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Study Indicates Inhaler May Replace Needle for
Diabetes Patients?
Nov. 21, 2005 - There is clear evidence from
clinical trials that a new inhaled formulation of insulin, Exubera, is
as effective as traditional subcutaneous injections in controlling blood
glucose in patients with type 1 or type 2 diabetes. The new formulation,
which is likely to be the first non-injectable insulin on the market,
was preferred by a majority of patients due to ease of use and is sure
to be welcomed news for the nearly one in five of seniors over age 60
who suffer with diabetes.
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Clinical trials with Exubera are reviewed in the
journal Core Evidence, the first international peer-reviewed publication
to assess medications by critically evaluating evidence on clinical
effectiveness and outcomes.
Diabetes affects an estimated 194 million people
worldwide, and prevalence is expected to almost double within the next
20 years.
Type 2 diabetes is the most common form of the
disease, accounting for over 90% of cases. In most patients, the disease
is initially controlled by diet and exercise, usually with the addition
of oral antidiabetic medications. However, many patients will require
insulin therapy over the course of their disease to control blood
glucose and avoid serious complications including cardiovascular
disease, neuropathy, and nephropathy. Insulin is the mainstay of
treatment of type 1 diabetes.
Despite the well known benefit of tight management
of blood glucose, however, it is estimated that many patients are not
adequately controlled, particularly those with type 2 diabetes.
One reason for this is that physicians and
patients are often reluctant to initiate insulin therapy, because of the
burden of daily injections, and the risk of hypoglycemia and weight
gain, said Louise Profit, PhD, author of the review. Alternative
routes of insulin administration are therefore being investigated.
Exubera is a dry powder formulation packaged into
blisters and delivered via a hand-held inhaler device developed by
Nektar Therapeutics. It is jointly developed by Pfizer and Sanofi-Aventis,
and is likely to be the first available non-injectable insulin on the
market. Its approval has been recommended by an FDA Advisory Board in
the United States, and by the Committee for Medicinal Products for Human
Use of the European Medicines Agency.
The review in Core Evidence states that there is
clear evidence that Exubera is as effective as subcutaneous insulin in
reducing HbA1c levels, the key indicator of blood glucose control, in
patients with type 1 or type 2 diabetes.
The article also reports that inhaled insulin had
a greater acceptance relating to convenience and ease of use. The
incidence of weight gain and hypoglycemia was no greater with Exubera
compared with subcutaneous insulin, and in short-term trials there was
no effect on pulmonary function.
Although no economic analyses have been published,
the review suggests that Exubera may prove cost effective if it improves
blood glucose control through better patient acceptability.
Even a 1% increase in HbA1c can increase
healthcare costs because of more frequent and earlier onset of diabetic
complications, said Dr Profit. Drugs make up a relatively small
proportion of the overall cost of managing diabetes, which may be offset
by savings from better disease control. However, comparisons with other
inhaled insulin formulations and formal economic studies are required to
confirm this for Exubera.
The article nevertheless concludes that current
evidence suggests that Exubera is an alternative to short-acting
subcutaneous insulin therapy providing a further choice for the
treatment of patients with type 1 or type 2 diabetes, and that a major
benefit of Exubera
appears to be the improvement in patient treatment
satisfaction which is related to its ease of use, leading to better
adherence to treatment.
Published by Core Medical Publishing Ltd (http://www.coremedicalpublishing.com),
a new company with offices in Manchester, UK and New York, Core Evidence
is the first international peer-reviewed journal to rigorously evaluate
the evidence for rational drug selection based on outcomes central to
informed medical decision-making, with the goal of improved quality of
care. Core Evidence is available in print and/or online formats. For
subscription information, call toll-free 866-246-3817 or email
custserv@coreevidence.com
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