Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2003 Aug;89(8):887-92.
doi: 10.1136/heart.89.8.887.

Long term effects of nisoldipine on the progression of coronary atherosclerosis and the occurrence of clinical events: the NICOLE study

J A Dens  1 , W J Desmet, P Coussement, I K De Scheerder, K Kostopoulos, P Kerdsinchai, C Supanantaroek, J H Piessens
Affiliations
Clinical Trial

Long term effects of nisoldipine on the progression of coronary atherosclerosis and the occurrence of clinical events: the NICOLE study

J A Dens et al. Heart. 2003 Aug.

Abstract

Background: Earlier angiographic studies have suggested that calcium antagonists may prevent the formation of new coronary lesions and the progression of minimal lesions. Conversely, a meta-analysis suggested that these drugs may increase cardiovascular mortality and morbidity in patients with coronary heart disease.

Objective: To investigate whether nisoldipine retards the progression of coronary atherosclerosis or reduces the occurrence of clinical events.

Design and setting: The NICOLE study (NIsoldipine in COronary artery disease in LEuven) is a single centre, randomised, double blind, placebo controlled trial with coronary angiography at baseline, six months, and three years of follow up.

Patients: 826 patients who had undergone successful coronary angioplasty were randomised to nisoldipine 40 mg once daily or placebo. The intention to treat and per protocol population consisted of 819 and 578 patients, respectively.

Results: In the per protocol population, 625 of the nisoldipine treated and 655 of the placebo treated patients (NS) showed angiographic progression in at least one coronary arterial segment, defined as an increase in diameter stenosis of > or = 13%. The average minimum luminal diameter of the non-dilated lesions decreased by 0.163 mm and 0.167 mm in the nisoldipine and placebo groups, respectively (NS). The respective numbers of new lesions detected were 7 and 13 (NS). In the intention to treat population, the rates of death, stroke, and acute myocardial infarction were similar in both treatment groups. However, nisoldipine use was associated with fewer revascularisation procedures and thus the percentage of patients with any clinical event was lower (44.6% v 52.6%, p = 0.02).

Conclusions: Nisoldipine has no demonstrable effect on the angiographic progression of coronary atherosclerosis or the risk of major cardiovascular events but its use is associated with fewer revascularisation procedures.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Patient flow chart. Differences between the treatment groups are not significant.
See this image and copyright information in PMC

References

    1. Lüscher T, Wenzel R, Moreau P, et al. Vascular protective effects of ACE inhibitors and calcium antagonists: theoretical basis for a combination therapy in hypertension and other cardiovascular diseases. Cardiovasc Drugs Ther 1995;9:509–23. - PubMed
    1. Henry PD, Bentley KI. Suppression of atherogenesis in cholesterol-fed rabbits treated with nifedipine. J Clin Invest 1981;68:1366–9. - PMC - PubMed
    1. Willis AL, Nagel B, Churchill V, et al. Antiatherosclerotic effects of nicardipine and nifedipine in cholesterol-fed rabbits. Atherosclerosis 1985;5:250–5. - PubMed
    1. Lichtlen P, Hugenholtz P, Rafflenbeul W, et al, on behalf of the INTACT Group Investigators. Retardation of angiographic progression of coronary artery disease by nifedipine. Results of the international nifedipine trial on antiatherosclerotic therapy (INTACT). Lancet 1990;335:109–13. - PubMed
    1. Waters D, Lespérance J, Francetich M, et al. A controlled clinical trial to assess the effect of a calcium channel blocker on the progression of coronary arteriosclerosis. Circulation 1990;82:940–53. - PubMed

Publication types