Myo-inositol trial for retinopathy in preemies terminated early

  • Phelps DL & al.
  • JAMA
  • 23 Oct 2018

  • curated by Emily Willingham, PhD
  • Clinical Essentials
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Takeaway

  • A trial of myo-inositol to reduce type 1 retinopathy (ROP) risk in premature infants
  • Trial was initially halted because of glass particle contamination of a drug lot and was not restarted because of higher mortality in intervention group.

Why this matters

  • Some findings had suggested reduced risk for ROP, related complications in preterm infants.

Key results

  • In myo-inositol vs placebo group, respectively (95% CIs):
    • Death/ROP: 29% vs 21%;
      • adjusted risk difference (aRD), 7% (0%-13%);
      • adjusted relative risk (aRR), 1.41 (1.08-1.83; P=.01).
    • All-cause death: 18% vs 11%;
      • aRD, 6% (0%-11%);
      • aRR, 1.66 (1.14-2.43; P=.007).
  • Adverse events all were higher with myo-inositol vs placebo, e.g.:
    • Necrotizing entercolitis: 6% vs 4%.
    • Systemic infection: 16% vs 11%.
    • Respiratory distress: 15% vs 13%.
  • Trial suspended at 18 months for glass particle contamination in 1.9% of drug lot 2.
  • Trial then stopped entirely because of higher mortality in intervention group.

Study design

  • Randomized, placebo-controlled trial, 317 infants receiving myo-inositol, 321 receiving placebo.
  • Outcome: ROP or death was unfavorable outcome. 
  • Funding: NIH, National Eye Institute, others; Abbott Laboratories provided the drug.

Limitations

  • Terminated early.

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