Abstract
Introduction:
Is metabolic syndrome a disease itself-or merely a grouping of diagnoses that
identify a person as being at increased risk for cardiovascular disease?
Current medical practice, regulatory guidance, and drug development appear to
be shifting away from the concept of metabolic syndrome as a discrete
condition; rather, aspects of metabolic syndrome-including diabetes,
hypertension, dyslipidemia, and obesity-are beginning to be included as part
of an assessment of patients' overall global cardiovascular risk. Drug makers
are thus likely to have greater success developing agents for the individual
components of metabolic syndrome rather than trying to treat multiple aspects
concurrently.
Get the Answers Needed to Shape Your Strategy:
- The FDA recently increased the challenges associated with obtaining
approval for an agent for metabolic syndrome, stating that the only way an
agent will be approved is if it addresses multiple aspects of the disease.
What approaches are drug companies taking to fi nding agents that
effectively treat multiple components of metabolic syndrome? Which companies
already have such agents in Phase II and Phase III trials?
- DiObex is developing an agent to inhibit cortisol production-the primary
glucocorticoid in humans. Inhibiting cortisol production provides a potential
approach to treating both diabetes and metabolic syndrome. What aspect of
DiObex' s agent should help facilitate the agent' s clinical development?
- Despite being the only available agent that treats multiple components of
metabolic syndrome, Pfi zer' s Caduet has seen limited uptake. Why aren' t
physicians prescribing Caduet more frequently?
- Currently, type 2 diabetes appears to be the indication of focus for most
companies developing drugs for metabolic syndrome. Why do companies fi nd
type 2 diabetes to be a particularly attractive indication?
- 11beta-HSD1, one of the two 11beta-hydroxysteroid dehydrogenase enzymes
that regulate the production of cortisol from cortisone, is attracting a great
deal of attention from pharmaceutical companies. Three 11beta-HSD1 inhibitors
are currently confi rmed to be in clinical development. Which companies are
developing these agents? Which company has reported preliminary results of a
Phase IIa trial that indicated a compound' s complete inhibition of
11beta-HSD1?
Scope:
- The metabolic syndrome controversy: disease defi nitions, FDA
perspective, payer reimbursement issues.
- Current treatment options: lifestyle modifi cations; treatments for
obesity, dyslipidemia, hypertension, and insulin resistance; Pfi zer' s Caduet.
- Strategies for drug development: multimodal approaches and fi
xed-dose combinations.
- The future for metabolic syndrome treatment: FDA requirements for
new agents, the shift to a focus on reducing overall cardiovascular risk, the
likelihood of new agents being approved, reimbursement challenges, antiobesity
agents currently in development, and will metabolic syndrome emerge as a
discrete indication?
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