trial using a nearly 100-year-old tuberculosis vaccine. The vaccine is not thought to protect directly against Covid-19 but might boost the body’s non-specific immune response.
  • University of Oxford/AstraZeneca: The University of Oxford vaccine is delivered via a chimpanzee virus, called the vaccine vector. The vector contains the genetic code of the protein spikes found on the coronavirus and triggers a strong immune response in the human body. The vaccine is in a combined phase 2/3 trial in the UK and has recently gone into phase 3 trials in South Africa and Brazil.
    CanSino Biologics Inc./Beijing Institute of Biotechnology
    The vaccine developed by Chinese company CanSino Biologics and the Beijing Institute of Biotechnology – a university close to the Chinese military – reportedly showed promising results in phase 2 testing, although no data from the trial has been published. In a world first, the vaccine has now been approved for military use, but it is unclear how broadly it will be distributed.
  • Moderna/NIAID: American biotech company Moderna is developing a vaccine candidate using messenger RNA (or mRNA for short) to trick the body into producing viral proteins itself. No mRNA vaccine has ever been approved for an infectious disease, and Moderna has never brought a product to market. But proponents of the vaccine say it could be easier to mass produce than traditional vaccines.
  • Inovio Pharmaceuticals/ International Vaccine Institute
  • Cadila Healthcare Limited
  • Wuhan Institute of Biological Products/Sinopharm
  • Beijing Institute of Biological Products/Sinopharm
  • Novavax
  • BioNTech/Fosun Pharma/Pfizer
  • Genexine Consortium
  • Osaka University/ AnGes/ Takara Bio
  • Institute of Medical Biology, Chinese Academy of Medical Sciences
  • Gamaleya Research Institute
  • Clover Biopharmaceuticals Inc./GSK/Dynavax
  • Anhui Zhifei Longcom Biopharmaceutical/ Institute of Microbiology,
  • Chinese Academy of Sciences
  • Vaxine Pty Ltd/Medytox
  • Imperial College London
  • Curevac
  • People’s Liberation Army (PLA) Academy of Military Sciences/Walvax Biotech.
  • Medicago Inc./ Université Laval
  • University of Melbourne/Murdoch Children’s Research Institute

Draft landscape of COVID-19 candidate vaccines by WHO: Download PDF ›

Source: WHO

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