Effects of phytosterols on pattern and effectiveness of statin use: Preliminary results of a post-marketing study

Simone Eussen, Menno Van Der Elst, Cathy Rompelberg, Johan Garssen, Henk Van Loveren, Marcel Bouvy, Marco Oosterveld, Anthonius De Boer, Johan De Gier, Olaf Klungel

Research output: Contribution to conferenceAbstractOther research output


Background: Functional foods enriched with phytosterols have cholesterol-lowering effects. However, interactions with drugs, eg statins, cannot be excluded. Phytosterols may influence the cholesterol-lowering properties of statins or intake behavior of statin-users. Objectives: To assess whether the use of phytosterols affects the effectiveness and pattern of statin use in a postmarketing setting. Methods: We used data from the Statin Intervention Program, a pharmacy care program to improve compliance in statin-users. We identified users and non-users of phytosterols by questionnaires filled in by the participants at baseline, and at 6 and 12 months. Cholesterol levels were measured at 3, 6 and 12 months. We used multivariate linear regression to estimate the effect of phytosterols on the effectiveness of statin use. Cox regression was conducted to estimate the hazard ratio of ceasing statin therapy in phytosterol users and non-users. Results: We included 478 new statin users. Compared to nonusers of phytosterols, users had significant higher HDL cholesterol levels at 3 months (median HDL 1.28mmol/L [range 1.06;1.70] vs 1.18 [0.93;1.54], p = 0.033). Phytosterol use was not associated with changes in total or LDL cholesterol, but HDL cholesterol (mean difference: -0.020 mmol/L per month [95%CI -0.034; -0.005]) and triglycerides (mean difference: -0.042mmol/L per month [95%CI -0.079;-0.005]) decreased significantly more in users compared to non-users. Use of phytosterols was not associated with non-persistence with statins (HRadj 0.87 [95%CI 0.47;1.60]). Conclusions: Although clinical trials showed additive total and LDL cholesterol-lowering effects when phytosterols were added to statins, these findings could not be reproduced under customary conditions. Phytosterol use is unlikely to affect the persistence to statin therapy.
Original languageEnglish
Number of pages2
Publication statusPublished - 1 Aug 2009


  • phytosterol
  • statin (protein)
  • hydroxymethylglutaryl coenzyme A reductase inhibitor
  • cholesterol
  • low density lipoprotein cholesterol
  • high density lipoprotein cholesterol
  • high density lipoprotein
  • low density lipoprotein
  • triacylglycerol
  • risk management
  • pharmacoepidemiology
  • marketing
  • therapy
  • clinical trial
  • questionnaire
  • linear regression analysis
  • functional food
  • pharmacy
  • proportional hazards model
  • hazard ratio


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