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COX-2 withdrawal - Therapeutic, R&D and pharmaceutical impact
Lead Discovery, Oct 2004, Pages: 59
1. The biology of the cyclooxygenase pathway
Prostaglandin production
(Patho)physiological effects of the prostaglandins
Inflammatory response to prostaglandins
Immunomodulatory effects of prostaglandins
Hyperalgesic effects of prostaglandins
Pyretic effects of prostaglandins
Prostaglandin-mediated mucosal protection
Cardiovascular effects of the prostaglandins
Thrombotic effects of the prostaglandins
Angiogenic activity of the prostaglandins
Airway effects of the prostaglandins
An introduction to COX inhibitors: The mechanism of action of aspirin and its therapeutic effects
Other early COX inhibitors
Complications associated with NSAIDs
Misoprotol as a strategy for reducing gastrointestinal injury with NSAIDs
2. The rational for COX-2 development
The identification of COX-2
Expression of COX-1 and COX-2-challenges to the constitutive COX-1/Inducible COX-2 paradigm
Improved gastrointestinal safety as the rational for COX-2 development
Role of COX-2 in atherosclerosis
Role of COX-2 in angiogenesis
The existence of COX-3-an under-investigated molecular target for novel analgesics
3. Clinical data on approved and late stage COX-2 inhibitors
Pharmacology and therapeutic activity of the serendipitous selective COX-2 inhibitors Nimesulide, Etodolac and Meloxicam
The specific COX-2 inhibitors
First generation COX-2 specific inhibitors
Rofecoxib (Vioxx; Merck)
Pharmacology & Clinical data
VIGOR (Vioxx Gastrointestinal Outcomes Research) study
Gastrointestinal safety
Cardiovascular safety
APPROVe (Adenomatous Polyp Prevention on Vioxx) trial
Data from studies of the elderly
Safety of Vioxx compared to placebo
Celecoxib (Celebrex; Pfizer)
Pharmacology & Clinical data
CLASS (Celecoxib Long-Term Arthritis Safety Study) trial
Gastrointestinal safety
Cardiovascular safety
Second generation COX-2 specific inhibitors
Valdecoxib (Bextra; Pfizer)
Pharmacology & Clinical data
Paracoxib (Dynastat; Pfizer)
Pharmacology & Clinical data
Etoricoxib (Arcoxia; Merck)
Pharmacology & Clinical data
Lumiracoxib (Prexige; Merck)
Pharmacology & Clinical data
TARGET trial
4. The market for COX-2 inhibitors
The Market
Regional breakdown of COX-2 prescribing Prescription trends decline
Bextra’s launch subdued by contracting market
5. Adverse effects of COX-2 inhibitors
Cardiovascular safety
Vioxx
An in depth look at VIGOR
An in depth look at APPROVe
Arguments for the safety of Vioxx
Cardioprotective effects of naproxen
Does TARGET data lend support to the safety of Vioxx
Cardiovascular risk in the elderly
Causes of cardiovascular risk
Arcoxia
Celebrex
Prexige
Long-term studies to settle the ongoing CV debate
EMEA view all COX-2 inhibitors high cardiovascular risk
Cardioprotective effects of COX-2 inhibitors
Gastrointestinal safety
Vioxx
Celebrex
Arcoxia
Bextra
Prexige
Attractive safety profile of Prexige
6. Differentiating the risk of COX-2 inhibitor family members
Differentiating the safety profile of each COX-2
Risk of skin rash
Cardiovascular risk
Hypertension Risk-The underlying cause of increased cardiovascular risk in elderly Vioxx-treated patients?
Effect of COX-2 inhibition on atherosclerosis
An introduction to atherosclerosis
Effect of COX-2 inhibitors on thrombosis
Unanswered questions
7. Knock-on effect of Vioxx's withdrawal - Estimated sales performance of other COX-2 inhibitors
Immediate effects
Increase vigilance of safety of old and new products
Adjustment to existing labels potentially use of NSAIDS rather than COX-2s
Greater marketing and DTC needed to persuade physicians of safety
Increased flow of clinical data over the next few years to maintain
Greater emphasis on cost-effectiveness studies
Slowing down of COX-2 prescriptions
Scenario Analysis
Sales forecasts 2003A to 2010F
Global
US
Non-US
8. Emerging alternatives to COX-2 inhibitors
NO-NSAIDs
LOX/COX inhibitors
DMARDs
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