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HOPE-3: Remarks on a recent statin trial

Inner Circle Member Forum >> Coronary Disease & Cholesterol Protocol >> HOPE-3: Remarks on a recent statin trial

Bob Niland

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Posted: 4/5/2016 9:44:11 AM
Edited: 2/18/2018 12:19:57 PM (7)
 
HOPE-3: Statin mildly beneficial (but in what context)

Remarks on the HOPE-3 Trial

Edition: 2018-02-17

The fulltext is available for open access on the NEJM:
Blood-Pressure and Cholesterol Lowering in Persons without Cardiovascular Disease (PDF)
The Appendix PDF is here. The Protocol PDF is here.


Subsequent to my authoring the article following, a formal paper was published analyzing HOPE-3:
JCMBR: Recent Flaws in Evidence-Based Medicine: Statin Effects in Primary Prevention and Consequences of Suspending the Treatment
Even the deminimus touted news from HOPE-3 may be no such thing.


This was a 7-year randomized trial of 12705 “intermediate risk” subjects assigned to one of four arms, shown in the table below.

The results are being touted as: “The decrease in the LDL cholesterol level was 33.7 mg per deciliter (0.87 mmol per liter) greater in the combined-therapy group than in the dual-placebo group, and the decrease in systolic blood pressure was 6.2 mm Hg greater with combined therapy than with dual placebo. … The combination of rosuvastatin …, candesartan …, and hydrochlorothiazide … was associated with a significantly lower rate of cardiovascular events than dual placebo among persons at intermediate risk who did not have cardiovascular disease.”.

Yes, they drove LDL (presumably the mythical LDL-C) down by a striking ~30%.

You may see headlines about a “24%” reduction in heart attack and stroke, and “5%” reduction in all-cause mortality, but those are the notorious “relative risk” numbers favored by Marketing. The absolute MI/stroke reduction was a less impressive 1.1%, and deaths from other causes went up. What really matters is all-cause mortality.

Arm All-cause
Mortality
Relative Risk
Improvement
Absolute Risk
Improvement
.vs
placebo + placebo
 
5.62%
(178/3168)
- - -
statin + placebo
 
5.38%
(171/3181)
4.46%
 
0.24%
 
placebo only
 
placebo + BP meds
 
5.64%
(179/3176)
0.36%
adverse
0.02%
adverse
placebo only
 
statin + BP meds
 
5.13%
(163/3180)
9.94%
10.49%
0.41%
0.45%
placebo only
statin+placebo

For driving LDL down by a whopping 30%, total all-cause mortality only went down by 0.24% or 0.41% (yep, ¼ or ½ of 1%).

You’d think that between this and the CETP results, they might figure out that there’s not very much leverage in shoving LDL-C around. Don’t count on it (video from the early 2016 conference): ’I Have a Patient Who Won’t Take a Statin...’ leads off with Captain Statin.

And due to confounders not recorded or reported in HOPE-3, we don’t even know if the ¼% or ½% are real. Apart from the normal suspicion of bias due to being funded by the product producer, suppose, for example, that the placebos were calcium pills (or capsules containing sugar or soybean oil). In real life, people declining statin treatment don’t take placebos that might actually be antagonist agents. Had they included an untreated arm, they might have been able to shed some light on that.

The statin was rosuvastatin (Crestor, 10 mg per day). The BP meds were candesartan (16 mg per day) plus hydrochlorothiazide (12.5 mg per day). The placebo was not specified (and so may have been no such thing).

You can check Table 1 (PDF page 5) for a list of other meds that the arms were on. It may or may not be comprehensive, excluding perhaps things like CoQ10 and K vitamins.

Persons with [diagnosed] cardiovascular disease and those with an indication for or contraindication to statins, angiotensin-receptor blockers, angiotensin-converting–enzyme inhibitors, or thiazide diuretics were excluded.

But these were not healthy people, despite lacking a CVD diagnosis:

Measure Average Baseline Reading
TG 128 mg/dL
BP 138:82
BMI 27
B100/A1 Ratio 0.75
HDL 45 mg/dL

HbA1c and actual lipoproteins were not reported. There’s no indication that any attention whatever was paid to diet, so the volunteers may well have continued to eat in the same manner that made them unhealthy (or followed their doctors’ advice on how to eat, which might amount to the same thing).

This trial is already being spun as a justification for broader prophylactic use of statins. As a commenter on a statin skeptic site put it: that’s not a study - it’s an advertisement.

___________
Bob Niland [disclosures] [topics]

Tags: ,Statins

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Posted: 4/5/2016 10:18:05 AM
 
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Bob Niland

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Posted: 4/5/2016 11:09:34 AM
Edited: 4/5/2016 8:15:01 PM (4)
 
{remarks merged into basenote}
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Boo

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Posted: 4/5/2016 6:45:31 PM
 
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Bob Niland

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Posted: 4/10/2016 12:30:27 PM
 
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Posted: 4/2/2017 1:32:35 PM
 
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Boo

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Posted: 4/3/2017 8:47:33 AM
 
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Malcolm

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Posted: 4/5/2017 11:11:32 PM
 
Boo:

Can you recommend any citrulline and pycnogenol products and doses to take?

Thanks.


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Posted: 4/6/2017 4:14:10 PM
 
Boo is spot on for the Cit.


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Posted: 4/6/2017 9:34:02 PM
 
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Posted: 4/7/2017 9:10:17 PM
 
Dr. Peter Langsjoen et al found that statin-induced impairment in heart muscle appears to be permanent.

https://www.youtube.com/watch?v=7HUUAvnALQo


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Bob Niland

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Posted: 2/18/2018 8:39:58 PM
 
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Posted: 2/28/2018 6:02:07 PM
 
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Posted: 3/12/2018 8:36:52 AM
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