Day: 05/18/2022
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FDA approves tirzepatide, first dual incretin agonist for type 2 diabetes
The FDA announced it approved the injectable dual incretin agonist tirzepatide to improve glucose response in adults with type 2 diabetes in addition to diet and exercise.
Tirzepatide (Mounjaro, Eli Lilly) is a first-in-class medicine that activates both the GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) receptors, which leads to improved glucose control. Tirzepatide is injected once weekly, with the dose adjusted as tolerated to meet blood glucose goals.
“Given the challenges many patients experience in achieving their target blood sugar goals, today’s approval of Mounjaro is an important advance in the treatment of type 2 diabetes,” Patrick Archdeacon, MD, associate director of the division of diabetes, lipid disorders and obesity in the FDA’s Center for Drug Evaluation and Research, said in a press release.
As Healio previously reported, the SURPASS clinical trial program, which assessed three different doses of tirzepatide (5 mg, 10 mg and 15 mg) across five trials, demonstrated that tirzepatide significantly reduced HbA1c for adults with type 2 diabetes with low rates of hypoglycemia. Tirzepatide was compared against placebo, the GLP-1 receptor agonist semaglutide (Ozempic, Novo Nordisk) and two long-acting insulin analogs.
On average, patients randomly assigned the 15 mg dose of tirzepatide experienced a 1.6% decrease in HbA1c vs. placebo and 1.5% more than placebo when used in combination with a long-acting insulin.
In trials comparing tirzepatide with other diabetes medications, patients who received the 15 mg dose experienced a 0.5% greater reduction in HbA1c compared with patients assigned semaglutide, a 0.9% greater reduction compared with those assigned insulin degludec (Tresiba, Novo Nordisk) and a 1% greater reduction compared with those assigned insulin glargine (Lantus, Sanofi).
Obesity was common among study participants, with an average BMI of 32 to 34 kg/m2 at enrollment. Among patients randomized to 15 mg dose, average weight loss with tirzepatide was 15 pounds more than placebo when neither were used with insulin and 23 pounds more than placebo when both were used with insulin.
Adverse events with tirzepatide include nausea, vomiting, diarrhea, decreased appetite, constipation, upper abdominal discomfort and abdominal pain.
The FDA noted that tirzepatide causes thyroid C-cell tumors in rats; it is unknown whether the drug causes such tumors, including medullary thyroid cancer, in humans. Tirzepatide should not be used in patients with a personal or family history of medullary thyroid cancer or in patients with multiple endocrine neoplasia syndrome type 2, according to the FDA.
Tirzepatide has not been studied in patients with a history of pancreatitis and it is not indicated for use in people with type 1 diabetes, the agency stated in the release.
Tirzepatide received priority review designation for this indication from the FDA. A priority review designation directs overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions.
PERSPECTIVE
Daniel S. Hsia, MD
To have another novel agent to add to our armamentarium — the first combination GLP-1/GIP agonist — is really exciting. On top of that, the added benefit of weight loss for patients with type 2 diabetes is equally exciting. From the clinical trial data, GLP-1 and GIP seem to work synergistically. From a CV standpoint, we want to make sure these agents are safe; that trial is currently ongoing. We also hope to see additional benefits, similar to what we see with the SGLT2 inhibitors and GLP-1 receptor agonists with lowering CV risk; SGLT2 inhibitors are approved specifically for heart failure. The weight loss benefits of tirzepatide are promising. Many of our patients do not have type 2 diabetes alone; there are other comorbidities. If we can treat multiple diseases with one drug, our patients are much better off. Hopefully, this will be covered by insurance plans, so our patients have access to it.
Daniel S. Hsia, MD
Associate Professor and Endocrinologist, Clinical Trials Unit
Pennington Biomedical Research Center
The health benefits of 3 herbal teas
They say there’s nothing a cup of tea can’t fix, and there is some truth to that. With historical roots in East Asia, people of different cultures from around the world have been drinking tea for thousands of years. Science appears to support this practice.
But what is tea, exactly? In short, tea is the second most popular beverage in the world, next to water. Tea is produced by steeping the young leaves and leaf buds of the tea plant, Camellia sinensis into boiled water. Two types of tea are commonly used—the small-leaved China plant (C. sinensis variety sinensis) and the large-leaved Assam plant (C. sinensis variety assamica).
A number of studies have shown that certain teas, such as green tea, can boost your immune system, fight off inflammation, promote cardiovascular health, and even prevent the development of certain cancers. These health benefits are associated with specific antioxidants found in tea, known as polyphenols.
