Treatment of isolated systolic hypertension: The SHELL study results

Ettore Malacco, Giuseppe Mancia, Alessandro Rappelli, Alessandro Menotti, M. Stefano Zuccaro, Alessandro Coppini, Augusto Achilli, Ettore Antoncecchi, Ferdinando Anzivino, Danilo Banda, Luisa Bartorelli, Antonio Bavazzano, Giorgio Bellodi, Livio Bernardini, Umberto Berrettini, Vanda Berti, Giuseppe Bianchini, Tiziano Biasion, Vincenzo Bisesti, Antonio BlasioFiorella Bonomolo, Gianpaolo Bragagni, Santi Branca, Vincenzo Brundo, Francesco Cabasino, Fernando Caione, Mariano Califano, Domenico Caruso, Angelo Antonio Caso, Pietro Cassani, Giuseppe Castiglioni, Antonio Catamo, Sannita Cesareo, Raffaele Chiarappa, Claudio Chiavinato, Michele Ciaburri, Fernando Cicerone, Donatina Cilla, Antonino Coglitore, Fabrizio Colombo, Domenico Compagnone, Pietro Corigliano, Paolo Corradini, Susanna Cozzio, Mario Cristofari, Edoardo Dal Monte, Carmine De Matteis, Michele Decembrino, Domenico Di Biasi, Pietro Di Fresco, Ernesta Dolce, Valter Donadon, Giovanni Farino, Roberto Fogari, Giuseppe Forestiero, Giuseppina Franzone, Gian Pietro Fusari, Giuseppe Galetti, Oriana Garognoli, Giuseppe Gaudio, Raffaele Giannella, Carlo Giorda, Stefano Giustiniani, Nicola Glorioso, Paolo Granata, Luigi Grezzana, Adriano Guala, Giuseppe Guizzardi, Biagio Ierardi, Vincenzo Indelicato, Pietro Infriccioli, Biagio Ingignoli, Ermanno Landmann, Giorgio Laurini, Giovanni Lecciso, Giuliano Lo Pinto, Antonio Lombardo, Vincenzo Lopez, Fabio Lunati, Valter Lutri, Cosimo Manca, Sandro Mancarella, Marcello Mancini, Tiziana Maniscalchi, Roberto Manopulo, Giovanni Mantini, Albert Marc, Paola Marchi, Fausto Marrocco, Michele Martorano, Luciano Marullo, Giovanni Marzara, Arturo Mastropasqua, Vincenzo Mazzeo, Maria Rachele Meroni, Loris Montanari, Paolo Moscato, Ernesto Mossuti, Carolina Nardelli

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: Our aim was to compare the effect of lacidipine and chlorthalidone on cardiovascular outcome as a primary parameter and blood pressure as a secondary in elderly patients with isolated systolic hypertension in a prospective study with an open design. Methods: 1882 males and females outpatients ≥60 years were randomly assigned to the administration of chlorthalidone 12.5 mg o.d. or lacidipine 4 mg o.d. Patients were recruited if sitting systolic blood pressure was ≥160 mmHg with a diastolic blood pressure equal or lower than 95 mmHg. Primary endpoint was a composite of cardiovascular and cerebrovascular events. Results: At randomization mean systolic blood pressure was 178.1 mmHg in the lacidipine and 178.2 mmHg in the chlorthalidone group, the corresponding mean diastolic values being 86.9 and 86.8 mmHg. In both lacidipine and chlorthalidone groups treatment caused a significant (p <0.001) and marked systolic blood pressure reduction which was maintained throughout the treatment period with a significant (p <0.001) and steady although less marked reduction in diastolic blood pressure as well. At the end of treatment period (median 32 months), the reduction was 36.8/8.1 mmHg (systolic/diastolic) in the chlorthalidone and 38.4/7.9 mmHg in the lacidipine group, the final on treatment blood pressures being 142.0/79.2 and 143.2/79.5 mmHg, respectively. Treatments were similarly effective in males and females and in age groups between 60 and 69 years (n = 763), 70 and 79 years (n = 744) and ≥80 years (n = 375). Similar reductions were obtained in a subgroup of patients (n = 209) followed in double-blind fashion for 1 year. The overall incidence of the primary endpoints was 9.3% with no significant between-group difference. Total mortality was also similar between groups. Conclusions: In elderly patients with isolated systolic hypertension, administration of lacidipine or chlorthalidone markedly reduced systolic blood pressure with no difference in the incidence of cardiovascular events and total mortality.

Original languageEnglish
Pages (from-to)160-167
Number of pages8
JournalBlood Pressure
Volume12
Issue number3
DOIs
Publication statusPublished - 2003

Keywords

  • Calcium channel blocker
  • Dihydropyridine
  • Diuretic
  • Hydrochlorothiazide
  • Isolated systolic hypertension
  • Mortality

ASJC Scopus subject areas

  • Internal Medicine
  • Cardiology and Cardiovascular Medicine

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