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Biomedical subjects

G Pollavini

Publications and source records attributed to G Pollavini.

At least 19 recordsLinked to original sources
PubMed1993

Effects of transdermal nitroglycerin in combination with an ACE inhibitor in patients with chronic stable angina pectoris.

We have previously shown that transdermal nitroglycerin may induce an increase in the activity of the adrenergic and the renin-angiotensin-aldosterone systems (SRAA) in patients with chronic stable angina pectoris (SA); when the activation of these systems is more pronounced, the antianginal effect of this drug seems to be reduced. The aim of this study was to evaluate the antianginal efficacy of transdermal nitroglycerin administration (TTS-NG 10 mg.24 h-1) in combination with an ACE inhibitor without sulphydryl groups (BNZ, benazepril 10 mg b.i.d.) in respect to placebo, or to TTS-NG or BNZ administered as monotherapy. Twenty-four patients (21M, 3F) were admitted to this multicentre, randomized, double-blind, latin square, placebo-controlled study. Patients received all the treatments (placebo, TTS-NG, BNZ and BNZ + TTS-NG) each for one week; at the end of each week patients performed two exercise tests 2 and 22 h post-dosing. Two hours post-dosing, exercise duration at 1 mm ST depression was significantly increased in respect to placebo during TTS-NG (P < 0.05) and TTS-NG + BNZ (P < 0.05) treatments. Two hours post-dosing, exercise duration at peak exercise was also increased in respect to placebo during TTS-NG (P < 0.05) and TTS-NG + BNZ (P < 0.05); 22 h post-dosing the increase in exercise duration was significant only during TTS-NG + BNZ treatment (P < 0.05) in respect to placebo, but not during TTS-NG given alone. Rate-pressure product at 1 mm ST depression was significantly increased 2 h post-dosing during TTS-NG treatment (P < 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Cutaneous↗
PubMed1992

Transdermal nitroglycerin efficacy in patients with chronic stable angina pectoris as related to sympathetic and renin-angiotensin-aldosterone activity.

The aim of this study was to evaluate the acute effects of transdermal nitroglycerin on the sympathetic and renin-angiotensin-aldosterone systems activity, in a group of patients with stable exercise induced angina pectoris. Eighteen outpatients (15M, 3F, age range 47-65 years) were included in this double-blind, randomized, crossover trial comparing the antianginal effects of a transdermal system delivering 20 mg.day-1 of nitroglycerin to an identical placebo. Plasma renin activity, plasma aldosterone and catecholamine concentrations were measured in resting basal conditions and at 4, 8, 24, and 32 h post-dosing. Patients were subdivided in two groups according to the increase in exercise duration after patch application greater than 30% (responders, n = 8) and less or equal to 30% (non-responders, n = 10) in respect to placebo. In responders plasma norepinephrine was slightly increased during transdermal nitroglycerin administration in comparison to placebo while no change was observed in plasma adrenaline and aldosterone concentrations and in plasma renin activity. In non-responders plasma norepinephrine levels significantly increased during nitroglycerin treatment in comparison with placebo. Multiple comparisons showed that this increase was significant at 4, 8 and 24 h post-dosing. Plasma epinephrine and aldosterone concentrations and plasma renin activity were also increased after nitroglycerin administration. In the population as a whole, a significant inverse correlation was found between the percent increase in exercise duration (active drug vs placebo) and the absolute values of plasma norepinephrine and aldosterone, 4 h post-dosing.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Cutaneous↗
PubMed1991

Efficacy of continuous and intermittent transdermal treatment with nitroglycerin in effort angina pectoris: a multicentric study. The Collaborative Nitro Group.

