gms | German Medical Science

27. Wissenschaftlicher Kongress der Deutschen Hochdruckliga

Deutsche Liga zur Bekämpfung des hohen Blutdrucks – Deutsche Hypertonie Gesellschaft e. V.

26. bis 29.11.2003, Bonn

Fixed-dose combination (ramipril-felodipine ER) in the first line therapy of essential hypertension ("IndComb"-Study)

Fixkombination - Ramipril plus Felodipin ER - Indikation in der first-line Therapie der essentiellen Hypertonie ("Indkomb"-Studie)

Meeting Abstract (Hypertonie 2003)

  • presenting/speaker J. Scholze - Charité CCM (Berlin, D)
  • M. Bida - Charité CCM (Berlin, D)
  • D. Juncken - Charité CCM (Berlin, D)
  • A. Ritz - Charité CCM (Berlin, D)
  • Y. Dörffel - Charité CCM (Berlin, D)
  • A. Hansen - Charité CCM (Berlin, D)

Hypertonie 2003. 27. Wissenschaftlicher Kongress der Deutschen Hochdruckliga. Bonn, 26.-29.11.2003. Düsseldorf, Köln: German Medical Science; 2004. Doc03hochP11

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Veröffentlicht: 11. November 2004

© 2004 Scholze et al.
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The therapy of hypertension is characterized by an initial use of monotherapies, which are combined in the later course if necessary. Despite the availability of a large number of effective drugs, less than a quarter of hypertensive patients are normotensive worldwide. This poor situation leads to the question of a therapy-paradigm change, which was first official published in a statement at the JNC VII (2003).

To prove the hypothesis that fixed-dose combinations are not only more effective on long term but also safe in the first-line use, we conducted a randomised prospective multicenter pilot study, in which the fixed-dose combination of ramipril and felodipine ER was compared with the ramipril and felodipine monotherapy, in 150 patients with hypertension grad II-III. To identify symptomatic and asymptomatic hypotensive episodes we combined the 24-h-ambulatory-blood pressure monitoring (ABPM) on the first day of drug intake with a careful registration of all adverse events.

The acute effects on BP are listed in table 1 [Tab. 1]. There were no differences between the groups with regard to the number and intensity of the adverse effects. After 4 weeks of treatment the fixed-dose combination ram + fel lowered the systolic and diastolic blood pressure (office BP, daily profile of self-BP-measurement and ABPM) significantly more than the monotherapies. Furthermore the fixed-dose combination showed a trend for better tolerability.

The results support the primary use of the fixed-dose combination ramipril and felodipine in the arterial hypertension to improve the antihypertensive efficacy and tolerability, which should be re-evaluated in a further large double-blind study.