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The evening versus morning polypill utilization study: the TEMPUS rationale and design
Melvin Lafeber1, Diederick E Grobbee, Michiel L Bots
1University Medical Center Utrecht, Utrecht, The Netherlands.
European Journal of Preventive Cardiology
|February 6, 2013
Summary
Taking a cardiovascular polypill in the evening may improve LDL cholesterol and blood pressure control. This study compared evening versus morning polypill administration in high-risk patients.
Area of Science:
- Cardiovascular medicine
- Clinical pharmacology
- Preventive cardiology
Background:
- Current guidelines recommend morning administration for BP-lowering agents and evening for statins.
- Evening statin use is linked to superior LDL-c reduction and improved BP control with aspirin and BP agents.
- Optimal polypill timing is uncertain due to potential adherence issues with evening dosing.
Purpose of the Study:
- To evaluate if evening vs. morning polypill intake affects LDL-c levels and 24-hour ambulatory BP.
- To compare polypill efficacy to separate, identically dosed components.
- To assess the impact on cardiovascular risk in high-risk individuals.
Main Methods:
- A prospective, randomized, open-blinded endpoint crossover trial (TEMPUS).
- 75 participants with cardiovascular disease or high risk were randomized to three regimens.
- Treatments included polypill (aspirin, simvastatin, lisinopril, HCTZ) in evening/morning or separate pills.
Main Results:
- Primary endpoint: difference in LDL-c and mean 24-hour ambulatory systolic BP.
- Secondary outcomes: relative risk reduction, biochemistry, platelet function, adherence, and acceptability.
- Analysis focused on comparing evening vs. morning polypill administration.
Conclusions:
- The TEMPUS trial will determine the effect of polypill administration timing on LDL-c and BP.
- Findings will inform optimal dosing strategies for cardiovascular combination therapies.
- Results are relevant for patients at intermediate to high risk for cardiovascular disease.
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