A Pharmacist's Perspective: Proceedings from the Third Canadian Consensus Conference: An Evidence-Based Approach to Prescribing NSAIDs in the Treatment of Osteoarthritis and Rheumatoid Arthritis
Restricted accessReview articleFirst published online July, 2007
A Pharmacist's Perspective: Proceedings from the Third Canadian Consensus Conference: An Evidence-Based Approach to Prescribing NSAIDs in the Treatment of Osteoarthritis and Rheumatoid Arthritis
Recent events such as the withdrawal of rofecoxib and valdecoxib from the marketplace
have led to confusion among physicians and patients about the safety of coxibs. Eight
evidence-based recommendations regarding the appropriate and safe use of NSAIDs/coxibs
were made by the Third Canadian Consensus Conference Group on the following specific
topics: patient-physician communication, indication for the use of NSAIDs,
gastrointestinal toxicity, renal considerations, hypertension, cardiovascular risk,
geriatric considerations, and pharmacoeconomics. This article discusses how pharmacists
are to interpret new observations regarding the safety and efficacy of coxibs/NSAIDs, and
what role pharmacists should play in maximizing the appropriate and safe use of NSAIDs
based on the evidence-based guidelines.
TramerMRMooreRAReynoldsDJMcQuayHJ. Quantitative estimation of rare adverse events
which follow a biological progression: a new model applied to chronic NSAID
use. Pain2000;85:169–182
FDA/Center for Drug
Evaluation and Research.FDA Statement on Celebrex DTC Promotion. December 20,
2004. Available: www.fda.gov/bbs/topics/news/2004/new01147.html (accessed June 2,
2007)
ChanATMansonJEAlbertCMNonsteroidal antiinflammatory drugs, acetaminophen, and the risk of
cardiovascular events. Circulation2006:113:1578–87
7.
KearneyPMBaigentCGodwinJDo selective cyclooxygenase-2 inhibitors and traditional nonsteroidal
anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis of
randomized trials. BMJ2006:332:1302–8
8.
TannenbaumHBombardierCDavisPRussellAS;Third Canadian Consensus
Group. An evidence-based approach to prescribing nonsteroidal
anti-inflammatory drugs: Third Canadian Consensus Conference. J
Rheumatol2006; 33
(1):140–57
9.
ZhangWJonesADohertyM. Does paracetamol (acetaminophen) reduce the pain
of osteoarthritis? A meta-analysis of randomised controlled trials.
Ann Rheum Dis2004;63:901–7
10.
GebaGPWeaverALPolisABVioxx, Acetaminophen, Celecoxib Trial (VACT) Group. Efficacy of rofecoxib,
celecoxib, and acetaminophen in osteoarthritis of the knee: a randomized
trial. JAMA2002;287:64–71
11.
PincusTKochGLeiHPatient Preference for Placebo, Acetaminophen (paracetamol) or Celecoxib
Efficacy Studies (PACES): two randomised, double blind, placebo controlled, crossover
clinical trials in patients with knee or hip osteoarthritis. Ann
Rheum Dis2004;63:931–9
12.
PincusTKochGGSokkaTA randomized, double-blind, crossover clinical trial of diclofenac plus
misoprostol versus acetaminophen in patients with osteoarthritis of the hip or
knee. Arthritis Rheum2001;44:1587–98
13.
WolfeFZhaoSLaneN. Preference for nonsteroidal antiinflammatory
drugs over acetaminophen by rheumatic disease patients: a survey of 1,799 patients with
osteoarthritis, rheumatoid arthritis and fibromyalgia. Arthritis
Rheum2000;43:378–85
14.
Recommendations for the medical management of osteoarthritis of the hip and knee: 2000
updateAmerican College of Rheumatology Subcommittee on Osteoarthritis
Guidelines. Arthritis Rheum2000;43:1905–15
15.
JordanKMArdenNKDohertyMEULAR Recommendations 2003: an evidence based approach to the management of
knee osteoarthritis: Report of a Task Force of the Standing Committee for International
Clinical Studies Including Therapeutic Trials (ESCISIT). Ann
Rheum Dis2003:62;1145–55
16.
Pennsaid. In: RepchinskyCarol, editor. Compendium of Pharmaceuticals and
Specialties.Ottawa, ON: Canadian Pharmacists
Association; 2004. p.
1503–6
17.
TugwellPSWellsGAShainhouseJZ. Equivalence study of a topical diclofenac
solution (Pennsaid) compared with oral diclofenac in symptomatic treatment of
osteoarthritis of the knee: a randomized controlled trial. J
Rheumatol2004;31:2002–12
18.
