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.
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.
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.
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.
The Endocrine Society released its guidelines on postmenopausal osteoporosis in March 2019. The treatment algorithm is primarily based on fracture risk categories. Categories include three essential ingredients; fragility fracture history, T-scores, and FRAX-scores.
Guidelines prefer bisphosphonates, specially alendronate (Fosamax) and zoledronic acid (Reclast), as the first-line therapy for women at high risk of fractures. Denosumab (Prolia) and anabolic hormones (Tymlos and Forteo) can also be used.
Adverse events from osteoporosis therapies ― osteonecrosis of the jaw (ONJ) and atypical femur fractures (AFF) ― have become a public concern in recent years. Although ONJ and AFF are real, the risk of developing fragility fractures from withholding pharmacological therapy far exceeds these potential side effects in high risk and very high-risk women. Providers need to make their patients aware of the benefit vs. harm ratio.
Endocrine Society recently published new guidelines on metabolic risk. Metabolic risk is characterized similarly to metabolic syndrome (syndrome X) but with the name change to emphasize action rather than description. Presence of three or more of the following entities defines high metabolic risk: high blood pressure, high glucose, high triglycerides, low HDLc, and increased waist circumference.
Although guidelines are similar to those of other national association such as ACC/AHA, ADA, AACE, and NLA; they introduce or emphasize the following elements:
- Should measure waist circumference routinely.
- Include A1c in the definition of metabolic risk (vs. fasting glucose only).
- Be more aggressive in using statin therapy for primary prevention.
- Can add fenofibrate rather than ezetimibe if triglycerides are above 200 mg/dL and HDLc is low.
These guidelines are essential as they further raise awareness of the real cardiovascular and diabetes risk associated with metabolic syndrome, and more importantly encouraging providers to act upon it.
I anticipate elaboration and incorporation of the above critical changes in other national guidelines. Prevention, always first.
The various large meta-analysis, Mendelian randomizations, and prospective population-based studies have found the Lipoprotein (a) to be an independent risk factor for atherosclerosis, aortic valve stenosis, and thrombosis. Lp(a) test is considered to be high when its value is >50 mg/dL or >100 nmol/L. These measures correspond to the top 20th percentile of the general population.
Currently, there are no approved specific therapies for Lp(a). The NLA does not recommend the use of Niacin, HRT (hormonal replacement therapy) or Lomitapide (microsomal triglyceride transfer protein inhibitor). Recent trials such as FOURIER and ODYSSEY have shown that addition of PCSK9 inhibitors to Statin therapy can lower Lp(a) by 30%.
However, various guidelines including 2018 AHA/ACC and 2019 NLA scientific statement recommend the use of PCSK9 inhibitors only in the context of uncontrolled LDLc/non-HDLc in patients at high-risk or very-high-risk for ASCVD events.
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.
Guidelines do not say how to read between the lines. Experience, judgment, and reasoning do.
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!