Standard Care versus celecoxib Outcome Trial - SCOT

Oct 11, 2016
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Pfizer
Date Presented:
08/31/2015
Date Published:
10/03/2016
Date Updated:
10/11/2016
Original Posted Date:
08/31/2015
References

Contribution To Literature:

The SCOT trial showed that adverse cardiovascular event rates were similar between celecoxib and nonselective NSAIDs.

Description:

The goal of the trial was to evaluate treatment with celecoxib compared with a nonselective nonsteroidal anti-inflammatory drug (NSAID) among subjects with arthritis and no known cardiovascular disease.

Study Design

  • Randomized
  • Parallel

Subjects with arthritis and no known cardiovascular disease were randomized to celecoxib versus a nonselective NSAID. Study medicines were prescribed by primary care physicians within the context of clinical care.

Inclusion criteria:

  • Subjects ≥60 years of age with rheumatoid or osteoarthritis
  • Chronic use of an NSAID
  • Total number of enrollees: 7,297
  • Duration of follow-up: 3.2 years
  • Mean patient age: 69 years
  • Percentage female: 58%
  • Percentage diabetics: 8%
  • At baseline, use of diclofenac 39% and ibuprofen 32%

Exclusion criteria:

  • Known cardiovascular disease

Principal Findings:

The primary outcome of cardiovascular death, myocardial infarction, or stroke occurred at a similar frequency for celecoxib versus nonselective NSAIDs (hazard ratio [HR] 1.04, p = 0.75). Results were similar for celecoxib versus ibuprofen, celecoxib versus diclofenac, or celecoxib versus other nonselective NSAIDs.

Secondary outcomes were all-cause mortality for celecoxib versus nonselective NSAIDs (HR 0.92, p = 0.56). Withdrawal from study drug was 50.9% with celecoxib versus 30.2% with nonselective NSAIDs (p < 0.001). The most common reason cited for withdrawal in the celecoxib group was lack of efficacy.

  • Serious gastrointestinal (GI) adverse events: 38 for celecoxib vs. 66 for nonselective NSAIDs (p < 0.007)

Interpretation:

Among patients with arthritis and no known cardiovascular disease, the use of celecoxib was associated with a similar adverse cardiovascular event rate compared with a nonselective NSAID. Serious adverse GI events were less frequent among celecoxib users. This was a pragmatic trial; therefore, study medications were administered within clinical care and given to patients in a nonblinded fashion. All of these agents have been associated with some cardiovascular toxicity. The event rate for a selective COX-2 inhibitor or a nonselective NSAID compared to placebo is unknown.

References:

MacDonald TM, Hawkey CJ, Ford I, et al. Randomized trial of switching from prescribed non-selective non-steroidal anti-inflammatory drugs to prescribed celecoxib: the Standard care vs. Celecoxib Outcome Trial (SCOT). Eur Heart J 2016;Oct 4:[Epub ahead of print].

Presented by Dr. Thomas MacDonald at the European Society of Cardiology Congress, London, August 31, 2015.

Keywords: Anti-Inflammatory Agents, Non-Steroidal, Arthritis, Cyclooxygenase 2 Inhibitors, Diclofenac, Ibuprofen, Myocardial Infarction, Osteoarthritis, Primary Prevention, Pyrazoles, Stroke, Sulfonamides, ESC Congress


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