Flushing profile of extended-release niacin/laropiprant at initiation of therapy in Asian lipid clinic patients.
Niacin is underutilized due to flushing, which occurs in over 90% of niacin-treated patients. Laropiprant (LRPT) reduces flushing associated with niacin. This study compared flushing with a combination tablet of extended-release (ER) niacin (ERN)/LRPT to niacin ER (N-ER; without LRPT) during the first week of therapy among patients in Asia.



Following a 1-week placebo run-in, 332 patients with dyslipidemia from China, Korea and Singapore were randomized to ERN/LRPT 1 g/20 mg, N-ER 1 g (given as Niaspan(R)) or placebo in a 2:2:1 ratio for 1 week. Patient-reported flushing severity was assessed using the Global Flushing Severity Score (GFSS; none/mild = 0-3; moderate = 4-6; severe = 7-9; extreme = 10).



Compared with N-ER, the ERN/LRPT group experienced significantly less flushing (p < 0.001), as measured by maximum GFSS categorized as none/mild, moderate, severe or extreme. Overall, 23.8% of patients in the ERN/LRPT group and 50.0% in the N-ER group (p < 0.001), versus 12.1% in the placebo group, had moderate or greater flushing (GFSS > or =4). Except for flushing, which occurred more frequently in the N-ER group, ERN/LRPT had a safety/tolerability profile similar to that of N-ER.



ERN/LRPT produced significantly less flushing than N-ER during the initiation of therapy and was generally well tolerated in Asian patients with dyslipidemia.
Kush
Debra
D
Merck Research Laboratories, Rahway, NJ 07065, USA. debra_kush@merck.com
Hu
Da-Yi
DY
Ye
Ping
P
Kim
Hyo-Soo
HS
Chen
Erluo
E
Sirah
Waheeda
W
McCrary Sisk
Christine
C
Paolini
John F
JF
Maccubbin
Darbie
D
D000328:Adult; D000368:Aged; D044466:Asian People; D004311:Double-Blind Method; D004338:Drug Combinations; D050171:Dyslipidemias / Q000188:drug therapy*; D005260:Female; D005483:Flushing / Q000139:chemically induced*; D006801:Humans; D000960:Hypolipidemic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D007211:Indoles / Q000008:administration & dosage / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D009525:Niacin / Q000008:administration & dosage / Q000009:adverse effects*
D004338:Drug Combinations; D000960:Hypolipidemic Agents; D007211:Indoles; C518174:MK-0524; D009525:Niacin