Evaluation of Risk Profiles for Gastrointestinal and Cardiovascular Adverse Effects in Nonselective NSAID and COX-2 Inhibitor Users

Drug Safety ◽  
2008 ◽  
Vol 31 (2) ◽  
pp. 143-158 ◽  
Author(s):  
Deborah Layton ◽  
Patrick C Souverein ◽  
Eibert R Heerdink ◽  
Saad A W Shakir ◽  
Antoine C G Egberts
Keyword(s):  
Adverse Effects ◽  
Nonselective Nsaid ◽  
Risk Profiles ◽  
Cox 2

scholarly journals Pulsed Shortwave Therapy in Cervical Osteoarthritis: an NSAID- Controlled, Randomized Clinical Trial

2021 ◽  
Author(s):  
A. Rachid El Mohammad ◽  
Sree Koneru ◽  
Richard Staelin ◽  
Kenneth McLeod ◽  
Omar Tabbouche ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Outcome Measures ◽  
Neck Disability Index ◽  
Primary Outcome Measure ◽  
Pain Medication ◽  
Secondary Outcome ◽  
Pain Duration ◽  
Cox 2 ◽  
Neck Disability ◽  
Pain At Rest

AbstractAssess treatment superiority of pulsed shortwave therapy (PSWT) against COX-2 NSAID therapy, in reducing disability and pain due to cervical osteoarthritis. Two hundred chronic pain suffers (average pain duration about 2 years) diagnosed with cervical osteoarthritis by radiological imaging were randomized into one of two treatment arms: COX-2 NSAID treatment; etoricoxib 60 mg/day for 4 weeks; or PSWT treatment worn 24 h/day for 4 weeks. The primary outcome measure was the 4-week score on the Neck Disability Index (NDI), a 10-question assessment on a 50-point scale. Secondary outcome measures included pain (at rest and during activity) measured on a visual analog scale (VAS) of 0–100 mm, dose count of rescue pain medication (paracetamol) use, and a treatment satisfaction rating. These 4-week scores were compared across the two arms to assess superiority. After 4 weeks of treatment, subjects in both study arms reported statistically significant (p < 0.0001) reductions in NDI, with final scores of 11.24-NSAID and 9.34-PSWT, VASrest, with final scores of 30.08-NSAID; 22.76-PSWT, and VASactivity, with final scores of 36.40-NSAID; 27.42-PSWT. The absolute reduction from baseline in NDI was significantly greater in the PSWT arm than NSAID arm (3.66 points; 95% CI 2.3 to 5.02; p < 0.0001). Similarly, the reductions from baseline in VASrest and VASactivity were significantly greater in the PSWT arm than NSAID arm (10.89 mm; 95% CI 6.90 to 14.87; p < 0.0001; and 12.05 mm; 95% CI 7.76 to 16.33; p < 0.0001, respectively). The PSWT arm used 50% less rescue pain medication. Eleven adverse effects were reported in the NSAID arm and zero in the PSWT arm. Both NSAID and PSWT treatments resulted in statistically significant improvements in quality of life (NDI) and reduction in pain (VAS) resulting from cervical osteoarthritis. However, the PSWT intervention showed superior improvements in all outcome measures when compared to the NSAID arm with no adverse effects. Clinicaltrials.gov (NCT03542955).

scholarly journals Factors Associated with Celecoxib and Rofecoxib Utilization

2005 ◽  
Vol 39 (4) ◽  
pp. 597-602 ◽  
Author(s):  
Nigel SB Rawson ◽  
Parivash Nourjah ◽  
Stella C Grosser ◽  
David J Graham
Keyword(s):  
Cardiovascular Disease ◽  
Disease Burden ◽  
Multiple Logistic Regression Analysis ◽  
Underlying Disease ◽  
Nonsteroidal Antiinflammatory Drugs ◽  
Nonselective Nsaid ◽  
Antiinflammatory Drugs ◽  
The Past ◽  
Increased Risk ◽  
Cox 2

