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Pilot Study of Ruboxistaurin Showed Favorable Effects on Kidney Damage and Function in People with Type 2 Diabetes and Nephropathy

Athens, Greece (ots/PRNewswire)

- Approximately 40 percent of people with diabetes develop
nephropathy, the leading cause of kidney failure
Eli Lilly and Company (NYSE: LLY) today announced encouraging
results from a one-year pilot study examining the effect of
ruboxistaurin mesylate in persons with type 2 diabetes and kidney
disease (also known as "diabetic nephropathy"). Data reported at the
European Association for the Study of Diabetes (EASD) Annual Meeting
in Athens, Greece, showed that in patients being treated with
angiotensin converting enzyme inhibitors (ACE inhibitors),
angiotensin receptor blockers (ARBs), or both, ruboxistaurin
significantly reduced albuminuria (an indicator of diabetic kidney
damage) by 24%, compared to a nonsignificant 9% reduction in patients
taking placebo.
"The results from this study are very encouraging for people with
type 2 diabetes who suffer from diabetic nephropathy," said Katherine
R. Tuttle, MD, lead investigator of the study, from Providence
Medical Research Center and The Heart Institute of Spokane, Spokane,
Wash, USA. "The significant improvement of albuminuria with
ruboxistaurin in patients already treated with ACE inhibitors or ARBs
suggests that the drug may be helpful in further slowing the
progression of kidney disease."
Albuminuria is a condition in which the kidneys lose increased
amounts of albumin (a protein marker of kidney damage) into the
urine, and is considered the first clinical indication of diabetic
nephropathy. Diabetic nephropathy is a diabetic microvascular
complication (DMC) caused by damage to the small blood vessels in the
kidneys. It occurs in approximately 40 percent of people with
diabetes and is the leading cause of kidney failure in the developed
world.
Reductions in albuminuria with ruboxistaurin were seen after one
month of treatment and remained consistent throughout the study. In
addition, patients taking placebo experienced a significant loss of
kidney function after 1 year, however kidney function was stable in
patients treated with ruboxistaurin.
About the Study
In this multicenter, randomized, double-blinded, parallel
placebo-controlled trial, 123 subjects were randomized at 17 clinical
sites in the United States to receive either 32 mg/day of
ruboxistaurin or placebo. Participants were required to be taking
stable doses of either ACE inhibitors, ARBs, or both, for 6 months
prior to the study and these agents were continued throughout the
trial. Baseline characteristics did not differ significantly between
treatment groups. Blood glucose and blood pressure control was
similar at the beginning and throughout the study.
Analyses of adverse events in this trial revealed no significant
differences between the ruboxistaurin (15 reported) and placebo (9
reported) groups, except in the placebo group for episodes of
hypertension requiring intervention (8% of placebo participants had
an episode of hypertension requiring intervention compared with 0% in
ruboxistaurin treated group). The most frequently reported adverse
event in this clinical trial was hypertension. Three
ruboxistaurin-treated participants withdrew due to adverse events
(decreased libido, impaired mental status, and metastatic cancer).
Based upon the results of this pilot study, ruboxistaurin was well
tolerated; but the small sample size and limited duration of
follow-up precludes a firm conclusion about safety.
About Ruboxistaurin
Ruboxistaurin is a specific protein kinase C beta (PKC beta)
inhibitor, the first of a new class of compounds being investigated
for the treatment of diabetic peripheral neuropathy (damage to the
nerves), diabetic retinopathy (damage to the eyes) and diabetic
nephropathy, the three major diabetic microvascular complications
(DMCs) associated with type 1 and type 2 diabetes. Metabolic factors
associated with diabetes often lead to damage to the small blood
vessels in the nerves, eyes and kidneys, ultimately leading to DMCs.
Pre-clinical data show that ruboxistaurin is a specific inhibitor
of PKC beta. PKC beta is an enzyme that has been implicated in the
underlying process of microvascular damage caused by diabetes.
Lilly's Leadership in Diabetes
Through a long-standing commitment to diabetes care, Lilly
provides patients with breakthrough treatments that enable them to
live longer, healthier and fuller lives. Since 1923, Lilly has been
the industry leader in pioneering therapies to help health care
professionals improve the lives of people with diabetes, and research
continues on innovative medicines to address the unmet needs of
patients.
About Lilly
Lilly, a leading innovation-driven corporation, is developing a
growing portfolio of first-in-class and best-in-class pharmaceutical
products by applying the latest research from its own worldwide
laboratories and from collaborations with eminent scientific
organizations. Headquartered in Indianapolis, Ind., Lilly provides
answers -- through medicines and information -- for some of the
world's most urgent medical needs.
P-LLY
This press release contains forward-looking statements about the
potential of the investigational compound ruboxistaurin for the
treatment of diabetic microvascular complications and reflects
Lilly's current beliefs. However, as with any pharmaceutical product
under development, there are substantial risks and uncertainties in
the process of development and regulatory review. There is no
guarantee that the product will receive regulatory approvals, or that
the regulatory approval will be for the indication(s) anticipated by
the company. There is also no guarantee that the product will prove
to be commercially successful. For further discussion of these and
other risks and uncertainties, see Lilly's filings with the United
States Securities and Exchange Commission. Lilly undertakes no duty
to update forward-looking statements.
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )

Contact:

Marni Lemons of Eli Lilly and Company, +1-317-433-8990 / Photo:
NewsCom: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO , PRN
Photo Desk, photodesk@prnewswire.com

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