Eighty-eight patients (84 men and 4 women; mean age 59.3 years) with stable exercise-induced angina pectoris were enrolled in this within-patient, placebo-controlled study aimed at comparing the efficacy of the continuous and intermittent (12 hour on, 12 hour off) application of transdermal nitroglycerin. Eighty-one patients completed the study. After a 1-week placebo run-in period, during which the stability of angina was assessed on a bicycle ergometer, the patients received continuous treatment (two 10 mg/24 hour patches twice daily, at 8 a.m. and 8 p.m.), intermittent treatment (two 10 mg/24 hour patches at 8 a.m. and two placebo patches at 8 p.m.) and placebo (two placebo patches twice daily, at 8 a.m. and 8 p.m.), each given for one week in a double-blind randomised sequence, according to a 3 x 3 latin-square design. A cycloergometric exercise test was performed at the end of each period of treatment, 4 and 10 hours after the application of the morning patch. In comparison with placebo, both schedules of the active treatment induced a significant increase in both the ischemic (duration of exercise to 1 mm ST segment depression) and the angina threshold (duration of exercise to mild angina) at the 4th and at the 10th hours after-dosing. A significant difference was also found between continuous and intermittent treatment at the same times of observation, in favour of the intermittent schedule. The limited number of anginal attacks recorded during placebo prevented any clinical evaluation of the treatments. This study shows that the efficacy of transdermal nitroglycerin is more pronounced when it is given following an intermittent schedule.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗
PubMed1991

Extended release felodipine in essential hypertension. Variations in blood pressure during whole-day continuous ambulatory recording.

Intraarterial blood pressure (BP) monitoring during free ambulation (Oxford technique) was carried out in 12 essential mild-to-moderate hypertensive patients undergoing 4 weeks treatment with felodipine, 10 mg given once daily in an extended release formulation. Compared to placebo, felodipine significantly reduced systolic and diastolic blood pressure throughout 24 h. The greatest reduction was observed at 10 AM, 3 h after drug administration (-32 +/- 6/-24 +/- 5 mm Hg for systolic and diastolic BP, respectively, P less than .001). Hourly BP values remained significantly lower up to and including the 24th hour during felodipine extended release treatment (-18 +/- 5/-11 +/- 3 mm Hg, P less than .001). Felodipine extended release also reduced 24 h blood pressure variability, evaluated on the standard deviation of each hourly mean (from 16.3 +/- 0.9/12.6 +/- 0.6 to 13.4 +/- 0.6/10.4 +/- 0.6 mm Hg, P less than .01). Furthermore, absolute BP values dropped significantly at the peaks of dynamic exercise (bicycle ergometer: from 248 +/- 13/123 +/- 11 to 204 +/- 24/102 +/- 13 mm Hg, P less than .001), isometric exercise (hand grip: from 232 +/- 18/133 +/- 16 to 180 +/- 20/101 +/- 16 mm Hg, P less than .001), and cold pressor test (from 229 +/- 20/127 +/- 14 to 178 +/- 22/99 +/- 15 mm Hg, P less than .001). In conclusion, felodipine extended release exerts a good antihypertensive effect which is maintained for 24 h and reduces the level of blood pressure peaks reached under different physical stresses.

Adult↗
PubMed1991

Acute effects on exercise tolerance of felodipine and diltiazem, alone and in combination, in stable effort angina.

The acute effects on exercise tolerance and electrocardiographic ischaemia of felodipine and diltiazem, alone or in combination, were investigated in 12 patients with documented stable effort-induced angina pectoris. After being withdrawn from their previous antianginal treatments, patients received a single oral dose of felodipine 10 mg, diltiazem 60 mg, their combination or placebo on four different days, according to a double-blind, 4 x 4 latin-square design. Exercise time to ischaemic threshold (ST-segment depression = 1 mm) and to peak exercise was significantly prolonged by the felodipine-diltiazem combination (492 and 504 s, respectively) against placebo (301 and 370 s, both P less than 0.01), felodipine alone (381 and 428 s, both P less than 0.01) and diltiazem alone (367 and 422 s, both P less than 0.01). The effects on total work followed a similar pattern. In comparison with placebo, the administration of felodipine and diltiazem alone significantly increased exercise duration as well as total work to ischaemic threshold and to peak exercise, with no differences between the two drugs. Systolic blood pressure during exercise was not affected by any of the treatments. However, in comparison with both placebo and diltiazem, the combination induced an increase (P less than 0.01) in heart rate during exercise. One patient suffered from symptomatic hypotension with the combination, and another had sinus tachycardia after felodipine. In conclusion, the acute concomitant administration of felodipine and diltiazem in patients with stable effort angina induces a marked improvement in exercise tolerance in comparison with placebo, felodipine alone and diltiazem alone. However, the benefit/risk profile of such a combination requires further, long-term investigation.

