Trials and tribulations in 25 years of

pharmacoepidemiologySamy Suissa

McGill University and Jewish General Hospital

April 29-30, 2015

The daring 90s

Series10.5

1

1.5

2

Non use

Salbutamol

Fenoterol

SASKATCHEWAN

The Saskatchewan study: 12,000 asthma patients

Healthcare databases

Computerized Doctor visits Medications Hospitalizations Death certificates

Risk of asthma death with bronchodilators

Asthma death and inhaled corticosteroids

Suissa et al., N Engl J Med 2000;332–6.

Worldwide impact?

Japan Portugal

Israel New Zealand

The roaring 2000s

CPRD: UK Clinical Practice Research Datalink

>1000 GPs 10 million patients 1990-today Diagnoses, lab tests Drug prescriptions,

hospitalizations, etc..

The painkillerVioxx

WASHINGTON (Reuters) -- Pharmaceutical giant Merck & Co Inc. had evidence by 2000 that its painkiller Vioxx, which was pulled off the market on Sept. 30 (2004), was not safe, a heart specialist told CBS News program "60 Minutes" on Sunday.

Monday, November 15, 2004 Posted: 1516 GMT (2316 HKT)

Series10

1

2

3

4

5

Non use

Etoricoxib (Arcoxia)

Valdecoxib (Bex-tra)

Parkinson’s disease

medications

Series10

2

4

6

8

Non use

Cabergoline (Dostinex)

Pergolide (Permax)

Pharmaco-epidemiology

methods

Time-related biases

The soaring 2010s

Canadian Pharmacoepidemiology

Healthcare databases

Computerized Doctor visits Medications Hospitalizations Death certificates

Why CNODES

?

Ontario Quebec Saskatchewan

VIGOR RCT

Canadian VIOXX observational studies

OntarioQuebec

Saskatchewan

VIGOR RCT

Canadian VIOXX observational studies

British Columbia? Alberta? Manitoba? Nova Scotia?

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CIHR DSEN COORDINATING OFFICE

CNODES COORDINATING CENTRE

S. SUISSA

CNODES EXECUTIVE S. SUISSA, D. HENRY

NOVA SCOTIA A. LEVY

BRITISH COLUMBIA C. DORMUTH

SASKATCHEWAN G. TEARE

ONTARIO M. PATERSON, D. HENRY

CPRD P. ERNST

ALBERTA B. HEMMELGARN

MANITOBA P. MARTENS, P. CAETANO,

D. CHATEAU

QUEBEC J. LELORIER

KNOWLEDGE TRANSLATION TEAM

I. SKETRIS

TRAINING TEAM C. DORMUTH

DATABASE TEAM D. HENRY

METHODS TEAM R. PLATT

CNODES: Challenges

Small drug effects

Large sample sizes

Computerized databases

Consistent results

Rapid

High-dose statins and the risk of acute kidney injury

BACKGROUND:Ridker PM et al, JUPITER Study Group. N Engl J Med 2008;359

Event

Rosuvastatin 20mg

n=8901Placebo n=8901

Rate Ratio P-value

n % n %

Primary Endpoint 142 1.6 251 2.8 0.57 <0.0001

Renal disorder 535 6.0 480 5.4 1.19 0.08

Does treatment with high potency statins increase the risk of serious

acute kidney injury ?

METHODS/RESULTS

9 new-user cohorts of statin initiators

Over 2 million patients initiating statin therapy

1/3 starting on high-dose statins Over 24,000 hospitalized for AKI

during the first 2 years of follow-up

HIGH-POTENCY STATINS AND AKI

CNODES Studies

CNODES Methods Team

25 years later ?

Visit us at: WWW.CNODES.CA