Transcript Pharmacoepidemiology: Kris Filion

Pharmacoepidemiology
Kristian B. Filion, PhD
CIHR New Investigator
Assistant Professor of Medicine
Division of Clinical Epidemiology
Lady Davis Institute for Medical Research
Jewish General Hospital/McGill University
Definition
Pharmacoepidemiology is the study of the
use of and the effects of drugs in large
numbers
of
people.
The
term
pharmacoepidemiology obviously contains
two
components:
“pharmaco”
and
“epidemiology”.
Brian L. Storm (editor). Pharmacoepidemiology (fourth edition)
Drug Safety and Effectiveness
• Drug Safety:
– Post-Marketing Surveillance of Adverse Drug Effects
• Comparative Effectiveness Research:
– Designed to inform health-care decisions by providing
evidence on the effectiveness, benefits, and harms of
different treatment options
– Evidence is generated from research studies that
compare drugs, medical devices, tests, surgeries, or
ways to deliver health care
http://effectivehealthcare.ahrq.gov/index.cfm/what-is-comparative-effectiveness-research1/
Drug Safety and Effectiveness
Network (DSEN)
• Joint CIHR-Health Canada initiative ($32M over 5 years)
• Part of the Food and Consumer Safety Action Plan
• Key objectives:
– Increase the available evidence on drug safety and effectiveness
available to regulators, policy-makers, health care providers and
patients
– Increase capacity within Canada to undertake high-quality postmarket research
• Team grants:
– Canadian Network for Observational Drug Effect Studies
(CNODES)
– Drug Safety and Effectiveness Network Collaborating Centre for
Prospective Studies
http://www.cihr-irsc.gc.ca/e/40269.html
Potential Contributions of
Pharmacoepidemiology
• Information which supplements the information
available from premarketing studies – better
quantitation of the incidence of known adverse
and beneficial effects
– Higher precision
– In patients not studied prior to marketing (e.g., the
elderly, children, in pregnant women)
– As modified by other drugs and other illnesses
– Relative to other drugs used for the same indication
Brian L. Storm (editor). Pharmacoepidemiology (fourth edition)
Potential Contributions of
Pharmacoepidemiology (Cont.)
• New types of information not available from
premarketing studies
– Discovery of previously undetected adverse and
beneficial effects (e.g., Uncommon effects, Delayed
effects)
– Patterns of drug utilization
– The effects of drug overdoses
– The economic implications of drug use
• General contributions of pharmacoepidemiology
– Reassurances about drug safety
– Fulfillment of ethical and legal obligations
Brian L. Storm (editor). Pharmacoepidemiology (fourth edition)
Dormandy et. al. Lancet 2005.
Bladder Cancer in PROACTIVE
Pioglitazone
(n=2,605)
Placebo
(n=2,633)
P Value
Any serious adverse event
1,204 (46%)
1,275 (48%)
0.110
Endpoint events
389 (15%)
434 (16%)
0.123
Non-endpoint events
1,079 (41%)
1,150 (44%)
0.099
Most common events (excluding endpoints)
Neoplasms
112 (4%)
113 (4%)
Malignant
97 (4%)
99 (4%)
Colon/rectal
16(1%)
15 (1%)
0.834
Lung
15 (1%)
12 (1%)
0.544
Bladder
14 (1%)
6 (<1%)
0.069
Bladder (after exclusion)*
6 (<1%)
3 (<1%)
0.309
* Cases remaining after blinded review
Dormandy et. al. Lancet 2005.
Azoulay et. al. BMJ 2012.
Thiazolidinediones and Risk of
Bladder Cancer
N (%)
Cases*
(n=376)
Controls*
(n=6,699)
Adjusted
Rate Ratio
(95% CI)†
319 (84.8)
5,856 (87.4)
1.00 (Ref.)
Exclusive ever use of
pioglitazone
19 (5.1)
191 (2.9)
1.83 (1.10, 3.05)
Exclusive ever use of
rosiglitazone
36 (9.6)
595 (8.9)
1.14 (0.78, 1.68)
Ever use of both pioglitazone
and rosiglitazone
2 (0.5)
56 (0.8)
0.78 (0.18, 3.29)
Use of Thiazolidinediones
Never use of any
thiazolidinedione
*Matched on year of birth, year of cohort entry, sex, and duration of follow-up.
†Adjusted for excessive alcohol use, obesity, smoking status, HbA1c , previous bladder conditions, previous cancer
(other then non-melanoma skin cancer), Charlson comorbidity score, and ever use of other antidiabetic agents
(metformin, sulfonylureas, insulin, and other oral hypoglycaemic agents).
Azoulay et. al. BMJ 2012.
Other Examples of
Pharmacoepidemiology at McGill
Other Examples of
Pharmacoepidemiology at McGill
Other Examples of
Pharmacoepidemiology at McGill
International Psychogeriatrics
Assessing the cumulative effects of exposure to selected benzodiazepines on the
risk of fall-related injuries in the elderly
Marie-Pierre Sylvestre, Michal Abrahamowicz, Radan Čapek and Robyn Tamblyn
Other Examples of
Pharmacoepidemiology at McGill
Pharmacoepidemiology
Investigators at McGill
• Laurent Azoulay
• Sacha Bernatsky
• Jean-François
Boivin
• Paul Brassard
• James Brophy
• Jaimie Caro
•
•
•
•
•
•
•
Pierre Ernst
Kristian Filion
Elham Rahme
Michel Rossignol
Samy Suissa
Vicky Tagalakis
Robyn Tamblyn
Prospective Jobs
• Academia
• Government
• Consulting
• Pharmaceutical Industry
THANK YOU!
[email protected]