TY - JOUR
T1 - Safety and tolerability of prolonged-release nicotinic acid in statin-treated patients
AU - Birjmohun, R. S.
AU - Kastelein, J. J. P.
AU - Poldermans, D.
AU - Stroes, E. S. G.
AU - Hostalek, U.
AU - Assmann, G.
PY - 2007
Y1 - 2007
N2 - Objective: To evaluate the safety and tolerability of prolonged -release nicotinic acid (Niaspan*) added to statin therapy in patients at increased cardiovascular risk. Methods: This was a 6-month, prospective, observational, multicentre, open-label evaluation of prolonged-release nicotinic acid (maximum dose 2000 mg/day) in statin-treated patients with cardiovascular disease and/ or type 2 diabetes. The primary endpoint was the safety and tolerability of prolonged- release nicotinic acid, with special regard to treatment-related adverse drug reactions (ADRs). Secondary endpoints were changes in lipids and 1 0-year cardiovascular risk (Prospective Cardiovascular Munster (PROGAM) score). Results: The study population included 1053 patients: 50% had hypertension, diabetes and/or metabolic syndrome (National Cholesterol Education Program/Adult Treatment Panel III criteria) and 80% had cardiovascular disease. Flushing (mostly mild or moderate) occurred in 430 patients (40.8%). Other ADRs occurred in 125 patients (12.5%), most commonly pruritus (2.7%), gastrointestinal symptoms (3.8%) and nervous system-related complaints (3.8%). Serious ADRs were uncommon (0.6%). All patients recovered completely from these ADRs after treatment discontinuation. In total, 11.1 % of the patients discontinued study medication for flushing and 8.4% for other ADRs. There was no evidence of hepatotoxicity or myopathy. New-onset hyperglycaemia was negligible. Overall tolerability of prolonged -release nicotinic acid treatment (n = 734 patients at closeout) was 'very good' in 130 (17.7%),'good' in 262 (35.7%), and 'acceptable' in 144 (19.6%) patients. High-density lipoprotein (HDL) cholesterol increased by 23%, triglycerides decreased by 15% and LDL-C decreased by 4%. Conclusions: Prolonged-release nicotinic acid was safe and generally well tolerated and effective in combination with statin therapy in patients at high risk of cardiovascular events, with a side-effect profile consistent with previous clinical experience
AB - Objective: To evaluate the safety and tolerability of prolonged -release nicotinic acid (Niaspan*) added to statin therapy in patients at increased cardiovascular risk. Methods: This was a 6-month, prospective, observational, multicentre, open-label evaluation of prolonged-release nicotinic acid (maximum dose 2000 mg/day) in statin-treated patients with cardiovascular disease and/ or type 2 diabetes. The primary endpoint was the safety and tolerability of prolonged- release nicotinic acid, with special regard to treatment-related adverse drug reactions (ADRs). Secondary endpoints were changes in lipids and 1 0-year cardiovascular risk (Prospective Cardiovascular Munster (PROGAM) score). Results: The study population included 1053 patients: 50% had hypertension, diabetes and/or metabolic syndrome (National Cholesterol Education Program/Adult Treatment Panel III criteria) and 80% had cardiovascular disease. Flushing (mostly mild or moderate) occurred in 430 patients (40.8%). Other ADRs occurred in 125 patients (12.5%), most commonly pruritus (2.7%), gastrointestinal symptoms (3.8%) and nervous system-related complaints (3.8%). Serious ADRs were uncommon (0.6%). All patients recovered completely from these ADRs after treatment discontinuation. In total, 11.1 % of the patients discontinued study medication for flushing and 8.4% for other ADRs. There was no evidence of hepatotoxicity or myopathy. New-onset hyperglycaemia was negligible. Overall tolerability of prolonged -release nicotinic acid treatment (n = 734 patients at closeout) was 'very good' in 130 (17.7%),'good' in 262 (35.7%), and 'acceptable' in 144 (19.6%) patients. High-density lipoprotein (HDL) cholesterol increased by 23%, triglycerides decreased by 15% and LDL-C decreased by 4%. Conclusions: Prolonged-release nicotinic acid was safe and generally well tolerated and effective in combination with statin therapy in patients at high risk of cardiovascular events, with a side-effect profile consistent with previous clinical experience
U2 - https://doi.org/10.1185/030079907X199682
DO - https://doi.org/10.1185/030079907X199682
M3 - Article
C2 - 17588301
SN - 0300-7995
VL - 23
SP - 1707
EP - 1713
JO - Current medical research and opinion
JF - Current medical research and opinion
IS - 7
ER -