What is herbal tea?
Despite the name, herbal tea is not actually “tea” as these beverages typically do not contain the leaves or leaf buds of tea plants. Herbal teas are made from tisanes, which are blends or infusions of dried fruits, flowers, spices or herbs in water. Tisanes have been shown to offer medicinal effects. Be an informed consumer—many beverages marketed as “herbal tea” with “herbal tea benefits” are nothing more than sugary juice. Is herbal tea good for you? Some herbal teas offer health-promoting properties and have been used as natural remedies for centuries.
Dieticians recommend herbal teas in moderation with medical approval as they can pose some risks to individuals with certain health conditions. Avoid herbal teas that contain added sugar and other additives. Herbal tea should not be used as a substitute for medical treatment.
Three healthy herbal teas
1. Ginger tea
Best known as a trusted nausea remedy, ginger tea has a spicy and full-bodied flavor. It contains the antioxidant gingerol, which is the main bioactive disease-fighting compound found in ancient ginger root. Ginger also contains trace amounts of vitamins and minerals such as vitamin B3 and B6, iron, potassium and vitamin C.
Despite a lack of scientific research on ginger tea, there is research on ginger itself as it has been used as an herbal medicine for a variety of health problems. Ginger has been shown to boost the immune system and combat inflammation. A recent systematic review of ginger’s effects on human health supports its ability to help treat a range of ailments, such as gastrointestinal function, pain, inflammation, metabolic syndromes, and more.
Ginger may slow blood clotting, and can be potentially dangerous for people taking antiplatelet drugs like aspirin or clopidogrel (Plavix) or anticoagulant drugs, such as warfarin (Coumadin), apixaban (Eliquis), dabigatran (Pradaxa), or rivaroxaban (Xarelto). Also ginger can cause extra bleeding during and after surgery.
If you have a health condition or you are pregnant, consult with your doctor to determine whether drinking ginger tea is safe for you.
2. Chamomile tea
Chamomile tea is more than just a calming beverage to consume before bedtime. Chamomile is an herb taken from the flowers of the Asteraceae plant family. People around the world have been using it as natural remedy for several health conditions since ancient times. Chamomile contains a variety of bioactive phytochemicals, notably flavonoids which function as antioxidants. It also contains small amounts of minerals and vitamins, such as potassium, calcium, carotene and folate, among other nutrients.
Research studies suggest several possible chamomile benefits, including a lower risk of death from heart disease, immune system support, and possible protection against some cancers. According to a research review, chamomile tea may also help women who suffer from premenstrual syndrome. Researchers tout the tea’s anti-inflammatory and anti-anxiety effects. Interestingly, studies show chamomile might even slow age-related bone loss.
If you have a history of severe allergies—especially to pollens, you should avoid chamomile as it may be cross-contaminated with pollen from other plants.
3. Hibiscus tea
Last but not least, hibiscus tea is made from the brightly colored flowers of the hibiscus plant. The most common colors of the beautiful blooms are red-orange, pink, yellow, and white. The “calyx” is the part of the hibiscus plant that protects the bloom. Dried calyces are used in hibiscus tea, offering a refreshing yet tart flavor. In addition to providing antioxidant power, hibiscus tea contains small amounts of potassium, calcium, magnesium and other trace minerals.
Hibiscus tea offers antiviral and cardiovascular benefits, mainly due to the antioxidant “anthocyanins.” This herbal tea has been shown to be effective against some strains of bird flu. A study showed hibiscus tea may help lower blood pressure. A meta-analysis of studies on the topic echo these benefits. Another interesting cardiovascular benefit of this herbal tea is its ability to help decrease LDL (bad) cholesterol levels. A research review showed that consuming hibiscus tea or extract decreases bad LDL cholesterol and triglyceride levels.Avoid drinking hibiscus tea if you take the diuretic medication hydrochlorothiazide because the two may negatively interact. Hibiscus tea may also interfere with a the effects of aspirin, and health professionals recommend they be taken 3–4 hours apart. Check with your physician to verify what is best for you.
Discovering a New Standard for Treating Depressive Symptoms
Summary
Depression is currently ranked as the third leading contributor to global disease burden, and it is estimated that it will be number one by 2030. Care coordination models have been shown to help improve patient outcomes and reduce costs. Yet evidence-based standards for successfully contacting and engaging patients through care coordination are lacking. This study examines Integrated Health Hawaii’s engagement-focused care coordination model to provide evidence for the most effective utilization of care coordination with those suffering from depression in a diverse population. The current standard of making a “good effort,” three attempts, may only be reaching 60% of patients. To reach at least 75% of patients, seven attempts should be made; and to reach 95% of patients, 10 attempts should be made. These attempts can be made within a 2-week period, and the outcomes prevented are substantial in terms of alleviating symptoms, reducing Patient Health Questionnaire-9 scores, and preventing more costly care, including ER visits and self-harm.
