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Effect of a Low Dose of Salmon Oil on Triglycerides and Lipid Parameters in HIV Patients Receiving a HAART Regimen and Having Elevated Serum Triglyceride Levels and Total Cholesterol / High Density Lipoprotein Ratio
Jean-Guy Baril*1, C Kovacs2, S Trottier3, G Roederer4, A Martel5, N Ackad6, N Longo7,8, C Liao7,8, and J Sampalis7,8
1Clin du Quartier Latin, Montréal, Canada; 2Maple Leaf Med Clin, Toronto, Canada; 3Ctr Hosp Univ Laval Res Ctr, Ste-Foy, Canada; 4Clin Med L'Actuel, Montréal, Canada; 5Ctr Med de Halles Ste-Foy, Canada; 6Abbott Labs, Montréal, Canada; 7JSS Med Res, Montreal, Canada; and 8McGill Univ, Montréal, Canada
Background: Dyslipidemia is a risk factor for
cardiovascular disease (CVD) and ART may disturb lipid profiles. Salmon oil may
be effective in improving lipid profile in HIV+ patients.
Methods: This was a phase IV, randomized, parallel and
cross-over, open-label, 24-week, multicenter trial. HIV+ patients on
HAART with elevated triglycerides and total cholesterol/HDL ratio were
randomized to receive 1 g of salmon oil 3
times daily for 24 weeks (group A) or to no additional treatment for 12 weeks
and then receive salmon oil for the next 12 weeks (group B). Student’s t-test for independent samples (A vs B)
and paired samples (B-cross over) were used.
Results: Of the 67 patients enrolled, 58 completed the
study (26 group A; 32 group B). A total of 9 patients discontinued for the
following reasons: 5 (7.5%) due to an
adverse event, 3 (4.5%) withdrew consent, and 1 (1.5%) stopped ART. The mean
(SD) age was 49.2 (7.1) years and 57 (98.3%) were male. At baseline 96.6% had
viral load <50 copies/mL, mean (SD) CD4: 627.0 (390.8) cell/mm3; 10 (17.2%)
had CVD and 8 (13.8%) had diabetes. Concomitant use of fibrates, statins, or
both were reported by 16 (27.6%), 10 (17.2%), and 8 (13.8%), respectively. The
treatment groups were similar with respect to baseline characteristics. The
table describes triglycerides and total cholesterol/HDL during the study
periods. At 12 weeks, group A had mean reduction in triglycerides of 95.7 mg/dL
compared with an increase of 26.9 mg/dL for group B (p = 0.040). When patients in group B were crossed over to salmon
oil, mean triglycerides decreased by 62.7 mg/dL (p = 0.056). A non-significant decrease of total cholesterol/HDL
ratio (p = 0.409) was observed
primarily because of the reduction in total cholesterol. No significant
differences in other lipid parameters were observed. There were 26 non-serious
and predominately mild adverse events reported by 17 (29.3%) patients.
|
Mean (SD)
|
Group A
|
Group B
|
|
Triglycerides (mg/dL)
|
Total cholesterol/HDL
|
Triglycerides (mg/dL)
|
Total cholesterol/HDL
|
|
Baseline
|
476.2 (233.7)
|
6.64 (1.1)
|
404.9 (165.4)
|
6.72 (2.2)
|
|
Week
12
|
380.5 (205.8)
|
6.33 (2.5)
|
431.8 (210.6)
|
6.53 (1.7)
|
|
Week
24
|
417.6 (309.1)
|
6.42 (2.6)
|
369.1 (163.1)
|
5.98 (1.7)
|
|
Change:
week 12 vs baseline
|
–95.7 (248.9)
|
–0.31 (2.1)
|
26.9 (191.3)
|
–0.19 (1.3)
|
|
Change:
week 24 vs baseline
|
–58.6 (299.1)
|
–0.22 (2.3)
|
–35.8 (190.8)
|
–0.74 (1.8)
|
|
Change:
week 24 vs week 12
|
37.1 (212.8)
|
0.09 (0.9)
|
–62.7 (172.5)
|
–0.55 (1.3)
|
* p-value based on Student’s t-test.
Conclusions: Low-dose salmon oil (3 g/day) is well
tolerated and effective in reducing serum triglycerides and could decrease total
cholesterol/HDL ratio in HIV+ patients receiving HAART with
uncontrolled hyperlipidemia.
|
