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FDA approves novel drug for resistant hypertension based on PRECISION trial.

The USA FDA has approved Aprocitentan (Brand name TRYVIO) for the treatment of resistant hypertension in combination with other antihypertensive drugs.

Dose: 12.5 mg 1OD PO.

MOA: Dual endothelin receptor antagonist.

Contraindications: Pregnancy, Hypersensitivity.

Adverse effects: Edema, anemia, ⬇️ sperm count.

Warning & precautions: ERAs cause hepatotoxicity & liver failure.

Trial: PRECISION was a multicentre, blinded, randomised, parallel-group, phase 3 studydone in Europe, North America, Asia &  Australia in June 18, 2018, to April 25, 2022 by Prof Markus P Schlaich, MD et al.

Inclusion criteria: Patients with SBP > 140 mmhg who were on 3 different anti hypertensive medications including diuretics.

Objectives: The primary endpoints were changes in SBP from baseline to 4 week & from withdrawal baseline to 40 week. Secondary endpoints included 24-h ambulatory blood pressure changes.

Methods: Study consisted of 3 sequential parts:

Part 1 was 4-week double-blind, randomised, & placebo-controlled part, in which patients received aprocitentan 12·5 mg, 25 mg, or placebo in a 1:1:1 ratio.

Part 2 was a 32-week single patient blind part, in which all patients received aprocitentan 25 mg.

Part 3 was a 12-week double-blind, randomised, placebo-controlled withdrawal part, in which patients were re-randomised to aprocitentan 25 mg or placebo in a 1:1 ratio.

Findings: In patients with resistant hypertension, aprocitentan was well tolerated & superior to placebo in lowering blood pressure at 4 week with a sustained effect at 40 week.

Reference: http://clinicaltrials.gov/show/NCT03541174
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FDA approves Nivolumab for resected stage IIB/C melanoma

The US FDA has approved nivolumab for the treatment of completely resected stage IIB/C melanoma for patients aged 12 years and older, expanding the melanoma indication for the programmed death receptor-1 (PD-1) inhibitor.

Dose – For patients >40 kg,  480 mg every 4 weeks or 240 mg every 2 weeks until disease recurrence or unacceptable toxicity for up to 1 year. For pediatric patients < 40 kg, 3 mg/kg every 2 weeks or 6 mg/kg every 4 weeks until disease recurrence or unacceptable toxicity for up to 1 year.

Adverse reactions – fatigue, musculoskeletal pain, rash, diarrhea &  pruritis.

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Ritlecitinib for severe alopecia areata by European Commission

The European Commission has approved ritlecitinib to treat adults and adolescents 12 years of age and older with severe alopecia areata. Ritlecitinib is a dual inhibitor of the TEC family of tyrosine kinases and of Janus kinase 3. According to results from ALLEGRO-LT phase 3 trial, the most common adverse reactions included diarrhea (9.2%), acne (6.2%), URTI (6.2%), urticaria (4.6%), rash (3.8%), folliculitis (3.1%), and dizziness (2.3%).

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Elon Musk’s Neuralink to start human trial of brain implant for paralysis patients

Elon Musk’s brain-chip startup Neuralink has received approval to begin recruitment for the first human trial of its brain implant for paralysis patients. Those with paralysis due to cervical spinal cord injury or amyotrophic lateral sclerosis may qualify for the study. The study will use a robot to surgically place a brain-computer interface (BCI) implant in a region of the brain that controls the intention to move, Neuralink said, adding that its initial goal is to enable people to control a computer cursor or keyboard using their thoughts alone.

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FDA approves Talquetamab for multiple myeloma

The USA FDA approves Talquetamab, a first-in-class bispecific antibody targeting the GPRC5D receptor, for heavily pretreated adults with relapsed or refractory multiple myeloma.

Indication for usage: Patients must have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Dose: Both the weekly 0.4 mg/kg and biweekly 0.8 mg/kg doses are recommended. Check out the full regimens.

Adverse effects: CRS, dysgeusia, musculoskeletal pain, skin disorder, rash, fatigue, decreased weight, dry mouth, pyrexia, xerosis, dysphagia, upper respiratory tract infection & diarrhea.

Talquetamab was evaluated in the single-arm, open-label MonumenTAL-1 study of 187 patients who had previously been treated with at least four prior systemic therapies.

