Presentation is loading. Please wait.

Presentation is loading. Please wait.

Breanne Fleming, PharmD PGY2 Ambulatory Care Resident Richard L. Roudebush VA Medical Center This speaker has no actual or potential.

Similar presentations


Presentation on theme: "Breanne Fleming, PharmD PGY2 Ambulatory Care Resident Richard L. Roudebush VA Medical Center This speaker has no actual or potential."— Presentation transcript:

1 Breanne Fleming, PharmD PGY2 Ambulatory Care Resident Richard L. Roudebush VA Medical Center This speaker has no actual or potential conflicts of interest to disclose in relation to this presentation

2 Mack GS. Nat Biotechnol Dec;25(12):

3 Challenges Size of device Difficult dose adjustment Dosage form inconsistencies Risk of lung disease Insurance barriers Withdrawn from the market in 2007 Business Week. Pfizer’s Exubera Flop. Available at: Accessed July 25, Mack GS. Nat Biotechnol Dec;25(12):

4 FDA approved June 2014 Patients with type 1 and type 2 diabetes Ultra rapid-acting insulin Afrezza(R) [package insert]. Danbury, CT: MannKind Corporation; 2014.

5

6

7

8

9

10

11 Insulin naïve Start 4 units at each meal Patients on subcutaneous mealtime insulin Afrezza(R) [package insert]. Danbury, CT: MannKind Corporation; 2014.

12 Hypoglycemia Cough Throat pain/irritation Acute bronchospasm in patients with chronic lung disease Decline in pulmonary function Lung cancer Diabetic ketoacidosis (DKA) Hypersensitivity reactions Afrezza(R) [package insert]. Danbury, CT: MannKind Corporation; 2014.

13 Patients with chronic lung disease Asthma COPD History of hypersensitivity to regular human insulin or any excipients Afrezza(R) [package insert]. Danbury, CT: MannKind Corporation; 2014.

14 Clinical EffectAbsorption Afrezza(R) [package insert]. Danbury, CT: MannKind Corporation;

15 Population: Patients with T2DM Intervention: Inhaled insulin + OAD* vs. placebo + OAD* *OAD= max dose metformin or >2 oral antidiabetic agents Primary Outcome: Reduction in HgbA1c Afrezza(R) [package insert]. Danbury, CT: MannKind Corporation; 2014.

16 Efficacy Parameter Afrezza + OAD N= 177 Placebo + OAD N= 176 Confidence Interval Change in HgbA1c (%) (-0.57, -0.23) % Patients achieving HgbA1c < 7% Afrezza(R) [package insert]. Danbury, CT: MannKind Corporation; 2014.

17 Population: Patients with T1DM Intervention: Inhaled insulin + basal insulin vs. aspart + basal insulin Primary Outcome: Non-inferiority in HgbA1c reduction Afrezza(R) [package insert]. Danbury, CT: MannKind Corporation; 2014.

18 Efficacy Parameter Inhaled insulin + basal insulin n = 174 Insulin aspart + basal insulin n = 170 Confidence Interval Change in HgbA1c (%) (-0.57, -0.23) % Patients achieving HgbA1c < 7% Afrezza(R) [package insert]. Danbury, CT: MannKind Corporation; 2014.

19 Fear of needles Dexterity issues Post-meal hypoglycemia Less weight gain Rosenstock J, et al. Lancet Jun 26;375(9733):

20 Breanne Fleming, PharmD PGY2 Ambulatory Care Resident Richard L. Roudebush VA Medical Center


Download ppt "Breanne Fleming, PharmD PGY2 Ambulatory Care Resident Richard L. Roudebush VA Medical Center This speaker has no actual or potential."

Similar presentations


Ads by Google