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The choice of a tocolytic for the treatment of preterm labor: a critical evaluation of nifedipine versus atosiban.
Lyndrup, J, Lamont, RF
Expert opinion on investigational drugs. 2007;(6):843-53
Abstract
Preterm birth is the major cause of neonatal mortality and morbidity in the developed world. The perfect tocolytic that is uniformly effective with complete fetomaternal safety does not exist. Tocolytic agents differ in cost, utero-specificity, safety, efficacy and whether they are licensed for use. The main three agents that are used worldwide are beta-agonists, Ca(2+) channel blockers and vasopressin/oxytocin receptor antagonists. beta-Agonists are gradually being phased out of use and are being replaced by either nifedipine or atosiban. The evidence base for atosiban is strong but the evidence is of poor quality for nifedipine. The balance of evidence indicates that atosiban is as effective as nifedipine and more effective than beta-agonists and is significantly safer than both. Atosiban was developed specifically to treat preterm labor, so the cost is higher than nifedipine or ritodrine. However, the cost of a course of atosiban (approximately 200 pounds) should not only be considered in comparison with other tocolytic agents but to other medical budgets (e.g., oncology, fertility, cardiology and psychiatry) and to the huge healthcare costs associated with the morbidity and mortality caused by preterm birth. Atosiban is a new advance in the management of spontaneous preterm labor.
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2.
[STONE study and INSIGHT study: efficacy of nifedipine in the prevention of cardiovascular disease in hypertensive patients].
Matsuoka, H
Drugs. 2006;:13-5
Abstract
Treatment with antihypertensive drugs improves prognosis in patients with hypertension. The single-blind STONE (Shanghai Trial of Nifedipine in the Elderly) study conducted in elderly Chinese patients with hypertension proved that treatment with a Ca2+ channel antagonist led to improvement of prognosis. Compared with placebo, treatment with twice-daily nifedipine significantly decreased the relative risk of cardiovascular events, especially stroke. The randomised, double-blind INSIGHT (International Nifedipine GITS study: Intervention as a Goal in Hypertension Treatment) study compared nifedipine GITS with the diuretic combination of amiloride plus hydrochlorothiazide (co-amilozide) in hypertensive patients. The investigators found a similar cardiovascular event rate with nifedipine GITS and co-amilozide, but nifedipine prevented new-onset of diabetes and hyperlipidaemia. Besides, inhibition of carotid artery thickening and slowing of coronary artery calcification was also confirmed with nifedipine GITS in a side-arm study of the INSIGHT study. From these data it is evident that treatment with long-acting nifedipine improves prognosis in patients with hypertension.
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3.
[Medication of the month. Adalat Oros 60 mg].
Kulbertus, H
Revue medicale de Liege. 2004;(3):158-61
Abstract
The release of Adalat Oros 60 on the Belgian market was justified since it has been clearly demonstrated that the dosage of 60 mg significantly increases the proportion of responders to nifedipine monotherapy. This gives us the opportunity to briefly review the history of nifedipine and to describe the original and ingenious galenic controlled-release formulation known as Oros (Gastrointestinal Therapeutic System, or GITS in the anglo-saxon world). Cleary, nifedipine is a potent calcium antagonist the action of which is now smooth and devoid of the usual ups and downs observed with the regular capsules, even in their Retard form. These abrupt changes in plasma concentrations, with the subsequent variations in heart rate and blood pressure, were dangerous and bothersome. Oros allows plasma concentrations of nifedipine to plateau for at least 24 hours after oral administration. This reduces the incidence of side-effects which remain those classically attributable to calcium antagonists (i.e.: flushes, headaches); interestingly, they tend to appear early after treatment initiation which allows to easily ascribe them to the drug and to quickly assess tolerance. The INSIGHT trial compared the effects on nifedipine Oros to those of a classical diuretic combination (hydrochlorothiazide-amiloride) in 6321 hypertensives who had at least one additional risk factor for cardiovascular disease. The rate of the primary outcome (a composite of cardiovascular death, myocardial infarction, heart failure, stroke) was similar in the two treatment groups, but nifedipine was superior among the subgroup of diabetics. Substudies suggested that nifedipine slows the progression of atherosclerotic lesions (carotid and coronary arteries), preserves renal function, and prevents the development of new diabetes.
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4.
Role of calcium channel blockers in the future, in view of the INSIGHT Study.
