Evidence map›Paper›PMID 8309029›Full record

Trial reportJAMA1994

A comparison of the efficacy and toxic effects of sustained- vs immediate-release niacin in hypercholesterolemic patients.

J M McKenney, J D Proctor, S Harris, V M Chinchili

Registry-linked trialAbstract readClinical TrialComparative StudyRandomized Controlled Trial
PubMed
In one paragraph

Trial report in JAMA, 1994. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00046267. Cited by 47 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 3 pooled it
15.1field-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.

NCT00046267 nacompleted

A Pilot Study of the Safety, Efficacy, and Tolerability of Extended-Release Niacin (Niaspan) for the Treatment of Elevated Non-HDL Cholesterol and Elevated Triglycerides in HIV-Infected Subjects

Enrolled30Registered outcomes0Posted comparisons0ConditionsDiabetes Mellitus, HIV Infections, Hypercholesterolemia, HypertriglyceridemiaArmsniacin
PMID 10708054PMID 11073755PMID 11118392PMID 9761083other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 3 syntheses or guidelines pooled it, 301 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Review
  8. Article
  9. Very low HDL levels: clinical assessment and management.Archives of endocrinology and metabolism · 2023
    Review
  10. Article
  11. Review
  12. Review
  13. Article
  14. Role of endothelial NADAmerican journal of physiology. Heart and circulatory physiology · 2019
    Review
  15. Article
  16. Article
  17. Ocular Effects of Niacin: A Review of the Literature.Medical hypothesis, discovery & innovation ophthalmology journal · 2015
    Review
  18. Article
  19. HDL-targeted therapies: progress, failures and future.Nature reviews. Drug discovery · 2014
    Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors at 1 institution in 1 country.

J M McKenneySchool of Pharmacy, Medical College of Virginia, Virginia Commonwealth University, Richmond 23298.
J D Proctor
S Harris
V M Chinchili
Virginia Commonwealth University Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo compare escalating doses of immediate-release (IR) and sustained-release (SR) niacin for effectiveness in reducing levels of low-density lipoprotein cholesterol and triglycerides and increasing levels of high-density lipoprotein cholesterol, and for the occurrence of adverse reactions, especially hepatotoxicity.

designRandomized, double-blind, parallel comparison of IR and SR niacin administered sequentially at 500, 1000, 1500, 2000, and 3000 mg/d, each for 6 weeks.

settingCholesterol research center. PATIENTS: Forty-six adults, 23 in each group, with low-density lipoprotein cholesterol levels greater than 4.14 mmol/L (160 mg/dL) after 1 month of a step 1 National Cholesterol Education Program diet. OUTCOME MEASURES: Fourteen-hour fasting lipid and lipoprotein cholesterol levels, results of clinical laboratory tests, a symptom questionnaire, and withdrawal rates.

resultsThe SR niacin lowered low-density lipoprotein cholesterol levels significantly more than IR niacin did at the dosage of 1500 mg/d and above, while IR niacin increased high-density lipoprotein cholesterol levels significantly more than SR niacin did at all dosage levels. The reduction in triglyceride levels was similar with IR and SR niacin. Nine (39%) of the 23 patients assigned to the IR dosage form withdrew before completing the 3000-mg daily dose; the most common reasons for withdrawal were vasodilatory symptoms, fatigue, and acanthosis nigricans. Eighteen (78%) of the 23 patients assigned to the SR dosage form withdrew before completing the 3000-mg daily dose; the most common reasons for withdrawal were gastrointestinal tract symptoms, fatigue, and increases in levels of liver aminotransferases, often with symptoms of hepatic dysfunction. None of the patients taking IR niacin developed hepatotoxic effects, while 12 (52%) of the 23 patients taking SR niacin did.

conclusionThe SR form of niacin is hepatotoxic and should be restricted from use. The IR niacin is preferred for the management of hypercholesterolemia but can also cause significant adverse effects and should be given only to patients who can be carefully monitored by experienced health professionals.

Indexed as

AdultCapsulesCholesterol, HDLCholesterol, LDLDelayed-Action PreparationsDouble-Blind MethodDrug Administration ScheduleFemaleHumansHypercholesterolemiaLipidsLiverMaleMiddle AgedNiacinStatistics as TopicCapsulesCholesterol, HDLCholesterol, LDLDelayed-Action PreparationsLipidsNiacinTriglycerides

Identifiers

PMID8309029
OpenAlexW1988179941

What OpenQuestion holds

Textmetadata
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.