This bugs me. This is in fact the same trial as reported on at EASD.
Message 18015407
So yes, there were chest X-rays.
Yet the authors of the ADA abstract report two adverse events, while the authors of the EASD abstract reported "no major pulmonary safety issues." Is there some fine distinction here I'm not getting? Sheesh. The EASD folks report no change in mean PFT for the group as a whole. That phrasing allowed these two patients with decreased PFT that were considered to be adverse events to be left out of the EASD abstract without the authors contradicting themselves or having to indicate that anything at all was cause for concern. The most optimistic viewpoint is that the adverse events were not deemed attributable to the inhaled insulin. Hopefully, the details will come out tomorrow, when the ADA abstract will be discussed. Or perhaps these two were discussed at the EASD meeting, but not in the abstract, and I'm getting upset about old news that I'm simply not privy to. Anybody hear about these two patients before now?! Arrrgh!!
Anyhow, here's the last abstract:
>>Compliance with Inhaled Insulin Treatment Using
AERx[reg] iDMS Insulin Diabetes Management
System
Abstract Information
Abstract Number:
442-P
Authors:
JOYCE A. CRAMER, JERRY OKIKAWA, PER CLAUSON
Institution:
New Haven, CT; Hayward, CA; Bagsvaerd, Denmark
Results:
The objective was to demonstrate the ability of patients to use AERx[reg] iDMS to
deliver mealtime inhaled insulin doses and explore preliminary data on importance of
compliance for glycemic control. AERx[reg] iDMS was evaluated in a 12-week,
multicenter open trial with 107 type 2 diabetes patients currently taking insulin.
Patients were randomized to treatment with inhaled insulin using AERx[reg] iDMS or
fast-acting human insulin injections, both before main meals and in combination with
bedtime NPH insulin. AERx[reg] iDMS recorded the date and time of each insulin
inhalation, units used, and inhalation technique during aerosol delivery. Preliminary
analyses included 32 patients (mean age 57.6±7.0, diabetes duration 10.8±8.0
years) who used AERx[reg] iDMS. Compliance was defined as percentage of
prescribed doses taken during treatment period (83±5 days, range 76-92, 237±22
doses, range 186-270). Mean compliance with inhaled insulin was 92.6±14.6%
(22%-100%). Mean percentage of missed doses was 7.3±14.4% including 1 patient
who omitted 78% of doses, or 4.8±20.4% excluding that outlier. Overall, 25 of 32
patients took [ge]90% of prescribed doses, 30 patients took [ge]80% of doses (the
2 poor compliers took 22%, 57% of doses). Patients with compliance rates [ge]90%
achieved mean 0.53±0.98% decreased HbA1c levels. Nine of 12 patients whose
HbA1c decreased by [ge]1% were excellent compliers ([ge]93%). HbA1c level
increased 0.6 for the patient with the poorest compliance rate (22%). Few patients
experienced poor inhalation technique ([le]5 doses, <2.5% of doses overall), with
only 2 patients experiencing >10 dosing episodes with insufficient inhaled volume.
These preliminary data demonstrate that patients converting from insulin injections
to inhaled insulin using AERx[reg] iDMS can achieve excellent compliance with a
mealtime dosing regimen. High rates of compliance with insulin inhalation suggest
that AERx[reg] iDMS is an acceptable and convenient system for self-administration
of insulin leading to improved glycemic control. The electronic compliance monitoring
feature provides clinicians with valuable information about patient dosing regimens
and compliance.<<
Cheers, Tuck |
