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Statins, antihypertensive treatment, and blood pressure control in clinic and over 24 hours: evidence from PHYLLIS randomised double blind trial

BMJ 2010; 340 doi: https://doi.org/10.1136/bmj.c1197 (Published 26 March 2010) Cite this as: BMJ 2010;340:c1197
  1. Giuseppe Mancia, professor12,
  2. Gianfranco Parati, professor13,
  3. Miriam Revera, research assistant13,
  4. Grzegorz Bilo, research assistant13,
  5. Andrea Giuliano, research assistant3,
  6. Fabrizio Veglia, statistician4,
  7. Gaetano Crepaldi, professor5,
  8. Alberto Zanchetti, professor6, scientific director7
  1. 1Department of Clinical Medicine and Prevention, University of Milano-Bicocca, Milan, Italy
  2. 2Clinica Medica, Ospedale S. Gerardo, 20052 Monza, Italy
  3. 3Department of Cardiology, Istituto Auxologico Italiano, IRCCS, 20149 Milan
  4. 4Biostatistics Unit, Centro Cardiologico Monzino, IRCCS, 20138 Milan
  5. 5Clinica Medica I, University of Padova, 35128 Padova, Italy
  6. 6Centre of Clinical Physiology and Hypertension, University of Milan, Milan
  7. 7 Istituto Auxologico Italiano, IRCCS, 20145 Milan
  1. Correspondence to: G Mancia giuseppe.mancia{at}unimib.it
  • Accepted 17 November 2009

Abstract

Objective To investigate the possibility that statins reduce blood pressure as well as cholesterol concentrations through clinic and 24 hour ambulatory blood pressure monitoring.

Design Randomised placebo controlled double blind trial.

Setting 13 hospitals in Italy

Participants 508 patients with mild hypertension and hypercholesterolaemia, aged 45 to 70 years.

Intervention Participants were randomised to antihypertensive treatment (hydrochlorothiazide 25 mg once daily or fosinopril 20 mg once daily) with or without the addition of a statin (pravastatin 40 mg once daily).

Main outcome measures Clinic and ambulatory blood pressure measured every year throughout an average 2.6 year treatment period.

Results Both the group receiving antihypertensive treatment without pravastatin (n=254) (with little change in total cholesterol) and the group receiving antihypertensive treatment with pravastatin (n=253) (with marked and sustained reduction in total cholesterol and low density lipoprotein cholesterol) had a clear cut sustained reduction in clinic measured systolic and diastolic blood pressure as well as in 24 hour, and day and night, systolic and diastolic blood pressure. Pravastatin performed slightly worse than placebo, and between group differences did not exceed 1.9 (95% confidence interval −0.6 to 4.3, P=0.13) mm Hg throughout the treatment period. This was also the case when participants who remained on monotherapy with hydrochlorothiazide or fosinopril throughout the study were considered separately.

Conclusions Administration of a statin in hypertensive patients in whom blood pressure is effectively reduced by concomitant antihypertensive treatment does not have an additional blood pressure lowering effect.

Trial registration BRISQUI_*IV_2004_001 (registered at Osservatorio Nazionale sulla Sperimentazione Clinica dei Medicinali—National Monitoring Centre on Clinical Research with Medicines).

Footnotes

  • Contributors: GM was involved in study conception and design, study supervision, data interpretation, and drafting and revision of the paper. GP was involved in study design, data interpretation, and drafting and revision of the paper. MR, GB, and AG were involved in data interpretation and analysis and drafting and revision of the paper. FV was the study statistician and was involved in study design, data analysis, and revision of the paper. GC was involved in study conception and design and in revision of the paper. AZ was involved in study conception and design, study supervision, data interpretation, and drafting and revision of the paper. All authors approved the final version of the paper. GM is the guarantor.

  • Funding: PHYLLIS was an investigator generated trial sponsored by Bristol-Myers Squibb Italy, Rome, and Menarini, Florence. All authors carried out this research project in full independence from funders.

  • Competing interests: GC, GM, AZ, and GP have received research grants or honorariums for lectures from the sponsors. FV has received research grants from Menarini and Bristol-Myers Squibb Italy.

  • Ethical approval: The protocol of the study was approved by the ethics committees of the institutions involved.

  • Data sharing: No additional data available.

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