Evidence map›Paper›PMID 26675485›Full record

ArticleJournal of clinical and diagnostic research : JCDR2015

Pattern of Adverse Drug Reactions Reported with Cardiovascular Drugs in a Tertiary Care Teaching Hospital.

Muthiah Palaniappan, Sandhiya Selvarajan, Melvin George, Ganesan Subramaniyan, Steven Aibor Dkhar, Ajith Ananthakrishna Pillai, Balachander Jayaraman, Adithan Chandrasekaran

Open access · goldAbstract read
In one paragraph

Article in Journal of clinical and diagnostic research : JCDR, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.9field-weighted citation impact, top 16% 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

10 citing papers in PubMed, 25 citations in OpenAlex.

  1. Review
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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

8 authors at 1 institution in 1 country.

Muthiah PalaniappanSafety Reviewer, Accenture , Chennai, India .
Sandhiya SelvarajanAssistant Professor, Department of Clinical Pharmacology, JIPMER , Puducherry, India .
Melvin GeorgeAssistant Professor, Cardiac Clinical Trials, Department of Cardiology, SRM Medical College Hospital & Research Centre , Kattankulathur, Chennai, India .
Ganesan SubramaniyanPhD Scholar, Department of Pharmacology, JIPMER , Puducherry, India .
Steven Aibor DkharProfessor, Department of Pharmacology, JIPMER , Puducherry, India .
Ajith Ananthakrishna PillaiAssociate Professor, Department of Cardiology, JIPMER , Puducherry, India .
Balachander JayaramanSenior Professor, Department of Cardiology, JIPMER , Puducherry, India .
Adithan ChandrasekaranSenior Professor & Head, Department of Clinical Pharmacology, JIPMER , Puducherry, India .
Accenture (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCardiovascular diseases (CVD) are one of the leading causes of non-communicable disease related deaths globally. Patients with cardiovascular diseases are often prescribed multiple drugs and have higher risk for developing more adverse drug reactions due to polypharmacy.

aimTo evaluate the pattern of adverse drug reactions reported with cardiovascular drugs in an adverse drug reaction monitoring centre (AMC) of a tertiary care hospital. SETTINGS AND

designAdverse drug reactions related to cardiovascular drugs reported to an AMC of a tertiary care hospital were included in this prospective observational study. MATERIALS AND

methodsAll cardiovascular drugs related adverse drug reactions (ADRs) received in AMC through spontaneous reporting system and active surveillance method from January 2011 to March 2013 were analysed for demographic profile, ADR pattern, severity and causality assessment. STATISTICAL ANALYSIS USED: The study used descriptive statistics and the values were expressed in numbers and percentages.

resultsDuring the study period, a total of 463 ADRs were reported from 397 patients which included 319 males (80.4%) and 78 females (19.6%). The cardiovascular drug related reports constituted 18.1% of the total 2188 ADR reports. In this study, the most common ADRs observed were cough (17.3%), gastritis (7.5%) and fatigue (6.5%). Assessment of ADRs using WHO-causality scale revealed that 62% of ADRs were possible, 28.2% certain and 6.8% probable. As per Naranjo's scale most of the reports were possible (68.8%) followed by probable (29.7%). According to Hartwig severity scale majority of the reports were mild (95%) followed by moderate (4.5%). A system wise classification of ADRs showed that gastrointestinal system (20.7%) related reactions were the most frequently observed adverse reactions followed by respiratory system (18.4%) related adverse effects. From the reported ADRs, the drugs most commonly associated with ADRs were found to be enalapril (17.5%), atorvastatin (14.9%), aspirin (8.4%) and metoprolol (8.4%).

conclusionThe cardiovascular drug related adverse effects constituted 18.1% of the total ADRs reported during the study period. Cough, gastritis, fatigue and myalgia by enalapril, aspirin, β-blockers and atorvastatin respectively were found to be the most commonly reported ADRs among the cardiovascular drugs.

Indexed as

Active surveillanceCausalitySpontaneous reporting

Identifiers

PMID26675485
PMCPMC4668425
OpenAlexW2418509016

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Registered trials

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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.