Visual information shortens time to initiation of statin treatment
Time to initiation of lipid-lowering drugs for subclinical atherosclerosis: sub-study of VIPVIZA randomized controlled trial, with single-arm cross-over
Introduction and methods
Background
The use of risk scores, such as the European systematic coronary risk evaluation (SCORE) and Framingham risk score, to communicate increased risk of CVD are possibly suboptimal. Also, these risk scores are too abstract for many and not sensitive enough to identify large groups of asymptomatic individuals [1-2]. Pictorial risk information to physicians and patients may be more actionable and lead to earlier initiation of statin therapy to prevent CVD [1, 3].
This observational substudy utilizes data collected during the Visualization of asymptomatic atherosclerotic disease for optimum cardiovascular prevention (VIPVIZA) trial [1].
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Aim of the study
The study aims were: (1) to examine if an intervention with pictorial risk information influenced time to first dispensing of statins compared with a control group during the first 3 years and during an additional 2 years after re-intervention of the intervention group and cross-over of the control group; (2) to evaluate the impact of gender, education, presence of plaque, and enrolment year.
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Methods
A total of 3532 participants were enrolled in VIPVIZA between April 29, 2013, and June 7, 2016, of which 3000, those not on lipid-lowering medication at baseline, were randomly assigned to either a control group (n=1529) or an intervention group (n=1471). Participants in the intervention group received pictorial risk information; for those in the control group, pictorial risk information was unavailable. Pictorial risk information included an ultrasound-based image of asymptomatic atherosclerosis [1].
After 3 years, both groups were re-examined. Also, at this time the pictorial and risk factor results were presented to both the intervention and the control group, and their physicians (single-arm, cross-over). Follow-up time extended to 5 years after baseline examination. At the 5-year follow-up, time to initiation of statins was assessed through the Swedish prescribed drug register.
Data were stratified conditional on no statins before the start of the intervals. Two strata contained person-time from the first 3 years (2013-2016), while two other strata start at 3-year follow-up (2016-2019) with re-intervention of the intervention group and first intervention of the control group.
Main results
- The effect of presence of plaque was stronger across all strata where the ultrasound results were available to physicians and participants. The hazard ratio (HR) for initiation of statin treatment for participants with plaque ranged from 2.8 to 3.6 across these strata relative to participants with no plaque.
- The average intensity for initiation of statins tripled after 3 years follow-up in the intervention group.
- In the control group, participants with plaque received statins quicker or more often than those without plaque (HR:1.6; 95% CI: 1.1–2.3); although, no information regarding ultrasound results was available to the participants or their physician during that period.
- After 5 years, a significant intervention effect was shown in the intervention group and in the control group after single-arm cross-over.
- A temporal effect, regarding intervention/reintervention/ inclusion year was observed. The physicians were more “successful” in convincing participants the later they were enrolled. In the first 3 years intervention group, participants enrolled in 2014 had a higher initiation rate (HR:2.6; 95%CI: 1.6–4.4), followed by a further increased initiation rate (HR:7.5; 95%CI: 4.3-13.1) in 2015, and an even greater increase the last inclusion year 2016, all relative to 2013.
- The temporal effect is also present after 3 years follow-up in the controls first intervention and the re-intervention of the intervention group, where years 2018 and 2019 have an increase in HR relative to 2016, although less extreme than the increase observed in the first 3 years intervention group.
- Sex and educational level had no effect on time to initiation of statin treatment in any of the groups or strata.
Conclusion
Pictorial risk information increased the propensity to initiate statin therapy. This occurred in the first 3 years in the intervention group, in the reintervention of the intervention group, and in the control group after cross-over. Neither sex nor education level had an effect on time to initiation of statin treatment in any of the groups or strata. This substudy of the VIPVIZA trial further supports the importance of pictorial risk information to both physicians and patients. Improved risk communication may lead to earlier initiation of statin therapy, and thereby improve the prevention of CVD.
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