BookmanAAWilliamsKSShainhouseJZ. Effect of a topical diclofenac solution for
relieving symptoms of primary osteoarthritis of the knee: a randomized controlled
trial. CMAJ2004;171:333–8
19.
LinJZhangWJonesADohertyM. Efficacy of topical nonsteroidal
anti-inflammatory drugs in the treatment of osteoarthritis: meta-analysis of randomized
controlled trials. BMJ2004;329:324
20.
RothSHShainhouseJZ. Efficacy and safety of a topical diclofenac
solution (Pennsaid) in the treatment of primary osteoarthritis of the knee: a
randomized, double-blind, vehicle-controlled clinical trial.
Arch Intern Med.2004;164:2017–23
21.
GabrielSEJaakkimainenLBombardierC. Risk for serious gastrointestinal complications
related to use of nonsteroidal anti-inflammatory drugs: a meta-analysis.
Ann Intern Med.1991;115:787–96
22.
RodriguezLA GarciaJickH. Risk of upper gastrointestinal bleeding and
perforation associated with individual nonsteroidal anti-inflammatory
drugs. Lancet1994;343:769–72
23.
SilversteinFEGrahamDYSeniorJRMisoprostol reduces serious gastrointestinal complications in patients with
rheumatoid arthritis receiving nonsteroidal anti-inflammatory drugs. A randomized,
double-blind, placebo-controlled trial. Ann Intern Med.1995;123:241–9
24.
HuangJQSridharSHuntRH. Role of Helicobacter pylori
infection and non-steroidal anti-inflammatory drugs in pepticulcer disease: a
meta-analysis. Lancet2002;359:14–22
25.
KellyJPKaufmanDWJurgelonJMRisk of aspirin-associated major upper-gastrointestinal bleeding with
enteric-coated or buffered product. Lancet1996;348:1413–6
26.
ChanFKChungSCSuenBYPreventing recurrent upper gastrointestinal bleeding in patients with
Helicobacter pylori infection who are taking low-dose aspirin or
naproxen. N Engl J Med.2001;344:967–73
27.
DaltonSOJohansenCMellemkjaerLUse of selective serotonin reuptake inhibitors and risk of upper
gastrointestinal tract bleeding: a population-based cohort study.
Arch Intern Med.2003;163:59–64
28.
Van HeckenADepreMWynantsKEffect of clopidogrel on naproxen-induced gastrointestinal blood loss in
healthy volunteers. Drug Metabol Drug Interact1998;14:193–205
29.
SpiegelBMChiouCFOfmanJJ. Minimizing complications from nonsteroidal
antiinflammatory drugs: cost-effectiveness of competing strategies in varying risk
groups. Arthritis Rheum2005:53;185–97
30.
RahmeEBardouMDasguptaKGastrointestinal safety of rofecoxib and celecoxib versus NSAIDs among
patients on low dose aspirin [abstract]. Pharmacoepidemiol Drug
Saf2004;13 (suppl
1):S233
31.
MooreRADerrySMakinsonGTMcQuayHJ. Tolerability and adverse events in clinical
trials of celecoxib in osteoarthritis and rheumatoid arthritis: systematic review and
meta-analysis of information from company clinical trial reports.
Arthritis Res Ther2005;7:R644–65
32.
SilversteinFEFaichGGoldsteinJLGastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory
drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: a randomized
controlled trial. Celecoxib Long-term Arthritis Safety Study.
JAMA2000;284:1247–55
33.
FarkouhMEKirschnerHHarringtonRA; TARGET Study Group. Comparison of
lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and
Gastrointestinal Event Trial (TARGET), cardiovascular outcomes: randomised controlled
trial. Lancet2004;364:675–84
34.
CockcroftDWGaultMH. Prediction of creatinine clearance from serum
creatinine. Nephron1976;16:31–41
35.
ThatteLVaamondeCA. Drug-Induced nephrotoxicity: The crucial role of
risk factors. Postgraduate Medicine1996;100 (6). Available: www.postgradmed.com/issues/1996/12_96/thatte.htm
(accessed June 2, 2007)
36.
AltmanRDPerezGOSfakianakisGN. Interaction of cyclosporin A and nonsteroidal
anti-inflammatory drugs on renal function in patients with rheumatoid
arthritis. Am J Med.1992:93:396–402
37.
WheltonASchulmanGWallemarkCEffects of celecoxib and naproxen on renal function in the
elderly. Arch Intern Med.2000;160:1465–70
38.
SwanSKRudyDWLasseterKCEffect of cyclooxygenase-2 inhibition on renal function in elderly persons
receiving a low-salt diet. Ann Intern Med.2000;133:1–9
39.
