Publications of the Week, March 18


High-dose iron in patients on hemodialysis

Macdougall IC, White C, Anker SD, et al; PIVOTAL Investigators and Committees. Intravenous Iron in Patients Undergoing Maintenance Hemodialysis. N Engl J Med. 2019 Jan 31;380(5):447-458. doi: 10.1056/NEJMoa1810742. Epub 2018 Oct 26. Erratum in: N Engl J Med. 2019 Jan 14;:. PubMed PMID: 30365356.

The use of higher doses of iron was beneficial in comparison with lower doses.

Iron replacement is part of standard care for patients with anemia undergoing hemodialysis, which is designed to prevent transfusions and reduce the cost of erythropoiesis-stimulating agents (ESAs).

This study compared 2 iron-replacement strategies. In one group, all patients received 400 mg of intravenous iron sucrose monthly unless their ferritin level was >700 microg/L or transferrin saturation was ≥40%. In the control group, patients were getting a monthly dose of iron sucrose necessary to maintain their ferritin level >200 microg/L and transferrin saturation >20%. The resulting median monthly dose of iron sucrose was 264 mg in the high-dose iron group versus 145 mg in the low-dose iron group. The median observation period was 2.1 years.

The median monthly dose of an ESA was about 8000 IU lower in the high-dose iron group. The main end point of composite of death, nonfatal myocardial infarction, nonfatal stroke, or heart failure hospital admission was lower in the high-dose group (29.3% vs 32.3%; hazard ratio [HR], 0.85; borderline statistical significance [95% CI, 0.73-1.00]; P = 0.04 for superiority). The rate of fatal or nonfatal myocardial infarction was also lower in that group (7.1% vs 9.7%; HR, 0.69; 95% CI, 0.52-0.93). Death from any cause occurred in 22.5% versus 25.7% of patients (HR, 0.84; borderline statistical significance [95% CI, 0.71-1.00]). There was no strong signal for harm among other examined outcomes.

Carpal tunnel syndrome: Steroid injections vs night splints

Chesterton LS, Blagojevic-Bucknall M, Burton C, et al. The clinical and cost-effectiveness of corticosteroid injection versus night splints for carpal tunnel syndrome (INSTINCTS trial): an open-label, parallel group, randomised controlled trial. Lancet. 2018 Oct 20;392(10156):1423-1433. doi: 10.1016/S0140-6736(18)31572-1. PubMed PMID: 30343858; PubMed Central PMCID: PMC6196880.

In patients with mild to moderate carpal tunnel syndrome, a single injection of 20 mg of methylprednisolone was superior to 6 weeks of night-time splints.

The study enrolled 234 patients who were randomized to glucocorticoid injections or night-time splint treatment. Patients who received the injections had greater early (within 6 weeks) improvement of symptoms and function (by about 0.3 points on a 5-point scale) as well as reduced pain intensity (by about 0.9 points on a 10-point scale). A total of 46% of patients reported discomfort after receiving an injection, out of whom the discomfort persisted for >3 days in 34%.

The authors interpret these results as a suggestion for glucocorticoid injections being the treatment of choice in patients with mild or moderate carpal tunnel syndrome.

UC remission after fecal microbiota transplantation

Costello SP, Hughes PA, Waters O, et al. Effect of Fecal Microbiota Transplantation on 8-Week Remission in Patients With Ulcerative Colitis: A Randomized Clinical Trial. JAMA. 2019 Jan 15;321(2):156-164. doi: 10.1001/jama.2018.20046. PubMed PMID: 30644982.

Anaerobically prepared fecal microbiota transplantation (FMT) resulted in ulcerative colitis (UC) remission.

In this study 73 patients were given either anaerobically prepared pooled donor FMT (n = 38) or autologous FMT (n = 35). The delivery was through colonoscopy (day 1) followed by 2 enemas over the subsequent 7 days.

Glucocorticoid-free remission was achieved in 12 out of the 38 patients (32%) receiving pooled donor FMT compared with 3 of the 35 (9%) patients receiving autologous FMT (absolute difference, 23%; 95% CI, 4%-42%).

A total of 5 of the 12 participants (42%) who achieved the primary end point at week 8 following pooled donor FMT maintained remission at 12 months.

The authors consider their findings preliminary.

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