Article Archives - Page 10 of 21

New drugs for migraine

Five recently approved acute migraine treatments were specifically noted: two small-molecule calcitonin gene-related peptide (CGRP) receptor antagonists — rimegepant and ubrogepant — along with the nonsteroidal anti-inflammatory drug celecoxib, the serotonin 5-HT1F agonist lasmiditan, and remote electrical neuromodulation (REN). Highlighted risks include serious cardiovascular thrombotic events in patients on celecoxib, along with driving impairment, sleepiness, and the possibility of overuse in patients on lasmiditan.

Regarding acute treatment overall, the statement recommended NSAIDs, nonopioid analgesics, acetaminophen, or caffeinated analgesic combinations — such as aspirin plus acetaminophen plus caffeine — for mild to moderate attacks. For moderate or severe attacks, they recommended migraine-specific agents such as triptans, small-molecule CGRP receptor antagonists (gepants), or selective serotonin 5-HT1F receptor agonists (ditans).

Source: Medscape

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Prasugrel better than Ticagrelor in ACS patients undergoing PCI

The ISAR-REACT 5 trial has demonstrated the superiority of prasugrel to ticagrelor for patients presenting with ACS. Ticagrelor and prasugrel are both potent inhibitors of the P2Y12 receptor, but their drug class and mechanism of action are different.

The new analysis included more than 3,300 patients, most of whom were men, with 1,676 in the ticagrelor arm and 1,701 in the prasugrel arm. The primary endpoint – a composite of all-cause death, myocardial infarction, or stroke at 12 months – was reached in 9.8% in the former group and 7.1% in the latter (hazard ratio, 1.41; P=0.005).

Source: Medscape

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FDA approves Finerenone for slowing CKD in T2DM

The FDA approved the anti-mineralocorticoid agent finerenone (Kerendia) for slowing the progression of chronic kidney disease in type 2 diabetes patients.

The first non-steroidal, selective mineralocorticoid receptor antagonist was approved to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adults with chronic kidney disease associated with type 2 diabetes.

The most common adverse events in the trial were hyperkalemia (18% vs 9% for those on placebo), hypotension, and hyponatremia. Finerenone should therefore not be used if serum potassium is above 5.0 mEq/L. Serum potassium and eGFR should also be measured in all patients prior to and during treatment and should be dosed according to these measures.

Source: FDA

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Lenvatinib-Pembrolizumab combo promising in advanced kidney cancer

The combination of the multikinase inhibitor lenvatinib and the anti-PD-1 antibody pembrolizumab has “encouraging” antitumor activity and a manageable side effect profile and might be an option following immune-checkpoint inhibitor (ICI) therapy in patients with metastatic renal-cell carcinoma (RCC), researchers report.

Pembrolizumab and lenvatinib are active as monotherapies in RCC. The phase-1b/2 Study 111/KEYNOTE-146 trialists tested the combination in 145 patients with metastatic RCC. Two patients with non-clear-cell RCC were excluded from the efficacy analysis but included in the safety analysis.

Source: Reuters Health

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Study shows tocilizumab and sarilumab reduce COVID-19 deaths

Treating critically ill COVID-19 patients with arthritis drugs tocilizumab and sarilumab significantly improves survival rates and reduces the amount of time patients need intensive care.

The immunosuppressive drugs, Actemra, also known as tocilizumab, and Kevzara, also known as sarilumab, reduced death rates by 8.5 percentage points among patients hospitalised and severely ill with the pandemic disease.

Among hospitalised Covid patients, administering one of the drugs in addition to corticosteroids reduced the risk of death by 17 percent, compared to the use of corticosteroids alone.

In patients who were not on ventilators, the risk of progressing to mechanical ventilation or death was reduced by 21 percent, compared to the use of corticosteroids alone.

Severely ill COVID patients experience an immune system overreaction known as a “cytokine storm” that can cause severe organ damage and death.

Tocilizumab and sarilumab are used to treat rheumatoid arthritis, an autoimmune condition, by inhibiting the effects of interleukin (IL)-6, a type of protein called a cytokine that signals the body to mount an inflammatory response.

