Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Case-control
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(C01) CARDIAC THERAPY
CARDIAC THERAPY
(J01) ANTIBACTERIALS FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
(R06) ANTIHISTAMINES FOR SYSTEMIC USE
ANTIHISTAMINES FOR SYSTEMIC USE
(A04) ANTIEMETICS AND ANTINAUSEANTS
ANTIEMETICS AND ANTINAUSEANTS
(N05) PSYCHOLEPTICS
PSYCHOLEPTICS
(N06) PSYCHOANALEPTICS
PSYCHOANALEPTICS
(C03) DIURETICS
DIURETICS

Medical condition to be studied

Sudden cardiac death
Population studied

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

5500
Study design details

Main study objective

Main objective: To determine the risk of unexplained sudden cardiac death (SCD) associated with proarrhythmic drug use. Secondary objectives: To describe and compare with controls the main characteristics of patients with unexplained SCD. To estimate the incidence of unexplained SCD. To determine the risk of unexplained SCD associated with pro-arrhythmic drug use in patients with cadiovascular dis

Outcomes

Risk of suddent death associated to the use of cardiac and noncardiac proarrhythmic drugs (drugs that prolong the QT interval, that cause extreme bradycardia, positive chronotropic drugs, drugs causing hydroelectrolytic disturbances), Incidence of sudden cardiac death (global, by groups of age and by gender).Risk of sudden death in patients with cardiovascular diseases and risk of the interaction between cardiovascular diseases and use of proarrhythmic drugs

Data analysis plan

OR and 95% CI through conditional logistic regression