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The Fenoterol Story in Pharmacoepidemiology

This study delves into the impact of fenoterol on asthma patients, investigating its association with severe asthma and mortality rates. Data from various sources such as the National Asthma Mortality Survey and hospital records are analyzed to understand the drug's effects.

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The Fenoterol Story in Pharmacoepidemiology

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  1. The fenoterol story Pharmacoepidemiology Jean-François Boivin 5 November 2010 1

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  9. 9 Lancet – 29 April 1989 – Pages 917 - 922

  10. Source of cases New Zealand National Asthma Mortality Survey 5 – 45 years old Source of controls Hospitalized asthma patients 10

  11. Sources of data, asthma treatment Cases: General practioner questionnaires completed for the National Asthma Mortality Survey Controls: Hospital record notes 11

  12. Drug A B SEVERE ASTHMA + Death RR = 0.5 - 1000 10 MILD ASTHMA + Death RR = 0.5 - TABLE 4 A cohort study 100 100 ALL PATIENTS + 202 8 Death RR = 2.5 - 898 102 1100 110 12

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  14. Source of cases Death from asthma • National Health Statistics Centre Hospitalized in 12 months before death Source of controls Hospitalized for asthma 14

  15. Source of data, asthma treatment Medical record notes 15

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  17. 17 NEJM 1992; 326: 501-506

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  19. Saskatchewan data bases Saskatchewan Drug Plan Deaths Hospital discharge diagnoses Procedure codes ( e.g.: intubation) Doctor billing codes Use of health services • Hospitalizations • Doctor visits 19

  20. x x 10 prescriptions of asthma drugs death • death certificates • coroner’s reports • autopsy reports • hospital discharge summaries x x 10 prescriptions alive 20

  21. 1 year 10 years x x 10 prescriptions of asthma drugs death 1 year 10 years x x 10 prescriptions alive 20

  22. Death rate in study cohort? 1 death 22 person – years ? 1 death 20 person –years ? 21

  23. 1 year 10 years x x 10 prescriptions of asthma drugs death 1 year 10 years x x 10 prescriptions alive 22

  24. 1 year 10 years x x 10 prescriptions of asthma drugs death 1 year 2 years 10 years x x x 10 prescriptions allergy treatment death 22

  25. 1 year 10 years x x 10 prescriptions of asthma drugs death 1 year 2 years 8 years x x x 10 prescriptions allergy treatment death 22

  26. 1 death 8 person – years ? Death rate, allergy treatment 1 death 10 person – years ? 1 death 11 person – years ? 23

  27. Pharmaco-surveillance: Vaccines 24

  28. Example: Time-trend studies Percentage of Children Receiving Measles-Mumps-Rubella (MMR) Immunization in Second Year of Life and Caseload of Children With Autism, by Year of Birth, California, 1980-1994 JAMA. 2001;285:1183-1185 Time Trends in Autism and in MMR Immunization Coverage in California 25

  29. Polio vaccine: Cutter incident Wyeth 26

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  43. Questions that can be studied with a case -crossover design (Rothman 2002, page 89) Exposure varies from time to time • coffee • exercise One cannot study • blood group • low weight at birth 40

  44. Case cross-over studies Exposure triggers a short-term effect • asthma • sudden death One cannot study • lung cancer • osteoporosis 41

  45. Case cross-over studies Disease must have abrupt onset • allergic reaction • myocardial infarction • car accident One cannot study • multiple sclerosis • hypercholesterolemia 42

  46. Case cross-over studies Effect of exposure must be brief • anxiety in traffic • distraction on cell phone • panic during earthquake One cannot study • sedentarity • personality disorder 43

  47. N Engl J Med 2000; 343: 1355-61 44

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  49. N Engl J Med 2004; 351: 1721-30 46

  50. N Engl J Med 1997; 336: 453-8 47

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