“Deprescribing” Insulin in Type 2 Diabetes Caroline Trapp, DNP Premier Internists Southfield, MI

Physicians Committee Washington, DC Used with permission of Dan Piraro

Disclosure to Participants Conflicts of interest and financial relationships: None Nada Zip Zero Not a bit Not any Not an iota Nil Zilch Naught (Thank you, David Katz, MD)

Lyle from Rabbit Brush, NM

[Insert Video Clip]

Objectives 1. Discuss the utility of exogenous insulin to achieve patient-centered outcomes. 2. Explore methods to safely de-prescribe insulin. 3. Describe resources for clinical practice.

The Miracle of Insulin

Type 1 vs. Type 2 Diabetes

Insulin-Dependent

Insulin-Requiring

INSULIN

1938

Treatment of Diabetes No medication 16%

Insulin only 12%

Insulin and oral medication 14%

Oral medication only 58%

National Diabetes Information Clearinghouse. National Diabetes Statistics, 2011. Available at: http://diabetes.niddk.nih.gov/dm/pubs/statistics/

The Big Picture

National Academies Press, 2013, http://www.nap.edu/catalog.php?record_id=13497

Case Study – Mr. G • 47 y.o., 10-year hx T2DM. • HTN, elevated creatinine, obesity, depression • 80 units basal insulin at bedtime • 40 units bolus insulin at each meal • A1c 10.2%; BMI 46

Reason # 10: Cost

$$$ Mr. G’s co-pay on 1400 units of insulin a week = $400/month

Mean Expenditure per Patient (Private Insurance) Insulin: 197% price increase in 11 years

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4886177/

Reason # 9: Higher Costs Ahead

$$$$ No generic coming anytime soon. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4

Worldwide insulin market by value and market share by volume in 2011

Schultz K. The global diabetes care market. Novo Nordisk, 2011

Reason # 8: “Evergreening”

Reason # 7: Adherence “A substantial proportion of people with type 2 diabetes do not take medication as prescribed…. approximately (only) 60% of insulin doses.” McGovern A, Tippu Z, Hinton W, et al. Systematic review of adherence rates by medication class in type 2 diabetes: a study protocol. BMJ Open 2016:6:e010469. doi:10.1136/bmjopen-2015-010469.

Mr. G. denied skipping doses; but others might, due to high cost, or side effects, such as weight gain and hypoglcemia.

Reasons # 6 &7: Safety and Efficacy • “Insulin is a treatment, not a cure.” Beran, Ewen & Laing, 2015 Health Action International

It appears to be neither for Mr. G., on 200 units a day, in poor control.

Would more insulin improve his quality of life?

Approach to the Management of Hyperglycemia A1C 7%

more stringent

Patient/Disease Features Risks associated with hypoglycemia & other drug adverse effects

less stringent

low

high

Disease Duration newly diagnosed

long-standing

Life expectancy long

short

Important comorbidities absent

Few/mild

severe

absent

Few/mild

severe

Established vascular complications

Patient attitude & expected treatment efforts highly motivated, adherent,

excellent self-care capabilities

less motivated, nonadherent, poor self-care capabilities

Resources & support system readily available

limited

American Diabetes Association Standards of Medical Care in Diabetes. Glycemic targets. Diabetes Care 2016; 39 (Suppl. 1): S39-S46

Intensive glycemic control reveals neutral effect on nonfatal CV events. Feb. 1, 2016 “However, there was an increased risk for CV-related death, according to the researchers.” Available here: http://www.healio.com/endocrinology/diabetes/news/o nline/%7B64dd5433-d630-4247-854d6331e32daa9e%7D/intensive-glycemic-controlreveals-neutral-effect-on-nonfatal-cv-events

http://www.thennt.com/nnt/tight-glycemic-control-for-type-2-diabetes-over-5-years/

