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Opicapone (Ongentys) - A COMT Inhibitor for Parkinson's Disease
The Medical Letter on Drugs and Therapeutics • Jan 11, 2021 (Issue 1615)
clinical trials, opicapone significantly reduced “off” time by
about 1 hour, compared to placebo. In one ...
The FDA has approved opicapone (Ongentys –
Neurocrine), a peripherally-acting reversible catechol-O-methyltransferase (COMT) inhibitor, for oral use as an
adjunct to carbidopa/levodopa in adults with Parkinson’s
disease (PD) who experience "off" episodes. It is the
third COMT inhibitor to be approved for this indication;
tolcapone (Tasmar, and generics) and entacapone
(Comtan, and generics) were approved earlier. Opicapone
has been available in Europe since 2016.
Drugs for Menopausal Symptoms
The Medical Letter on Drugs and Therapeutics • Mar 04, 2024 (Issue 1697)
is the most effective treatment for GSM.1 When OTC
nonhormonal products are ineffective, low-dose
vaginal ...
The primary symptoms of menopause are genitourinary
and vasomotor. The genitourinary syndrome
of menopause (GSM) includes symptoms such as
burning, irritation, dryness, dyspareunia, dysuria,
and recurrent urinary tract infection. Vasomotor
symptoms (VMS; hot flashes, night sweats) often
disrupt sleep.
Med Lett Drugs Ther. 2024 Mar 4;66(1697):33-8 doi:10.58347/tml.2024.1697a | Show Introduction Hide Introduction
An EUA for Baricitinib (Olumiant) for COVID-19
The Medical Letter on Drugs and Therapeutics • Dec 28, 2020 (Issue 1614)
in combination with the IV antiviral drug remdesivir
(Veklury).1 Baricitinib has been available for treatment ...
The oral Janus kinase (JAK) inhibitor baricitinib
(Olumiant – Lilly) has been granted an FDA Emergency
Use Authorization (EUA) for treatment of confirmed or
suspected COVID-19 in hospitalized patients ≥2 years
old who require supplemental oxygen, mechanical
ventilation, or extracorporeal membrane oxygenation
(ECMO); the EUA requires that baricitinib be used
in combination with the IV antiviral drug remdesivir
(Veklury). Baricitinib has been available for treatment
of rheumatoid arthritis since 2018. Remdesivir was
recently approved by the FDA for treatment of COVID-19
in...
COVID-19 Update: Bivalent Pfizer and Moderna COVID-19 Vaccines for Booster Immunization
The Medical Letter on Drugs and Therapeutics • Oct 03, 2022 (Issue 1660)
in persons ≥12 years old.1
THE NEW FORMULATIONS – The bivalent vaccine
formulations contain equal amounts ...
The FDA has amended its Emergency Use Authorizations
(EUAs) for the mRNA COVID-19 vaccines
manufactured by Pfizer/BioNTech (Comirnaty)
and Moderna (Spikevax) to permit use of bivalent
formulations of the products as a single booster dose
in persons ≥12 years old (Pfizer) or ≥18 years old
(Moderna) whose most recent COVID-19 vaccine dose
was a monovalent product given ≥2 months previously
as a booster or for completion of a primary series. The
bivalent formulations are not authorized for primary
immunization. Monovalent Pfizer and Moderna
COVID-19 vaccines are no longer...
In Brief: Empagliflozin (Jardiance) for Chronic Kidney Disease
The Medical Letter on Drugs and Therapeutics • Nov 13, 2023 (Issue 1689)
to improve renal outcomes (see
Table 1). The SGLT2 inhibitors ertugliflozin (Steglatro)
and bexagliflozin ...
The sodium-glucose cotransporter 2 (SGLT2) inhibitor
empagliflozin (Jardiance – Boehringer Ingelheim/Lilly) is now FDA-approved to reduce the risk of
sustained eGFR decline, end-stage kidney disease,
cardiovascular death, and hospitalization in adults with
chronic kidney disease (CKD) at risk of progression.
It is also approved to improve glycemic control in
patients ≥10 years old with type 2 diabetes, to reduce
the risk of cardiovascular death and hospitalization
for heart failure (HF) in adults with HF, and to reduce
the risk of cardiovascular death in adults with type...
