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NSAIDs in family medicine

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this is a power point presentation for family physicians on clinical use of NSAIDs

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NSAIDs in family medicine

  1. 1. 1 Bristafalm – EFFECTIVELY SAFE (OR SAFELY EFFECTIVE)?
  2. 2. A GLOBAL BRAND Bristaflam
  3. 3. Bristaflam key dates 1982 Bristaflam is synthesized 1986 First human Clinical Trial 1992 First launch in Spain 1997 Approval by mutual recognition in Europe 2004 Last launch in France
  4. 4. 1992-1994 Bristaflam a global presence 1992 Spain 1993 Portugal Dominican Republic Costa Rica Honduras Panama El Salvador Nicaragua Venezuela Bolivia Paraguay 1994 Mexico Peru Argentina Date of launch
  5. 5. 1995 Korea Guatemala Colombia Chile Senegal Mali Burkina Faso Niger Togo Benin Ivory Coast Gabon Cameroon Congo 1996 UK Greece Cyprus Ghana Kenya Madagascar Mauritius Brazil 1997 Ireland Sweden Denmark Germany Bristaflam a global presence 1995- 1997 Date of launch
  6. 6. 1998 Luxembourg Belgium Morocco Egypt Lebanon 1999 Finland Switzerland Austria 2000 The Netherlands 1998-2000 Date of launch Bristaflam a global presence
  7. 7. 2001 Hungary 2002 Italy Russia 2003-2004 France Portugal (Relaunch) Greece (Relaunch) Eastern countries 2005 Latvia 2006 Slovakia Romania 2001-2005 Bristaflam a global presence Date of launch
  8. 8. Registered in more than 60 countries Bristaflam a global presence
  9. 9. UK France Aceclofenac present in all key European markets Germany Belgium Italy Spain Portugal
  10. 10. Aceclofenac in Egypt is available as 100 mg/twice daily TABLETS
  11. 11. PRODUCT OVERVIEW
  12. 12. Extensive experience that offers: Bristaflam has been used in clinical practice for Bristaflam is registered in more than Bristaflam has over have been treated with Bristaflam. more than 15 years. 60 countries worldwide. 1.5 billion Defined Daily Doses Administered. 100 million patientsOver … the guarantee of reliability.
  13. 13. Pharmacodynamics: Multifactorial mechanism of action PHARMACODYNAMIC PROFILE GASTRIC TISSUE COX-1 PGE GASTRIC PROTECTION INJURY INFLAMMATION SITE Adhesion molecules Neutrophil migration COX-2 PGE2 Pro-inflammatory cytokines Free radicals INFLAMMATION
  14. 14. Pharmacodynamics: Multifactorial mechanism of action PHARMACODYNAMIC PROFILE GASTRIC TISSUE COX-1 PGE GASTRIC PROTECTION Weak inhibition of COX 1 TOLERABILITY EFFICACY INFLAMMATION SITE INJURY PGE2 Free radicals INFLAMMATION COX-2 Neutrophil migration Adhesion molecules Pro-inflammatory cytokinesReduces the expression of adhesion molecules Reduces migration and adhesion of neutrophils Inhibits production of PGE2 Presents antioxidant properties
  15. 15. inhibits the expression of COX-2 Multifactorial impact on inflammation Inhibits production of IL-1β Inhibits production of TNF-α Inhibits prostaglandin synthesis (intense inhibition of PGE2) Induces IL-1Ra synthesis (receptor antagonist of IL-1β) BRISTAFLAM PHARMACODYNAMIC PROFILE Reduces cell adhesion molecule expression Presents anti-oxidant properties: action on free radicals
  16. 16. CHRONIC DISORDERS
  17. 17. OSTEOARTHRITIS (OA) The most common arthropathy ANKYLOSING SPONDYLITIS (AS) Less common than RA RHEUMATOID ARTHRITIS (RA) Affects young and elderly patients CHRONIC DISEASES
