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Antiinflammatory Agents  and Nonsteroidal Antiinflammatory Drugs (NSAIDs)
NSAIDs ,[object Object],[object Object],[object Object],[object Object]
NSAIDs:  Mechanism of Action ,[object Object],[object Object],[object Object],[object Object],[object Object]
NSAIDs:  Mechanism of Action ,[object Object],[object Object]
NSAIDs:  Mechanism of Action ,[object Object],[object Object]
NSAIDs:  Mechanism of Action ,[object Object],[object Object]
NSAIDs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
NSAIDs:  Acetic Acid ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
NSAIDs:  Carboxylic Acids ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
NSAIDs:  Propionic Acids ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
NSAIDs:  Other Agents ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
NSAIDs:  Other Agents ,[object Object],[object Object],[object Object]
NSAIDs:  Drug Effects ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
NSAIDs:  Therapeutic Uses ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
NSAIDs:  Specific Agents ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
NSAIDs:  Specific Agents ,[object Object],[object Object],[object Object]
NSAIDs:  Side Effects ,[object Object],[object Object],[object Object],[object Object],[object Object]
NSAIDs:  Side Effects ,[object Object],[object Object],[object Object]
NSAIDs:  Side Effects ,[object Object],[object Object]
NSAIDs:  Salicylate Toxicity ,[object Object],[object Object],[object Object],[object Object]
NSAIDs:  Nursing Implications ,[object Object],[object Object],[object Object],[object Object],[object Object]
NSAIDs:  Nursing Implications ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
NSAIDs:  Nursing Implications ,[object Object],[object Object],[object Object]
NSAIDs:  Nursing Implications ,[object Object],[object Object],[object Object]
NSAIDs:  Nursing Implications ,[object Object],[object Object]
Nonsteroidal Anti-inflammatory Drugs (NSAIDs) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],www.freelivedoctor.com
www.freelivedoctor.com
www.freelivedoctor.com
Common Pharmacological Effects ,[object Object],[object Object],[object Object],[object Object],[object Object],www.freelivedoctor.com
Common Adverse Effects ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],www.freelivedoctor.com
NSAID ↑  Leukocyte-Endothelial Interactions Capillary  Obstruction Ischemic Cell Injury Proteases + Oxygen Radicals Endo/Epithelial Cell Injury Mucosal Ulceration Loss of PGE 2  and PGI 2  mediated inhibition of acid secretion and cytoprotective effect  Loss of PGI 2  induced inhibition of LTB 4  mediated  endothelial adhesion and activation  of neutrophils www.freelivedoctor.com
The Salicylates - Aspirin ,[object Object],[object Object],[object Object],[object Object],www.freelivedoctor.com
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Aspirin www.freelivedoctor.com
[object Object],[object Object],[object Object],[object Object],Aspirin - Therapeutic Uses www.freelivedoctor.com
Generation of Lipoxins by Aspirin www.freelivedoctor.com
Role of Lipoxins in Anti-inflammatory effects of Aspirin www.freelivedoctor.com
Effect of NSAID’s on Platelet-Endothelial Interactions www.freelivedoctor.com
Use of Aspirin in Unstable Angina www.freelivedoctor.com
Use of Aspirin in Unstable Angina www.freelivedoctor.com