PopeJEAndersonJJFelsonDT. A meta-analysis of the effects of nonsteroidal
anti-inflammatory drugs on blood pressure. Arch Int
Med.1993;153:477–84
40.
WheltonAFortJGPumaJA; SUCCESS VI Study Group.
Cyclooxygenase-2-specific inhibitors and cardiorenal function: a randomized, controlled
trial of celecoxib and rofecoxib in older hypertensive osteoarthritis
patients. Am J Ther2001;8:85–95
41.
WheltonAWhiteWBBelloAE; SUCCESS-VII Investigators. Effects of
celecoxib and rofecoxib on blood pressure and edema in patients 65 years of age with
systolic hypertension and osteoarthritis. Am J Cardiol2002;90:959–63
42.
WhiteWBKentJTaylorAEffects of celecoxib on ambulatory blood pressure in hypertensive patients
on ACE inhibitors. Hypertension2002;39:929–34
43.
SolomonDHSchneeweissSLevinRAvornJ. Relationship between COX-2 specific inhibitors
and hypertension. Hypertension2004;44:140–5
44.
SchwartzJIVandormaelKMaliceMPComparison of rofecoxib, celecoxib, and naproxen on renal function in
elderly subjects receiving a normal-salt diet. Clin Pharmacol
Ther2002;72:50–61
45.
SowersJRWhiteWBPittB; Celecoxib Rofecoxib Efficacy and Safety in
Comorbidities Evaluation Trial (CRESCENT) Investigators. The effects of cyclooxygenase-2
inhibitors and nonsteroidal anti-inflammatory therapy on 24-hour blood pressure in
patients with hypertension, osteoarthritis and type 2 diabetes mellitus.
Arch Intern Med.2005;165:161–8
46.
BombardierCLaineLReicinA; VIGOR Study Group. Comparison of upper
gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid
arthritis. VIGOR Study Group. N Engl J Med.2000;343:1520–8
47.
Vioxx (rofexocib tablets and oral suspension)FDA Advisory Committee background information. Merck Research
Laboratories; February 16–18, 2005: 81. NDA
21–052
48.
KonstamMAWeirMRReicinACardiovascular thrombotic events in controlled, clinical trials of
rofecoxib. Circulation2001;104:2280–8
49.
ReicinASShapiroDSperlingRSComparison of cardiovascular thrombotic events in patients with
osteoarthritis treated with rofecoxib versus nonselective nonsteroidal antiinflammatory
drugs (ibuprofen, diclofenac, and nabumetone). Am J
Cardiol2002;89:204–9
50.
BresalierRSSandlerRSQuanH; Adenomatous Polyp Prevention on Vioxx
(APPROVe) Trial Investigators. Cardiovascular events associated with rofecoxib in a
colorectal adenoma chemoprevention trial. N Engl J Med.2005;352:1092–102
51.
SolomonSDMcMurrayJJPfefferMA; Adenoma Prevention with Celecoxib (APC)
Study Investigators. Cardiovascular risk associated with celecoxib in a clinical trial
for colorectal adenoma prevention. N Engl J Med.2005;352:1071–80
Cardiovascular and cerebrovascular events in the randomized, controlled Alzheimer's
Disease Anti-inflammatory Prevention Trial (ADAPT)PLoS Clin Trials2006;1:e33
54.
CannonCPCurtisSPFitzGeraldGA; MEDAL Steering Committee. Cardiovascular
outcomes with etoricoxib and diclofenac in patients with osteoarthritis and rheumatoid
arthritis in the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL)
programme: a randomised comparison. Lancet2006;368:1771–81
55.
VinksTHde KoningFHde LangeTMEgbertsTC. Identification of potential drug-related problems
in the elderly: the role of the community pharmacist. Pharm
World Sci.2006; 28
(1):33–8
56.
TannenbaumHPelosoPMAn evidence-based approach to prescribing NSAIDs in the treatment of
osteoarthritis and rheumatoid arthritis: The Second Canadian Consensus
Conference. Can J Clin Pharmacol2000;7 Suppl A:
4A–16A
57.
RahmeEJosephLKongSXCost of prescribed NSAID-related gastrointestinal adverse events in elderly
patients. Br J Clin Pharmacol2001;52:185–92
58.
MaetzelAKrahnMNaglieG. The cost effectiveness of rofecoxib and celecoxib
in patients with osteoarthritis or rheumatoid arthritis.
Arthritis Rheum2003;49:283–92
59.
McGettiganPHenryD. Cardiovascular risk and inhibition of
cyclooxygenase: a systematic review of the observational studies of selective and
nonselective inhibitors of cyclooxygenase 2. JAMA2006;296:1633–44
