Evidence map›Paper›PMID 32342284›Full record

Observational studyDrugs in R&D2020

Public Health Outcomes May Differ After Switching from Brand-Name to Generic Angiotensin II Receptor Blockers.

Jacinthe Leclerc, Claudia Blais, Louis Rochette, Denis Hamel, Line Guénette, Claudia Beaudoin, Paul Poirier

Open access · goldAbstract readObservational Study
In one paragraph

Observational study in Drugs in R&D, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 17% 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

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Observational
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 3 institutions in 1 country.

Jacinthe LeclercInstitut national de santé publique du Québec, Bureau d'information et d'études en santé des populations, Quebec, QC, Canada. Jacinthe.leclerc@uqtr.ca.
Claudia BlaisInstitut national de santé publique du Québec, Bureau d'information et d'études en santé des populations, Quebec, QC, Canada.
Louis RochetteInstitut national de santé publique du Québec, Bureau d'information et d'études en santé des populations, Quebec, QC, Canada.
Denis HamelInstitut national de santé publique du Québec, Bureau d'information et d'études en santé des populations, Quebec, QC, Canada.
Line GuénetteFaculté de Pharmacie, Université Laval, Quebec City, QC, Canada.
Claudia BeaudoinInstitut national de santé publique du Québec, Bureau d'information et d'études en santé des populations, Quebec, QC, Canada.
Paul PoirierFaculté de Pharmacie, Université Laval, Quebec City, QC, Canada.
Institut National de Santé Publique du Québec · CAInstitut Universitaire de Cardiologie et de Pneumologie de Québec · CAUniversité Laval · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIt is unclear whether generics are as safe as brand-name drugs in cardiology. For public health surveillance purposes, we evaluated if switching from the brand-name losartan, valsartan, or candesartan impacted the occurrence of the following outcomes: emergency room (ER) consultations, hospitalizations, or death. STUDY

designThis was a retrospective cohort study.

methodsThis study was conducted in the Quebec Integrated Chronic Disease Surveillance System, including healthcare administrative data of the population of Quebec, Canada. We included brand-name users of losartan, valsartan, or candesartan aged ≥ 66 years who had undergone ≥ 30 days of stable treatment on the brand-name drug prior to cohort entry (substitution time-distribution matching was used to prevent immortal time bias). Outcomes up to 1 year were compared between groups using multivariable Cox proportional hazards regression models (validity assumptions were verified).

resultsIn our cohorts (losartan, n =15,783; valsartan, n =16,907; candesartan, n =26,178), mean age was 76-78 years, 59-66% were female, 90-92% had hypertension, and 13-15% had heart failure. Validity assumptions were violated for losartan only. For patients switched to generic valsartan, the hazard ratio (95% confidence interval) was 1.07 (0.99-1.14) for ER consultation, 1.26 (1.14-1.39) for hospitalization, and 1.01 (0.61-1.67) for death. The corresponding rates for candesartan were 1.00 (0.95-1.05), 0.96 (0.89-1.03), and 0.57 (0.37-0.88), respectively.

conclusionsWe observed an increased risk of hospitalizations for patients switched to generic valsartan, and a decreased risk of death for patients switched to generic candesartan, compared with those who continued taking the brand-name drug. The differences between generic and brand-name drugs may lead to some differences in public health outcomes, but this safety signal must be further studied using other cohorts and settings.

Indexed as

AgedAngiotensin Receptor AntagonistsBenzimidazolesBiphenyl CompoundsCanadaCohort StudiesFemaleHumansHypertensionMalePublic HealthReceptors, AngiotensinRetrospective StudiesTetrazolesTreatment OutcomeValsartanAngiotensin Receptor AntagonistsBenzimidazolesBiphenyl CompoundscandesartanReceptors, AngiotensinTetrazolesValsartan

Identifiers

PMID32342284
PMCPMC7221012
OpenAlexW3020645024

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.