Collectively, these newly identified effects of Invokana on heart and kidney disease show significantly enhanced benefits of this medicine. Safety information from recent clinical trials also suggests that the risk of amputation, while still increased with canagliflozin, is lower than previously described, particularly when appropriately monitored. Based on these considerations, we have concluded that the Boxed Warning should be removed.
American College of Physician committee systematically reviewed 38 randomized controlled clinical trials involving testosterone supplementation in patients with age-related hypogonadism. Subjects’ mean age was 66 years, with average baseline total testosterone measures ≤300 ng/dL. Authors reached consensus on the following soft recommendations:
Physicians should be open to initiating testosterone therapy in adults with age-related hypogonadism only from the sexual dysfunction perspective. The decision to treat should be reached after a complete patient-physician discussion that includes pharmacological options, benefits, safety, and cost.
ACP recommends the intramuscular route of testosterone administration due to its low cost and similar efficacy and safety to other modes of therapy. They do not advise starting testosterone supplementation for other symptoms – apart from sexual dysfunction – such as reduced physical capacity, cognition, stamina, and vitality.
The ADA guidelines still recommend Metformin as the first drug for patients with diabetes type 2 (DM2). The advantages of Metformin are its efficacy in lowering A1c, being inexpensive, improving insulin resistance, potential weight loss, not causing hypoglycemia, and having the most extended clinical safety data – since its approval in 1957 in France and 1995 in the U.S.
If the patient has established or risk factors for cardiovascular disease, then a GLP1 agonist with proven CVD benefits is the recommended second-line medication. Examples are Ozempic, Victoza, and Trulicity. However, if a person with DM2 has heart failure or chronic kidney disease ― defined by LVEF <45%, eGFR 30-60, or urinary albuminuria >300 ― an SGLT2 inhibitor should be used. Such medications are Invokana, Jardiance, and Farxiga.
The ADA recommends the following drugs as the third line option: GLP1 agonist if already on Metformin + SGLT2 inhibitor and SGLT2 inhibitor if the patient is taking Metformin + GLP1 agonist. Any of the following agents could be fourth line therapies; sulfonylurea, basal insulin, DDP4 inhibitor, or TZD if heart failure is absent.
The above drug algorithmic guidance is general. The ultimate clinical decision is based on medication tolerability, cost, clinical setting, glucose control, comorbidities, and patient’s preference.
The FDA has been working closely with other government agencies and academic centers that are investigating the use of the drug CHLOROQUINE, which is already approved for treating malaria, lupus and rheumatoid arthritis, to determine whether it can be used to treat patients with mild-to-moderate COVID-19 to potentially reduce the duration of symptoms, as well as viral shedding, which can help prevent the spread of disease. Studies are underway to determine the efficacy of using chloroquine to treat COVID-19.
The test we’re authorizing today will be able to provide Americans with results within hours, rather than days like the existing tests, and the company plans to roll it out by March 30, which is an incredibly rapid timeline for such an effort. With new tools like point-of-care diagnostics, we are moving into a new phase of testing, where tests will be much more easily accessible to Americans who need them.
With the development of point of care diagnostics, Americans who need tests will be able to get results faster than ever before. More and more options for reliable, convenient testing are becoming available at an incredibly rapid pace, thanks to the hard work of our FDA team and the ingenuity of the American industry.
Today marks an important step in expanding the availability of testing and, importantly, rapid results. Point-of-care testing means that results are delivered to patients in the patient care settings, like hospitals, urgent care centers, and emergency rooms, instead of samples being sent to a laboratory. With today’s authorization, there is now an option for testing at the point of care, which enables patient access to more immediate results.
We believe the actual number of 2019-nCoV cases in mainland China is likely much higher than that reported to date. Specifically, we estimate there to be around 58,000 cumulative cases of 2019-nCoV in mainland China by the end of January (as of January 31, the reported cases are close to 12,000). This estimate is in line with our previous analysis on January 25, which estimated the proportion of reported to estimated cases to be close to 10%.
It is likely that part of this discrepancy is due to reporting delays. However, the substantially larger number of estimated cases suggest a majority of the cases may be mild (or asymptomatic), do not require seeking medical care, and thus are not reported. Furthermore, based on this analysis, we believe the outbreak began in November, and there were already hundreds of human cases of 2019-nCoV in Wuhan in early December. The estimated verses confirmed cases during January are presented below.
There were 181 confirmed cases with identifiable exposure and symptom onset windows to estimate the incubation period of COVID-19. The median incubation period was estimated to be 5.1 days, and 97.5% of those who develop symptoms will do so within 11.5 days of infection. These estimates imply that, under conservative assumptions, 1% (1 in 100) of infected cases will develop symptoms after 14 days of active monitoring or quarantine.
In 2008, the Food and Drug Administration mandated the pharmaceutical industry to prove cardiovascular safety for all new anti-diabetes medications. As a consequence, we presently have critically useful safety data from clinical trials like LEADER, SUSTAIN, CANVAS, PIONEER 6, DECLARE-TIMI 58, and REWIND.
The FDA has now issued a new draft recommendation to broaden the above requirement by including safety clinical trials for nephropathy, neuropathy, retinopathy, and sleep apnea, in addition to ischemic atherosclerosis. The rationale is that the above non-ASCVD complications can also increase the mortality risk in patients with type 2 diabetes.
Although recommendations have not been specified or finalized, they will change the landscape of anti-diabetes clinical research for the next 15 years. Stay tuned.
Here you can find the critical modifications in 2020 ADA guidelines. Particular emphasis is placed on pharmacological therapy with GLP-1 agonists or SGLT-2 inhibitors for patients with established cardiovascular disease, heart failure, or chronic kidney disease. Guidelines are published yearly in the month of January.
Here is a good summary of the enlightenment period lasting approximately from 1685 to 1815. Enlightenment was founded on Italian and Northern Renaissance Humanism, which in turn gave way to Romanticism, Liberalism, Classicism, and Modernism.
“If I have seen further than others, it is by standing upon the shoulders of giants.”
“It is dangerous to be right in matters on which the established authorities are wrong.”
“Dare to know! Have the courage to use your own reason!”
The above three quotes of legendaries, Isaac Newton, Voltaire, and Immanuel Kant, capture the spirit of the age:
Cushing’s syndrome (CS) is a rare condition. It’s health consequences can be severe, leading to visceral adiposity, muscle weakness, depression, insulin resistance, diabetes, blood clots, reduced immune system, and cardiovascular disease.
A portion of patients diagnosed with CS has Cushing’s disease (CD). In Cushing’s disease, the root cause of hypercortisolism is a pituitary tumor producing excessive ACTH hormone. The preferred treatment is pituitary surgery. Unfortunately, in a small subset of patients, the operation is not successful or indicated.
To address the health concerns for individuals who are not responsive or candidates for pituitary tumor resection, the FDA has now approved a backup treatment via the oral drug Isturisa.
Isturisa, taken twice daily, is a potent inhibitor of 11-β-hydroxylase, a key enzyme in cortisol production. Side effects can include relative adrenal insufficiency, swelling, nausea, vomiting, and headaches. Clinical studies have shown that about 50% of patients respond to therapy.
Isturisa is an excellent addition to the arsenal of combating refractory Cushing’s disease.
Women who are diagnosed accurately with hypoactive sexual desire dysfunction (HSDD) and female sexual arousal disorder (FSAD), could benefit from testosterone supplementation. Testosterone therapy appears to be helpful and safe when the dose does not exceed premenopausal physiological levels. For more details, refer to the Global Position Statement published in JCEM in October 2019.