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Naltrexone is safe & beneficial in AUD with Cirrhosis

Naltrexone can be safely administered to patients with alcohol use disorder (AUD) and compensated cirrhosis to help them achieve abstinence and decrease craving, results of the first such randomized controlled trial show. The prospective, double-blind, single-center study at the ILBS, in New Delhi, enrolled 100 patients with alcohol dependence and cirrhosis between 2020 and 2022. Participants were randomly assigned in a 1:1 ratio to receive naltrexone (50 mg/d) or placebo for 12 weeks.

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FDA approves Sotagliflozin for heart failure

Sotagliflozin, a novel agent that inhibits sodium-glucose co transporter SGLT 1 & SGLT2 both as a treatment for adults with heart failure with or without diabetes and for T1DM & T2DM.

Dose: 200mg/400mg 1 OD.

MOA: Inhibiting SGLT2 reduces renal reabsorption of glucose and sodium which may influence several physiological functions, such as lowering both pre-and afterload of the heart and downregulating sympathetic activity. Inhibiting SGLT1 reduces intestinal absorption of glucose and sodium which likely contributes to diarrhea.

Adverse Effects:  >10% UTI, Diarrhea, Hypoglycemia, Dizziness, Genital mycotic infection.

Other approved drugs are SGLT2 inhibitors empagliflozin & dapagliflozin , both of which now have labeled indications across the spectrum of LVEF.

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FDA approves Inj Buprenorphine for opioid use disorder

The US FDA has approved extended-release injection buprenorphine (Brixadi, Braeburn Inc) for the treatment of moderate to severe opioid use disorder (OUD). The medication comes in two formulations: a weekly and a monthly version. The  adverse reactions include headache, constipation, nausea, injection-site erythema, injection-site pruritus, insomnia & UTI.

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FDA expands Atogepant approval for chronic migraine

Atogepant is the first and only, oral calcitonin gene-related peptide (CGRP) receptor antagonist approved for migraine. Dose: 60 mg dose 1 OD in chronic migraine. 30 mg and 60 mg for prevention of episodic migraine.

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Global Strategy for Diagnosis, Management & Prevention of COPD 2023 Updates

The 2023 GOLD report contains numerous updates:

Chapter 1
► A new definition of COPD has been proposed (Page 5)
► A section on Chronic Bronchitis has been added (Page 13)
► A table has been added with Proposed Taxonomy (Etiotypes) for COPD (Table 1.1)

Chapter 2
► Additional information on screening for COPD and case-finding has been included (Page 36)
► Information on Imaging and Computed Tomography (CT) has been included (Page 43)
► A table with information on the Use of CT in Stable COPD has been added (Table 2.8)

Chapter 3
► Vaccination Recommendations for people with COPD have been updated in line with current guidance from the CDC (Page 54)
► Further information on therapeutic interventions to reduce COPD mortality has been added (Page 67)
► A table has been added with information on the Evidence Supporting a Reduction in Mortality with Pharmacotherapy and Non-pharmacotherapy in COPD Patients (Table 3.6)
► Issues Related to Inhaled Delivery have been addressed (Page 69)
► Information on the topic of Adherence to Inhaled COPD Medications has been included (Page 71)
► A section on Tele-rehabilitation has been added (Page 76) Page 2 of 16
► The section on Interventional & Surgical Therapies for COPD has been expanded (Page 82)
► A figure has been added giving an Overview of Current and Proposed Surgical and Bronchoscopic Interventions for People with COPD (Figure 3.2)

Chapter 4
► A section on the choice of inhaler device has been added (Page 112)
► A table has been added with information on Basic Principles for Appropriate Inhalation Device Choice (Table 4.5)
► The ABCD Assessment Tool has been revised to the ABE Assessment Tool to recognize the clinical relevance of exacerbations, independent of the level of symptoms (Page 115)
► The information and figures outlining Initial Pharmacological Treatment and Follow-up Pharmacological Treatment have been updated. In particular, the positioning of LABA+LAMA and of LABA+ICS has been changed (Page 115)

Chapter 5
► The topic of management of exacerbations has been expanded to include details of possible alternative causes
of symptoms
► A new definition of COPD Exacerbation and a new set of parameters to assess exacerbation severity at the point of care has been included (Page 134)
► A new paragraph and a new figure on the Classification of the Severity of COPD Exacerbations have been added (Figure 5.1)
► A new table on Diagnosis and Assessment has been added (Table 5.3)

Chapter 6
► The chapter on COPD and Co-morbidities has been updated with the latest evidence.

Chapter 7
► The chapter on COVID-19 and COPD has been updated with new references and the latest evidence.

Download 2023 GOLD guide
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