Outcomes and Healthcare Resource Utilization Associated with Medically Attended Hypoglycemia in Older Patients with Type 2 Diabetes Initiating Basal Insulin in a US Managed Care Setting Results: Of 31,000 patients (mean age 72 years [SD 9.2]), 3100 (10%) experienced [severe] hypoglycemia during the first year of basal insulin initiation. After adjustment for demographic, comorbidity and medication history, hypoglycemia was associated with risk of hospitalization (HR 1.59; 95%CI:1.53-1.65) and death (HR 1.50; 95% CI:1.40-1.60). Javier Escalada, Laura Liao, Chunshen Pan, Hongwei Wang & Mohan Bala (2016): Outcomes and Healthcare Resource Utilization Associated with Medically Attended Hypoglycaemia in Older Patients with Type 2 Diabetes Initiating Basal Insulin in a US Managed Care Setting, Current Medical Research and Opinion, DOI: 10.1080/03007995.2016.1189893

Outcomes that matter? • Good numbers • Quality and quantity of life Mr. G’s Priorities: 1. Increase energy 2. Avoid kidney failure 3. Reduce medication expenses

Number 5: Insulin “Early-Start” Benefits Oversold

“Insulin treatment is neither durable in maintaining glycemic control nor is unique in preserving beta cells.” “Better clinical outcomes than those that occur with other antihyperglycemic regimens have not been shown.” Lebovitz HE. Insulin: Potential negative consequences of early routine use in patients with type 2 diabetes. Diabetes Care, 34(Suppl.2), May 2011.

Reason # 4: Pharma marketing practices Mr. G. does not want a clinician who is a shill for the pharmaceutical industry.

Medication Sample Closet and Refrigerator

If all you have is a hammer, everything looks like a nail.

It is reasonable to reconsider prescribing patterns To be approved, diabetes medications must lower blood glucose. The FDA does not require that they prevent complications or extend lives.

Gandhi GY, Murad MH, Fujiyoshi A, et al. Patient-important outcomes in registered diabetes trials. JAMA 2008; 299:2543-2549.

Cartoon by permission of Dan Piraro, creator of Bizarro, Bizarro.com

http://www.phrma.org/sites/default/files/pdf/diabete s2014.pdf

Reasons # 3-1 Safer, less expensive, highly effective alternatives to insulin exist for people with type 2 diabetes.

AACE 2016 Recommendations

Plant-based diet

Case Study – Mr. G • 47 y.o., 10-year Hx T2DM. • HTN, obesity, depression, CRI • 80 units basal insulin at bedtime • 40 units bolus insulin at each meal • A1c 10.2%; BMI 38

Diet history: Had success with a whole food plant-based diet 8 years earlier, when he was on 3 oral agents and first told he needed insulin. Lost 60 pounds and was able to eliminate all medications.

Meet Mr. G – 10+ years of diabetes; 200 units of insulin/day

Now: no insulin or other medications.

Conclusions – Deprescribing Insulin: Part 1 1. Insulin for type 2 diabetes will very effectively reduce blood glucose levels. However, not every patient will benefit, and some will suffer a range of harms. These range from moderate inconvenience to lifethreatening emergencies. 2. Lifestyle intervention is the safest way to lower A1c. 3. Patients should be fully informed.

Part 2 - Deprescribing

Approach To Starting and Adjusting Insulin in Type 2 Diabetes

ADA. 7. Approaches to Glycemic Treatment. Diabetes Care 2015;38(suppl 1):S46. Figure 7.2; adapted with permission from Inzucchi SE, et al. Diabetes Care, 2015;38:140-149

Algorithm to Deprescribe Insulin • Review of the literature: None Found Recommended reading: Jardine, M. Plant-based lifestyle therapy and medication adjustment. Academy of Nutrition and Dietetics Vegetarian Nutrition Group. Vol XXVI, 3, 2016, p. 13-15.

Dr. Mark Sklar • Protocol: Initiate dietary interventions. • BG