Evidence map›Paper›PMID 35696069›Full record

ArticleAdvances in therapy2022

Lower Risk of Cardiovascular Events in Adult Patients with Chronic Hypoparathyroidism Treated with rhPTH(1-84): A Retrospective Cohort Study.

Olulade Ayodele, Fan Mu, Richard Berman, Elyse Swallow, Lars Rejnmark, Elvira O Gosmanova, Sanjiv Kaul

3 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in Advances in therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 24% 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.

NCT00732615 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH[1-84]) for the Treatment of Adults With Hypoparathyroidism

TypeinterventionalSponsorShireRan2008 to 2011Enrolled124ConditionsHypoparathyroidismArmsPlacebo, NPSP558
NCT01268098 phase3completednot on this map

A Randomized, Dose-blinded Study to Investigate the Safety and Efficacy of NPSP558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)], at Fixed Doses of 25 µg and 50 µg for the Treatment of Adults With Hypoparathyroidism

TypeinterventionalSponsorShireRan2011 to 2011Enrolled42ConditionsHypoparathyroidismArmsNPSP558
NCT01297309 phase3completednot on this map

A Long-term Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH[1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study (RACE)

TypeinterventionalSponsorShireRan2011 to 2018Enrolled51ConditionsHypoparathyroidismArmsNPSP558
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. 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

7 authors at 5 institutions in 3 countries.

Olulade AyodeleTakeda Pharmaceuticals USA, Inc., 55 Hayden Ave, Lexington, MA, 02420, USA. Lade.ayodele@takeda.com.ORCID http://orcid.org/0000-0001-6084-5900
Fan MuAnalysis Group, Inc., Boston, MA, USA.
Richard BermanAnalysis Group, Inc., Boston, MA, USA.
Elyse SwallowAnalysis Group, Inc., Boston, MA, USA.
Lars RejnmarkAarhus University and Aarhus University Hospital, Aarhus, Denmark.
Elvira O GosmanovaAlbany Medical College, Albany, NY, USA.
Sanjiv KaulKnight Cardiovascular Institute, Oregon Health and Science University, Portland, OR, USA.
Analysis Group (United States) · USAarhus University Hospital · DKAlbany Medical Center Hospital · USOregon Health & Science University · USTakeda (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatients with chronic hypoparathyroidism are at increased risk of cardiovascular disease. This study evaluated the risk of developing cardiovascular conditions over a period of 5 years in adult patients with chronic hypoparathyroidism treated with recombinant human parathyroid hormone (1-84), rhPTH(1-84), compared with a historical control cohort of patients not treated with rhPTH(1-84).

methodsThis retrospective cohort study comprised patients with chronic hypoparathyroidism treated with rhPTH(1-84) in the REPLACE (NCT00732615), RELAY (NCT01268098), and RACE (NCT01297309) clinical trials, and controls selected from the IBM

resultsWe evaluated 113 adult patients with chronic hypoparathyroidism treated with rhPTH(1-84) and 618 control patients who did not receive rhPTH(1-84). Over the 5-year follow-up period, 3.5% of patients (n = 4) in the rhPTH(1-84) cohort had a cardiovascular event compared with 16.3% (n = 101) in the control cohort. Kaplan-Meier analysis demonstrated that patients in the rhPTH(1-84) cohort had lower risk of experiencing a cardiovascular event compared with patients in the control cohort (P = 0.005). Multivariable analyses adjusted for baseline variables showed that patients in the rhPTH(1-84) cohort had 75% lower risk for a cardiovascular event compared with patients in the control cohort (adjusted hazard ratio, 0.25 [95% CI 0.08-0.81]; P = 0.020).

conclusionLong-term treatment with rhPTH(1-84) was associated with a lower risk of incident cardiovascular conditions compared with conventional therapy in patients with chronic hypoparathyroidism. Previous studies demonstrated that mineral homeostasis was maintained with lower use of calcium and active vitamin D when rhPTH(1-84) was added to conventional therapy. Future studies are needed to understand whether improved regulation of mineral homeostasis conferred by rhPTH(1-84) may provide long-term cardiovascular benefits to patients with chronic hypoparathyroidism.

Indexed as

Cardiovascular DiseasesHypoparathyroidismAdultHumansParathyroid HormoneRecombinant ProteinsRetrospective StudiesParathyroid HormoneRecombinant ProteinsCardiovascular diseaseElectronic health recordsHypoparathyroidismParathyroid hormoneRetrospective cohort studyrhPTH(1–84)

Identifiers

PMID35696069
PMCPMC9309129
OpenAlexW4282572872

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.