Trials and tribulations in 25 years of pharmacoepidemiology Samy Suissa McGill University and Jewish General Hospital April 29-30, 2015.

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Presentation transcript:

Trials and tribulations in 25 years of pharmacoepidemiology Samy Suissa McGill University and Jewish General Hospital April 29-30, 2015

The daring 90s

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 painkiller Vioxx

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)

Parkinson’s disease medications

Pharmaco- epidemiology methods

Time-related biases

The soaring 2010s

Canadian Pharmacoepidemiology  Healthcare databases  Computerized  Doctor visits  Medications  Hospitalizations  Death certificates

Why CNODES ?

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)

Ontario Quebec Saskatchewan VIGOR RCT Canadian VIOXX observational studies

Ontario Quebec Saskatchewan VIGOR RCT Canadian VIOXX observational studies British Columbia? Alberta? Manitoba? Nova Scotia?

British Columbia Alberta Nova Scotia *CPRD MarketScan CNODES Quebec Ontario Manitoba Saskatchewan

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=8901 Placebo n=8901 Rate RatioP-value n%n% Primary Endpoint < Renal disorder 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 ?

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