A framework for evaluating the clinical consequences of initial therapy with NSAIDs, NSAIDs plus gastroprotective agents, or celecoxib in the treatment of arthritis.
OBJECTIVE
The purpose of this study is to provide a framework for estimating the economic efficiency of nonselective nonsteroidal anti-inflammatory drugs (NSAIDs), concomitant gastroprotective agents (GPAs) to reduce the risk of NSAID toxicity, and celecoxib, a specific cyclo-oxygenase-2 inhibitor. Concomitant GPA therapies considered include one of the following: proton pump inhibitors (PPIs) plus NSAIDs, histamine H2 receptor antagonists (H2RAs) plus NSAIDs, misoprostol plus NSAIDs, and a single tablet formulation of diclofenac/misoprostol.


METHODS
The study employs a decision-tree framework to establish probabilities of upper gastrointestinal (GI) adverse events occurring over a 6-month time frame. Celecoxib clinical trial data are used to establish probabilities of upper GI events for celecoxib and NSAIDs, and published literature is used to predict upper GI events for the other concomitant therapies. Upper GI adverse events included in the decision-tree are as follows: GI discomfort, symptomatic ulcer, serious GI complications (with and without death), and anaemia with occult bleeding.


RESULTS
Clinical probabilities indicate celecoxib has significant tolerability and safety advantages compared with nonselective NSAIDs. Celecoxib also reduces the risk of GI adverse events to a similar or superior degree when compared with reductions observed with NSAIDs with concomitant GPAs.


CONCLUSIONS
Use of celecoxib is expected to significantly reduce the economic costs of GI toxicity and its associated morbidity.
Burke
T A
TA
Pharmacia Corporation, Global Health Outcomes, Skokie, Illinois, USA. tom.a.burke@monsanto.com
Zabinski
R A
RA
Pettitt
D
D
Maniadakis
N
N
Maurath
C J
CJ
Goldstein
J L
JL
D000740:Anemia / Q000139:chemically induced; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001168:Arthritis / Q000188:drug therapy* / Q000191:economics; D000068579:Celecoxib; D002986:Clinical Trials as Topic; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*; D003663:Decision Trees; D004359:Drug Therapy, Combination; D004381:Duodenal Ulcer / Q000139:chemically induced / Q000517:prevention & control*; D017850:Economics, Pharmaceutical; D006801:Humans; D016595:Misoprostol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D011336:Probability; D011720:Pyrazoles; D013449:Sulfonamides / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D000897:Anti-Ulcer Agents; D016861:Cyclooxygenase Inhibitors; D011720:Pyrazoles; D013449:Sulfonamides; D016595:Misoprostol; D000068579:Celecoxib