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Aspirin Toxicity - Salicylism www.freelivedoctor.com
[object Object],[object Object],[object Object],Aspirin Toxicity - Treatment www.freelivedoctor.com
Other NSAID’s ,[object Object],[object Object],[object Object],[object Object],www.freelivedoctor.com
www.freelivedoctor.com
Attempts to  Decrease  Toxicity of  NSAID’s –  Nitroaspirins www.freelivedoctor.com
www.freelivedoctor.com
Selective COX-II Inhibitors ,[object Object],[object Object],[object Object],[object Object],www.freelivedoctor.com
VIGOR - Summary of GI Endpoints † p < 0.001. *  p = 0.005. 0 1 2 3 4 5 Confirmed Clinical  Upper GI Events Confirmed Complicated  Upper GI Events  All Clinical GI Bleeding RR: 0.46 † (0.33, 0.64) RR: 0.43 * (0.24, 0.78) RR: 0.38 †  (0.25, 0.57) Rates per 100 Patient-Years Rofecoxib Naproxen ( ) = 95% CI. Source: Bombardier, et al.  N Engl J Med . 2000. www.freelivedoctor.com
VIGOR - Confirmed Thrombotic Cardiovascular Events Patients with Events (Rates per 100 Patient-Years) Event Category Rofecoxib N=4047 Naproxen N=4029 Relative Risk (95% CI) Confirmed CV events 45 (1.7) 19 (0.7) 0.42 (0.25, 0.72) Cardiac events 28 (1.0) 10 (0.4) 0.36 (0.17, 0.74) Cerebrovascular events 11 (0.4) 8 (0.3) 0.73 (0.29, 1.80) Peripheral vascular events 6 (0.2) 1 (0.04) 0.17 (0.00, 1.37) Source: Data on file, MSD www.freelivedoctor.com
Effect of Celecoxib & Rofecoxib on PGIM  * p<0.05 vs. placebo. 0 40 80 120 160 200 Placebo N=7 Celecoxib  400 mg N=7 Ibuprofen  800 mg N=7 Urinary PGI-M (pg/mg creatinine)  (Mean ± SE) ** * Placebo N=12 Rofecoxib 50 mg QD N=12 Indomethacin 50 mg TID N=10 ** ** Single Dose Rx † Two Weeks Rx †† 0 40 80 120 160 200 †   Proc. Natl. Acad Sci. USA  1999;96:272-277. Urinary 2,3 dinor-6-keto-PGF 1  (PGIM) ††   J. Pharmacol. Exp. Ther . 1999;289:735-741. **p<0.01 vs. placebo. www.freelivedoctor.com
Investigator-Reported Thrombotic Cardiovascular Events in the VIGOR Study Compared with Phase IIb/III OA Study 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 Months of Follow-up 0 2 4 6 8 10 12 14 Cumulative Incidence % Rofecoxib   (OA) FDA files Ibuprofen, Diclofenac, Nabumetone (OA) www.freelivedoctor.com Rofecoxib (VIGOR) Naproxen (VIGOR)
Treatment of Gout www.freelivedoctor.com

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Antiinflammatory and nsai ds

  • 1. Antiinflammatory Agents and Nonsteroidal Antiinflammatory Drugs (NSAIDs)
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  • 26.
  • 29.
  • 30.
  • 31. NSAID ↑ Leukocyte-Endothelial Interactions Capillary Obstruction Ischemic Cell Injury Proteases + Oxygen Radicals Endo/Epithelial Cell Injury Mucosal Ulceration Loss of PGE 2 and PGI 2 mediated inhibition of acid secretion and cytoprotective effect Loss of PGI 2 induced inhibition of LTB 4 mediated endothelial adhesion and activation of neutrophils www.freelivedoctor.com
  • 32.
  • 33.
  • 34.
  • 35. Generation of Lipoxins by Aspirin www.freelivedoctor.com
  • 36. Role of Lipoxins in Anti-inflammatory effects of Aspirin www.freelivedoctor.com
  • 37. Effect of NSAID’s on Platelet-Endothelial Interactions www.freelivedoctor.com
  • 38. Use of Aspirin in Unstable Angina www.freelivedoctor.com
  • 39. Use of Aspirin in Unstable Angina www.freelivedoctor.com
  • 40.
  • 41.
  • 42.
  • 44. Attempts to Decrease Toxicity of NSAID’s – Nitroaspirins www.freelivedoctor.com
  • 46.