Med Lett Drugs Ther. 2023 Nov 13;65(1689):183-4 doi:10.58347/tml.2023.1689c | Show Introduction Hide Introduction
Lemborexant (Dayvigo) for Insomnia
The Medical Letter on Drugs and Therapeutics • Jun 29, 2020 (Issue 1601)
)
was the first.1
Table 1. Pharmacology
Class Orexin receptor antagonist
Formulation 5, 10 mg tablets
Route ...
The FDA has approved lemborexant (Dayvigo – Eisai),
an orexin receptor antagonist, for treatment of sleep-onset
and/or sleep-maintenance insomnia in adults. It
is the second orexin receptor antagonist to be approved
for this indication; suvorexant (Belsomra) was the first.
In Brief: A New Glucagon Injection (Gvoke) for Severe Hypoglycemia
The Medical Letter on Drugs and Therapeutics • Nov 18, 2019 (Issue 1585)
for use in patients ≥4 years old.1
Children ...
The FDA has approved a new formulation of glucagon
(Gvoke – Xeris) for subcutaneous treatment of severe
hypoglycemia in patients ≥2 years old with diabetes.
Conscious patients with symptoms of hypoglycemia can
take oral glucose. Glucagon is usually administered by a
caregiver to an unresponsive patient. The new formulation is
available in a single-use prefilled syringe (Gvoke PFS) and is
expected to become available in a single-use auto-injector
(Gvoke HypoPen) in 2020. Unlike previously available
injectable glucagon products (Glucagon Emergency Kit,
and others), Gvoke does not...
In Brief: Semaglutide (Wegovy) for Weight Loss in Children
The Medical Letter on Drugs and Therapeutics • Feb 20, 2023 (Issue 1670)
IN BRIEF
Semaglutide (Wegovy) for Weight Loss in Children
The injectable glucagon-like peptide-1 ...
The injectable glucagon-like peptide-1 (GLP-1)
receptor agonist semaglutide (Wegovy), which was
approved by the FDA in 2021 for chronic weight
management in adults, has now been approved for
chronic weight management in children ≥12 years old
with an initial BMI in the ≥95th percentile for age and
sex.Semaglutide is also available as Ozempic and
Rybelsus for treatment of type 2 diabetes in adults.
Med Lett Drugs Ther. 2023 Feb 20;65(1670):31-2 doi:10.58347/tml.2023.1670d | Show Introduction Hide Introduction
Dostarlimab (Jemperli) for Endometrial Cancer (online only)
The Medical Letter on Drugs and Therapeutics • Apr 03, 2023 (Issue 1673)
, estimated PFS at 24 months
was also significantly higher with dostarlimab than
with placebo (36.1% vs 18.1 ...
The FDA has granted regular approval to dostarlimabgxly
(Jemperli – GSK), an immune checkpoint
inhibitor, for treatment of adults with mismatch repair
deficient (dMMR) recurrent or advanced endometrial
cancer that has progressed on or following a prior
platinum-containing regimen in any setting and who
are not candidates for curative surgery or radiation.
Dostarlimab received accelerated approval in 2021
for treatment of adults with dMMR recurrent or
advanced endometrial cancer or nonendometrial
solid tumors that progressed on or following prior
treatment and who have no...
Med Lett Drugs Ther. 2023 Apr 3;65(1673):e64-5 doi:10.58347/tml.2023.1673h | Show Introduction Hide Introduction
Vibrant – An Oral Vibrating Capsule for Chronic Idiopathic Constipation
The Medical Letter on Drugs and Therapeutics • May 01, 2023 (Issue 1675)
,
and a need for manual maneuvers to aid defecation.1
STANDARD TREATMENT — Dietary changes, fiber
supplements ...
The Vibrant orally administered vibrating capsule
(Vibrant Gastro), an FDA-cleared medical device, is
now available by prescription for treatment of adults
with chronic idiopathic constipation (CIC) who have
not experienced relief of their bowel symptoms
by using laxative therapies at the recommended
dosage for at least one month. It is the first drug-free
treatment to be authorized by the FDA for this
indication.
Med Lett Drugs Ther. 2023 May 1;65(1675):65-7 doi:10.58347/tml.2023.1675a | Show Introduction Hide Introduction