Special intervention reduces CVD mortality for adherent participants in the multiple risk factor intervention trial
Key result
Special Intervention reduced CVD mortality for highly adherent men (RR 0.91; 95% CI 0.84-0.99) but increased it for poorly adherent men (RR 1.28; 95% CI 1.05-1.57) compared to Usual Care.
Why the study?
Does Special Intervention reduce cardiovascular disease mortality in men compared to Usual Care, and how does adherence modify this effect?
Population
12,338 men in the Multiple Risk Factor Intervention Trial (MRFIT)
Comparison
Special Intervention (SI) vs Usual Care (UC)
Design
RCT, Randomization to Special Intervention (SI) or Usual Care (UC)
Follow-up
9 years
Authors
Discussion
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Member takes
Implication
Adherence modifies multiple risk factor intervention effects on CVD mortality; challenges uniform application and extends trials by identifying harm in poorly adherent men.
Study Design
Type
RCT (n=12,338)
Randomization
Randomized
Structured PICO
Does Special Intervention reduce cardiovascular disease mortality in men compared to Usual Care, and how does adherence modify this effect?
P
Population
12,338 men followed for 9 years to evaluate the effect of adherence to a Special Intervention versus Usual Care on cardiovascular mortality.
I
Intervention
Special Intervention (SI)
C
Comparator
Usual Care (UC)
O
Outcome
Cardiovascular disease (CVD) mortality at 9-year follow-uphard clinical
Main Result
Relative Risk: 0.91 (95% CI 0.84–0.99)
p-value: p=0.002 for interaction
The efficacy of a multiple risk factor intervention on CVD mortality is highly dependent on patient adherence, with benefits seen in highly adherent patients and potential harm in poorly adherent patients.
Cite This Study
Gump et al. (2003) conducted an RCT in Cardiovascular disease (n=12,338). Special Intervention (SI) vs. Usual Care (UC) was evaluated on Cardiovascular disease (CVD) mortality for highly adherent participants (RR 0.91, 95% CI 0.84-0.99, p=0.002 for interaction). Special Intervention reduced CVD mortality for highly adherent men (RR 0.91; 95% CI 0.84-0.99) but increased it for poorly adherent men (RR 1.28; 95% CI 1.05-1.57) compared to Usual Care.