Evidence map›Paper›PMID 28814835›Full record

Trial reportDrug design, development and therapy2017

Efficacy and tolerability of two different formulations of atorvastatin in Korean patients with hypercholesterolemia: a multicenter, prospective, randomized clinical trial.

Ju-Hee Lee, Sang-Hyun Kim, Dong-Ju Choi, Seung-Jea Tahk, Jung-Han Yoon, Si Wan Choi, Taek-Jong Hong, Hyo-Soo Kim

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Drug design, development and therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
0.2field-weighted citation impact, top 39% 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, 2 syntheses or guidelines pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Review
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 5 institutions in 3 countries.

Ju-Hee LeeDivision of Cardiology, Department of Internal Medicine, Chungbuk National University College of Medicine.
Sang-Hyun KimDivision of Cardiology, Department of Internal Medicine, Seoul National University College of Medicine.
Dong-Ju ChoiDivision of Cardiology, Department of Internal Medicine, Seoul National University College of Medicine.
Seung-Jea TahkDepartment of Cardiology, Ajou University Hospital, Suwon.
Jung-Han YoonDepartment of Cardiology, Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital, Wonju.
Si Wan ChoiDepartment of Cardiology, Chungnam National University Hospital, Daejeon.
Taek-Jong HongDepartment of Cardiology, Pusan National University Hospital, Pusan.
Hyo-Soo KimDivision of Cardiology, Department of Internal Medicine, Seoul National University College of Medicine.
New Generation University College · ETAjou University Hospital · KRChungnam National University Hospital · KRPusan National University Hospital · KRWonju Severance Christian Hospital · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis study was designed to compare the efficacy and tolerability of the generic formulation (Atorva

methodsThis study was a prospective open-label, randomized controlled study. Hypercholesterolemic patients who had not achieved low-density lipoprotein (LDL) cholesterol goals according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATP III) guideline were randomized to generic formulation or reference formulation of atorvastatin. The primary end point was the percent change of blood LDL cholesterol at 8 weeks from the baseline. The secondary end points included the percent changes of total cholesterol, high-density lipoprotein (HDL) cholesterol, triglyceride (TG), apolipoprotein B (ApoB), and apolipoprotein A1 (ApoA1) levels, the percent changes of ApoB/ApoA1 and total cholesterol/HDL cholesterol ratios, and the change in high-sensitivity C-reactive protein (hsCRP) levels. The LDL cholesterol goal achievement rate according to the NCEP-ATP III guideline was also evaluated.

resultsThree hundred and seventy-six patients were randomized, and 346 patients (176 in the generic group and 170 in the reference group) completed the study. After the 8 weeks of treatment, LDL cholesterol level was significantly decreased in both the groups, and the decrement was comparable between the two groups (-43.9%±15.3% in the generic group, -43.3%±17.0% in the reference group,

conclusionThe generic formulation of atorvastatin 20 mg was not inferior to the reference formulation of atorvastatin 20 mg in the management of hypercholesterolemia.

Indexed as

Drug CompoundingAtorvastatinDrug Administration ScheduleDrug ToleranceFemaleHumansHypercholesterolemiaMaleMiddle AgedMolecular ConformationProspective StudiesRepublic of KoreaAtorvastatinatorvastatinhypercholesterolemialow-density lipoprotein cholesterol

Identifiers

PMID28814835
PMCPMC5546732
OpenAlexW2740301569

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.