Angina Pectoris↗
PubMed1990

[Circadian pressure variability and pressure peaks during treatment of mild to moderate essential hypertension with felodipine].

It is not yet known how blood pressure variability contributes to the vascular changes associated with hypertension, but 2 possibly relevant factors are mean blood pressure levels over time and pressure peaks. It has been observed that patients in whom the variability in 24-hour blood pressure is low have a lower prevalence and severity of target organ damage. We carried out a whole-day continuous intraarterial blood pressure recording (Oxford method) in 12 essential hypertensive patients after a 2-week placebo period and after a 4-week felodipine treatment, administered in an extended release formulation, 10 mg once daily at 7 am. Felodipine significantly lowered systolic and diastolic blood pressure values throughout the 24 hours (p less than 0.005 to 0.001). Also, hourly variabilities of systolic and diastolic blood pressure during whole-day monitoring were significantly reduced (p less than 0.05 to 0.001), evaluated on the basis of the hourly means of standard deviation of systolic and diastolic blood pressure. In addition, felodipine significantly lowered the values of blood pressure reached during both dynamic exercise (bicycle ergometer, p less than 0.001) and isometric exercise (handgrip, p less than 0.001).

Adult↗
PubMed1989

Ambulatory blood pressure monitoring during sustained treatment with conventional and extended-release felodipine in mild-to-moderate hypertension.

To assess the duration of the antihypertensive effect of the dihydropiridine calcium antagonist felodipine in conventional (C-F) and slow-release (ER-F) formulations, 12 patients with essential hypertension underwent ambulatory blood pressure monitoring (ABPM) at the end of a 2-week treatment period with C-F 5 mg b.d., ER-F 10 mg once daily (o.d.) and placebo. C-F, ER-F and placebo were given in a double-blind 3 x 3 latin square design 4 times replicated. There was no systematic change in the ABP profile over the three study periods regardless of the treatment. In comparison to placebo, the mean 24-h systolic and diastolic blood pressures showed a significant and similar reduction after both formulations of F. Compared to placebo, C-F and ER-F induced a significant reduction in systolic blood pressure for 15 and 21 h, respectively, and of diastolic blood pressure for 16 and 21 h, respectively. Three patients complained of headache (mild in 2, moderately severe in 1), and two patients of nocturia, with either formulation of F.

Adult↗
PubMed1989

Increased exercise tolerance and reduced electrocardiographic ischaemia 3 and 12 hours after oral felodipine in effort angina.

The antianginal properties and the duration of action of two doses of felodipine, a dihydropyridine calcium antagonist with a vascular:myocardial potency ratio approximating 100:1, were investigated in 15 patients suffering from disabling effort angina pectoris with reproducible exercise tolerance. Felodipine (5 mg, 10 mg) and placebo were administered once in the morning on three different days, with a 24 h interval between them, according to a double-blind 3 x 3 latin square design, 5 times replicated. Symptom-limited cycloergometric exercise tests were performed 3 and 12 h after administration. Duration of exercise to ST segment depression of 1 mm and to peak exercise was increased (all P less than 0.01) by both doses of felodipine in comparison with placebo. Twelve hours after administration, the 10-mg dose induced a significant improvement in the exercise time and a smaller ST segment depression (all P less than 0.01) in comparison with the 5-mg dose. The relationship between ST segment depression and the pressure-rate product during exercise was favourably influenced by the 10-mg dose at 3 and 12 h after intake, and by the 5-mg dose only at 3 h after intake. These findings suggest an increase in coronary blood flow induced by felodipine. Apart from mild headache there were no other unwanted effects. In conclusion, felodipine improves exercise tolerance and reduces electrocardiographic ischaemia for up to 12 h after single oral administration in patients with effort angina. Increasing the dose from 5 mg to 10 mg produces a more prolonged effect, with increased exercise tolerance 12 h after intake.

Administration, Oral↗
PubMed1989

Intermittent transdermal nitroglycerin monotherapy in stable exercise-induced angina: a comparison with a continuous schedule.

