Do supplements measure up to statins for lipid-lowering?
13 Dec 2022
In individuals with increased 10-year risk for ASCVD*, rosuvastatin 5 mg significantly reduced LDL-C** and other lipid and inflammatory biomarkers compared with placebo and six widely used heart health supplements, results from the SPORT*** trial have shown.
“The genesis of this study is that we see patients that have their medication list littered with dietary supplements,” said Dr Luke Laffin from the Cleveland Clinic, Cleveland, Ohio, US, at AHA 2022. Over three-quarters of Americans take a dietary supplement. Of these, 18 percent take one that promotes ‘heart health’, sporting labels such as ‘healthy cholesterol formula’, ‘cholesterol’s natural enemy’, ‘supports CV health’. Despite the usual disclaimer indicating the lack of FDA evaluation, Laffin stressed, “no one looks at that. Therefore, we took it upon ourselves to look at this.”
A total of 199 participants from the Cleveland Clinic Health System were randomized to daily rosuvastatin 5 mg, placebo, fish oil 2,400 mg, cinnamon 2,400 mg, garlic (with allicin 5,000 mcg), turmeric (4,500 mg), plant sterols (1,600 mg), or red yeast rice (2,400 mg). [AHA 2022, session LBS.05]
“Over the 4-week period, not necessarily surprisingly, we saw a 38-percent reduction in LDL-C with rosuvastatin,” highlighted Laffin. This reduction was vastly superior compared with placebo and all other supplements and was statistically significant by a wide margin (p<0.001 for each comparison).
The waterfall plot showing individual patient data amplified this result, reflecting at least an 18-percent LDL-C reduction with the statin. “In fact, half of participants randomized to rosuvastatin had >40 percent reduction in LDL-C,” Laffin said. For placebo and the supplements, LDL-C went either up or down.
Total cholesterol dropped by 24 percent with rosuvastatin, which was greater than anything else tested (p<0.001 for all comparisons). Rosuvastatin also outdid all other comparators in terms of triglyceride reduction (19 percent; p<0.005 for all comparisons).
For HDL-C** and hsCRP#, no significant differences were seen between rosuvastatin and any other group. However, plant sterols appeared to be better than rosuvastatin in reducing HDL-C (–4.02 percent vs 3.44 percent; p=0.01).
Looking at the comparisons between supplements and placebo, none reduced LDL-C relative to placebo. “In fact, the garlic supplement increased LDL-C by almost 8 percent (p=0.01),” Laffin noted. With HDL-C reduction, plant sterols outdid rosuvastatin (–7 percent; p=0.02). No significant differences were noted in terms of hsCRP, total cholesterol, and triglycerides.
‘Astounding’ safety results
Adverse event rates were similar across most groups (ranging between 12 and 20 percent), but slightly higher with plant sterols and red yeast rice (28 percent for both). Musculoskeletal complaints were not present in the rosuvastatin arm, nor were there any neurological complaints. There was no significant elevation in liver function tests nor meaningful changes in blood glucose.
Dr David Ellison from the Oregon Health and Science University, Portland, Oregon, US, noted that the safety results were “even more astounding” relative to the efficacy outcomes that were ‘expected’, during the AHAtv session. “There is no reason for people to [choose] these supplements instead of clearly effective statins.”
“I think this is a great opportunity for the AHA## to [address the public and discuss] the fact that you are really losing out if you are taking an ineffective therapy that has the same number of side effects as the effective therapy and that we really need to move to get more people to take their statins,” Ellison added.
“[While there are other options, SPORT] underscores the fact that using a low-dose, high-potency statin is associated with a very low risk of side effects,” commented discussant Dr Chiadi Ndumele from the Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease, Lutherville, Maryland, US.
A positive step forward
However, the trial duration may not have been sufficient to fully capture the impact of supplements on lipid and inflammatory biomarkers, Laffin said. “It is not a CV outcomes trial either so [it remains to be seen whether] there are other biomarkers being affected by these supplements.”
“[Nonetheless, the results] and its message are important for public health,” he stressed. “As cardiologists [and] primary care doctors … we should use these results to have evidence-based discussions with patients about the benefits of low-dose statins and the lack of benefit [of] ‘heart health supplements’.”
“As we try to translate this into public health, it would be important to consider the next concrete steps – how [these data can be incorporated in] the patient-provider risk discussion to inform patients and assess whether this could move the need, increase trust, or change the rates of appropriate statin utilization,” added Ndumele.
More patients treated will equate to more CV events prevented, said Ndumele. “[Therefore,] it is hopeful that SPORT can be a positive step forward as we try to connect those at risk to therapies that will help prevent CV events.”