Pharmacoepidemiology

Kristian B. Filion, PhD

CIHR New InvestigatorAssistant Professor of MedicineDivision of Clinical Epidemiology

Lady Davis Institute for Medical ResearchJewish 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 post-market 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

Dormandy et. al. Lancet 2005.

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

Azoulay et. al. BMJ 2012.

Thiazolidinediones and Risk of Bladder Cancer

N (%)

Use of Thiazolidinediones Cases* (n=376)

Controls* (n=6,699)

Adjusted Rate Ratio (95% CI)†

Never use of any thiazolidinedione

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)

*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 PsychogeriatricsAssessing the cumulative effects of exposure to selected benzodiazepines on the risk of fall-related injuries in the elderlyMarie-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!Kristian.filion@mcgill.ca