  18. 18. Diclofenac Piroxicam Naproxen EFFICACY DATA Proven efficacy in Osteoarthritis In Osteoarthritis, similar efficacy to
  19. 19. Proven efficacy in Osteoarthritis: key publications EFFICACY DATA Diaz C, Rodriguez de la Serna A, Geli C, et al. Efficacy and tolerability of Aceclofenac vs. Diclofenac in the treatment of knee Osteoarthritis. A multicenter study. Eur J Rheumatol Inflamm 1996; 16: 17–22. Ward D, Veys E, Bowdler J. Comparison of Aceclofenac with Diclofenac in the treatment of Osteoarthritis. Clin Rheumatol 1995; 14: 656-62. Torri G, Vignati C, Agrifoglio E, et al. Aceclofenac vs. Piroxicam in the management of Osteoarthritis of the knee: a double-blind controlled study. Curr Ther Res Clin Exp 1994; 55: 576–83. Perez-Busquier M, Carero E, Rodriguez M, et al. Comparison of Aceclofenac with Piroxicam in the treatment of Osteoarthritis. Clin Rheumatol 1997; 16 (2): 154–9. Kornasoff D, Frerick H, Bowdler J, et al. Aceclofenac is a well-tolerated alternative to Naproxen in the treatment of Osteoarthritis. Clin Rheumatol 1997; 16 (1): 32–8.
  20. 20. Prospective, controlled, randomized, parallel double-blind clinical trial. Aceclofenac showed significant improvements from baseline after 15 days, for both Osteoarthritis Severity Index (OSI) and VAS (p<0.001) as well as for knee function, (p<0.01) which were sustained for the 6-month study period. DESCRIPTION PATIENTS OBJECTIVE RESULTS Similar efficacy to Diclofenac in Osteoarthritis EFFICACY DATA To assess the efficacy and tolerability of Aceclofenac in comparison to Diclofenac in the treatment of Knee Osteoarthritis. 170 patients affected by Osteoarthritis were included in the Aceclofenac group (100mg bid) and 165 patients in the Diclofenac group (50mg tid) for 6 months. Diaz C, Rodriguez de la Serna A, Geli C, et al. Efficacy and tolerability of Aceclofenac vs. Diclofenac in the treatment of knee Osteoarthritis. A multicenter study. Eur J Rheumatol Inflamm 1996; 16: 17–22.
  21. 21. Similar efficacy to Diclofenac in Osteoarthritis Mean percentage of Osteoarthritis Severity Index. Diaz C, Rodriguez de la Serna A, Geli C, et al. Efficacy and tolerability of Aceclofenac vs. Diclofenac in the treatment of Knee Osteoarthritis. A multicenter study. Eur J Rheumatol Inflamm 1996; 16: 17–22. 100Percentage(OSI) 80 60 40 Baseline 0,5 1 2 3 4 5 6 months Time Aceclofenac (n=170) Diclofenac (n=165) *p<0.001 vs baseline * * * * * * * * * * * * * * EFFICACY DATA
  22. 22. Diclofenac Indomethacin Ketoprofen EFFICACY DATA Proven efficacy in Rheumatoid Arthritis In Rheumatoid Arthritis, similar efficacy to Tenoxicam
  23. 23. Martín-Mola E, Gijón-Baños J, Ansoleaga JJ. Aceclofenac in comparison to Ketoprofen in the treatment of Rheumatoid Arthritis. Rheumatol Int 1995; 15: 111–16. Kornasoff D, Maisenbacher J, Bowdler J et al. The efficacy and tolerability of Aceclofenac compared to Indomethacin in patients with Rheumatoid Arthritis. Rheumatol Int 1996; 15: 225–30. Proven efficacy in Rheumatoid Arthritis: key publications EFFICACY DATA Pasero G, Marcolongo R, Serni U, et al. A multi-centre, double-blind comparative Study of the efficacy and safety of Aceclofenac and Diclofenac in the treatment of Rheumatoid Arthritis. Curr Med Res Opin 1995; 13: 305–15. Perez-Ruiz F, Alonso-Ruiz A, Ansoleaga JJ. Comparative study of the efficacy and safety of Aceclofenac and Tenoxicam in Rheumatoid Arthritis. Clin Rheumatol 1996; 15 (5): 473–7.
