Clinic Hours, Author at Clinic Hours

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

Clinical Inshorts by ClinicHours

Clinic Hours In Medical Cases

Posterior wall myocardial Infarction case

History: A 55 yr old male presented to ED with severe left-sided chest pain from 20 minutes radiating to the left arm associated with SOB and diaphoresis. Bp – 140/82mmhg, P – 84 bpm, spo2 – 92% on RA. ECG done. What’s the diagnosis?

Answer: Posterior MI is suggested by the following changes in V1-3:

Horizontal ST depression
Tall, broad R waves (>30ms)
Upright T waves
Dominant R wave (R/S ratio > 1) in V2

Posterior infarction is confirmed by the presence of ST elevation and Q waves in the posterior leads (V7-9). Leads V7-9 are placed on the posterior chest wall in the following positions (see diagram below):

Posterior leads V7 V8 V9 ECG placement

Source: LITFL

OR you can invert the ECG to see a typical STEMI. For example:

ECG Posterior AMI flip image V2

Source: LITFL

The above patient was taken for thrombolysis after stabilization. ECG after thrombolysis.

Clinical Rounds by ClinicHours

Clinic Hours In Article, FDA Updates

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.

Clinical Inshorts by ClinicHours

Clinic Hours In Medical Cases

Atrial fibrillation in CKD patient case

History: A 67-year-old male k/c/o CKD-5 on MHD thrice weekly with Type2DM & HTN presented to ED with SOB, anasarca and AMS. P – 164 bpm irregular, SP02- 80 % on RA, RR – 30, R/E – B/L AE ↓ with B/L crepitations +nt. E3V2M5. ABG – pH 7.17, pCO2 9.7, Na+ 135, k+ 4.5, Lac 10.7, Glu 141, HCO3- 3.6. ECG was done. What’s the diagnosis?

Answer: ECG shows irregularly irregular narrow complex tachycardia with absent P waves & ST ↓ V4-V6 which is s/o Atrial fibrillation.

Classification is dependent on the presentation and duration of atrial fibrillation as below:

First episode – initial detection of AF regardless of symptoms or duration
Recurrent AF – More than 2 episodes of AF
Paroxysmal AF – Self-terminating episode < 7 days
Persistent AF – Not self-terminating, duration > 7 days
Long-standing persistent AF – > 1 year
Permanent AF – Duration > 1 yr in which rhythm control interventions are not pursued or are unsuccessful.

How will you manage the above patient in the ED? Write down in the comment section.

Clinical Rounds by ClinicHours

Clinic Hours In Article, New Drug

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%).

Clinical Inshorts by ClinicHours

Clinic Hours In 1 min, Article

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.

Clinical Inshorts by Clinic Hours

Clinic Hours In Medical Cases

Intracranial hemorrhage in CKD patient case

History: A 47-year-old male was brought to ED in an unresponsive state with h/o 1 episode of seizure at home. He is k/c/o CKD5 on MHD twice weekly. BP – 200/120 mmHg, P -118 bpm, Sp02 – 92 % on RA. GCS – E2V1M4. B\L plantar – mute. RBS – 124 mg/dl. ABG (on o2 support) – PH 7.35 PCO2 34.4 PO2 106 HCO3 19.3 Lac – 4. NCCT head was done. What’s the diagnosis?

Answer: NCCT head reveals Intraparenchymal hemorrhage bleed with surrounding edema in left fronto-parieto-temporal, left gangliocapsular region and thalamus extending to the ventricular region with midline shift towards the contralateral side. The patient was intubated i/v/o low GCS and was admitted to the neurosurgery ICU after giving Inj. Levetiracetam 1.5 gm, Inj. Furosemide 40mg, IVF 3% Nacl.

Clinical Rounds by ClinicHours

Clinic Hours In Article, FDA Updates

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.

Clinical Inshorts by Clinic Hours

Clinic Hours In Medical Cases

Port wine stain case

History: A 8-month girl was brought to Dermatology OPD by her mother with a diffuse reddish macular lesion on the right side of her face present since birth. Lesion was smaller, lighter in colour & gradually increased in size. What’s the diagnosis?

Intro: Port wine stain (nevus flammeus) is a discoloration caused by a capillary malformation in the skin. Named after fortified red wine from Portugal.

Cause: Mutation in GNAQ gene on chromosome 9q21 & RASA1 gene. Associated with Sturge-Weber syndrome or Klippel–Trénaunay-Weber syndrome.

Types: Nevus flammeus nuchae, Midline nevus flammeus.

CF: Flat & pink asymptomatic macular patch usually seen at birth or may be acquired. Color may deepen to a dark red or purplish color in adults. Common sites are face, head, neck, abdomen, legs, or arms.

Dx: History based, skin biopsy, MRI Brain (R/O Sturge–Weber syndrome).

Rx: Pulse Dye or Nd: YAG or KTP Laser, surgery excision, radiation, tattooing, rapamycin LA. If left untreated, these vascular lesions may deepen in color or may undergo hypertrophy & nodular thickening.

Clinical Rounds by ClinicHours

Clinic Hours In 1 min, Article

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.