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Evinacumab (Evkeeza) for Homozygous Familial Hypercholesterolemia

   
The Medical Letter on Drugs and Therapeutics • May 03, 2021  (Issue 1623)
in the US is about 1:250,000 persons.1,2 STANDARD TREATMENT — High-intensity statin therapy (atorvastatin 40-80 mg ...
The FDA has approved evinacumab-dgnb (Evkeeza – Regeneron), an angiopoietin-like 3 (ANGPTL3) inhibitor, for adjunctive IV treatment of homozygous familial hypercholesterolemia (HoFH) in patients ≥12 years old. Evinacumab is the first ANGPTL3 inhibitor to be approved in the US.
Med Lett Drugs Ther. 2021 May 3;63(1623):66-7 |  Show IntroductionHide Introduction

Tirbanibulin 1% Ointment (Klisyri) for Actinic Keratosis

   
The Medical Letter on Drugs and Therapeutics • May 03, 2021  (Issue 1623)
Tirbanibulin 1% Ointment (Klisyri) for Actinic Keratosis ...
Tirbanibulin, a microtubule inhibitor, has been approved by the FDA as a 1% ointment (Klisyri – Almirall) for topical treatment of actinic keratosis of the face or scalp.
Med Lett Drugs Ther. 2021 May 3;63(1623):70-1 |  Show IntroductionHide Introduction

Fluvoxamine for COVID-19?

   
The Medical Letter on Drugs and Therapeutics • May 03, 2021  (Issue 1623)
for treatment of COVID-19,1 and several monoclonal antibodies have been granted emergency use authorizations ...
A recent article in JAMA and an interview of its senior author on 60 Minutes have heightened interest in off-label use of the oral selective serotonin reuptake inhibitor (SSRI) fluvoxamine (Luvox, and generics) to treat COVID-19.
Med Lett Drugs Ther. 2021 May 3;63(1623):69-70 |  Show IntroductionHide Introduction

In Brief: Sacubitril/Valsartan (Entresto) Expanded Indication

   
The Medical Letter on Drugs and Therapeutics • May 03, 2021  (Issue 1623)
; LVEF ...
The oral fixed-dose combination of the neprilysin inhibitor sacubitril and the angiotensin receptor blocker (ARB) valsartan (Entresto – Novartis) was approved in 2015 to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction (HFrEF; LVEF...
Med Lett Drugs Ther. 2021 May 3;63(1623):65 |  Show IntroductionHide Introduction

In Brief: New Recommendations for Gonococcal Infection

   
The Medical Letter on Drugs and Therapeutics • May 03, 2021  (Issue 1623)
for patients with uncomplicated urogenital, rectal, or pharyngeal gonorrhea.1 RATIONALE — Previous CDC ...
The CDC has issued new recommendations for treatment of gonococcal infection. A single 500-mg IM dose (1000 mg in patients weighing ≥150 kg) of the third-generation cephalosporin ceftriaxone is now the treatment of choice for patients with uncomplicated urogenital, rectal, or pharyngeal gonorrhea.
Med Lett Drugs Ther. 2021 May 3;63(1623):72 |  Show IntroductionHide Introduction

In Brief: Johnson & Johnson COVID-19 Vaccine Suspended (online only)

   
The Medical Letter on Drugs and Therapeutics • May 03, 2021  (Issue 1623)
administration of the vaccine.1,2 In an April 14 emergency meeting, the Advisory Committee on Immunization ...
On April 13, 2021, the FDA and CDC advised suspending use of the Johnson & Johnson adenovirus-based COVID-19 vaccine while the agencies investigate 6 cases of cerebral venous sinus thrombosis (CVST) and thrombocytopenia that occurred following administration of the vaccine. In an April 14 emergency meeting, the Advisory Committee on Immunization Practices (ACIP) recommended continuing the suspension until more data become available. About 7 million people in the US have received the Johnson & Johnson vaccine.
Med Lett Drugs Ther. 2021 May 3;63(1623):e1 |  Show IntroductionHide Introduction

Low-Dose Colchicine for Coronary Artery Disease

   
The Medical Letter on Drugs and Therapeutics • Apr 05, 2021  (Issue 1621)
Low-Dose Colchicine for Coronary Artery Disease Table 1. Pharmacology Formulations 0.6 mg tabs ...
The centuries-old anti-inflammatory drug colchicine (Colcrys, and others) is FDA-approved for prophylaxis and treatment of gout flares and for treatment of familial Mediterranean fever. It is also used off-label to treat pericarditis, and in recent years has been investigated for reduction of cardiovascular risk in patients with coronary artery disease (CAD).
Med Lett Drugs Ther. 2021 Apr 5;63(1621):54-5 |  Show IntroductionHide Introduction

An EUA for Bamlanivimab and Etesevimab for COVID-19

   
The Medical Letter on Drugs and Therapeutics • Apr 05, 2021  (Issue 1621)
(see Table 1).1 Bamlanivimab received an EUA for use as monotherapy in such patients in November ...
The FDA has issued an Emergency Use Authorization (EUA) for Lilly's investigational monoclonal antibodies bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) to be administered together for treatment of mild to moderate COVID-19 in patients ≥12 years old who weigh ≥40 kg and are at high risk of progressing to severe disease and/or hospitalization (see Table 1). Bamlanivimab received an EUA for use as monotherapy in such patients in November 2020. Regeneron's investigational monoclonal antibodies casirivimab (REGN10933) and imdevimab (REGN10987) are also authorized for use...
Med Lett Drugs Ther. 2021 Apr 5;63(1621):49-50 |  Show IntroductionHide Introduction

Semaglutide (Ozempic) for Weight Loss

   
The Medical Letter on Drugs and Therapeutics • Apr 05, 2021  (Issue 1621)
subcutaneous injection of the glucagon-like peptide 1 (GLP-1) receptor agonist semaglutide (Ozempic – Novo ...
In recently published clinical trials, once-weekly subcutaneous injection of the glucagon-like peptide 1 (GLP-1) receptor agonist semaglutide (Ozempic – Novo Nordisk), which is FDA-approved for treatment of type 2 diabetes and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease, has reduced body weight significantly in patients with and without type 2 diabetes when given in addition to lifestyle intervention. Liraglutide (Saxenda), another GLP-1 receptor agonist, has been FDA-approved for chronic weight...
Med Lett Drugs Ther. 2021 Apr 5;63(1621):53-4 |  Show IntroductionHide Introduction

In Brief: Hypertension with Erenumab (Aimovig)

   
The Medical Letter on Drugs and Therapeutics • Apr 05, 2021  (Issue 1621)
in 2018 for preventive treatment of migraine in adults.1 Now the FDA has added a new warning to its ...
The once-monthly, subcutaneously injected calcitonin gene-related peptide (CGRP) receptor antagonist erenumab-aooe (Aimovig) was approved by the FDA in 2018 for preventive treatment of migraine in adults. Now the FDA has added a new warning to its labeling about a risk of new-onset hypertension and worsening of preexisting hypertension associated with use of the drug. CGRP is a potent microvascular vasodilator; blocking or deleting it has produced hypertensive effects in animals.
Med Lett Drugs Ther. 2021 Apr 5;63(1621):56 |  Show IntroductionHide Introduction