  24. 24. To investigate the efficacy and safety of Aceclofenac in comparison with Diclofenac in patients with active Rheumatoid Arthritis. Long-term multicenter, double-blind, parallel group study. Both treatment groups showed significant improvement from baseline in evaluations of pain (VAS) and inflammation (Ritchie Index) and a reduction in morning stiffness. There were no significant differences between the groups. However, a trend towards greater improvement in hand grip strength with Aceclofenac (22% improvement vs. 17% with Diclofenac) was found. DESCRIPTION PATIENTS OBJECTIVE RESULTS Similar efficacy to Diclofenac in Rheumatoid Arthritis EFFICACY DATA 131 patients affected by Rheumatoid Arthritis were analysed in the Aceclofenac group (100mg bid) and 130 patients in the Diclofenac group (50mg tid) for 6 months. Pasero G, Marcolongo R, Serni U, et al. A multi-centre, double-blind comparative study of the efficacy and safety of Aceclofenac and Diclofenac in the treatment of Rheumatoid Arthritis. Curr Med Res Opin 1995; 13: 305–15.
  25. 25. Pasero G, Marcolongo R, Serni U, et al. A multi-centre, double-blind comparative study of the efficacy and safety of Aceclofenac and Diclofenac in the treatment of Rheumatoid Arthritis. Curr Med Res Opin 1995; 13: 305–15. RitchieIndex(meanvalues) Baseline Time Aceclofenac (n=131) Diclofenac (n=130) *p<0.01vs. Baseline Similar efficacy to Diclofenac in Rheumatoid Arthritis 20 18 16 14 12 10 22 0.5 1 2 4 6 months 24 * * * * * * * * * * Improvement in the Ritchie Index. Assessment of joint inflammation EFFICACY DATA
  26. 26. Indomethacin Tenoxicam Naproxen EFFICACY DATA Proven efficacy in Ankylosing Spondylitis In Ankylosing Spondylitis, Similar efficacy to
  27. 27. Proven efficacy in Ankylosing Spondylitis: key publications EFFICACY DATA Pasero G, Ruju G, Marcolongo R, et al. Aceclofenac vs. Naproxen in the treatment of Ankylosing Spondylitis: a double-blind, controlled study. Curr Ther Res Clin Exp 1994; 55: 833–42. Batlle-Gualda E, Figueroa M, Ivorra J, et al. The efficacy and tolerability of Aceclofenac in the treatment of patients with Ankylosing Spondylitis. A multicenter controlled clinical trial. J Rheumatol 1996; 23 (7): 1200–6. Abstract. Villa Alcázar LF, Álvarez de Buergo M, Rico Lenza H, et al. Aceclofenac is as safe and effective as Tenoxicam in the treatment of Ankylosing Spondylitis: a 3 month multicentre comparative trial. J Rheumatol 1996; 27 (7): 1194-9.
  28. 28. Similar efficacy to Naproxen in Ankylosing Spondylitis EFFICACY DATA To compare the efficacy and tolerability of Aceclofenac and Naproxen in the treatment of Ankylosing Spondylitis. Efficacy was evaluated using a visual analogue scale for spontaneous pain, a scale for pain on movement and at rest, and measurements of chest expansion, hand-to-floor distance, Schober’s test and normal daily activities. Double-blind, multicenter, controlled study. Both drugs provided effective analgesia and a corresponding improvement in functional activity. Overall efficacy assessment was not significantly different between both groups. 60 patients with Ankylosing Spondylitis were included in the Aceclofenac group (100mg bid) and 66 patients in the Naproxen group (500mg bid) for 3 months. DESCRIPTION PATIENTS OBJECTIVE RESULTS Pasero G, Ruju G, Marcolongo R, et al. Aceclofenac vs. Naproxen in the treatment of Ankylosing Spondylitis : a double-blind, controlled study. Curr Ther Res Clin Exp 1994; 55: 833–42.
