← Statins × quality of life & behaviour

TrialLancet (London, England)2017

Adverse events associated with unblinded, but not with blinded, statin therapy in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid-Lowering Arm (ASCOT-LLA): a randomised double-blind placebo-controlled trial and its non-randomised non-blind extension phase.

Ajay Gupta et al.PubMed ↗Publisher ↗

  • Atorvastatin 10 mg dailylooks bad hereLower sleep disturbance, higher renal and urinary AEs, no clear effect on muscle-related AEs.Randomised, large.
  • Statin use (atorvastatin 10 mg daily open label)looks bad hereHigher musculoskeletal and connective tissue disorders, higher muscle-related AEs, higher blood and lymphatic system disorders.Correlation only, not a test of it.

What the trial testedrandomised · 9,899 people · 2017

Randomised vs matching placebo

Lowered sleep disturbance

−31%−44% to −15%

atorvastatin 10 mg daily vs matching placebo

Bigger than 6 in 10 on the map

As reported

HR 0.69, 95% CI 0.56–0.85

Randomised vs matching placebo

Raised renal and urinary AEs

+23%+8% to +41%

atorvastatin 10 mg daily vs matching placebo

Bigger than 4 in 10 on the map

As reported

HR 1.23, 95% CI 1.08–1.41

Range includes no effect

No clear effect on muscle-related AEs

+3%−12% to +21%

atorvastatin 10 mg daily vs matching placebo

Bigger than 1 in 10 for adverse events & safety

As reported

HR 1.03, 95% CI 0.88–1.21

Range includes no effect

No clear effect on erectile dysfunction

−12%−25% to +4%

atorvastatin 10 mg daily vs matching placebo

Bigger than 3 in 10 on the map

As reported

HR 0.88, 95% CI 0.75–1.04

What moved togetherboth groups pooled, not the treatment’s effect

Correlation, not cause

Statin use (atorvastatin 10 mg daily open label) went with higher musculoskeletal and connective tissue disorders

+17%+6% to +29%

statin use (atorvastatin 10 mg daily open label) vs non-use of statins

Bigger than 4 in 10 for adverse events & safety

As reported

HR 1.17, 95% CI 1.06–1.29

Correlation, not cause

Statin use (atorvastatin 10 mg daily open label) went with higher muscle-related AEs

+41%+10% to +79%

statin use (atorvastatin 10 mg daily open label) vs non-use of statins

Bigger than 6 in 10 for adverse events & safety

As reported

HR 1.41, 95% CI 1.10–1.79

Correlation, not cause

Statin use (atorvastatin 10 mg daily open label) went with higher blood and lymphatic system disorders

+40%+4% to +88%

statin use (atorvastatin 10 mg daily open label) vs non-use of statins

Bigger than 6 in 10 for adverse events & safety

As reported

HR 1.40, 95% CI 1.04–1.88

+1 more in the walkthrough ↓

Who was studied, and how

9,899people with dyslipidemia, in this paper

The trial randomly assignedassigned by chance

atorvastatin 10 mg daily
matching placebo

Lowered sleep disturbance−31%

Raised renal and urinary AEs+23%

No clear effect on muscle-related AEs+3%

randomised

Already taking statin use (atorvastatin 10 mg daily open label), or nottheir own situation, not assigned

on statin use (atorvastatin 10 mg daily open label)
not on use of statins

Statin use (atorvastatin 10 mg daily open label) went with higher musculoskeletal and connective tissue disorders+17%

Statin use (atorvastatin 10 mg daily open label) went with higher muscle-related AEs+41%

Statin use (atorvastatin 10 mg daily open label) went with higher blood and lymphatic system disorders+40%

correlation, not a test

the abstract, start to end

… vs 283 [2.00% per annum]; hazard ratio 1.03 [95% CI 0.88-1.21]; p=0.72) and erectile …

… per annum] vs 32 [0.22% per annum]; 0.94 [0.57-1.54]; p=0.81).

… per annum] vs 210 [1.46% per annum]; 0.69 [0.56-0.85]; p=0.0005).

… per annum] vs 831 [7.45% per annum]; 1.17 [1.06-1.29]; p=0.001) and blood and lymphatic system disorders (114 [0.88% per annum] vs 80 [0.64% per annum]; 1.40 [1.04-1.88]; p=0.03), which …

… per annum vs 392 [1.51%] per annum; 1.23 [1.08-1.41]; p=0.002).

… per annum] vs 124 [1.00% per annum]; 1.41 [1.10-1.79]; p=0.006).

← favours treatmentfavours comparator →
could be chance
Muscle-related AEsatorvastatin 10 mg daily vs matching placebo
HR 1.030.88–1.21
Erectile dysfunctionatorvastatin 10 mg daily vs matching placebo
HR 0.880.75–1.04
Cognitive impairmentatorvastatin 10 mg daily vs matching placebo
HR 0.940.57–1.54
Sleep disturbanceatorvastatin 10 mg daily vs matching placebo
HR 0.690.56–0.85
Musculoskeletal and connective tissue disordersstatin use (atorvastatin 10 mg daily open label) vs non-use of statins
HR 1.171.06–1.29
Renal and urinary AEsatorvastatin 10 mg daily vs matching placebo
HR 1.231.08–1.41
Muscle-related AEsstatin use (atorvastatin 10 mg daily open label) vs non-use of statins
HR 1.411.10–1.79
Blood and lymphatic system disordersstatin use (atorvastatin 10 mg daily open label) vs non-use of statins
HR 1.401.04–1.88
StatinsKidney outcomesNeuropathy, eye & footAdverse events & safetyQuality of life & behaviour

Statins × quality of life & behaviourhelps?no deciding trial

unlikelylikely
0.250.25 without it

Statins × kidney outcomeshelps?mixed

unlikelylikely
0.000.25 without it

Statins × neuropathy, eye & foothelps?no deciding trial

unlikelylikely
0.250.25 without it
← favours comparatorfavours treatment →
this papermore certainless certain
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2 trials

NCT06248671phase 2450 enrolled2024NCT06485336phase 2300 enrolled2024
Full record →Abstract, authors, funding and every citing paper · PMID 28476288