Evidence map›Paper›PMID 11403509›Full record

Trial reportClinical cardiology2001

Low-dose combination therapy with colesevelam hydrochloride and lovastatin effectively decreases low-density lipoprotein cholesterol in patients with primary hypercholesterolemia.

M H Davidson, P Toth, S Weiss, J McKenney, D Hunninghake, J Isaacsohn, J M Donovan, S K Burke

Open access · bronzeAbstract readClinical TrialRandomized Controlled Trial
In one paragraph

Trial report in Clinical cardiology, 2001. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
5.8field-weighted citation impact, top 4% 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

17 citing papers in PubMed, 102 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
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  5. Role of colesevelam in combination lipid-lowering therapy.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2013
    Review
  6. Review
  7. Review
  8. Article
  9. Overcoming obstacles in risk factor management in type 2 diabetes mellitus.Journal of clinical hypertension (Greenwich, Conn.) · 2011
    Review
  10. Article
  11. Review
  12. Review
  13. Article
  14. Statins and C-reactive protein levels.Journal of clinical hypertension (Greenwich, Conn.) · 2007
    Review
  15. Effective use of combination lipid therapy.Current atherosclerosis reports · 2006
    Article
  16. Effective use of combination lipid therapy.Current cardiology reports · 2005
    Review
  17. 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 6 institutions in 1 country.

M H DavidsonThe Chicago Center for Clinical Research, Chicago, Illinois, USA.
P Toth
S Weiss
J McKenney
D Hunninghake
J Isaacsohn
J M Donovan
S K Burke
Eloxx Pharmaceuticals (United States) · USCenter for Clinical Research (United States) · USLouisville Metabolic and Atherosclerosis Research Center · USMRIGlobal · USNational Clinical Research · USUniversity of Minnesota · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundColesevelam hydrochloride is a novel, lipid-lowering agent that binds bile acids with high affinity. A multicenter, randomized, double-blind, placebo-controlled, parallel-design study was conducted to assess the efficacy and tolerability of combination low-dose colesevelam and lovastatin treatment in patients with primary hypercholesterolemia. HYPOTHESIS: Combination therapy with low doses of colesevelam and lovastatin decreases low density (LDL) cholesterol with minimal adverse events.

methodsFollowing a 4- to 6-week dietary lead in, 135 patients were randomized into five groups for a 4-week treatment period: placebo, colesevelam 2.3 g at dinner, lovastatin 10 mg at dinner, the combination of colesevelam and lovastatin given at dinner (dosed together), and combination treatment with colesevelam given at dinner and lovastatin administered at bedtime (dosed apart).

resultsCombination colesevelam and lovastatin treatment decreased LDL cholesterol by 34% (60 mg/dl, p < 0.0001) and 32% (53 mg/dl, p < 0.0001) when colesevelam and lovastatin were dosed together or dosed apart, respectively. Both combination therapies were superior to either agent alone (p < 0.05). Decreases in LDL cholesterol exceeded the combined decreases observed for colesevelam alone (13 mg/dl, 7%) and lovastatin alone (39 mg/dl, 22%). Both combination treatments reduced total cholesterol by 21% (p < 0.0001) and apolipoprotein B by 24% (p < 0.0001). Neither combination treatment significantly altered high-density lipoprotein cholesterol or triglycerides. Adverse side effects were not significantly different among randomized groups.

conclusionsCombination colesevelam and lovastatin was efficacious and well tolerated, resulting in additive decreases in LDL cholesterol levels whether or not both agents were administered simultaneously.

Indexed as

AllylamineAnalysis of VarianceAnticholesteremic AgentsCholesterol, LDLColesevelam HydrochlorideDrug Administration ScheduleDrug Therapy, CombinationFemaleHumansHypercholesterolemiaLovastatinMaleMiddle AgedTreatment OutcomeAllylamineAnticholesteremic AgentsCholesterol, LDLColesevelam HydrochlorideLovastatin

Identifiers

PMID11403509
PMCPMC6655189
OpenAlexW2085737093

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.