Savellavs. Cymbaltain the  management ofFibromyalgia The pharmacy and Therapeutics Committee <br />Munzur Morshed, Pharm D...
What is Fibromyalgia?<br />Chronic disorder affecting 5 million Americans<br />A combination of neuropsychiatric and muscu...
Symptoms<br />
Etiology<br />Stress and stress-related disorders<br />PTSD<br />IBS<br />Depression<br />Alteration of HPA axis secondary...
Diagnosis<br />
FDA approved management options<br />
Comparisons of two management options<br />
Savella Vs. Cymbalta<br />
FDA and Non-FDA Indications<br />Cymbalta<br />savella<br />
Doses<br />
Doses- Cymbalta<br />
Pharmacokinetics<br />
Pharmacokinetics cont…<br />
Warnings<br />
Precautions<br />
Adverse Drug Reactions- Savella<br />
Adverse Drug Reactions- Cymbalta<br />
Drug Interactions<br />
Drug Interactions<br />
Cost Comparisons<br />
Cost Comparisons<br />
Clinical Trial #1: Milnacipran for the Treatment of Fibromyalgia in Adults: A 15-Week, Multicenter, Randomized, Double-Bli...
Clinical Trial #1: Milnacipran for the Treatment of Fibromyalgia in Adults: A 15-Week, Multicenter, Randomized, Double-Bli...
Clinical Trial #1: Milnacipran for the Treatment of Fibromyalgia in Adults: A 15-Week, Multicenter, Randomized, Double-Bli...
Clinical Trial #1: Milnacipran for the Treatment of Fibromyalgia in Adults: A 15-Week, Multicenter, Randomized, Double-Bli...
Clinical Trial #1: Milnacipran for the Treatment of Fibromyalgia in Adults: A 15-Week, Multicenter, Randomized, Double-Bli...
Clinical Trial #2: A European Multicenter Randomized Double-blind Placebo-controlled Monotherapy Clinical Trial of Milnaci...
Clinical Trial #2: A European Multicenter Randomized Double-blind Placebo-controlled Monotherapy Clinical Trial of Milnaci...
Clinical Trial #2: A European Multicenter Randomized Double-blind Placebo-controlled Monotherapy Clinical Trial of Milnaci...
Clinical Trial #2: A European Multicenter Randomized Double-blind Placebo-controlled Monotherapy Clinical Trial of Milnaci...
Clinical Trial #2: A European Multicenter Randomized Double-blind Placebo-controlled Monotherapy Clinical Trial of Milnaci...
Consideration for formulary- Savella<br />
Weight of Balance-Savella<br />
Consideration for formulary-Cymbalta<br />
Weight of Balance-Cymbalta<br />
Formulary Choice<br />
Thank You!<br />
References <br /> MICROMEDEX Healthcare Series: Micromedex, Greenwood Village, Colorado.  Updated June 8th, 2010.<br />Lex...
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Savella Vs. Cymbalta Consideration For Formulary

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  • The hallmark of fibromyalgia is muscle pain through out the body, usually seen by fatigue, sleep problems, anxiety or depression, specific tender points. The most common and debilitating symptom of fibromyalgia is fatigue. This type of fatigue is not the normal fatigue that one would feel after a very exhausting day. Patients may feel tired the first thing in the morning even after hours spent in bed, which can in turn make anyone irritable, anxious and depressed.
  • Dopamine is a catecholamine neurotransmitterwith roles in pain perception and natural analgesia.Some doctors believe hormonal or chemical imbalances disrupt the way nerves signal pain. Others suggest a traumatic event or chronic stress may increase a person&apos;s susceptibility. Most experts agree that fibromyalgia probably results from a combination of factors, rather than a single cause.
  • There are no lab tests to diagnose for Fibromyalgia. One of the most unique characteristics of Fibromyalgia is the presence of tender points on specific locations on the body. And when you press on these areas, patients who has fibromyalgia feels pain, while patients without this condition only feels pressure.So in total there are eighteen tender points, and to be diagnosed with fibromyalgia, a patient must be sensitive in about 11 or more of these areas.
  • Cymbalta Capsules should never be opened, chewed or crushed, b/c it destroys the enteric coating properties
  • You start at 30 mg for 1 week to allow the patient to adjust to the dose prior to getting the recommended dose. No evidence states greater than 60 mg will provide any more or less benefit. So can be adjusted if necessary.