BACKGROUND: The cyclooxygenase-2 (COX-2) selective nonsteroidal antiinflammatory drugs (NSAIDs) celecoxib and rofecoxib (before its removal) are marketed as having fewer gastrointestinal (GI)-related complications than nonselective NSAIDs. However, adverse reaction data suggest that the use of COX-2 selective NSAIDs is associated with clinically significant GI events. OBJECTIVE: To assess whether patients receiving celecoxib and rofecoxib have a greater underlying disease burden than patients prescribed nonselective NSAIDs. METHODS: The study population consisted of members of 11 health plans, aged >34 years, with a pharmacy claim for celecoxib or rofecoxib or a nonselective NSAID dispensed between February 1, 1999, and July 31, 2001, who had been continuously enrolled for >364 days before the dispensing date. Celecoxib and rofecoxib patients were randomly selected without replacement from a pool of eligible users in each of the 30 months. Nonselective NSAID users were randomly chosen without replacement within each month on a 2:1 ratio to cases; they could be chosen in more than one month. Univariate analyses comparing 9000 cases and 18 000 controls were performed, followed by a multiple logistic regression analysis conditioned on time. RESULTS: Increasing age, treatment by a rheumatologist or an orthopedic specialist, treatment with a high number of different medications in the past year, treatment with oral corticosteroids in the past year, and having had a previous GI bleed increased the likelihood of receiving celecoxib or rofecoxib, whereas treatment with a high number of nonselective NSAID prescriptions in the past year decreased it. Treatment with a high number of different medications was a predictor of increased prevalence of underlying diabetes mellitus and cardiovascular disease. CONCLUSIONS: Patients having a greater underlying disease burden were more likely to receive COX-2 selective NSAIDs than nonselective ones. Paradoxically, patients at higher risk for cardiovascular disease were channeled toward treatment with COX-2 selective NSAIDs, many of which may confer an increased risk of acute myocardial infarction and other adverse cardiovascular outcomes.

Gastrointestinal-related adverse effects of COX-2 inhibitors

2003 ◽  
Vol 39 (12) ◽  
pp. 939
Author(s):  
P.A. Foral ◽  
K.K. Nystrom ◽  
A.F. Wilson ◽  
C.M. Christensen
Keyword(s):  
Adverse Effects ◽  
Cox 2 ◽  
Cox 2 Inhibitors

Cox-2 inhibition can lead to adverse effects in a rat model for temporal lobe epilepsy

2010 ◽  
Vol 91 (1) ◽  
pp. 49-56 ◽  
Author(s):  
Linda Holtman ◽  
Erwin A. van Vliet ◽  
Peter M. Edelbroek ◽  
Eleonora Aronica ◽  
Jan A. Gorter
Keyword(s):  
Adverse Effects ◽  
Temporal Lobe Epilepsy ◽  
Temporal Lobe ◽  
Rat Model ◽  
Cox 2

scholarly journals Pulsed Shortwave Therapy in Cervical Osteoarthritis: An NSAID- Controlled, Randomized Clinical Trial

2020 ◽  
Author(s):  
Rachid El Mohameed ◽  
Sree Koneru ◽  
Richard Staelin ◽  
Kenneth McLeod ◽  
Omar Tabbouche ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Outcome Measures ◽  
Neck Disability Index ◽  
Primary Outcome Measure ◽  
Pain Medication ◽  
Secondary Outcome ◽  
Pain Duration ◽  
Cox 2 ◽  
Neck Disability ◽  
Pain At Rest

Abstract Objective Assess treatment superiority of Pulsed Shortwave Therapy (PSWT) against COX-2 NSAID therapy, in reducing disability and pain due to cervical osteoarthritis.Design 200chronic pain suffers (average pain duration about 2 years)diagnosed with cervical osteoarthritis by radiological imaging were randomized into one of two treatmentarms: COX-2 NSAID treatment: Etoricoxib 60mg/day for 4 weeks; or, PSWT treatmentworn 24 hours/day for 4 weeks. The primary outcome measure was the 4-week score on the Neck Disability Index (NDI): a 10-question assessment on a 50-point scale. Secondary outcome measures included pain(at rest and during activity)measured on a Visual Analog Scale (VAS)of0-100 mm, dose count of rescue pain medication (paracetamol)use and a treatment satisfaction rating. These 4-week scores were compared across the two arms to assess superiority.Results After 4 weeks of treatment,subjects in both study arms reported significantly lower (p<0.0001) 4-week measures (11.24-NSAID;9.34-PSWT; 0-50 points),VASrest (30.08-NSAID;22.76-PSWT; 0-100 mm) and VASactivity (36.40-NSAID; 27.42-PSWT; 0-100 mm).The absolute reduction from baseline in NDI was significantly greater in the PSWT arm than NSAID arm(by 3.66 points; 95% CI 2.3 to 5.02; p<0.0001). Similarly, the reductions from baseline inVASrest and VASactivitywere significantly greater in the PSWT arm than NSAID arm(by 10.89 mm;95% CI 6.90 to 14.87; p<0.0001 and 12.05 mm;95% CI 7.76 to 16.33; p<0.0001 respectively).The PSWT arm used 50% less rescue pain medication. Eleven adverse effects were reported in the NSAID arm and zero in the PSWT arm.Conclusion Both NSAID and PSWT treatments resulted in clinically meaningful increases in quality of life(NDI) and decreases in pain (VAS) associated with cervicalosteoarthritis. However, the PSWT armshowed superior improvements in all outcome measures when compared to the NSAID armwith no adverse effects.

Comparative Adverse Effects Of Cox-1 and Cox-2 Inhibitors in Rat Liver: An Experimental Study."

