Evidence map›Paper›PMID 25985907›Full record

Trial reportLipids in health and disease2015

Patient and physician factors influence decision-making in hypercholesterolemia: a questionnaire-based survey.

Michel Krempf, Ross J Simpson, Dena Rosen Ramey, Philippe Brudi, Hilde Giezek, Joanne E Tomassini, Raymond Lee, Michel Farnier

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Lipids in health and disease, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01154036 (A Randomized, Double-Blind, Active-Controlled, Multicenter Study of Patients With Primary Hypercholesterolemia and High Cardiovascular Risk Who Are Not Adequately Controlled With Atorvastatin 10 mg), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.7field-weighted citation impact, top 11% 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.

NCT01154036 phase3completednot on this map

A Randomized, Double-Blind, Active-Controlled, Multicenter Study of Patients With Primary Hypercholesterolemia and High Cardiovascular Risk Who Are Not Adequately Controlled With Atorvastatin 10 mg: A Comparison of the Efficacy and Safety of Switching to Coadministration Ezetimibe and Atorvastatin Versus Doubling the Dose of Atorvastatin or Switching to Rosuvastatin

TypeinterventionalSponsorOrganon and CoRan2010 to 2012Enrolled1,547ConditionsHypercholesterolemiaArmsezetimibe 10 mg, atorvastatin, Comparator: rosuvastatin
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 16 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Observational
  5. Physicians' perceptions and beliefs on the current dyslipidemia management practices within Saudi Arabia.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2023
    Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. 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 5 institutions in 3 countries.

Michel KrempfEndocrinology and Nutrition, Hôpital Laënnec, Nantes, 44035, France. michel.krempf@univ-nantes.fr.
Ross J SimpsonCenter for Heart and Vascular Care, University of North Carolina, Chapel Hill, NC, USA. ross_simpson@med.unc.edu.
Dena Rosen RameyMerck & Co, Inc., Kenilworth, NJ, USA. dena_ramey@merck.com.
Philippe BrudiMerck & Co, Inc., Kenilworth, NJ, USA. philippe_brudi@merck.com.
Hilde GiezekMSD Inc., Brussels, Belgium. hilde_giezek@merck.com.
Joanne E TomassiniMerck & Co, Inc., Kenilworth, NJ, USA. joanne_tomassini@merck.com.
Raymond LeeMerck & Co, Inc., Kenilworth, NJ, USA. raymond_lee2@merck.com.
Michel FarnierPoint Medical, 21000, Dijon, France. michelfarnier@nerim.net.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USCenter Point · USHôpital Laennec · FRMSD (Belgium) · BEUniversity of North Carolina at Chapel Hill · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGoal attainment of guideline-recommended low-density lipoprotein cholesterol (LDL-C) is suboptimal. Little is known about how patient factors influence physicians' treatment decision-making in hypercholesterolemia. We examined physicians' treatment recommendations in high-risk patients whose LDL-C remained uncontrolled despite statin monotherapy.

methodsPhysicians completed a questionnaire prior to randomization into period I of a two-period randomized controlled trial evaluating LDL-C goal attainment in patients whose LDL-C remained ≥100 mg/dL after 5 weeks' treatment with atorvastatin 10 mg/day (NCT01154036). Physicians' treatment recommendations were surveyed for two hypothetical and one real scenario: (1) LDL-C presumed near goal (between 100-105 mg/dL), (2) LDL-C presumed far from goal (~120 mg/dL), and (3) observed baseline LDL-C of enrolled patients. Prognostic factors considered during decision-making were identified by regression analysis. Observed lipid outcomes at the end of period I (following 6 weeks' treatment with ezetimibe 10 mg plus atorvastatin 10 mg, atorvastatin 20 mg, or rosuvastatin 10 mg) were compared with estimated LDL-C outcomes for physicians' treatment recommendations after 6 weeks (based on individual patients' pre-randomization LDL-C and expected incremental change).

resultsQuestionnaires were completed for 1,534 patients. No change in therapy, or double atorvastatin dose, were frequently recommended, even when LDL-C was far from goal (6.5% and 52.2% of patients, respectively). Double atorvastatin dose was commonly recommended in all scenarios (43-52% of patients). More intensive LDL-C-lowering regimens were recommended infrequently e.g. double atorvastatin dose and add ezetimibe only <12% in all scenarios. Overall, cardiovascular risk factors and desire to achieve a more aggressive LDL-C goal were prominent factors in decision-making for treatment. Comparison of observed and estimated LDL-C levels showed that physicians tended to overestimate the effectiveness of their recommendations.

conclusionsThis study provides insight into physicians' perspectives on clinical management of hypercholesterolemia and highlights a gap in knowledge translation from guidelines to clinical practice. The need for lower LDL-C and cardiovascular risk were key drivers in clinical decision-making, but physicians' treatment choices were more conservative than guideline recommendations, potentially resulting in poorer LDL-C reduction. When compared with actual outcomes, projected LDL-C control was better if physicians used more comprehensive strategies rather than simply doubling the statin dose.

trial registrationClinicaltrials.gov: NCT01154036.

Indexed as

AgedAnticholesteremic AgentsAtorvastatinCholesterol, LDLDrug Therapy, CombinationEzetimibeFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypercholesterolemiaMaleMiddle AgedPatient Care PlanningPractice Patterns, Physicians'Rosuvastatin CalciumSurveys and QuestionnairesAnticholesteremic AgentsAtorvastatinCholesterol, LDLEzetimibeHydroxymethylglutaryl-CoA Reductase InhibitorsRosuvastatin Calcium

Identifiers

PMID25985907
PMCPMC4457981
OpenAlexW1535043470

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.