Evidence map›Paper›PMID 27807083›Full record

ArticleBMJ open2016

Therapy discontinuation or substitution in patients with cardiovascular disease, switching among different products of the same off-patent active substance: a 'real-world' retrospective cohort study.

Luca Degli Esposti, Diego Sangiorgi, Stefano Buda, Ezio Degli Esposti, Francesco Scaglione

Open access · goldAbstract read
In one paragraph

Article in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
10.1field-weighted citation impact, top 2% 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

5 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Review
  3. Observational
  4. Improving Adherence to Treatment and Reducing Economic Costs of Hypertension: The Role of Olmesartan-Based Treatment.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2017
    Review
  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

5 authors at 1 institution in 1 country.

Luca Degli EspostiCliCon S.r.l. Health, Economics and Outcomes Research, Ravenna, Italy.
Diego SangiorgiCliCon S.r.l. Health, Economics and Outcomes Research, Ravenna, Italy.
Stefano BudaCliCon S.r.l. Health, Economics and Outcomes Research, Ravenna, Italy.
Ezio Degli EspostiCliCon S.r.l. Health, Economics and Outcomes Research, Ravenna, Italy.
Francesco ScaglioneDepartment of Medical Biotechnology and Translational Medicine, University of Milan, Milan, Italy.
University of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe present study investigated the effects of switching to different products of the same off-patent active substance (brand name or generic) on therapy discontinuation or substitution with another molecule of the same class, in patients with cardiovascular disease treated with statins and antihypertensives in a 'real-world' setting.

designA retrospective cohort study in a 'real-world' setting.

settingAnalysis of data performed by integrating administrative databases that included approximately two million individuals who are assisted by the National Health System from three Local Health Units located in three different regions of Italy.

participantsAll patients aged ≥18 years with at least one prescription of simvastatin, ramipril or amlodipine in the period 1 January to 31 December 2010 were included and followed up for 2 years.

main outcome measuresPrescription refills occurring during follow-up were evaluated. Frequency of discontinuation of therapy or substitution with another molecule of the same class (eg, from simvastatin to a different statin) during follow-up was identified.

resultsDuring follow-up, therapy discontinuation or substitution was found to be more frequent in patients switching to a different product of the same active substance compared with non-switching patients (11.5% vs 10.8% and 22.2% vs 20.8% (p=0.002), respectively, in the simvastatin group; 4.0% vs 3.5% and 24.6% vs 22.7% (p<0.001), respectively, in the amlodipine group). In the ramipril group, 8% of patients undertook a therapy substitution to another molecule; no trend towards a lower percentage of substitution was observed in the non-switching group, while 18% of patients discontinued treatment, with a significant difference in favour of patients not switching. These findings were partially confirmed by multivariate analysis.

conclusionsSwitches among products of the same active substance are quite common in patients with cardiovascular disease. Our study suggests that switching may expose patients to a higher risk of therapy discontinuation or substitution.

Indexed as

Drug MonitoringAgedAmlodipineAntihypertensive AgentsCardiovascular DiseasesDatabases, FactualDrugs, GenericDrug SubstitutionFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsItalyMaleMiddle AgedMultivariate AnalysisRamiprilAmlodipineAntihypertensive AgentsDrugs, GenericHydroxymethylglutaryl-CoA Reductase InhibitorsRamiprilSimvastatinAdherence to treatmentAmlodipineRamiprilSimvastatinSwitching

Identifiers

PMID27807083
PMCPMC5129038
OpenAlexW2546894557

What OpenQuestion holds

Texttitle and abstract
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.