Transcript Afrezza® Inhaled Insulin - Indiana Pharmacists Alliance

Breanne Fleming, PharmD
PGY2 Ambulatory Care Resident
Richard L. Roudebush VA Medical Center
[email protected]
This speaker has no actual or potential conflicts of interest to
disclose in relation to this presentation
Mack GS. Nat Biotechnol. 2007 Dec;25(12):1331-2.
• Challenges
• Size of device
• Difficult dose adjustment
• Dosage form inconsistencies
• Risk of lung disease
• Insurance barriers
• Withdrawn from the market
in 2007
Mack GS. Nat Biotechnol. 2007 Dec;25(12):1331-2.
Business Week. Pfizer’s Exubera Flop. Available at: http://www.businessweek.com. Accessed July 25, 2014.
• 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.
Afrezza(R) [package insert]. Danbury, CT: MannKind Corporation; 2014.
Afrezza(R) [package insert]. Danbury, CT: MannKind Corporation; 2014.
Afrezza(R) [package insert]. Danbury, CT: MannKind Corporation; 2014.
Afrezza(R) [package insert]. Danbury, CT: MannKind Corporation; 2014.
Afrezza(R) [package insert]. Danbury, CT: MannKind Corporation; 2014.
Afrezza(R) [package insert]. Danbury, CT: MannKind Corporation; 2014.
• Insulin naïve
• Start 4 units at each meal
• Patients on subcutaneous mealtime insulin
Afrezza(R) [package insert]. Danbury, CT: MannKind Corporation; 2014.
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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.
• 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.
Clinical Effect
Absorption
Afrezza(R) [package insert]. Danbury, CT: MannKind Corporation; 2014.
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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.
Efficacy
Parameter
Afrezza + OAD
N= 177
Placebo + OAD
N= 176
Confidence
Interval
Change in
HgbA1c (%)
-0.82
-0.42
(-0.57, -0.23)
% Patients
achieving
HgbA1c < 7%
32.2
15.3
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Afrezza(R) [package insert]. Danbury, CT: MannKind Corporation; 2014.
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.
Efficacy
Parameter
Inhaled insulin
+ basal insulin
n = 174
Insulin aspart +
basal insulin
n = 170
Confidence
Interval
Change in
HgbA1c (%)
-0.21
-0.4
(-0.57, -0.23)
% Patients
achieving
HgbA1c < 7%
13.8
27.1
-
Afrezza(R) [package insert]. Danbury, CT: MannKind Corporation; 2014.
• Fear of needles
• Dexterity issues
• Post-meal hypoglycemia
• Less weight gain
Rosenstock J, et al. Lancet. 2010 Jun 26;375(9733):2244-53.
Breanne Fleming, PharmD
PGY2 Ambulatory Care Resident
Richard L. Roudebush VA Medical Center
[email protected]