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Type 1 Diabetes
Is Afrezza worth the risk?
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<blockquote data-quote="tim2000s" data-source="post: 1029408" data-attributes="member: 30007"><p><span style="font-family: 'Book Antiqua'">In answer to the commentary about Hypos, in the FDAs analysis of the Hypo data during the (3rd) NDA process, there were a number of observations. The first interesting one from a T1 perspective is:</span></p><p></p><p>In active comparator studies where Afrezza TI was compared with another insulin, the incidence of hypoglycemia was generally lower for Afrezza TI than comparator, but in these studies the comparator groups had better glycemic efficacy than the Afrezza TI groups, confounding the hypoglycemia analyses.</p><p></p><p><span style="font-family: 'Book Antiqua'">The second looks at incident rate analysis and states that there wasn't a statistically significant difference between Insulin Aspart and Afrezza, although incidence rates were lower.</span></p><p></p><p>The incidence of any hypoglycemia during the randomized treatment period of the study was comparable in the Afrezza TI Gen2 (167 subjects, 96.0%) and the Afrezza TI MedTone (166 subjects, 96.0%) groups and in the insulin aspart group (170 subjects, 99.4%) (Table 33).</p><p></p><p>The exposure-adjusted incidence per subject-month was similar across groups for any hypoglycemia and mild/moderate hypoglycemia.</p><p></p><p>The incidence of severe hypoglycemia during the randomized treatment period of the study was slightly lower in the Afrezza TI Gen2 (32 subjects, 18.4%) and the Afrezza TI MedTone (37 subjects, 21.4%) groups than in the insulin aspart group (50 subjects, 29.2%).</p><p></p><p>The exposure adjusted incidence per subject-month for severe hypoglycemia was also lower among Afrezza TI-treated patients vs. aspart-treated patients (exposure-adjusted incidence per subject-month was 0.48, 0.52, and 0.67, for Gen2, MedTone and insulin aspart, respectively).</p><p></p><p><span style="font-family: 'Book Antiqua'">The FDA Reviewer noted:</span></p><p></p><p>For the T1DM trial, conclusions regarding hypoglycemia are confounded by the difference in efficacy observed between the two study arms and are entirely consistent with the fact that Afrezza was demonstrated to be less effective than comparator. For the T2DM trial, the result of greater hypoglycemia risk vs. placebo is expected.</p><p></p><p><span style="font-family: 'Book Antiqua'">It's worth noting that there's a huge amount of data relating to the mechanism by which titration of Afrezza dosage was undertaken in the trials and how, if hypo- or hyper-glycaemia was observed post meals, doses were then adjusted. </span></p><p><span style="font-family: 'Book Antiqua'"></span></p><p><span style="font-family: 'Book Antiqua'">The full set of documents is available <a href="http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM390864.pdf" target="_blank">here</a>.</span></p></blockquote><p></p>
[QUOTE="tim2000s, post: 1029408, member: 30007"] [FONT=Book Antiqua]In answer to the commentary about Hypos, in the FDAs analysis of the Hypo data during the (3rd) NDA process, there were a number of observations. The first interesting one from a T1 perspective is:[/FONT] In active comparator studies where Afrezza TI was compared with another insulin, the incidence of hypoglycemia was generally lower for Afrezza TI than comparator, but in these studies the comparator groups had better glycemic efficacy than the Afrezza TI groups, confounding the hypoglycemia analyses. [FONT=Book Antiqua]The second looks at incident rate analysis and states that there wasn't a statistically significant difference between Insulin Aspart and Afrezza, although incidence rates were lower.[/FONT] The incidence of any hypoglycemia during the randomized treatment period of the study was comparable in the Afrezza TI Gen2 (167 subjects, 96.0%) and the Afrezza TI MedTone (166 subjects, 96.0%) groups and in the insulin aspart group (170 subjects, 99.4%) (Table 33). The exposure-adjusted incidence per subject-month was similar across groups for any hypoglycemia and mild/moderate hypoglycemia. The incidence of severe hypoglycemia during the randomized treatment period of the study was slightly lower in the Afrezza TI Gen2 (32 subjects, 18.4%) and the Afrezza TI MedTone (37 subjects, 21.4%) groups than in the insulin aspart group (50 subjects, 29.2%). The exposure adjusted incidence per subject-month for severe hypoglycemia was also lower among Afrezza TI-treated patients vs. aspart-treated patients (exposure-adjusted incidence per subject-month was 0.48, 0.52, and 0.67, for Gen2, MedTone and insulin aspart, respectively). [FONT=Book Antiqua]The FDA Reviewer noted:[/FONT] For the T1DM trial, conclusions regarding hypoglycemia are confounded by the difference in efficacy observed between the two study arms and are entirely consistent with the fact that Afrezza was demonstrated to be less effective than comparator. For the T2DM trial, the result of greater hypoglycemia risk vs. placebo is expected. [FONT=Book Antiqua]It's worth noting that there's a huge amount of data relating to the mechanism by which titration of Afrezza dosage was undertaken in the trials and how, if hypo- or hyper-glycaemia was observed post meals, doses were then adjusted. The full set of documents is available [URL='http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM390864.pdf']here[/URL].[/FONT] [/QUOTE]
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