Meds – New Warnings and Updates

Treating type 2 diabetes is complicated. Supporting behavior change is the foundation of diabetes self-management. Medications are the next line of defense to prevent diabetes complications and get to the best health possible.

As providers and educators we are compelled be familiar with the wide range of medications that are currently available to treat diabetes. As patient advocates, we also perform a cost/benefit analysis to determine which medication would be the best match, considering cost, side effects and complexity.

There have been flurry of updates on existing medications. And many of the newly approved medications offer the hope of decreasing complexity, by combining 2 of different classes of medication in one shot. Plus, there are now four different concentrated insulins. Read on to learn more >>

Important Medication Updates

Metformin – new GFR renal threshold info approved by FDA.

  • If GFR <30, do not use
  • If GFR <45, don’t start metformin
  • If pt on metformin and GFR falls to 30-45, eval risk vs. benefit and consider decreasing dose.

For dye study, if GFR <60, or with liver disease, alcoholism or heart failure, restart metformin after 48 hrs if renal function stable.

DPP-IV Inhibitors – New Warnings

  • This class of med can cause disabling joint pain. Stop med, contact provider.
  • Saxagliptin (Onglyza) and alogliptin (Nesina) can increase risk of heart failure. Notify provider if patient experiences shortness of breath, edema.

SGLT-2 Inhibitors – Considerations

  • Can increase risk of ketoacidosis
  • Empagliflozin (Jardiance) lowers all cause mortality 32%

To keep up with the latest medication updates, download our FREE Medication Pocket Cards

This paper is arranged by different strategies to improve glucose control. This makes it very easy to navigate and find specific information.

1. Lifestyle Therapy is essential for all patients

Eat Primarily a Plant-Based Diet 

Patients should strive to maintain an optimal weight through a primarily plant based diet high in polyunsaturated and monounsaturated fats while limiting saturated fats and eating no trans-fats. Information on specific foods, meal planning, grocery shopping and dining out strategies should be discussed.

Patients who are overweight or obese, need to restrict caloric intake to reduce body weight by 5-10%. As shown the by Look AHEAD and DPP program, eating less calories is the main driver of weight loss.

Get Moving 

Physical activity is a main component of weight loss and maintenance programs. Aerobic activity and strength training improve glucose control, lipids and blood pressure, while reducing the risk of falls and fractures, improving independent function and sense of well being.

To support weight loss, the Look AHEAD Trial demonstrated that participants who exercised for 175 minutes a week or more, lost significantly more weight. 

In addition to moderate intensity exercise, (brisk walking), patients should also be encouraged to do strength training a few times a week. See exercise resource page for teaching tools and handouts »  

For all patients, assess for safety and limitations and create an individualized exercise plan based on their strengths and limitations.

Get enough sleep  

The goal is to achieve 7 hours of sleep per night. There is evidence that getting 6-9 hours of sleep a night reduces insulin resistance and decreases cardiovascular risk and inflammation. Assess patients for sleep health and sleep apnea.

Quit Smoking

Avoid all tobacco products! Offer resources and structured programs to help patients succeed at kicking the habit!

2. Obesity 

it is a disease with genetic, environmental and behavioral determinants. All overweight and obese patients with prediabetes or diabetes should be provided tools to support sustained weight loss. These options include lifestyle counseling, pharmacologic intervention and bariatric surgery for those with a BMI of 35 or greater, especially with comorbidities.

3. PreDiabetes 

This is a sign of failing beta-cell compensation for underlying insulin resistance, usually associated with excess body weight.

The primary goal of prediabetes management is weight loss through lifestyle and pharmacotherapy.  However, in some people, weight loss may not fix the pathogenesis of ongoing beta cell destruction. When indicated, bariatric surgery can be highly effective in halting progression from prediabetes to diabetes.

No weight loss or diabetes medications are approved by the FDA soley for the management of prediabetes or prevention of type 2.  However, metformin and acarbose reduce the risk of converting from prediabetes to diabetes by 25-30% and they are relatively safe and well-tolerated, plus they may reduce cardiovascular risk.

Prediabetes is associated with increase risk of cardiovascular disease. And as such, patients with prediabetes should be offered lifestyle and therapy and pharmacotherapy to achieve lipid and BP targets to reduce risk of future CV events.

Glucose Targets and Medication Algorithm

A1c targets are more stringent than the ADA targets. Individualization of glycemic goals based on patients clinical picture is critical.

  • A1c < 6.5%  for most healthy patients at low risk for hypoglycemia.
  • A1c > 6.5% up to 8% if lower targets can’t be achieved without adverse outcomes.

Download our Medication PocketCards for a complete listing of the meds with dosing, efficacy and considerations and precautions.

Download AACE Diabetes Management Algorithm Slides >>  


Entry A1c Levels and Med Algorithm

  • Entry A1c < 7.5% – start one med (metformin)
  • Entry A1c >7.5% – start 2-3 meds (add on to metformin)
  • Entry A1c > 9%
    • No Symptoms, start 2-3 meds
    • Symptoms, start insulin and metformin

Medications – Listed in order of AACE Ranking 

1. Metformin 

This is the first diabetes med of choice due to its low risk of hypoglycemia and exceptional blood glucose lowering effect. Metformin is considered durable, which means it maintains its effectiveness (in years) longer than sulfonylureas, plus it lowers LDL cholesterol and is weight neutral.