  • Because cymbalta is highly bound to plasma proteins, administering cymbalta to another patient
  • This is for both Savella and Cymbalta- Two slides combined in oneMAOI- Selegiline, Phenelgine, Tranylcypromine,With MAOI’s at least 2 weeks must elapse before starting either of these agents. And 5 days must elapse after the stoping either one of these agents prior to initiating any MAOI
  • Abnormal bleeding- especially if used with aspirin, NSAIDS, WarfarinRenal Impairment- dose adjust if SevereSeizure- Close monitoring RequiredThe Italacized is because its use is not recommendedTCA’s- Nortriptylline, Amitryptilline, Imipramine.Type 1C- Antiarrythmics-propafenone, and flecainide
  • BOLD LETTERS= Means increase effect of SavellaITALICIZED LETTERS= Means decrease effect of the drugBOLD ITALICIZED= means increase effect of the drug
  • ITALICIZED LETTERS=Means use alternativeBOLD ITALICIZED= AVOID COMBINATIONS
  • Transcript of "Savella Vs. Cymbalta Consideration For Formulary"

    1. 1. Savellavs. Cymbaltain the management ofFibromyalgia The pharmacy and Therapeutics Committee <br />Munzur Morshed, Pharm D. candidate 2011Arnold & Marie Schwartz College of Pharmacy and Health Sciences of The Long Island UniversityThe International Drug Information Center July 09, 2010<br />
    2. 2. What is Fibromyalgia?<br />Chronic disorder affecting 5 million Americans<br />A combination of neuropsychiatric and musculoskeletal disorder<br />Pain and stiffness of the muscles <br />Does not damage the joint or organs<br />Female : Male-9:1<br />
    3. 3. Symptoms<br />
    4. 4. Etiology<br />Stress and stress-related disorders<br />PTSD<br />IBS<br />Depression<br />Alteration of HPA axis secondary to stress-related disorders<br />Low level of AM cortisol level and elevated level of evening Cortisol<br />Development of widespread pain<br />Disruption of dopamine related neurotransmission<br />Dysfunction in serotonin metabolism<br />Central Sensitization theory<br />Decrease pain threshold due to increase sensitization of the brain to pain stimulus<br />
    5. 5. Diagnosis<br />
    6. 6. FDA approved management options<br />
    7. 7. Comparisons of two management options<br />
    8. 8. Savella Vs. Cymbalta<br />
    9. 9. FDA and Non-FDA Indications<br />Cymbalta<br />savella<br />
    10. 10. Doses<br />
    11. 11. Doses- Cymbalta<br />
    12. 12. Pharmacokinetics<br />
    13. 13. Pharmacokinetics cont…<br />
    14. 14. Warnings<br />
    15. 15. Precautions<br />
    16. 16. Adverse Drug Reactions- Savella<br />
    17. 17. Adverse Drug Reactions- Cymbalta<br />
    18. 18. Drug Interactions<br />
    19. 19. Drug Interactions<br />
    20. 20. Cost Comparisons<br />
    21. 21. Cost Comparisons<br />
    22. 22. Clinical Trial #1: Milnacipran for the Treatment of Fibromyalgia in Adults: A 15-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Clinical Trial<br />Purpose<br />To evaluate whether or not milnacipran(Savella) is efficacious and tolerable in treating patients with fibromyalgia and fibromyalgia pain<br />
    23. 23. Clinical Trial #1: Milnacipran for the Treatment of Fibromyalgia in Adults: A 15-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Clinical Trial cont….<br />Methods<br />Randomized, multicenter, double-blind, placebo-controlled, 3 arm, parallel-group design<br />86 centers throughout the United States from November 29,2004 to December 18,2006<br />1207 patients were randomized among three groups <br />About 400 patients per group<br />Group1- 100mg/d; Group2-200mg/d; group 3-placebo<br />Doses were titrated in the 100mg dose group; No titration were performed in the 200mg dose group<br />A four week washout period followed prior to start of the trial drug<br />
    24. 24. Clinical Trial #1: Milnacipran for the Treatment of Fibromyalgia in Adults: A 15-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Clinical Trial cont….<br />Endpoints<br />Primary Endpoint<br />Fibromyalgia composite responder rate at week 15<br />The mean morning recall pain scores <br />Rating of global impression of change due to tx.<br />Change in physical function<br />Fibromyalgia pain responder rate<br />Secondary Endpoint<br />Length of time or the time weighted average of the individual components of the composite responder rate<br />
    25. 25. Clinical Trial #1: Milnacipran for the Treatment of Fibromyalgia in Adults: A 15-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Clinical Trial cont….<br />Results<br />Response rate of the doses that were used had double the response rate of the placebo group<br />milnacipran 100mg/d, P=0.002; milnacipran 200mg/d,<br /> P< 0.001<br />Greater improvement in pain score<br />milnacipran 100mg/d,P= 0.001; milnacipran 200mg/d, P<0.001<br />Large number of patients had rated their status as a “very much improved or much improved” after 15 weeks<br />milnacipran 100mg/d=48.3%; milnacipran 200mg/d= 51.0%; placebo= 32.9%<br />For secondary endpoints- significant improvements in the time weighted averages of the weekly morning recall pain scores (P<0.001)<br />