Epinephrine (adrenaline) compared to selective beta-2-agonist in adults or children with acute asthma: a systematic review and meta-analysis
Abstract
Background International asthma guidelines recommend against epinephrine (adrenaline) administration in acute asthma unless associated with anaphylaxis or angio-oedema. However, administration of intramuscular epinephrine in addition to nebulised selective β2-agonist is recommended for acute severe or life-threatening asthma in many prehospital guidelines. We conducted a systematic review to determine the efficacy of epinephrine in comparison to selective β2-agonist in acute asthma.
Methods We included peer-reviewed publications of randomised controlled trials (RCTs) that enrolled children or adults in any healthcare setting and compared epinephrine by any route to selective β2-agonist by any route for an acute asthma exacerbation. The primary outcome was treatment failure, including hospitalisation, need for intubation or death.
Results Thirty-eight of 1140 studies were included. Overall quality of evidence was low. Seventeen studies contributed data on 1299 participants to the meta-analysis. There was significant statistical heterogeneity, I2=56%. The pooled Peto’s OR for treatment failure with epinephrine versus selective β2-agonist was 0.99 (0.75 to 1.32), p=0.95. There was strong evidence that recruitment age group was associated with different estimates of the odds of treatment failure; with studies recruiting adults-only having lower odds of treatment failure with epinephrine. It was not possible to determine whether epinephrine in addition to selective β2-agonist improved outcomes.
Conclusion The low-quality evidence available suggests that epinephrine and selective β2-agonists have similar efficacy in acute asthma. There is a need for high-quality double-blind RCTs to determine whether addition of intramuscular epinephrine to inhaled or nebulised selective β2-agonist improves outcome.
Sjögren’s syndrome ‘not curable, but certainly treatable’ with available therapies
Although not currently curable, the symptoms of Sjögren’s syndrome, like dry eyes and dry mouth, can be effectively managed using a variety of therapies, said a speaker said at the Congress of Clinical Rheumatology East 2022 meeting.
“There are no curative therapies, but we certainly have the tools to palliate these symptoms and prevent complications,” Frederick B. Vivino, MD, MS, of Penn Presbyterian Medical Center, in Philadelphia, said in his presentation.
Vivino noted that although dry eyes and mouth are consistently the most important issues reported by patients, there are options to treat the full range of Sjögren’s manifestations, including lung disease.
Regarding the “all-important” dry eyes, Vivino suggested that multiple options are available, depending on the severity of the complication. These include anti-inflammatory drops, omega-3 fatty acids, punctal plugs and moisture chamber glasses. Steroid eye drops may also be used in certain cases.
“But, of course, after a month, the incidence of glaucoma and cataracts caused by steroids tends to go up,” Vivino said.
Autologous serum tears created from the patient’s own blood are available in severe cases.
“Sometimes that provides the best relief of all,” Vivino said. However, he noted that most insurance companies will not pay for this treatment.
When patients develop eye infections, azithromycin drops may be used, along with antibiotic ointments such as 0.5% erythromycin ocular ointment or oral doxycycline.
“The issue here is that because Sjögren’s is a chronic condition, these infections may recur,” Vivino said.
There can be many causes of Sjögren’s-associated dry mouth, but Vivino stressed that many medications can also cause this complication.
“Sometimes a common-sense approach is to work with primary care and other clinicians to eliminate as many drugs as possible,” he said.
For patients with mild dry mouth, gustatory or masticatory stimulus with sugar-free lozenges is a “perfectly adequate” approach, according to Vivino. As severity increases, secretagogues are an effective option.
“The most important thing is to ignore the manufacturers’ directions for dosing secretagogues,” Vivino said, noting that these recommendations are often too aggressive. “Start low and go slow.”
For still more severe cases, pilocarpine 5 mg or cevimeline 30 mg after dinner may have utility, he added.
“When you try this therapeutic approach, make sure you try both [drugs] before you give up,” Vivino said.
Turning to systemic manifestations of Sjögren’s syndrome, Vivino noted that interstitial lung disease can warrant immediate attention.
“Over the last several years, it has become apparent that ILD has become a source of not only morbidity, but mortality in Sjögren’s,” he said.