But previous research on whether IL-6 inhibitors can be useful against severe COVID have variously reported benefit, no effect, and harm.

This prompted the WHO to coordinate the new study that combined data from 27 randomized trials conducted across 28 countries.

Source: Journal of the American Medical Association

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Insulin-Pramlintide combo improves type 1 diabetes control

A novel investigational coformulation of prandial insulin and pramlintide improves blood glucose control and reduces body weight in people with type 1 diabetes, early research suggests.

The injectable product combines a novel human prandial (pre-meal) insulin (A21G) with the amylin analog pramlintide. The latter reduces post-meal glucose spikes by slowing gastric emptying, reducing postprandial glucagon production, and increasing satiety.

Source: Medscape

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Adalimumab safe and effective in children with UC

Adalimumab is effective and well-tolerated in children with moderate-to-severe ulcerative colitis (UC), with “clinically meaningful” rates of clinical remission and response, including steroid-free remission and mucosal healing, according to results of the ENVISION I study.

Adalimumab is a monoclonal TNF inhibitor long used to treat adults with UC. Earlier this year, the U.S. Food and Drug Administration (FDA) approved its use in children age 5 years and older with moderately to severely active UC.

The ENVISION I study was a phase-3, randomized, double-blind, multicenter study testing high-dose and standard-dose subcutaneously administered adalimumab in 93 children aged 4 to 17 years with moderate to severe UC, defined as a full Mayo score (FMS) of six to 12 with endoscopy subscore of 2 to 3 points, despite stable oral corticosteroid of immunosuppressant therapy.

Source: Reuters Health

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What’s best for diabetes after metformin? GRADE trial states

Liraglutide and insulin glargine outperformed glimepiride and sitagliptin as single add-on agents to metformin for treating patients with type 2 diabetes in a multicenter US trial that randomized just over 5000 patients.

The GRADE trial ran for roughly 5 years at 36 US centers and was designed to answer the question of which is the best second-line agent for patients with type 2 diabetes already taking metformin. Results were reported at the virtual American Diabetes Association (ADA) 81st Scientific Sessions.

The comparison included two oral medications — the sulfonylurea glimepiride and dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin — and two injectable medications — insulin glargine and glucagon-like peptide 1 (GLP-1) receptor agonist liraglutide.

The primary endpoint was change in A1c level and overall glycemic control. Secondary endpoints include changes in weight, as well as cardiovascular, renal, gastrointestinal, and other complications.

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Hepatitis C antivirals may fight SARS-CoV-2

Sofosbuvir/ledipasvir and nitazoxanide both appeared to clear SARS-CoV-2, the virus that causes COVID-19 in a preliminary trial, said Mohamed Medhat, lecturer in the department of gastroenterology and tropical medicine at Assiut University Hospitals in Assiut, Egypt.

SARS-CoV-2 shares similarities to the hepatitis C virus in the way it replicates, Medhat said. Molecular docking studies, which use computation to find ligands that bind to proteins, suggested that both sofosbuvir/ledipasvir and nitazoxanide might block key proteins in SARS-CoV-2.

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EC approves Cemiplimab for advanced or metastatic BCC after HHI therapy

The European Commission (EC) has approved cemiplimab (Libtayo) for the treatment of adults with locally advanced or metastatic basal cell carcinoma (BCC) who progressed on or could not tolerate treatment with a hedgehog pathway inhibitor (HHI).

The safety profile of cemiplimab has been generally consistent across approved indications. Serious adverse events have been reported in 30% of 816 patients from all four cemiplimab monotherapy pivotal trials, and these led to permanent discontinuation of treatment in 8% of patients.

Immune-related adverse reactions occurred in 22% of patients, and led to permanent discontinuation in 4%. The most common such reactions were hypothyroidism (8%), hyperthyroidism (3%), pneumonitis (3%), hepatitis (2%), colitis (2%) and immune-related skin adverse reactions (2%).