Bisphosphonate infusion for osteopenia

Bisphosphonate infusion for osteopenia

A group of 2,000 women with osteopenia receiving either zolendronate infusion or placebo were followed for 6 years. Zoledronate 5 mg or placebo were provided every 1.5 years. At the end of the study, the intravenous bisphosphonate reduced vertebral and nonvertebral fractions significantly by about 55% and 35% respectively.

Findings are of major significance as bisphosphonates in general and zolendronate specifically have been approved only for osteoporosis and not osteopenia. Would this expand indications for zoledronate? Should patients with osteopenia be treated or monitored?

GT

Invokana protects the heart and kidneys

Invokana protects the heart and kidneys

Patients with type 2 diabetes receiving Invokana experienced 30% and 20% lower rates of kidney disease progression and cardiovascular events respectively, when compared to the placebo group.

Results were so obvious and significant that the study was terminated early. About 4500 subjects with DM2 were followed for about 2.5 years. No increased rates of fractures or amputations were seen with Invokana.

GT

Metformin found to be safe during pregnancy

Metformin found to be safe during pregnancy

The study found no major adverse events of metformin during pregnancy. This is good news as metformin is an important intervention for hyperglycemia of pregnancy. The following birth outcomes were assessed: cesarean section, neonatal weight, and serious neonatal adverse events.

GT

New FDA Approval: hydrogel capsule for weight loss

New FDA Approval: hydrogel capsule for weight loss

About 450 overweight or obese adults with BMI 27-40 kg/m2 were randomized to receive Gelesis100 or placebo. Subjects were followed for 6 months. At the end of the trial, patients receiving Gelesis100 lost a significant amount of weight compared to placebo group: about 60% and 25% of the adults lost ≥5% (≥10 lbs) and ≥10% (≥20 lbs) body weight.

Gelesis100 comes in a capsule form. It is taken with plenty of water twice daily before meals. The capsule contains particles, that in the presence of water, have the capability of expanding massively in the stomach, thus triggering a sense of fullness and decreased appetite.

The particles are not absorbed in the bloodstream. No serious adverse events were seen. Gastrointestinal upset was the most common side effect.

GT

2019 Endocrine Society Guidelines: diabetes approach in older adults

2019 Endocrine Society Guidelines: diabetes approach in older adults


The Endocrine Society has just released its guidelines on how to manage the elderly with diabetes. Guidelines are overall similar to those of ADA and AACE but with greater emphasis in avoidance of adverse events such; as hypoglycemia, malnutrition, excessive weight loss, frailty, falls, and drug side effects. See below for more details.

GT

New FDA Approval: romosozumab for osteoporosis

New FDA Approval: romosozumab for osteoporosis

Romosozumab , brand name Evenity, has now been approved by the FDA as a viable option for patients with advanced osteoporosis.

Romosozumab is a monoclonal antibody that specifically inhibits sclerostin. The approval comes with a major black box warning as the sclerostin inhibitor elevates the risk of heart attack, stroke and cardiovascular deaths.

Prior to Evenity initiation, patients need to be screened carefully for background cardiovascular disease. As the prevalence of both CVD and osteoporosis increases with age, the most likely candidates for such a therapy would be those at the highest risk for fragility or compression fractures.

GT

A continuous stream of process

A continuous stream of process

Bach is a continuous stream of process, not a punctuated string of big moments. He never gives us exactly what we want; he is continuously pushing us further back from the goalpost: there is a sense in which his music is deeply human, but also a sense in which it refuses to join us on our own ground, and I think that's a valid, if perhaps short-sighted, criticism.

Curtis Lindsay

More evidence of Metformin benefits in early prediabetes

More evidence of Metformin benefits in early prediabetes

More good news for metformin. MET-REMODEL trial tested patients with known cardiovascular disease and insulin resistance, but without gross diabetes. Patients received metformin or placebo for 12 months.

Compared to the placebo group, subjects receiving metformin experienced the following improvements in 12 months: Less left ventricular mass index,  less LVM, lower systolic BP, decreased body weight and less oxidative stress.

Early start of metformin could be useful in adults with insulin resistance.  Long term side effects of metformin, however, need to be discussed thoroughly with patients.

GT

2019 AACE Guidelines: Diabetes Type 2 principles

2019 AACE Guidelines: Diabetes Type 2 principles

AACE standards were published in January 2019. They are a continual update of the original 2013 guidelines. Unlike ADA which recommends a general A1c target ≤7.0%, AACE promotes a tighter A1c goal of ≤6.5% for most patients with type 2 diabetes.

Recommendations also address lifestyle interventions, obesity, prediabetes, hypoglycemia, hypertension and dyslipidemia. Oral and injectable medications including insulin are discussed. A key priority is the avoidance of hypoglycemia — do no harm!

GT

Addition of PCSK9 inhibitor Alirocumab further lowers CVD events.

Addition of PCSK9 inhibitor Alirocumab further lowers CVD events.

In ODYSSEY trial, the addition of PCSK9 inhibitor, Alirocumab to high-intensity statin further reduced cardiovascular events by 15% in patients with very-high baseline CVD risk (prior ACS) and elevated atherogenic cholesterol particles. Atherogenicity was defined by LDLc ≥70 mg/dL, non-HDLc ≥100 mg/dL, or Apo B ≥80 mg/dL.

About 19,000 patients with acute coronary syndrome 1-12 months prior to study initiation were followed for 3 years. The study target was final LDLc between 25-50 mg/dL. Similar to FOURIER 2017 results, ODYSSEY 2018 adds more evidence to the notion “the lower the LDLc, the lower ASCVD events”

GT

Victoza use in children with diabetes type 2

Victoza use in children with diabetes type 2

Results of ELLIPSE trial are of major significance as they show that Victoza addition to Metformin helps in further reduction of A1c and fasting plasma glucose. The efficacy and safety appear to be similar as in adults. The most common side effects are gastrointestinal in nature. Based on ELLIPSE trial outcomes, I anticipate broadening of FDA indications for Victoza, to include children and adolescents

GT