Nifedipine in the treatment of hypertension: report of a double-blind controlled trial (original) (raw)
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Long-term therapy with slow-release nifedipine in essential hypertension
Cardiovascular Drugs and Therapy, 1990
The purpose of this study, designed as an open multicenter trial, was to test the antihypertensive efficacy, patient acceptability, and side effects of long-term treatment with slow-release nifedipine in a large population. The drug was studied in 330 outpatients with essential hypertension, WHO stage 1-2, recruited in 20 hospital centers. After washout period was completed, nifedipine (20 mg bid) was given for 1 month (phase 1). Then, the treatment was extended for 4 months (phase 2) with variable doses (range 20-80 mg daily). No other antihypertensive drugs were administered during phase 1. However diuretics, beta blockers, or captopril were added to nifedipine during phase 2 in 11 patients. Seventy patients did not meet criteria for inclusion at washout. During phase 1 and 2, 66 additional patients were excluded due to side effects, the need of other antihypertensive drugs, or noncompliance. Systolic blood pressure significantly lowered (10% or more) in 84% patients in phase 1 and in 76% in phase 2. No responders were 6.1% and 3.6~, respectively. Diastolic blood pressure was normalized in 60% of patients after 5 months of therapy. Effects on blood pressue were equal in young patients and in the .elderly, but a minimal rise in heart rate was recorded in younger patients. At least one side effect occurred in 46.6c~ patients, mainly headache (15.4%), hot flashes (13.3%), ankle edema (12.8G), or palpitation (6.6%). Sixteen patients (8.2~) were obliged to stop nifedipine treatment due to the severity of the side effects. This trial confirms the efficacy of nifedipine in hypertension, both in young and in aged patients. The adherence of patients to the twice-daily regimen was very good, without the development of tolerance in long-term treatment. The drug does not affect the physiologic cardiovascular response to standing, but induces several relatively common, very seldom severe, adverse reactions.
The American Journal of Cardiology, 1991
ifedipine has been extensively and successfully used for the treatment of various hypertensive syndromes in doses of > 10 mgl; such doses have a harmful potential, at least in the elderly.1-8 As there are only scant reports about the use of smaller doses of nifedipine,9~10 we undertook this clinical study to test the effectiveness and safety of a single 5-mg dose of oral nifedipine in patients admitted to our Emergency Care Department with uncontrolled moderate to severe hypertension. Only patients with essential hypertension were treated if the diagnosis had been present for 2 1 year and, if previously normotensive under medical treatment, they had a gradual elevation of the diastolic blood pressure (BP) to values from 110 to 129 mm Hg. Excluded were patients with coexisting valvular heart disease or acute myocardial infarction, those who were pregnant or who were receiving calcium antagonists within the previous 12 hours, or those with hypertensive urgencies and emergencies. Fifty-two consecutive patients (33 women and 19 men aged 31 to 70 years [mean f standard deviation 51 f Ill) full'lling the aforesaid criteria were treated. All underwent clinical history, physical examination, fundoscopy, electrocardiography at rest, chest roentgenography, and basic blood chemistry sampling. A monitor for continuous electrocardiographic display and intravenous 5% glucose in water were installed for safety reasons. Patients were divided into 2 groups: group A, diastolic BP from 110 to 119 mm Hg, and group B, diastolic BP from 120 to 129 mm Hg; 6 patients in group A and 7 in group B had signs of hypertensive heart disease on chest x-ray and on electrocardiography. In an open trial, all patients received a single 5mg dose of nifedipine by chewing a multipierced capsule. Heart rate and supine BP were recorded immediately before and 5, 15, 30, 45 and 60 minutes after drug ingestion and then every 30 minutes until minute 180. The same observers monitored all BP and heart From the Department of Emergency Care,