Rosenthal, T
Kidney international. Supplement. 2002;(82):S32-5
Abstract
The data from The International Nifedipine Intervention as a Goal in Hypertension Treatment (INSIGHT) Study indicate that effectively reducing blood pressure can decrease the incidence of cardiovascular events in high risk patients with concomitant pathology, including diabetes and hypercholesterolemia, as well as in smokers and those with poor family history. Old and new antihypertensive drugs were similar in preventing cardiovascular mortality as major events. The glomerular filtration rate of patients on co-amilozide went down compared to those on nifedipine. Metabolic parameters, as expected, were not disturbed during treatment with calcium channel blockers, in contrast to the high-dose diuretic-treated population. Ankle edema induced by nifedipine was very disturbing. It can be concluded that overall calcium channel blockers are neither better nor worse than conventional therapy, allowing for possible small differences in stroke (advantage to calcium channel blockers) and myocardial infarction (advantage to diuretics). Thus, calcium channel blockers should be included in the future among the first choice drugs.
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5.
Long-term protection in at-risk hypertensive patients--a role for nifedipine GITS?
Ruilope, LM
Blood pressure. 2002;(2):106-9
Abstract
Hypertensive patients who are at high risk of developing cardiovascular (CV) complications have become the focus of modern treatment guidelines. The choice of antihypertensive therapies in these patients should be evidence-based: in particular, there should be evidence of a beneficial impact on CV events in addition to blood pressure-lowering effects. The International Nifedipine GITS study: Intervention as a Goal in Hypertension Treatment (INSIGHT) is the first, large, randomized, double-blind study undertaken exclusively in high-risk hypertensive patients, with CV events as a prospectively defined primary end-point. The choice of a diuretic (co-amilozide) as a comparator reflects the fact that this group of antihypertensive drugs has been shown to reduce CV events in high-risk hypertensive patients. Nifedipine, administered in a long-acting gastrointestinal-transport-system (GITS) formulation, and co amilozide were equally effective in preventing overall CV or cerebrovascular complications. This finding extended to the subgroup of patients with diabetes at baseline. Substudies to INSIGHT showed that, compared with coamilozide, nifedipine GITS was significantly more effective at preventing an increase in intima-media thickness in the carotid artery and significantly slowed the progression of coronary calcification. The results from INSIGHT support incorporating nifedipine GITS in the management of high-risk hypertensive patients to prevent atherosclerosis-related illness and death.
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6.
Analgesia issues in palliative care: bone pain, controlled release opioids, managing opioid-induced constipation and nifedipine as an analgesic.
Fine, PG
Journal of pain & palliative care pharmacotherapy. 2002;(1):93-7
Abstract
Some recent literature relevant to analgesia in palliative care is reviewed. Reports on clinical use of bisphosphonates for bone pain in cancer, controlled release opioids, selection of laxatives for opioid-induced constipation and the calcium channel blocker nifedipine as an analgesic are described.
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7.
Effects of calcium channel blockers on atherosclerosis: new insights.
Simon, A, Levenson, J
Acta cardiologica. 2002;(4):249-55
Abstract
Atherosclerotic disease is the most frequent cause of death in the western world. The key role of calcium ions in atherogenesis has created interest in the antiatherogenic potential of calcium channel blockers. Nifedipine, administered in a long-acting gastrointestinal transport system (GITS) formulation, was shown to have similar efficacy to the diuretic co-amilozide in the International Nifedipine GITS Study: Intervention as a Goal in Hypertension Treatment (INSIGHT). Two side-arm studies of INSIGHT suggest that nifedipine GITS has a greater antiatherosclerotic effect than diuretic therapy, which may signal additional cardiovascular protection in the long term. This paper reviews the evidence for the antiatherogenic properties of calcium channel blockers and discusses their clinical implication.
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8.
[Misleading advertisement of Adalat Oros].
Verheugt, FW
Nederlands tijdschrift voor geneeskunde. 2001;(36):1751-2
Abstract
Referring to the INSIGHT trial published in The Lancet, Bayer Netherlands states in an advertisement in Dutch medical journals that nifedipine reduces cardiovascular events by 50% in patients with hypertension and at least one additional risk factor. However, the agent studied in the INSIGHT trial did not reduce cardiovascular events in comparison to treatment with a diuretic. On the contrary, the incidence of myocardial infarction increased (fatal infarction even increased significantly), and the risk of stroke was not significantly reduced. Therefore the advertisement is misleading.