Influence of the timing of low-dose aspirin on tolerability of prolonged-release nicotinic acid in patients at elevated cardiovascular risk

ABSTRACT

Objectives: To investigate the effect of low-dose aspirin administered in the morning or evening on the rate of discontinuation of prolonged-release nicotinic acid (Niaspan^*) due to flushing in patients at elevated cardiovascular risk.

Research design and methods: This was an observational, non-interventional study in patients at elevated cardiovascular risk due to cardiovascular disease or type 2 diabetes. Patients received prolonged-release nicotinic acid and aspirin under the usual care of their physician for 15 weeks.

Main outcome measures: The main outcome measure was the rate of treatment discontinuation for flushing. Other adverse drug reactions (ADRs) were also recorded. Lipid parameters were also measured.

Results: The patient population included 539 subjects (70% male); 36% had type 2 diabetes, 80% had prior cardiovascular disease, and 37% had a family history of cardiovascular disease. The rate of treatment discontinuation due to flushing did not differ ( p = 0.3375) between the morning aspirin group (10.6%) and the evening aspirin group (13.8%). The overall incidence of flushing was 57%. Most flushes were of mild or moderate severity and decreases occurred over time in both frequency and intensity. ADRs unrelated to flushing occurred in 6.6% of the morning aspirin group and 7.4% of the evening aspirin group. HDL-cholesterol increased by +21.3% in the overall population, together with moderate improvements in other lipid parameters.

Conclusions: Flushing was the most common ADR with prolonged-release nicotinic acid treatment, as expected. The timing of aspirin administration did not influence the rate of treatment discontinuations for flushing. Marked increases in HDL-cholesterol were observed.

Key words: :

• Cardiovascular risk
• HDL-cholesterol
• Lipid profiles
• Prolonged-release nicotinic acid
• Tolerability

* Niaspan is a trademark of Abbot Pharmaceuticals

* Niaspan is a trademark of Abbot Pharmaceuticals

Acknowledgements

Declaration of interest: The CAPTAIN study was funded by Merck KGaA, Darmstadt, Germany. U.H. is employed by Merck KGaA. S.-T., R.D. and A.V. have acted as consultants to Merck KGaA, the pharmaceutical sponsors of the agent under investigation, and/or have received research grants from Merck.

The authors acknowledge M. Gwilt, PhD, of GT Communications, for assistance with writing this article.

Notes

* Niaspan is a trademark of Abbot Pharmaceuticals