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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