  29. 29. Similar efficacy to Naproxen in Ankylosing Spondylitis Reduction in pain scores after 3 months Pasero G, Ruju G, Marcolongo R, et al. Aceclofenac vs. Naproxen in the treatment of Ankylosing Spondylitis : a double-blind, controlled study. Curr Ther Res Clin Exp 1994; 55: 833–42. Meanspontaneouspainscore(VAS) Baseline Time Aceclofenac (n=47) Naproxen (n=57) *p<0.01 vs. baseline 60 50 40 30 20 0.5 1 2 3 months * * * * * * * * EFFICACY DATA
  30. 30. ACUTE DISORDERS
  31. 31. VIRAL PHARYNGOTONSILLITIS LOW BACK PAIN ODONTALGIA DYSMENORRHOEA ACUTE DISEASES POST- SURGICAL PAIN MINOR MUSCULOSKELETAL INJURY
  32. 32. 35 Superior efficacy to Diclofenac in Low Back Pain EFFICACY DATA To evaluate the clinical analgesic effect (change in pain assessed by VAS score) in patients affected by Low Back Pain. Multi-center, double blind, randomized clinical trial. Aceclofenac is not inferior to Diclofenac resinate in analgesic efficacy and a trend towards a better safety and tolerability profile was found. 114 patients affected by Low Back Pain were studied in the Aceclofenac group (100mg bid) and 113 patients in the Indomethacin group (75mg bid) for 10 days. DESCRIPTION PATIENTS OBJECTIVE RESULTS Schattenkirchner M, Milachowski KA. A double blind, multicentre, randomised clinical trial comparing the efficacy and tolerability of Aceclofenac with Diclofenac resinate in patients with acute Low Back Pain. Clin Rheum 2003;22:127-35.
  33. 33. 36 Superior efficacy to Diclofenac in Low Back Pain Mean changes in pain scores at rest at visit 3 Painscores (VASmeanvaluesinmm) ITT Population –53 Schattenkirchner M, Milachowski KA. A double blind, multicentre, randomised clinical trial comparing the efficacy and tolerability of Aceclofenac with Diclofenac resinate in patients with acute Low Back Pain. Clin Rheum 2003;22:127-35. –54 –55 –56 –57 –58 –59 –60 –61 –62 –63 PP PopulationITT Population ACF (n=114) DCF (n=113) ACF (n=100) DCF (n=105) EFFICACY DATA
  34. 34. 37 BRISTAFLAM SAFETY DATA
  35. 35. Multicentre, case-control study. Among all NSAIDs included in the primary analysis, Aceclofenac was associated with a low risk of UGIB, while Meloxicam and Rofecoxib were associated with a medium risk. The results do not confirm that greater selectivity for COX-2 confers less risk of Upper Gastrointestinal Bleeding. DESCRIPTION PATIENTS OBJECTIVE RESULTS A low rate of Upper Gastrointestinal Bleeding (UGIB) SAFETY DATA All incident community cases of upper gastrointestinal bleeding from gastric or duodenal lesion in patients aged >18 years of age (4,309 cases). After secondary exclusions, 2,813 cases and 7,193 matched controls were included in the analysis. Setting: 18 hospitals in Spain and Italy with total study experience of 10,734,897 person-years. To estimate the risk of UGIB associated with the use of analgesics and NSAIDs. Laporte J.R., Ibáñez L., Vidal X. et al. Upper Gastro-Intestinal Bleeding associated with the use of NSAIDs New vs. Older Agents. Drug Safety 2004; 27(6): 411-20.