    26. 26. Clinical Trial #1: Milnacipran for the Treatment of Fibromyalgia in Adults: A 15-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Clinical Trial cont….<br />Conclusion<br />Both doses of 100 and 200 mg/d of Savellasignificant improvements in FM and rate of response to pain<br />Strong study- randomized, double-blind, multicenter, placebo-controlled trial<br />Study had met power of 80%<br />Weakness- funded by manufacturer + MD’s are employers of manufacturer<br />
    27. 27. Clinical Trial #2: A European Multicenter Randomized Double-blind Placebo-controlled Monotherapy Clinical Trial of Milnacipran in Treatment of Fibromyalgia<br />Purpose<br />To confirm the efficacy and safety of milnacipran 200mg/d for the treatment of FM among European populations<br />
    28. 28. Clinical Trial #2: A European Multicenter Randomized Double-blind Placebo-controlled Monotherapy Clinical Trial of Milnacipran in Treatment of Fibromyalgia cont…<br />Methods<br />Randomized, double-blind, placebo-controlled<br />89 outpt. clinical/research centers in 13 European countries<br />1406 patients screened; 884 randomized via 1:1 ratio among placebo and milnacipran group<br />Similar baseline characteristics among both groups<br />4 week wash out period followed prior to initiation of therapy<br />Doses were titrated over 4 weeks up to 200mg/d <br />
    29. 29. Clinical Trial #2: A European Multicenter Randomized Double-blind Placebo-controlled Monotherapy Clinical Trial of Milnacipran in Treatment of Fibromyalgia cont…<br />Endpoints<br />Primary endpoints<br />% of patient who had greater than 30% improvement from baseline in the pain visual analog scale(VAS)<br />Rating’s of “very much or much improved” in the Patients Global Impression of Change(PGIC) scale<br />Secondary endpoints<br />Composite of endpoints that looked at the individual components of the primary endpoints<br />Adverse event rates<br />
    30. 30. Clinical Trial #2: A European Multicenter Randomized Double-blind Placebo-controlled Monotherapy Clinical Trial of Milnacipran in Treatment of Fibromyalgia cont…<br />Results<br />Primary Endpoints<br />The number of patients that had a greater than 30% improvement in pain from baseline were much greater compared to the placebo group<br />38.6% vs. 30.0%, p=0.007, OR 1.48, 95% CI 1.41-2.60<br />Patients rating of “very much or much improved” was also significantly higher than the placebo group<br />33.3% vs. 20.6%; p< 0.0001, OR 1.92, 95% CI 1.41-2.60<br />Secondary Endpoints<br />Improvements in the individual components of the VAS or the PGIC scores, found to be statistically significant in the treatment group compared to the placebo<br />93% of the ADR’s were mild to moderate among both groups<br />
    31. 31. Clinical Trial #2: A European Multicenter Randomized Double-blind Placebo-controlled Monotherapy Clinical Trial of Milnacipran in Treatment of Fibromyalgia cont…<br />Conclusion<br />Milnacipran is safe and effective among patients in the European population<br />Can correlate the result to American population due to the equivalence in efficacy and tolerability among both populations<br />Strength<br />randomized, double-blind, placebo controlled<br />large sample size and longer time frame<br />Weakness<br />authors had received grant from the sponsor of the study<br />some authors were employees of the sponsored group<br />
    32. 32. Consideration for formulary- Savella<br />
    33. 33. Weight of Balance-Savella<br />
    34. 34. Consideration for formulary-Cymbalta<br />
    35. 35. Weight of Balance-Cymbalta<br />
    36. 36.
    37. 37. Formulary Choice<br />
    38. 38. Thank You!<br />
    39. 39. References <br /> MICROMEDEX Healthcare Series: Micromedex, Greenwood Village, Colorado. Updated June 8th, 2010.<br />Lexi-Comp Online (database online). Hudson, Oh; Lexi-Comp; 2010. Updated June 30th, 2010.<br />Forest Pharmaceuticals. Savella (milnacipran).Forest Pharmaceuticals, 2010. Available at http://www.frx.com/products/savella.aspx. Accessed on July 02,2010<br />Savella (package insert) St. Louis, MO: Forest Pharmaceuticals, 2009.<br />Cymbalta (package insert) Indianapolis, IN: Eli and Lilly and co. 2004.<br />Branco JC, Zachrisson O, Perrot S, Mainguy Y. A European Multicenter Randomized Double-blind Placebo-controlled Monotherapy Clinical Trial of Milnacipran in Treatment of Fibromyalgia. The Journal of Rhematology, 2010; 37(4); 851-859.<br />Clauw DJ, Mease P, Palmer RH, Gendreau RM, Wang Y. Milnacipran for the Treatment of Fibromyalgia in Adults: A 15-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Clinical Trial. Clin. Therap.2008;30(11); 1988-2004.<br />Red Book ( database online).Montvale, NJ; Thompson Healthcare;2010. <br />WebMD.Fibromyalgia,2o1o. Available at http://www.webmd.com/fibromyalgia/guide/fibromyalgia-overview-facts<br />

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