Trial reportHeart (British Cardiac Society)2003
Long term effects of nisoldipine on the progression of coronary atherosclerosis and the occurrence of clinical events: the NICOLE study.
Trial report in Heart (British Cardiac Society), 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed, 5 syntheses or guidelines pooled it, 46 citations in OpenAlex.
- Randomised controlled trials of antihypertensive therapy: does exclusion of orthostatic hypotension alter treatment effect? A systematic review and meta-analysis.Age and ageing · 2023Pooled it
- Association between antihypertensive treatment and adverse events: systematic review and meta-analysis.BMJ (Clinical research ed.) · 2021Pooled it
- Pharmacotherapy for hypertension in adults 60 years or older.The Cochrane database of systematic reviews · 2019Pooled it
- First-line drugs for hypertension.The Cochrane database of systematic reviews · 2018Pooled it
- The role of calcium antagonists in stroke prevention.Journal of clinical hypertension (Greenwich, Conn.) · 2005Pooled it
- Examining the therapeutic potential and side effects of calcium channel blockers in mortality and morbidity of patients with stroke: A systematic review of pre-clinical and clinical studies.IBRO neuroscience reports · 2025Review
- Benefits and risks of antihypertensive medication in adults with different systolic blood pressure: A meta-analysis from the perspective of the number needed to treat.Frontiers in cardiovascular medicine · 2022Article
- Blood pressure targets for hypertension in patients with type 2 diabetes.Annals of translational medicine · 2018Article
- Review of nifedipine GITS in the treatment of high risk patients with coronary artery disease and hypertension.Vascular health and risk management · 2009Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEarlier 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.
objectiveTo investigate whether nisoldipine retards the progression of coronary atherosclerosis or reduces the occurrence of clinical events. DESIGN AND
settingThe 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.
resultsIn 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).
conclusionsNisoldipine 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.
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