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India variant shows resistance to antibody drugs & vaccines

Antibody drugs and COVID-19 vaccines are less effective against a coronavirus variant that was first detected in India, researchers say. The variant, B.1.617.2, has mutations that make it more transmissible. It is now predominant in some parts of India and has spread to many other countries.

Antibodies in blood from unvaccinated COVID-19 survivors and from people who received both doses of the Pfizer/BioNTech vaccine were 3-fold to 6-fold less potent against the India variant than against the UK variant and a variant first identified in South Africa, according to a report posted on bioRxiv ahead of peer review.

The two-dose AstraZeneca vaccine, which does not protect against the South Africa variant, is likely to be ineffective against the India variant as well, the authors said. Antibodies from people who had received their first dose “barely inhibited” this India variant, said study co-author Olivier Schwartz of Institut Pasteur.

The study, Schwartz added, shows that the rapid spread of the India variant is associated with its ability to “escape” the effect of neutralizing antibodies.

Source: Medscape

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Lifileucel promising against unresponsive malignant melanoma

Lifileucel shows promise in metastatic-melanoma patients whose disease had progressed on standard immune-checkpoint inhibitors (ICI) and other therapies, according to a small open-label trial. “Lifileucel is a ground-breaking form of cellular immunotherapy that utilizes the immune cells of patients derived from their own tumors as a treatment,

Source: Reuters Health

Clinic Hours In Article, FDA Updates

FDA approves first drug for lung cancer with KRAS mutation

Sotorasib (Lumakras), specifically targets the KRAS G12C mutation, which accounts for about 13% of NSCLC mutations. KRAS mutations are the most common mutations to occur in NSCLC tumors, accounting for about 25% of them, but for a long time, they appeared to be resistant to drug therapy.

Dose: 960 mg once daily

Side effects: The most common adverse reactions (≥ 20%) were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough. The most common laboratory abnormalities (≥ 25%) were decreased lymphocytes, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, decreased calcium, increased alkaline phosphatase, increased urine protein, and decreased sodium.

Contraindications: Interstitial lung disease, CLD, along with drugs that are substrates of the P-glycoprotein.

Source: FDA

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Hybrid therapy for H. pylori infection

A 14-day course of hybrid therapy was as effective as 10-day bismuth quadruple therapy, but with fewer side effects, according to results of a randomized trial conducted in Taiwan.

In a prospective, randomized comparative study published in 2017, the eradication rates (93.9%) in patients receiving 14-day bismuth quadruple therapy (pantoprazole, bismuth subcitrate, tetracycline, and metronidazole) were comparable with eradication rates (92.8%) with 14-day hybrid therapy (dual therapy with pantoprazole plus amoxicillin for 7 days, followed by quadruple therapy with pantoprazole, amoxicillin, clarithromycin, and metronidazole for 7 days).

Source: Medscape

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FDA approves Ozanimod for Ulcerative Colitis

The US FDA has approved ozanimod (Zeposia) for adults with moderately to severely active ulcerative colitis (UC), the company has announced. Ozanimod (0.92 mg), an oral medication taken once daily, is the first sphingosine-1-phosphate (S1P) receptor modulator approved for UC.

In March 2020, the FDA approved ozanimod for adults with relapsing forms of multiple sclerosis

The approval, awarded to Bristol Myers Squibb, was based on the data from a placebo-controlled phase 3 trial dubbed True North. In the study, researchers evaluated ozanimod as a single, daily oral therapy for both adults and pediatric patients at least 12 years old with moderately to severely active ulcerative colitis.

More Info: FDA

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Mild cortisol excess increases mortality in adrenal incidentaloma

Mortality is two to three times higher in patients with adrenal incidentalomas who have autonomous cortisol secretion levels of 83 nmol/L (3 µg/dL) or more after a 1 mg dexamethasone suppression test (DST) compared with those with levels below this, new research finds.

Autonomous cortisol secretion (ACS) has been linked to hypertension, cardiovascular disease, type 2 diabetes, and early mortality, and risks vary by cortisol level.

Source: Annals of Internal Medicine

Clinic Hours In Article, New Drug

A novel drug most effective in sickest HFrEF patients

The greatest relative benefit from omecamtiv mecarbil, a novel myotropic drug class that improves cardiac performance, is produced in heart failure patients with the lowest left ventricular ejection fraction (LVEF), a new analysis of the recently published phase 3 GALACTIC-HF trial has found.

The phase 3 multinational GALACTIC-HF trial, published earlier this year, linked omecamtiv mecarbil with an 8% reduction in the risk of a heart failure-related events or cardiovascular death, relative to placebo, which was the primary outcome. For entry, HFrEF patients were required to have a LVEF of 35% or less.

Source: Medscape

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Sotagliflozin improves clinical outcomes in patients with HFpEF

The investigational sodium-glucose cotransporter (SGLT) 1/2 inhibitor sotagliflozin is the first agent clearly shown in a prespecified analysis of randomized trials to improve clinical outcomes in patients with heart failure with reduced ejection fraction (HFpEF).

Researchers who ran the SCORED and SOLOIST–WHF pivotal trials for sotagliflozin first made that claim in November 2020 when reporting top-line results from a prespecified meta-analysis of the two trials during the American Heart Association annual scientific sessions.

Source: Medscape

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Management protocol for Mucormycosis by AIIMS Rishikesh

Management by Inj Liposomal amphotericin B (LAmB):

Test dose

•Inj. Liposomal Amphotericin- B 1 vial (50 mg) to be diluted in 12 ml of the diluent and 0.25ml (1 mg) of a solution made, to be mixed in 100ml Dextrose and to be infused in 30 minutes.
•Observe for fever and reactions

Pre-hydration

•500 mL NS over 30 minutes
•To reduce the risk of renal toxicity and hypokalaemia:- 500ml Normal Saline + 1 Amp (20mmol) KCL

Therapeutic dose

•5mg-10 mg /kg/day Amphotericin B in 500 mL D5 with 10 Units HIR over 3 hrs (To be covered in black sheet)

PostHydration

•500 mL NS over 30 minutes

Postdose

•KFT with Serum electrolytes after Every dose of Amphotericin B
•Fill Amphotericin monitoring chart

Duration: Continue for 14 to 21 days depending on severity/till clinical resolution and radiological stabilization; after 14days of therapy, shift to oral Posaconazole (200mg four times a day) if clinically stable.

Download Full Protocol ›

Source: AIIMS

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Novel IL-6 antibody reduces CRP up to 92% in High-risk ASCVD

Inhibition of interleukin (IL)-6 with ziltivekimab reduces multiple biomarkers of inflammation and thrombosis in patients at high atherosclerotic risk with moderate to severe chronic kidney disease (CKD) and elevated C-reactive protein, results of the phase 2 RESCUE trial show.

At 12 weeks, median levels of high-sensitivity C-reactive protein (hsCRP) were reduced by 77%, 88%, and 92% with 7.5 mg, 15 mg, and 30 mg doses of ziltivekimab, respectively, every 4 weeks, compared with a 4% reduction with placebo.

Source: Medscape