  36. 36. A low rate of Upper Gastrointestinal Bleeding (UGIB) 25 20 15 10 5 0 Laporte J.R., Ibáñez L., Vidal X. et al. Upper Gastro-Intestinal Bleeding associated with the use of NSAIDs New vs. Older Agents. Drug Safety 2004; 27(6): 411-20. Oddsratios Risk of UGIB with NSAIDs taken the week before the Index Day* SAFETY DATA 1,4 3,1 3,2 3,7 4.9 5,7 7,2 8,0 10,010,0 10,0 15.5 16,6 24,7 Aceclofenac Ibuprofen Nimesulide Diclofenac Dexketoprofen Meloxicam Rofecoxib Aspirin(A.acid) Indomethacin Naproxen Ketoprofen Piroxicam NSAID+anti-Pl. Ketorolac * Index day: the day on which the upper gastrointestinal bleeding started
  37. 37. 40 An open-label, multicenter, observational surveillance study complying with the Safety Assessment of Marketed Medicines (SAMM) guidelines. Adverse events (p<0.001), gastrointestinal adverse events (p<0.001) and patients withdrawing from treatment (p<0.001) were significantly less common with Aceclofenac than with Diclofenac. DESCRIPTION PATIENTS OBJECTIVE RESULTS Better gastrointestinal tolerability than Diclofenac in Rheumatic Diseases SAFETY DATA 7,890 patients affected by rheumatic diseases were included in the Aceclofenac group (100mg bid) and 2,252 patients in the Diclofenac group (75mg bid) for 12 months. To investigate the safety and tolerance of Aceclofenac and Diclofenac in patients with Rheumatic Diseases in normal clinical practice. Huskisson E, Irani M, Murray F. A large prospective open-label, multicentre SAMM study, comparing the safety of Aceclofenac in patients with Rheumatic Disease. Eur J Rheumatol Inflamm 2000; 17 (1):1-7.
  38. 38. 41 20 Aceclofenac vs. Diclofenac : AEs and withdrawals Huskisson E, Irani M, Murray F. A large prospective open-label, multicentre SAMM study, comparing the safety of Aceclofenac in patients with Rheumatic Disease. Eur J Rheumatol Inflamm 2000 ; 17 (1):1-7. Percentages Adverse events 0 Discontinuation due to adverse events Aceclofenac n= 7890 Diclofenac n= 2252 * p<0.001 vs. Diclofenac 5 15 10 30 25 * * * GI adverse events Better gastrointestinal tolerability than Diclofenac in Rheumatic Diseases SAFETY DATA
  39. 39. 42 4 Aceclofenac vs. Diclofenac: adverse events ≥ 1% Huskisson E, Irani M, Murray F. A large prospective open-label, multicentre SAMM study, comparing the safety of Aceclofenac in patients with Rheumatic Disease. Eur J Rheumatol Inflamm 2000;1 7 (1):1-7. Percentages Dyspepsia 0 Diarrhoea Aceclofenac n= 7890 Diclofenac n= 2252 * p=0.017 vs. Diclofenac ** p=0.01 vs. Diclofenac *** p<0.001 vs. Diclofenac 1 3 2 6 5 Abdominal pain *** *** ** * Nausea Better gastrointestinal tolerability than Diclofenac in Rheumatic Diseases SAFETY DATA
  40. 40. CONCLUSIONS Bristaflam
  41. 41. Aceclofenac is as effective or even more effective than classic NSAIDs, as confirmed by clinical trials and in dail clinical practice (over 12 years) Better gastrointestinal safety profile than gold standard NSAID Its efficacy and tolerability make for higher levels of treatment compliance CONCLUSIONS Aceclofenac has extensive experience worldwide
  42. 42. A GLOBAL BRAND Thank you for your attention!! Bristaflam

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