Vitamin D Insufficiency
Program
Vitamin D insufficiency (defined for CKD patients
as serum total 25-hydroxyvitamin D levels < 30 ng/mL) is
common in patients with Stages 3, 4 & 5 CKD, and has been
shown to exacerbate the development of secondary hyperparathyroidism
and related bone disease (renal osteodystrophy). Emerging
data suggests that prolonged Vitamin D insufficiency contributes
substantially to increased mortality rates in dialysis patients.
Recent studies have documented that the great majority of
CKD patients have low blood levels of 25-hydroxyvitamin D
suggesting that the onset of CKD is a significant risk factor
for Vitamin D insufficiency and that the prevalence of Vitamin
D insufficiency increases as CKD progresses.
Parallel advances
in the understanding of Vitamin D insufficiency and its complications
have resulted in a new global initiative known as Kidney Disease:
Improving Global Outcomes (KDIGO). The forthcoming new guidelines
from KDIGO are expected to strongly advocate the use of Vitamin
D repletion therapy (for Vitamin D insufficiency), along with
the more accepted Vitamin D hormone replacement therapy (for
secondary hyperparathyroidism) to CKD patients.
Currently, in
the United States, there are only two prescription high-dose
Vitamin D repletion products available for the treatment of
Vitamin D insufficiency in CKD patients: Drisdol® and
its generic competition. Recent studies have shown that both
therapies have limited efficacy in restoring adequate Vitamin
D prohormone levels.
Market Opportunity
Vitamin D insufficiency is common in CKD
patients in Stages 3, 4 and 5, and has been shown to exacerbate
the development of SHPT and related bone diseases (e.g. renal
osteodystrophy). Current publications indicate that 70% of
Stage 3, 80% of Stage 4, and 95% of Stage 5 (dialysis) patients
suffer from Vitamin D insufficiency, totaling over 6.5 million
patients eligible for treatment in 2006. This market is expected
to grow significantly by 2010. Emerging data suggests that
prolonged Vitamin D insufficiency contributes substantially
to increased mortality rates in dialysis patients. For example,
recent studies from the Harvard School of Medicine using historical
cohort data have shown a significant survival advantage in
dialysis patients with normal levels of Vitamin D prohormone
versus those with low levels. Furthermore, several studies
have recently emerged linking low Vitamin D hormone levels
with cardiovascular disease and Type II diabetes, both prevalent
co-morbidities in CKD patients.
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