Challenge

I have worked in pharmaceutical company as medical team. I responsible to provide  communication to doctor and patients. With the new anti-diabetic drug that has the promising  benefit (i.e. reduce complication from heart and kidney disease). But also has the major adverse  event which lead to life-threatening effect but this adverse event can avoid and minimize the  risk.

With the adverse event, the doctor are struggle to prescribe this drug. The challenge is how to  provide the guidance for doctor to select appropriate patient and simplify the guidance for  patients.

Defining the real problem

After thorough discussion with medical association and key opinion leader. The real problem is  how to provide the guidance for doctor to select appropriate patient and simplify the guidance  for patients.

Application

Something that I know about the challenge is the fact that doctors do not know the reason the  they are struggling to prescribe the new drug. Therefore, I started discussing the key opinion  leader and I thought I would try out something different. Then I start to discuss with the patients’  perspective.

Organize the insights

Question for interview:

1. What is your goal for treating diabetes?  2.  What is the major cause of death for diabetes patients?  3. What is your major concern for the new medication?  4. How can we mitigate the potential adverse event?

PATIENT EDUCATION GUIDANCE SGLT2 inhibitor

Empagliflozin

Additional treatment option for

Type 2 diabetes > 45 eGFR

ml/min/1.73 m3

Mechanism

Glucose

Glucose Glucose

Glucose

Glucose

Glucose in blood pass through the kidney SGLT2 inhibitor reduces glucose re-absorption in the proximal tubule

Excess glucose excreted in urine

Glu

Glu

Glu

Glu

Glu

Glu

10 25

10 mg once daily

Starting dose

25 mg once daily If patient require additional glyce- mic control

Common Adverse Events Precaution

Dehydration Urinary Tract Infection (UTI)

Yeast Infection in genital tract (GTI)

Euglycemic Ketoacidosis (DKA)

ketone

Titrate to

Drink plenty of water

Drink plenty of water

Urinate ofen and wipe themselves carefully

Avoid excess alcohol intake

Inform your doctor, if you have symptoms suggestive of DKA    - abdominal pain    - nausea    - vomiting    - fatigue    - dyspnea

Patient Counseling AE management

Avoid very-low-carbohydrate diets

ketone

Where patients have another condition that may cause fluid loss (e.g.diarrhoea) careful mo- nitoring of fluid status is needed.

Standard care and treatment should be exercised when having UTIs.

Temporary interruption of empa- gliflozin may be considered in patient with complicated UTIs.

Know more about DKA from SGLT2 inhibitor

Ketoacidosis occurs in people with type 1 diabetes and can also occur in people with type 2 diabetes taking empagliflozin, even if blood sugar is less than 14 mmol/l (250 mg/dL).

Consider stopping the SGLT2 inhibitor at least 24 hours prior to elective surgery, planned invasive procedures, of antici- pated severe stressful physical activity

Consider stopping the SGLT2 inhibitor immidiately and proceed with traditional DKA treatment protocol

Risk Factor

Long history of diabetes. (Declination of Beta-cell function) Intercurrent illness Reduced food and fluid intake Reduced insulin dose History of alcohol

1. Jardiance prescribing information (2 Mar 16)

2. AACE/ACE Scientific and Clinical Review : Association of SGLT2 Inhibitors and DKA., 24-25 Oct 2016