  • 47. VIGOR - Summary of GI Endpoints † p < 0.001. * p = 0.005. 0 1 2 3 4 5 Confirmed Clinical Upper GI Events Confirmed Complicated Upper GI Events All Clinical GI Bleeding RR: 0.46 † (0.33, 0.64) RR: 0.43 * (0.24, 0.78) RR: 0.38 † (0.25, 0.57) Rates per 100 Patient-Years Rofecoxib Naproxen ( ) = 95% CI. Source: Bombardier, et al. N Engl J Med . 2000. www.freelivedoctor.com
  • 48. VIGOR - Confirmed Thrombotic Cardiovascular Events Patients with Events (Rates per 100 Patient-Years) Event Category Rofecoxib N=4047 Naproxen N=4029 Relative Risk (95% CI) Confirmed CV events 45 (1.7) 19 (0.7) 0.42 (0.25, 0.72) Cardiac events 28 (1.0) 10 (0.4) 0.36 (0.17, 0.74) Cerebrovascular events 11 (0.4) 8 (0.3) 0.73 (0.29, 1.80) Peripheral vascular events 6 (0.2) 1 (0.04) 0.17 (0.00, 1.37) Source: Data on file, MSD www.freelivedoctor.com
  • 49. Effect of Celecoxib & Rofecoxib on PGIM * p<0.05 vs. placebo. 0 40 80 120 160 200 Placebo N=7 Celecoxib 400 mg N=7 Ibuprofen 800 mg N=7 Urinary PGI-M (pg/mg creatinine) (Mean ± SE) ** * Placebo N=12 Rofecoxib 50 mg QD N=12 Indomethacin 50 mg TID N=10 ** ** Single Dose Rx † Two Weeks Rx †† 0 40 80 120 160 200 † Proc. Natl. Acad Sci. USA 1999;96:272-277. Urinary 2,3 dinor-6-keto-PGF 1  (PGIM) †† J. Pharmacol. Exp. Ther . 1999;289:735-741. **p<0.01 vs. placebo. www.freelivedoctor.com
  • 50. Investigator-Reported Thrombotic Cardiovascular Events in the VIGOR Study Compared with Phase IIb/III OA Study 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 Months of Follow-up 0 2 4 6 8 10 12 14 Cumulative Incidence % Rofecoxib (OA) FDA files Ibuprofen, Diclofenac, Nabumetone (OA) www.freelivedoctor.com Rofecoxib (VIGOR) Naproxen (VIGOR)
  • 51. Treatment of Gout www.freelivedoctor.com

Hinweis der Redaktion

  1. The discussion about the CV effects of coxibs really started after the publication of the VIGOR study. It may be worth while reminding oneself that this was really a GI safety study, and of course not a CV study - neither by design or actual patient years. VIGOR demonstrated VIOXX superior GI safety on all pre specified endpoints The bar chart here are depicting the events rate per 100 patient year for three of the key endpoints with the relative risk and 95%CI of the relative risk above the bars. For all three key endpoints, confirmed clinical upper GI events, confirmed Complicated events and all episodes of clinical GI bleeding there were highly significant reductions of 54, 57 and 62% respectively.
  2. In VIGOR, there were 45 confirmed thrombotic events on rofecoxib and 19 on naproxen. Therefore the relative risk of sustaining a confirmed CV event on naproxen compared with rofecoxib was 0.42 with 95% CI which do not cross 1 which implies statistical significance. Although there was a reduction in confirmed CV events, there was no difference in CV mortality. Seven patients died from a cardiovascular event in each group. If you break these events down by location you can see that the majority of events were cardiac events. The relative risk of sustaining a cardiac event on naproxen compared with rofecoxib was 0.36. Cardiac events drove the analyses. Within the cardiac event category, most of the events were myocardial infarctions and there was a significant reduction in myocardial infarctions on naproxen compared to rofecoxib. To better understand these results we looked at the clinical characteristics of patients with events. We found that the patients who had thrombotic events were those who you would have expected to have events--they were older, there was a higher percentage of males, and close to 80% had one or more CV risk factors
  3. On the vertical axis is the cumulative incidence of investigator reported CV events with time on the x-axis. In green is the combined NSAID group from the Phase IIB/III studies and orange is the rofecoxib group. Overlaid on top in yellow if the rofecoxib group from VIGOR with the blue showing the VIGOR naproxen group. What you see if that the rates of events in the rofecoxib group from VIGOR and Phase IIb/III and the combined NSADI group are virtually superimposable, the outlier is the naproxen group which appears to have a lower incidence of events compared to the other three groups.