Gerti Tashko

FIDELIO-DKD trial renders Kerendia (finerenone) the FDA approval

The study also compared the two groups for the number of patients who experienced cardiovascular death, a non-fatal heart attack, non-fatal stroke, or hospitalization for heart failure. Results showed that 367 of the 2,833 patients receiving Kerendia had at least one of the events in the composite endpoint compared to 420 of the 2,841 patients who received a placebo, with the treatment showing a reduction in the risk of cardiovascular death, non-fatal heart attack, and hospitalization for heart failure.

FDA

FDA removes boxed warning for leg amputations by Invokana

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.

FDA

2020 ADA guidelines: blood pressure care in adults with diabetes

Here is a concise summary of the 2020 ADA guidelines on the approach of hypertension in patients with diabetes. The authors discuss lifestyle, medications, drug side-effects, and blood pressure (BP) targets. Goals are to achieve BP <130/80, <135/85, and <140/90 mmHg in adults at high risk for ASCVD, gestational diabetes, and low-ASCVD risk, respectively.

Dr. Tashko

2020 ACP Guideline: testosterone supplementation for age-related hypogonadism

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.

GT

Anger and Courage

Hope has two beautiful daughters; their names are Anger and Courage. Anger at the way things are and Courage to see that they do not remain as they are.

Saint Augustine

2020 ADA Guidelines: Medications for Type 2 Diabetes

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.

GT

FDA facilitates new treatments for COVID-19

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.

FDA

Above human suffering

I needed Bach. Unlike Beethoven, who shakes his fist at the heavens, Bach could help me after everything I’d been through. His music is above human suffering.

Zuzana Ruzickova

FDA Approval: point of care testing for 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.

FDA

Estimated vs. Reported Cases of COVID-19 in mainland China

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.

Lauren Gardner

The Incubation Period of COVID-19

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.

AIM