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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.
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.
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.
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...
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.
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.
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).
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...
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...
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.