Papers/PMID:35751625
Modified-release nicotinamide for the treatment of hyperphosphataemia in haemodialysis patients: 52-week efficacy and safety results of the phase 3 randomized controlled NOPHOS trial.
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2023The record
4 findings · 1 compound · 4 endpoints · 1 null
What it reported
How to read these marksWhat moved
3 findings
nicotinamide — increases HDL cholesterol
ModerateEvidence strength: moderate. Human evidence with one recorded weakness, or capped at moderate by its design or by unread numbers.Finding“Mean HDL concentrations increased in the NAMR group, resulting in significant differences between the treatment groups at weeks 12, 24 and 52.”
Quoted verbatim from Modified-release nicotinamide for the treatment of hyperphosphataemia in haemodialysis patients: 52-week efficacy and safety results of the phase 3 randomized controlled NOPHOS trial.. - Study
- RCT
- Duration
- 12 months
- Dose
- modified-release nicotinamide 250-1500 mg/day (one to six 250 mg capsules once daily before bed)
- Population
- Adults on maintenance haemodialysis with hyperphosphataemia, modified-release nicotinamide versus placebo, both arms on their individual phosphate binders
Modified-release nicotinamide for the treatment of hyperphosphataemia in haemodialysis patients: 52-week efficacy and safety results of the phase 3 randomized controlled NOPHOS trial.2023PMID:35751625Industry fundedPermalink
nicotinamide — decreases triglycerides
ModerateEvidence strength: moderate. Human evidence with one recorded weakness, or capped at moderate by its design or by unread numbers.Finding“Mean triglyceride concentrations decreased over time in both treatment groups, although the decrease was more pronounced in the NAMR group, with significant differences between the treatment groups at weeks 12, 24 and 52.”
Quoted verbatim from Modified-release nicotinamide for the treatment of hyperphosphataemia in haemodialysis patients: 52-week efficacy and safety results of the phase 3 randomized controlled NOPHOS trial.. - Study
- RCT
- Duration
- 12 months
- Dose
- modified-release nicotinamide 250-1500 mg/day (one to six 250 mg capsules once daily before bed)
- Population
- Adults on maintenance haemodialysis with hyperphosphataemia, modified-release nicotinamide versus placebo, both arms on their individual phosphate binders
Modified-release nicotinamide for the treatment of hyperphosphataemia in haemodialysis patients: 52-week efficacy and safety results of the phase 3 randomized controlled NOPHOS trial.2023PMID:35751625Industry fundedPermalink
nicotinamide — increases withdrawal due to adverse events
ModerateEvidence strength: moderate. Human evidence with one recorded weakness, or capped at moderate by its design or by unread numbers.Finding“The percentage of patients who permanently discontinued the intake of study medication due to AEs was significantly higher in the NAMR group compared with the placebo group [NAMR: 21.5% (n = 116) versus placebo: 11.5% (n = 21), P =.003].”
Quoted verbatim from Modified-release nicotinamide for the treatment of hyperphosphataemia in haemodialysis patients: 52-week efficacy and safety results of the phase 3 randomized controlled NOPHOS trial.. - Study
- RCT
- Duration
- 12 months
- Dose
- modified-release nicotinamide 250-1500 mg/day (one to six 250 mg capsules once daily before bed)
- Population
- Safety population of adults on maintenance haemodialysis with hyperphosphataemia, modified-release nicotinamide versus placebo, both arms on their individual phosphate binders
Modified-release nicotinamide for the treatment of hyperphosphataemia in haemodialysis patients: 52-week efficacy and safety results of the phase 3 randomized controlled NOPHOS trial.2023PMID:35751625Industry fundedPermalink
What did not
1 finding
nicotinamide — no detected effect on all-cause mortality
ModerateEvidence strength: moderate. Human evidence with one recorded weakness, or capped at moderate by its design or by unread numbers.FindingNull result“All-cause mortality was comparable between the treatment groups [NAMR: 5.9% (n = 32) versus placebo: 6.0% (n = 11), P = 1.00].”
Quoted verbatim from Modified-release nicotinamide for the treatment of hyperphosphataemia in haemodialysis patients: 52-week efficacy and safety results of the phase 3 randomized controlled NOPHOS trial.. - Study
- RCT
- Duration
- 12 months
- Dose
- modified-release nicotinamide 250-1500 mg/day (one to six 250 mg capsules once daily before bed)
- Population
- Safety population of adults on maintenance haemodialysis with hyperphosphataemia, modified-release nicotinamide versus placebo, both arms on their individual phosphate binders
Modified-release nicotinamide for the treatment of hyperphosphataemia in haemodialysis patients: 52-week efficacy and safety results of the phase 3 randomized controlled NOPHOS trial.2023PMID:35751625Industry fundedPermalink