16% of patients on long term metformin therapy have B12 deficiency.  AACE recommends monitoring of B12 and providing B12 supplements as needed.

The risk of lactic acidosis is low and new guidelines suggest GFR be used to determine safety. AACE recommends that metformin not be used if GFR < 30.

2. GLP-1 Receptor Agonists 

These injectable gut hormone imitators have robust A1c lowering properties, promote weight loss and BP reduction. The hypoglyemic risk is low and this class stabilizes pre and post meal glucose levels. The long acting versions offer the convenience of a once a week injection.

3. SGLT2 Inhibitors 

These have “glucoretic” effects, decrease A1c, weight and systolic blood pressure. The recently released EMPA-Reg Study demonstrated that patients with diabetes who took the SGLT2 Inhibitor, Empagliflozin, had a significant 38% relative risk reduction in cardiovascular mortality, as well as a 32% relative reduction in all-cause mortality.  More studies are needed to see if this life prolonging outcome finding is a specific to empagliflozin or a SGLT-2 Inhibitor class effect.

4. DPP-IV Inhibitors 

These work by enhancing levels of gut hormone by inhibiting the 
DPP-IV enzyme.  This action stimulates insulin production with meals and suppresses glucagon release. This class has modest glucose lowering effects, are weight neutral, don’t cause hypoglycemia and have few side effects.

5. TZDs – 

Actos and Avandia are the only diabetes medications that directly reduce insulin resistance, lower A1c, don’t cause hypoglycemia and are very durable. Unfortunately, the side effects of weight gain, increased bone fracture risk and fluid retention that can worsen CHF, has limited its use.

6. Alpha Glucosidase Inhibitors 

Acarbose has a modest glucose lowering effect and low hypoglycemia risk. It may also offer some CVD protection.  Due to the GI side effects (gas and flatulence) its use in the United States has been very limited.

7. Sulfonylureas 

These are potent glucose lowering medications, but lack durability and can cause weight gain and severe hypoglycemia. There are also concerns regarding cardiovascular safety when compared to metformin.

8. Colesevelam

This is a bile acid sequestrant, has a modest glucose lowering effect, does not cause hypoglycemia and decreases LDL cholesterol. It is not widely used due to its’ modest effects and GI intolerance.

Insulin is the most potent glucose lowering agent.

Patients taking 2 or more diabetes medication or those with a longstanding A1c of 8% or more are less likely to reach their target with a 3rd agent (however the GLP-1s may be effective).

Next steps include adding basal insulin and then bolus insulin when prandial glucose targets are not met. See AACE Comprehensive Diabetes Management Algorithm 2016 for more info.

If you are ready to earn your CE’s, you can take our course on this topic – Meds Management for Type 2.

The leading cause of death for people with diabetes is cardiovascular disease. Adults with diabetes are two to four times more likely to have a heart attack or stroke than those with out diabetes. 


What’s the link between diabetes and stroke?
 
Many people with diabetes also have the following co-morbidities, which increases risk of experiencing a stroke:

  • High Blood Pressure doubles risk of vascular disease
  • Abnormal cholesterol levels
  • Obesity
  • Lack of physical activity
  • Unhealthy food choices
  • Family history of diabetes and/or heart disease

Interventions to Decrease Stroke Risk

  • Get A1c, Blood Pressure and Cholesterol to target
  • Exercise More 150 minutes a week of activity, plus moderate muscle-strengthening
  • Lose weight – Increase intake of plant based foods
  • Quit Smoking,
  • Drink – In moderation
  • Consider aspirin therapy and or other anticoagulants
  • Evaluate and treat atrial fibrillation, sickle cell, clotting disorders and inflammation, all of which can increase risk of stroke

Stroke Resources

American Heart and American Stroke Association – Infographic on SPOT A STROKE

SPOT A STROKE App – download app from Apple and Google Play

Power to End Stroke campaign developed to reduce incidence of stroke. Lots of good resources for professionals and patients alike.

American Heart Association Resource Page – great articles geared towards patients on keeping healthy

National Stroke Association – Information and resources for patients and families

Know the Facts about Stroke – CDC information on current stroke statistics

Cryptogenic Stroke A Public Health Conference Report

older adults and diabetesThe message is clear, a high prevalence of our older population is living with diabetes and this number is expected to grow rapidly in the coming decades.

  • Over a quarter (25.9%) of Americans age 65 or older have diabetes (diagnosed and undiagnosed). That’s 11.8 million seniors. See more info »
  • According to CDC Stats 2011, twenty percent of newly diagnosed cases of diabetes were in the age range 65–79 years.
  • Adults 75 years or older, have the highest rates of complications including myocardial infarction, amputations, visual impairment and kidney disease of any other age group.
  • The prevalence of diabetes will double in the next 20 years, in part due to the aging population (ADA Consensus Statement)

When does old age start?
As a diabetes specialist working with mainly retirees, I frequently consider this question. I counsel many 60 year olds who perceive themselves as unhealthy and burdened by one or more chronic diseases. On the other hand, I have met with many octogenarians with diabetes and multiple conditions, who report their health as good to excellent.  

