Review of nifedipine GITS in the treatment of high risk patients with coronary artery disease and hypertension

Figures & data

Table 1 Clinical studies utilizing nifedipine

Reference	n	Patients	Treatment (mg)	Mean duration (years)	Primary endpoint	Outcome
Gong et al^Citation29 (STONE)	1632	60–79 y/o with SBP ≥ 160 or DBP ≥ 96	nif 10–30 bida vs placebo	2.5	Combined CV events (stroke, HF, MI, severe arrhythmia, and sudden death)	62% risk reduction in combined CV events; (p = 0.0001)
Yui et al^Citation31 (JMIC-B)	1650	≤75 y/o with HTN and CAD	nif 10–20 bidb,c vs enal 5–10 daily or imid 5–10 daily or lis 10–20 daily	3	Overall incidence of cardiac events (cardiac death/sudden death, MI, hospitalization for angina pectoris or HF, serious arrhythmia, and coronary interventions	No significant difference between nif and ACE-I groups; p = 0.75
Brown et al^Citation39 (INSIGHT)	6321	55–80 y/o with HTN and 1 additional risk factord	nif 30–60 dailye vs co-amil 25–50/2.5–5 daily	4	CV death, MI, heart failure, and death	No significant difference between nif and co-amil group; p = 0.35
Poole-Wilson et al^Citation41 (ACTION)	3825	≥35 y/o with stable angina pectoris for ≥1 month and CAD	nif 30–60 daily vs placebo	5	CV event-free survival defined as death from any cause, acute MI, refractory angina, new overt heart failure, debilitating stroke, and peripheral revascularization	No significant difference between nif and placebo; p = 0.54

^a Additional therapy (if needed) included captopril 20 to 50 mg/day and/or dihydrochlorothiazide 25 mg/day to get BP to goal (<160/90).

^b Additional therapy (if needed) included doxazosin, bunazosin or prazosin to get BP to goal (<150/90).

^c Additional therapy (if needed) included long-acting or short-acting nitrates and/or beta-blockers if angina persisted on monotherapy.

^d Risk factors included hyperlipidemia, smoker, family history of MI in parent or sibling <50 y/o, left ventricular hypertrophy, coronary heart disease, left ventricular strain, peripheral vascular disease, or proteinuria.

^e Additional therapy (if needed) included atenolol 25 mg daily or enalapril 5 mg daily to get BP to goal (<140/90).

Abbreviations: nif, nifedipine; enal, enalapril; imid, imidapril; lis, lisinopril; co-amil, co-amilozide (hydrochlorothiazide/amiloride); CV, cardiovascular; HF, heart failure; MI, myocardial infarction; HTN, hypertension; CAD, coronary artery disease; ACE-I, angiotensin converting enzyme inhibitor, bid, twice daily; y/o, years of age.

GongLZhangWZhuYShanghai Trial of Nifedipine in the Elderly (STONE)J Hypertens19961410123712458906524

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YuiYSumiyoshiTKodamaKComparison of nifedipine retard with angiotensin converting enzyme inhibitors in Japanese hypertensive patients with coronary artery disease: the Japan multicenter investigation for cardiovascular diseases-B (JMIC-B) randomized trialHypertens Res200427318119115080377

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BrownMJPalmerCRCastaigneAMorbidity and mortality in patients randomized to double-blind treatment with long-acting calcium-channel blocker or diuretic in the international nifedipine GITS Study: intervention as a goal in hypertension treatment (INSIGHT)Lancet200035636637210972368

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Poole-WilsonPALubsenJKirwanBAEffect of long-acting nifedipine on mortality and cardiovascular morbidity in patients with stable angina requiring treatment (ACTION trial): randomized controlled trialLancet200436484985715351192

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