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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

Clinic Hours In Article

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

Clinic Hours In Article, New Drug

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

Clinic Hours In Article, COVID-19

Antibody status & incidence of SARS-CoV-2 infection in health care workers

The relationship between the presence of antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the risk of subsequent reinfection remains unclear.

The presence of anti-spike or anti-nucleocapsid IgG antibodies was associated with a substantially reduced risk of SARS-CoV-2 reinfection in the ensuing 6 months. Positive baseline anti-spike antibody assays were associated with lower rates of PCR-positive tests.

Full study: NEJM

Clinic Hours In Article, COVID-19

ICMR releases guidelines for COVID-19 associated Mucormycosis

The correlation between COVID-19 and Mucormycosis isn’t surprising, as the biggest risk factors are uncontrolled diabetes and immune suppressant steroids. Rhino-orbital-cerebral and pulmonary infections are the most common syndromes caused by these fungi. The genera most commonly found in human infections are Rhizopus, Mucor, and Rhizomucor; Cunninghamella, Absidia (now reclassified as Lichtheimia), Saksenaea, and Apophysomyces are genera that are less commonly implicated in infection.

Source: ICMR

Clinic Hours In 1 min, Article

Statins: A potential treatment in COVID-19?

In the HARP-2 trial of simvastatin in acute respiratory distress syndrome (ARDS), published a few years ago, the main results were neutral, but in the subgroup of patients with hyperinflammatory ARDS, there was a reduction in mortality with simvastatin in comparison with placebo.

Moreover, in a series of observational studies of patients with COVID-19, use of statins was associated with a reduction in mortality among hospitalized patients. However, there are limited high-quality data to guide clinical practice.

Source: Medscape

Clinic Hours In Article

Trastuzumab Deruxtecan has promising activity in Advanced Colorectal Cancer

Trastuzumab deruxtecan, an antibody-drug conjugate, showed “promising and durable activity” in HER2-positive metastatic colorectal cancer (CRC) refractory to standard treatment in an open-label phase-2 trial.

HER2 amplification is seen in 2% to 3% of colorectal tumors, but there are currently no approved HER2-targeted therapies for colorectal cancer.

The DESTINY-CRC01 trial evaluated trastuzumab deruxtecan in 78 patients with HER2-expressing metastatic CRC that had progressed on two or more previous regimens, including HER2-targeted therapies other than trastuzumab deruxtecan.

Patients were grouped by HER2-expression level: cohort A (HER2-positive, immunohistochemistry (IHC) 3+ or IHC2+ and in-situ hybridization (ISH)-positive; 53 patients); cohort B (IHC2+ and ISH-negative, seven patients); cohort C (IHC1+, 18 patients).

They received 6.4 mg/kg trastuzumab deruxtecan intravenously every three weeks until disease progression, unacceptable side effects, withdrawal of consent, or death.

After median follow up of 27 weeks, the objective response rate in cohort A (the primary endpoint) was 45.3% (24 of 53 patients). There was one (2%) complete response (2%) and 23 partial responses (43%), Dr. Salvatore Siena of the University of Milan, in Italy, and colleagues report in The Lancet Oncology.

Within cohort A, a greater proportion of patients with high levels of HER2 expression (IHC3+) had an objective response than did patients with IHC2+ and ISH-positive tumors (57.5% vs. 7.7%). “However, due to the low number of patients enrolled with IHC2+ and ISH-positive tumors, further studies are needed,” the investigators say.

“Although trastuzumab deruxtecan has shown antitumour activity in HER2-low breast tumors, no responses were seen among patients with HER2-low metastatic colorectal cancer tumors (cohort B, IHC2+ and ISH-negative; cohort C, IHC1+),” they note.

Source: Medscape

Clinic Hours In 1 min, Article

Varenicline nasal spray trial for Dry Eye

An experimental varenicline nasal spray can reduce signs and symptoms of dry eye disease, the results of a phase 3 trial suggest. That’s because Oyster Point’s OC-01 works by stimulating the trigeminal nerve through the nasal passage, causing the eyes to tear. By contrast, most current treatments are either anti-inflammatories or artificial tears that don’t include all the components of natural ones.

OC-01 also improves symptoms relatively fast — in as few as 14 days, rather than the 3-6 months needed for some other dry eye treatments.

Source: Medscape

Clinic Hours In Article, COVID-19

DCGI gives emergency approval of DRDO-developed anti-COVID oral drug

The Institute of Nuclear Medicine and Allied Sciences (Inmas) in collaboration with Dr Reddy’s Laboratories, Hyderabad, developed an anti-COVID-19 therapeutic application of the drug 2-deoxy-D-glucose (2-DG). The third phase of the clinical trial results has shown that this molecule helps in the faster recovery of hospitalized patients and reduces supplemental oxygen dependence. A higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in patients infected with the coronavirus.

Clinic Hours In 1 min, Article

Four months TB regimen

A new drug combination containing rifapentine and moxifloxacin has finally broken the 6-month treatment barrier for drug-susceptible pulmonary tuberculosis, requiring only 4 months to produce a disease-free state at 1 year in most patients.

In open-label, phase 3, multinational trial, Doctors pitted 4-month regimens containing 1200 mg of rifapentine taken once daily with or without 400 mg of moxifloxacin taken daily against a standard 6-month regimen of rifampin, isoniazid, pyrazinamide, and ethambutol. For both 4-month treatments, rifapentine replaced rifampin, and for one of them, moxifloxacin also replaced ethambutol.

Source: The New England Journal of Medicine