Evidence map›Paper›PMID 33757437›Full record

Trial reportBMC nephrology2021

A randomised controlled trial to examine the effects of cinacalcet on bone and cardiovascular parameters in haemodialysis patients with advanced secondary hyperparathyroidism.

Helen Eddington, Rajkumar Chinnadurai, Helen Alderson, Sara T Ibrahim, Constantina Chrysochou, Darren Green, Ibi Erekosima, Alastair Hutchison, Abdalla Bubtana, Janet Hegarty and 1 more

Open access · goldAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC nephrology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
2.1field-weighted citation impact, top 13% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 18 citations in OpenAlex.

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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

11 authors at 5 institutions in 2 countries.

Helen EddingtonRenal Department, University Hospitals of Birmingham NHS Trust, Birmingham, UK.
Rajkumar ChinnaduraiDepartment of Renal Medicine, Salford Royal NHS Foundation Trust, Salford, M6 8HD, UK. rajkumar.chinnadurai@srft.nhs.uk.ORCID 0000-0003-3973-6595
Helen AldersonDepartment of Renal Medicine, Salford Royal NHS Foundation Trust, Salford, M6 8HD, UK.
Sara T IbrahimDepartment of Internal Medicine and Nephrology, Faculty of Medicine, Alexandria University, Alexandria, Egypt.
Constantina ChrysochouDepartment of Renal Medicine, Salford Royal NHS Foundation Trust, Salford, M6 8HD, UK.
Darren GreenDepartment of Renal Medicine, Salford Royal NHS Foundation Trust, Salford, M6 8HD, UK.
Ibi ErekosimaDepartment of Renal Medicine, Salford Royal NHS Foundation Trust, Salford, M6 8HD, UK.
Alastair HutchisonDorset County Hospital Foundation Trust, Dorset, UK.
Abdalla BubtanaDepartment of Renal Medicine, Manchester University NHS Foundation Trust, Manchester, UK.
Janet HegartyDepartment of Renal Medicine, Salford Royal NHS Foundation Trust, Salford, M6 8HD, UK.
Philip A KalraDepartment of Renal Medicine, Salford Royal NHS Foundation Trust, Salford, M6 8HD, UK.
Salford Royal NHS Foundation Trust · GBAlexandria University · EGDorset County Hospital NHS Foundation Trust · GBManchester University NHS Foundation Trust · GBUniversity Hospitals Birmingham NHS Foundation Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSecondary hyperparathyroidism may lead to increased cardiovascular risk. The use of cinacalcet may improve bone and cardiovascular health with improved parathormone (PTH) and phosphate control.

methodsThis is an open-label prospective randomised controlled trial to compare progression of cardiovascular and chronic kidney disease mineral and bone disorder (CKD-MBD) parameters. Patients were randomised to receive cinacalcet alongside standard therapy or standard therapy alone. Thirty-six haemodialysis patients who had > 90 days on dialysis, iPTH > 300 pg/mL, calcium > 2.1 mmol/L and age 18-75 years were included. Following randomization, all 36 patients underwent an intensive 12-week period of bone disease management aiming for iPTH 150-300 pg/mL. The primary outcome was change in vascular calcification using CT agatston score. Secondary outcomes included pulse wave velocity (PWV), left ventricular mass index (LVMI), carotid intima-media thickness (CIMT), augmentation index (Aix) and bone measurements. The above measurements were obtained at baseline and 12 months.

resultsThere was no evidence of a group difference in the progression of calcification (median change (IQR) cinacalcet: 488 (0 to1539); standard therapy: 563 (50 to 1214)). In a post hoc analysis combining groups there was a mean (SD) phosphate reduction of 0.3 mmol/L (0.7) and median (IQR) iPTH reduction of 380 pg/mL (- 754, 120). Regression of LVMI and CIMT was seen (P = 0.03 and P = 0.001) and was significantly associated with change of phosphate on multi-factorial analyses.

conclusionsWith a policy of intense CKD-MBD parameter control, no significant benefit in bone and cardiovascular markers was seen with the addition of cinacalcet to standard therapy over one year. Tight control of hyperphosphataemia and secondary hyperparathyroidism may lead to a reduction in LVMI and CIMT but this needs further investigation. Although the sample size was small, meticulous trial supervision resulted in very few protocol deviations with therapy.

Indexed as

AdultCalcinosisCalcium-Regulating Hormones and AgentsCarotid Intima-Media ThicknessCinacalcetHeart VentriclesHumansHyperparathyroidism, SecondaryKidney Failure, ChronicMiddle AgedParathyroid HormonePhosphatesProspective StudiesRenal DialysisCalcium-Regulating Hormones and AgentsCinacalcetParathyroid HormonePhosphatesChronic kidney disease-mineral bone disorder (CKD-MBD)CinacalcetLeft ventricular mass index (LVMI)Parathormone (PTH)Secondary hyperparathyroidism

Identifiers

PMID33757437
PMCPMC7989372
OpenAlexW3137925695

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.