That said, there is hope.
“ILD in Sjögren’s is treatable and even curable,” Vivino said. “I would like you to remember that.”
Steroids are the first-line therapy for these patients.
“Patients are almost always steroid responsive, which is very gratifying,” Vivino said.
Next in line are mycophenolate mofetil or azathioprine. If these drugs fail and reassessment is necessary, rituximab (Rituxan, Genentech) or a calcineurin inhibitor is recommended.
“If it is in the fibrotic stage, it is nintedanib (Ofev, Boehringer Ingelheim),” he said.
Vivino urged clinicians to research the full spectrum of complications that can occur in patients with this condition.
“Sjögren’s syndrome, unfortunately, is not curable but it is certainly treatable,” he said. “These patients have syndromes that are worthy of your time and effort as rheumatologists.”
FDA proposes rules prohibiting menthol cigarettes, flavored cigars
The FDA proposed prohibiting menthol cigarettes and flavored cigars. The new product standards are designed to substantially prevent disease and death from combusted product use and to prevent young people from starting to smoke.
“The proposed rules would help prevent children from becoming the next generation of smokers and help adult smokers quit,” HHS SecretaryXavier Becerra said in an FDA news release. “Additionally, the proposed rules represent an important step to advance health equity by significantly reducing tobacco-related health disparities.”
This proposal is based on science and evidence establishing the addictiveness and harm of combusted tobacco products and build on the Family Smoking Prevention and Tobacco Control Act that prohibits all flavors, other than tobacco and menthol, in cigarettes in 2009, according to the release. The proposal will address manufacturers, distributers, wholesalers, importers and retailers involved with these products in the U.S.
The finalized proposal is meant to accomplish the following:
- Reduce cigarette and cigar appeal specifically among youths and young adults, which will decrease the likelihood or initiation.
- Improve the health and reduce the mortality risk for current smokers using menthol cigarettes through decreasing consumption and increasing cessation likelihood.
- Improve public health by increasing cigar cessation likelihood among current users.
“The authority to adopt tobacco product standards is one of the most powerful tools Congress gave the FDA, and the actions we are proposing can help significantly reduce youth initiation and increase the chances that current smokers quit,” FDA Commissioner Robert M. Califf, MD, said in the release. “It is clear that these efforts will help save lives. Through the rule-making process, there’s an important opportunity for the public to make their voices heard and help shape the FDA’s ongoing efforts to improve public health.”
PERSPECTIVE
Menthol decreases the harshness and increases the addictiveness of cigarettes. Young people who start smoking with menthol are more likely to go on to become regular smokers and less likely to stop. The tobacco industry has targeted marketing of menthol flavored products to communities of color to increase levels of addiction to their deadly product. Cigars with fruit and candy flavors are specifically designed to attract youth.
The proposed rules would not place individual consumers who use the products at risk – the enforcement action targets the only sellers – those who manufacture, distribute, wholesale, import, and retail sales of the products.
There is a strong evidence base supporting the public health benefits of banning menthol cigarettes and flavored cigars. Prohibitions on menthol cigarettes and flavored cigars are critically important tobacco control strategies to protect our youth.
I am hopeful that the FDA will implement this critically important regulation, and that the FDA does not stop at menthol cigarettes and flavored cigars. Flavors, including mint and menthol need to be banned from chewing tobacco (a US Tobacco – now part of Altria – representative once famously said, “Cherry Skoal is for somebody who likes the taste of candy, if you know what I’m saying.”), from electronic cigarette/vaping products (not restricted to just cartridge-based products), and other tobacco products. Protecting our youth and fulfilling the FDA Center for Tobacco Products responsibility to protect the public health demands no less.
Harold J. Farber, MD, MSPH
Professor of pediatrics, pulmonary section
Baylor College of Medicine and Texas Children’s Hospital
High levels of synthetic cooling agents in e-cigarettes may exceed safety thresholds
“We were concerned that menthol and synthetic compounds or artificial compounds that are similar to menthol are also in e-cigarettes,” Sven-Eric Jordt, PhD, associate professor in anesthesiology and associate professor of pharmacology and cancer biology at Duke University School of Medicine, told Healio during the American Thoracic Society International Conference. “These compounds have the same cooling effect as menthol. We wanted to see what the levels are, how much is added to the e-cigarettes and whether there might be some concerns about toxicity in these compounds. They are permitted for use in foods, but we don’t know their safety when you inhale them in tobacco products. Some international regulatory organizations have issued threshold values for raising toxicity concerns.”
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