Evidence map›Paper›PMID 27479781›Full record

ReviewNephrology (Carlton, Vic.)2016

Lanthanum carbonate: safety data after 10 years.

Alastair J Hutchison, Rosamund J Wilson, Svetlana Garafola, John Brian Copley

Registry-linked trialOpen access · hybridAbstract readReview
In one paragraph

Review in Nephrology (Carlton, Vic.), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00567723 (A Phase-IV, Long-term, Observational Safety Study in End Stage Renal Disease Subjects Treated With Lanthanum Carbonate), which is not on this map. Cited by 30 papers.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed
5.7field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00567723 completednot on this map

A Phase-IV, Long-term, Observational Safety Study in End Stage Renal Disease Subjects Treated With Lanthanum Carbonate (Fosrenol)

TypeobservationalSponsorShireRan2006 to 2016Enrolled2,105ConditionsHyperphosphatemia
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 79 citations in OpenAlex.

  1. Trial
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  7. Review
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  17. Design and Rationale of HiLo: A Pragmatic, Randomized Trial of Phosphate Management for Patients Receiving Maintenance Hemodialysis.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2021
    Article
  18. Review
  19. Evidence of an intestinal phosphate transporter alternative to type IIb sodium-dependent phosphate transporter in rats with chronic kidney disease.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2021
    Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 4 institutions in 3 countries.

Alastair J HutchisonManchester Royal Infirmary and Academic Health Science Centre, Manchester, UK.
Rosamund J WilsonSpica Consultants, Marlborough, UK.
Svetlana GarafolaShire, Pharmacovigilance and Risk Management, Lexington, MA, USA.
John Brian CopleyShire, Lexington, MA, USA.
Cambridge Consultants (United Kingdom) · GBManchester Royal Infirmary · GBNetherlands Pharmacovigilance Centre Lareb · NLTakeda (United States) · US

Funding

Department of Health PB-PG-0711-25112
6 · The paper itself

Abstract

Despite 10 years of post-marketing safety monitoring of the phosphate binder lanthanum carbonate, concerns about aluminium-like accumulation and toxicity persist. Here, we present a concise overview of the safety profile of lanthanum carbonate and interim results from a 5-year observational database study (SPD405-404; ClinicalTrials.gov identifier: NCT00567723). The pharmacokinetic paradigms of lanthanum and aluminium are different in that lanthanum is minimally absorbed and eliminated via the hepatobiliary pathway, whereas aluminium shows appreciable absorption and is eliminated by the kidneys. Randomised prospective studies of paired bone biopsies revealed no evidence of accumulation or toxicity in patients treated with lanthanum carbonate. Patients treated with lanthanum carbonate for up to 6 years showed no clinically relevant changes in liver enzyme or bilirubin levels. Lanthanum does not cross the intact blood-brain barrier. The most common adverse effects are mild/moderate nausea, diarrhoea and flatulence. An interim Kaplan-Meier analysis of SPD405-404 data from the United States Renal Data System revealed that the median 5-year survival was 51.6 months (95% CI: 49.1, 54.2) in patients who received lanthanum carbonate (test group), 48.9 months (95% CI: 47.3, 50.5) in patients treated with other phosphate binders (concomitant therapy control group) and 40.3 months (95% CI: 38.9, 41.5) in patients before the availability of lanthanum carbonate (historical control group). Bone fracture rates were 5.9%, 6.7% and 6.4%, respectively. After more than 850 000 person-years of worldwide patient exposure, there is no evidence that lanthanum carbonate is associated with adverse safety outcomes in patients with end-stage renal disease.

Indexed as

AdultAgedAnimalsBiomarkersChelating AgentsClinical Trials, Phase IV as TopicDatabases, FactualFemaleHumansHyperphosphatemiaKaplan-Meier EstimateKidney Failure, ChronicLanthanumMaleMiddle AgedPatient SafetyBiomarkersChelating AgentsLanthanumlanthanum carbonatePhosphatesend-stage renal diseasehyperphosphatemialanthanum carbonatelong-term safetypharmacokineticsphosphate binder

Identifiers

PMID27479781
PMCPMC5129531
OpenAlexW2504996048

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.