According to the World Health Organization, “The aging process is a biological reality which has its own dynamic, largely beyond human control. However, it is also subject to the constructs by which each society makes sense of old age.

In the developed world, chronological time plays a paramount role. The age of 60 or 65, roughly equivalent to retirement age in most developed countries, is said to be the beginning of old age.

In many parts of the developing world, chronological time has little or no importance in the meaning of old age. Old age is seen to begin at the point when active contribution is no longer possible.” (Gorman, 2000).

As with all patients, we first consider the individual, their strengths and limitations, and age is just one aspect of our overall assessment.

The following list highlights the ADA 2016 Standards of Care for Older Adults:

  • Start with a thorough assessment – During the initial interview, ask questions to reveal medical, functional, mental and social domains. This will help to provide a framework to determine realistic targets and best treatment approaches.

  • Pay special attention to complications and social issues that can quickly and significantly impair functional status – problems such as hypoglycemia, lower extremity complications, visual impairment, dementia and balance issues are paramount to evaluate.

    In addition, the inability to afford diabetes medication, food and shelter, can quickly lead to uncontrolled glucose levels.  Many older patients may be reluctant to share their financial struggles, but some well phrased questions by the interviewer, can provide  opportunities for sharing and collaborative problem solving.

  • Treatment Goals – Realizing that older adults have a wide variety of clinical and functional presentations, treatment goals for are adjusted based on:

    • Length of time living with diabetes (new onset, undiagnosed for many years or longer history)

    • Presence or absence of complications

    • Comorbidities

    • Degree of frailty

    • Cognitive function

    • Life expectancy (often longer than expected)

    • Functional status

Treatment Goals Based on Patient Status

Healthy Patients with Good Functional Status

Patients with good cognitive and physical function, who are expected to live long enough to reap the benefits of long term intensive management, can collaborate with providers to set more intensive glucose, blood pressure and cholesterol goals. Ongoing follow-up to evaluate safety is imperative

  • Reasonable A1c goal <7.5%, 
  • Fasting BG 90 – 130 
  • Blood Pressure < 140/90 
  • Statin unless contraindicated or not tolerated

Patients with Complications and Reduced Functionality 

For patients with advanced diabetes complications, life-limiting illnesses, or substantial cognitive and functional impairment, goals can be less intensive. These groups of patients are less likely to benefit from reduced risk of microvascular complications and are at higher risk of hypoglycemia, hypotension and adverse effects from taking a mountain of pills daily. 

For this group of patients, DE-Intensification of therapy should be considered.

Careful attention is still given to reaching goals, however they are more relaxed and adjusted based on shared decision making and safety.

  • Reasonable A1c goal <8.0%, 
  • Fasting BG 90 – 150 
  • Blood Pressure < 140/90 
  • Statin unless contraindicated or not tolerated

Very Complex Patients with Poor Health  

For patients with limited life expectancy and end stage chronic illnesses or moderate-to-severe chronic functional or cognitive issues, the focus is on quality of life and avoidance of hyperglycemic crisis.

  • Reasonable A1c goal <8.5%, 
  • Fasting BG 100 – 180 
  • Blood Pressure < 150/90 
  • Consider likely benefit of statin unless contraindicated or not tolerated

View summary chart of goals  >> 

For all these situations, a patient-centered approach and shared decision making can help establish goals and treatment strategies that are reasonable for the patient, family and provider.

You can earn 1.5 CE on our Online University – Older Adults with Diabetes Course >>. 

Further reading:

Some Older Patients Are Treated Not Wisely, but Too Much,” This 2015 New York Times article raises important concerns about the over treatment of people with diabetes;

Less in More | Appropriate Prescribing for Patients With Diabetes at High Risk for Hypoglycemia – National Survey of Veterans Affairs Health Care Professionals published in JAMA, 2015. In older people with diabetes, for instance, maintaining very low blood sugar — often called “tight control” — can do more harm than good. “People can feel fatigued and weak, get cold sweats, feel like they’re going to pass out,” said Dr. Tanner Caverly, lead author of the Michigan survey.

Rates of Deintensification of Blood Pressure and Glycemic Medication Treatment Based on Levels of Control and Life Expectancy in Older Patients With Diabetes Mellitus – JAMA, December 2015. Conclusions and Relevance  Among older patients whose treatment resulted in very low levels of HbA1c or BP, 27% or fewer underwent deintensification, representing a lost opportunity to reduce overtreatment. Low HbA1c or BP values or low life expectancy had little association with deintensification events. Practice guidelines and performance measures should place more focus on reducing overtreatment through deintensification.

Do I need a flu vaccination – Great infogram to get people motivated to get their flu shot.

 

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