2010 ◽  
Vol 59 (2) ◽  
pp. 182-186 ◽  
Author(s):  
Richa Niranjan ◽  
P. Manik ◽  
A.K. Srivastava ◽  
G. Palit ◽  
S.M. Natu
Keyword(s):  
Experimental Study ◽  
Adverse Effects ◽  
Rat Liver ◽  
Cox 2 ◽  
Cox 2 Inhibitors ◽  
Cox 1

scholarly journals Resveratrol-Enriched Rice Attenuates UVB-ROS-Induced Skin Aging via Downregulation of Inflammatory Cascades

2017 ◽  
Vol 2017 ◽  
pp. 1-15 ◽  
Author(s):  
Lalita Subedi ◽  
Taek Hwan Lee ◽  
Hussain Mustatab Wahedi ◽  
So-Hyeon Baek ◽  
Sun Yeou Kim
Keyword(s):  
Cytochrome C ◽  
Adverse Effects ◽  
Matrix Metalloproteinase ◽  
Uv Radiation ◽  
Chronic Exposure ◽  
Caspase 3 ◽  
Skin Aging ◽  
Ros Production ◽  
Uvb Radiation ◽  
Cox 2

The skin is the outermost protective barrier between the internal and external environments in humans. Chronic exposure to ultraviolet (UV) radiation is a major cause of skin aging. UVB radiation penetrates the skin and induces ROS production that activates three major skin aging cascades: matrix metalloproteinase- (MMP-) 1-mediated aging; MAPK-AP-1/NF-κB-TNF-α/IL-6, iNOS, and COX-2-mediated inflammation-induced aging; and p53-Bax-cleaved caspase-3-cytochrome C-mediated apoptosis-induced aging. These mechanisms are collectively responsible for the wrinkling and photoaging characteristic of UVB-induced skin aging. There is an urgent requirement for a treatment that not only controls these pathways to prevent skin aging but also avoids the adverse effects often encountered when applying bioactive compounds in concentrated doses. In this study, we investigated the efficacy of genetically modified normal edible rice (NR) that produces the antiaging compound resveratrol (R) as a treatment for skin aging. This resveratrol-enriched rice (RR) overcomes the drawbacks of R and enhances its antiaging potential by controlling the abovementioned three major pathways of skin aging. RR does not exhibit the toxicity of R alone and promisingly downregulates the pathways underlying UVB-ROS-induced skin aging. These findings advocate the use of RR as a nutraceutical for antiaging purposes.

Do Selective COX-2 Inhibitors Affect Pain Control and Healing After Arthroscopic Rotator Cuff Repair? A Preliminary Study

2017 ◽  
Vol 46 (3) ◽  
pp. 679-686 ◽  
Author(s):  
Joo Han Oh ◽  
Hyuk Jun Seo ◽  
Ye-Hyun Lee ◽  
Hye-Yeon Choi ◽  
Ho Yun Joung ◽  
...  
Keyword(s):  
Rotator Cuff ◽  
Adverse Effects ◽  
Rotator Cuff Repair ◽  
Pain Control ◽  
Arthroscopic Rotator Cuff Repair ◽  
Functional Scores ◽  
Cox 2 ◽  
Arthroscopic Rotator Cuff ◽  
Cox 2 Inhibitors ◽  
Cuff Repair

Background: Selective cyclooxygenase (COX)–2 inhibitors are commonly used analgesics that provide similar analgesia as that of other analgesics but with fewer adverse effects. However, few prospective studies have performed comparative analyses in this regard. Purpose: To evaluate the efficacy of a selective COX-2 inhibitor in early postoperative pain control, satisfaction with pain management, and incidence of systemic adverse effects in patients undergoing arthroscopic rotator cuff repair. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: This study included 180 patients who underwent arthroscopic rotator cuff repair between September 2011 and August 2012. The patients were randomly assigned to receive celecoxib, ibuprofen, or tramadol (n = 60 each). Visual analog scale (VAS) scores for pain intensity and satisfaction with medication, incidence of adverse effects, and use of rescue medication were recorded and compared between the 3 groups at 3 days and 2 weeks after surgery. Magnetic resonance and ultrasonography images of 82 patients were retrospectively reviewed at least 24 months after surgery, along with the range of motion and pain VAS and functional scores. Results: There were no significant differences among the 3 groups in terms of pain intensity, incidence of adverse effects, or dosage of rescue medication at 3 days or 2 weeks after surgery. Pain VAS and functional scores at the final follow-up were also comparable among the 3 groups. However, the retear rate in the celecoxib group (11/30 [37%]) was significantly higher than those in the ibuprofen (2/27 [7%]) and tramadol (1/25 [4%]) groups ( P = .009). Conclusion: Despite having similar postoperative analgesic effects as other nonsteroidal anti-inflammatory drugs and opioids, selective COX-2 inhibitors should not be used for postoperative analgesia because they might negatively affect tendon-to-bone healing after surgical repair. Registration: NCT02850211 ( ClinicalTrials.gov identifier)

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