Hypertension Research, 2014
This phase III, multicenter, randomized, double-blind, parallel-group study compared the efficacy and safety of nifedipine controlled-release (CR) 40 mg twice daily (b.i.d.) and once daily (q.d.) in 325 Japanese patients with essential hypertension uncontrolled with nifedipine CR 40 mg q.d. (ClinicalTrials.gov record: NCT01287260). The primary endpoint was the change from baseline in trough seated diastolic blood pressure (DBP) after 8 weeks. Nifedipine CR 40 mg b.i.d. showed significantly greater reductions in trough seated DBP ( À7.7±0.6 mm Hg vs. À3.6±0.6 mm Hg) and trough seated systolic blood pressure (BP) ( À11.1 ± 0.9 mm Hg vs. À3.7 ± 0.9 mm Hg) after 8 weeks of treatment compared with nifedipine CR 40 mg q.d. (both Po0.0001). At week 8, BP target achievement and responder rates were higher with nifedipine CR 40 mg b.i.d. (21.5% and 42.4% vs. 10.3% and 19.5%, respectively). Adverse events considered related to the study drug were reported in 9.0 and 9.7% of patients receiving nifedipine CR 40 mg b.i.d. and q.d., respectively. The frequency of drug-related adverse events commonly reported with nifedipine CR (headache, hot flush, palpitations, peripheral edema, hypotension, dizziness, tachycardia) was low and the results were similar between the treatment groups. In conclusion, a higher dose of nifedipine CR was associated with greater efficacy and a safety profile similar to that of the currently approved dose (40 mg q.d.) in Japanese patients with essential hypertension, and it may offer a valuable treatment choice for patients who do not achieve target BP levels with standard treatment.
Nifedipine in hypertensive emergencies
BMJ, 1983
The effects and safety of using oral nifedipine 10-20 mg as acute antihypertensive treatment were studied in a single-blind placebo-controlled study of 25 consecutive patients with very high blood pressure requiring emergency reduction. In addition the effect of this treatment on cerebral blood flow was investigated using xenon-133 in 10 patients randomly allocated to receive oral nifedipine or intravenous clonidine. Whereas placebo did not alter the blood pressure, oral nifedipine significantly reduced the systolic and diastolic blood pressures in all 25 patients (from 221 22/126 14 mm Hg to 152 1 20/89 12 mm Hg after 30 minutes, p <0001). Heart rate increased from 74 11 to 84-+ 11 beats/minute (p<001); this effect was inversely related to age (r 0 65, p <0 01). The falls in systolic and diastolic blood pressures were closely related to the blood pressures before treatment (r-=067, p <0 001 for systolic, and r-0-58, p <0 01 for diastolic values). No serious unwanted effects were observed. Measurement of cerebral blood flow after nifedipine showed an increase in flow in four out of five patients. Clonidine, by contrast, reduced cerebral blood flow in all patients by up to 28%. Nifedipine is a simple, effective, and safe alternative drug for managing hypertensive emergencies, especially when continuous monitoring of the patient cannot be guaranteed.
Treatment of Hypertensive Crisis with Intranasal Nifedipine
Critical Care Medicine, 1988
We report 31 episodes of hypertensive crises in children, managed with sublingual nifedipine at the following dosages: 10 mg in children with body weight (BW) higher than 20 kg, 5 mg in children with BW between 10 and 20 kg, and 2.5 mg in children with BW below 10 kg. The mean initial blood pressures were 161.41 mm Hg for the systolic pressure (mSBP) and 111.25mm Hg for the diastolic pressure (mDBP). After nifedipine, both the mSBP and the mDBP decreased, with onset of effect five minutes after dosage and maximum decrease at 60min (mSBP 134.93 mm Hg, mDBP 79.23 mm Hg, for decreases of 16.4 and 28.7%, respectively), and this effect persisted for 180 min. Blood pressure increased again from rain 240 to rain 360, yet without reaching the initial levels. One case did not respond to the first dose of nifedipine and required a second one. The effect of nifedipine was more pronounced on the DBP than on the SBP, and greater reductions of both pressures were achieved in the cases with higher initial readings. No side of medication were observed in our patients.