Evidence map›Paper›PMID 19050195›Full record

SynthesisJAMA2008

Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis.

Aaron S Kesselheim, Alexander S Misono, Joy L Lee, Margaret R Stedman, M Alan Brookhart, Niteesh K Choudhry, William H Shrank

Registry-linked trialOpen access · bronzeAbstract readMeta-AnalysisSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in JAMA, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04988646 (Pharmacokinetic Properties of Acyclovir), which is not on this map. Cited by 138 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
138citing papers in PubMed, 10 pooled it
89.2field-weighted citation impact, top 1% 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.

NCT04988646 nacompletednot on this mapstarted 2020, after this paper: background citation

Pharmacokinetic Properties of Acyclovir

TypeinterventionalSponsorPT. Kimia Farma (Persero) TbkRan2020 to 2020Enrolled56ConditionsDrug UseArmsAcyclovir 200 MG, Acyclovir 400 MG, Zovirax 200 MG Tablet, Zovirax 400 MG Tablet
3 · Its place in the literature

Who cites it

138 citing papers in PubMed, 10 syntheses or guidelines pooled it, 427 citations in OpenAlex.

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  16. Article
  17. Efficacy and safety of branded vs generic lacosamide in epilepsy: a retrospective real-world study.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025
    Observational
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  20. Not so great expectations: The role of price and name information in the nocebo effect.Exploratory research in clinical and social pharmacy · 2025
    Article

78 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 1 institution in 1 country.

Aaron S KesselheimDivision of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02120, USA. akesselheim@partners.org
Alexander S Misono
Joy L Lee
Margaret R Stedman
M Alan Brookhart
Niteesh K Choudhry
William H Shrank
Harvard University · US

Funding

Hierarchical models of prescription drug use in the elderlyK25AG027400 · NIA · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BROOKHART, MAURICE ALAN · 2006 to 2010
$653k
An intervention to improve rational prescribing in cardiovascular diseaseK23HL090505 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI SHRANK, WILLIAM · 2007 to 2010
$650k
NHLBI NIH HHS K23 HL090505NHLBI NIH HHS K23HL090505-01NIA NIH HHS AG027400NIA NIH HHS K25 AG027400
6 · The paper itself

Abstract

contextUse of generic drugs, which are bioequivalent to brand-name drugs, can help contain prescription drug spending. However, there is concern among patients and physicians that brand-name drugs may be clinically superior to generic drugs.

objectivesTo summarize clinical evidence comparing generic and brand-name drugs used in cardiovascular disease and to assess the perspectives of editorialists on this issue. DATA SOURCES: Systematic searches of peer-reviewed publications in MEDLINE, EMBASE, and International Pharmaceutical Abstracts from January 1984 to August 2008. STUDY SELECTION: Studies compared generic and brand-name cardiovascular drugs using clinical efficacy and safety end points. We separately identified editorials addressing generic substitution. DATA EXTRACTION: We extracted variables related to the study design, setting, participants, clinical end points, and funding. Methodological quality of the trials was assessed by Jadad and Newcastle-Ottawa scores, and a meta-analysis was performed to determine an aggregate effect size. For editorials, we categorized authors' positions on generic substitution as negative, positive, or neutral.

resultsWe identified 47 articles covering 9 subclasses of cardiovascular medications, of which 38 (81%) were randomized controlled trials (RCTs). Clinical equivalence was noted in 7 of 7 RCTs (100%) of beta-blockers, 10 of 11 RCTs (91%) of diuretics, 5 of 7 RCTs (71%) of calcium channel blockers, 3 of 3 RCTs (100%) of antiplatelet agents, 2 of 2 RCTs (100%) of statins, 1 of 1 RCT (100%) of angiotensin-converting enzyme inhibitors, and 1 of 1 RCT (100%) of alpha-blockers. Among narrow therapeutic index drugs, clinical equivalence was reported in 1 of 1 RCT (100%) of class 1 antiarrhythmic agents and 5 of 5 RCTs (100%) of warfarin. Aggregate effect size (n = 837) was -0.03 (95% confidence interval, -0.15 to 0.08), indicating no evidence of superiority of brand-name to generic drugs. Among 43 editorials, 23 (53%) expressed a negative view of generic drug substitution.

conclusionsWhereas evidence does not support the notion that brand-name drugs used in cardiovascular disease are superior to generic drugs, a substantial number of editorials counsel against the interchangeability of generic drugs.

Indexed as

Cardiovascular AgentsDrugs, GenericHumansTherapeutic EquivalencyCardiovascular AgentsDrugs, Generic

Identifiers

PMID19050195
PMCPMC2713758
OpenAlexW1989247444

What OpenQuestion holds

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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.