Evidence map›Paper›PMID 26951203›Full record

Observational studyClinical drug investigation2016

Safety Profile of Artemether-Lumefantrine: A Cohort Event Monitoring Study in Public Health Facilities in Tanzania.

Alambo K Mssusa, Adam M Fimbo, Alex F Nkayamba, Henry F Irunde, Hiiti B Sillo, Danstan H Shewiyo, Geraldine Hill, Omary M Minzi

Abstract readObservational Study
PubMed Publisher
In one paragraph

Observational study in Clinical drug investigation, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 28% 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. Review
  6. Article
  7. 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

8 authors at 3 institutions in 2 countries.

Alambo K MssusaDepartment of Clinical Trials Control and Pharmacovigilance, Tanzania Food and Drugs Authority, P.O. Box 77150, Dar Es Salaam, Tanzania. alambopharm@yahoo.com.
Adam M FimboDirectorate of Medicines and Complementary Products, Tanzania Food and Drugs Authority, P.O. Box 77150, Dar Es Salaam, Tanzania.
Alex F NkayambaDepartment of Clinical Trials Control and Pharmacovigilance, Tanzania Food and Drugs Authority, P.O. Box 77150, Dar Es Salaam, Tanzania.
Henry F IrundePharmaceutical Services Unit, Ministry of Health and Social Welfare, P.O. Box 9083, Dar Es Salaam, Tanzania.
Hiiti B SilloDirectorate of Medicines and Complementary Products, Tanzania Food and Drugs Authority, P.O. Box 77150, Dar Es Salaam, Tanzania.
Danstan H ShewiyoDirectorate of Laboratory Services, Tanzania Food and Drugs Authority, P.O. Box 77150, Dar Es Salaam, Tanzania.
Geraldine HillUppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Box 1051, 75140, Uppsala, Sweden.
Omary M MinziUnit of Pharmacology and Therapeutics, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P.O. Box 65013, Dar Es Salaam, Tanzania.
Ministry of Health and Social Welfare · TZMuhimbili University of Health and Allied Sciences · TZUppsala Monitoring Centre · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveArtemisinin combination therapies such as artemether-lumefantrine (AL) are effective for first-line treatment of uncomplicated acute Plasmodium falciparum malaria. However, the safety profile of AL in large populations has not been fully assessed. The objective of this study was to establish the safety of AL in public health facilities in Tanzania using the Cohort Event Monitoring (CEM) method. METHODOLOGY: Patients who presented to public health facilities in four regions of Tanzania who were prescribed AL were enrolled in a CEM study, a prospective, observational cohort study to establish a profile of adverse events (AEs) for the medicine when used in routine clinical practice. Pre- and post-treatment forms were used to record baseline information and new health events before and 7 days after treatment.

resultsA total of 8040 patients were enrolled in the study, of whom 6147 were included in the analysis. Following treatment initiation, a total of 530 AEs were reported in 6% (383) of the patients. The most frequent post-treatment AEs were in alimentary system (42%), including vomiting, nausea, diarrhoea, abdominal pain and anorexia, followed by AEs in the neurological system (25%). Causality assessment of the events showed that 51.9% (275/530) were possibly related to AL. There was a significant difference in the frequency of AEs by age-group with an increase in the number of AEs as age increased (P < 0.001). There was no statistically significant difference in the frequency of the events between males and females (P = 0.504). The AE profile was consistent with the AEs reported in the product information and in other studies; no new adverse drug reactions were identified. The majority of the reported AEs were the same as the symptoms of malaria and therefore indistinguishable from the underlying disease.

conclusionsThe safety profile of AL for treatment of malaria continues to be favourable. CEM as a pharmacovigilance tool has proven to provide reliable safety data in a short period.

Indexed as

AdolescentAdultAntimalarialsArtemether, Lumefantrine Drug CombinationArtemisininsChildChild, PreschoolCohort StudiesDrug CombinationsDrug MonitoringDrug-Related Side Effects and Adverse ReactionsEthanolaminesFemaleFluorenesHealth FacilitiesHumansAntimalarialsArtemether, Lumefantrine Drug CombinationArtemisininsDrug CombinationsEthanolaminesFluorenes

Identifiers

PMID26951203
OpenAlexW2298359671

What OpenQuestion holds

Textmetadata
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.