The aim of this study was to investigate nitrate tolerance during continuous treatment with nitroglycerin patches (NTG) as monotherapy, and to assess whether tolerance might be prevented by an overnight nitrate-free interval. Ten male patients, of mean age 53.2 years (range 41-62 years), with pathological coronary angiography and stable exercise-induced angina pectoris took part in a double-blind crossover study (two 15-day periods), during which the continuous and intermittent (12-h nitrate-free interval) application of NTG 20 mg (24 h)-1 patches were compared. Single-blind placebo was given acutely before and at the end of the crossover. Exercise testing was performed on a treadmill according to the Bruce protocol 4 and 12 h after dosing, both during placebo and at the end of the two active treatment periods. In comparison with continuous treatment, the intermittent administration of 20 mg (24 h)-1 NTG patches significantly increased ischaemic threshold and total work time at the 4th and the 12th hour. Night-time withdrawal of NTG transdermal delivery systems determined during the 15-day period a total of 11 night anginal attacks in six out of 10 patients (0.07 attacks per patient per nitrate-free interval).

Administration, Cutaneous↗
PubMed1988

Acute effects of felodipine in exertional angina pectoris.

To investigate the antianginal efficacy, duration of action and tolerability of 2 doses of the new calcium antagonist felodipine, 15 patients (14 men and 1 woman, mean age 62 years) with stable exertional angina pectoris and angiographically demonstrated coronary artery disease were randomly given felodipine, 5 and 10 mg, and placebo on 3 different days. A bicycle ergometer exercise test was performed 3 and 10 hours after dosing. In comparison with placebo, felodipine 5 and 10 mg significantly increased resting heart rate and decreased resting systolic and diastolic blood pressure 3 hours after administration (p less than 0.001). Ten hours after administration, only supine systolic blood pressure was still significantly lower (p less than 0.001). Anginal (time to mild chest pain) and ischemic (time to 1 mm ST depression) thresholds, as well as duration of exercise and total work at peak exercise, were higher in comparison with placebo at 3 and 10 hours (p less than 0.001). In comparison with the lower dose, 10 mg felodipine induced a decrease in supine (p less than 0.05) and sitting (p less than 0.01) systolic blood pressure at rest and an increase in total work to anginal threshold (p less than 0.01), as well as in total work and duration of exercise at peak exercise (p less than 0.05). These results suggest that a single administration of felodipine, 5 and 10 mg, may improve exercise capacity over a 10-hour period in patients with stable exercise-induced angina due to atherosclerotic heart disease.

Angina Pectoris↗
PubMed1988

Individual responses to transdermal nitrates after chronic administration in angina pectoris.

The aim of this study was to investigate whether, and to which extent, sustained treatment with transdermal nitroglycerin plasters may lead to the development of tolerance in patients with effort-induced angina pectoris. Ten patients, all men, mean age 62.7 years, took part in a double-blind, cross-over, acute study, comparing the transdermal therapeutic system of nitroglycerin 10 mg/24 hours with placebo. Patients were then treated for 1 month with the active drug in single-blind condition, and finally they took part in a further acute study identical to the first. Cycloergometric exercise tests were carried out 4 hours after dosing. In comparison with placebo, the active drug significantly (P less than 0.01) increased ischaemic threshold (ST depression = 1 mm) after both acute (from 299 +- 92 to 413 +- 120 sec) and chronic treatment (416 +- 107 sec). The same results were obtained for exercise duration to peak exercise (acute study: from 336 +- 65 to 482 +- 90 sec; chronic treatment: 466 +- 118 sec). The final acute study confirmed the stability of angina, showing that the improvement in exercise tolerance after chronic treatment was entirely due to the pharmacological effect of the drug. In terms of single patient response to the active treatment, 7 of the 10 patients showed an improvement in exercise tolerance after both acute and chronic treatment, while in 3 patients no antianginal effect was observed. These results suggest that nitrate tolerance cannot be considered an inevitable finding in patients chronically treated with transdermal patches.

Administration, Cutaneous↗
PubMed1988

Effects of a low-sodium high-potassium salt in hypertensive patients treated with metoprolol: a multicentre study.

A multicentre study, involving 358 subjects, was carried out to evaluate the effects of a low-Na/high-K dietary salt in hypertensive patients receiving beta-blocker monotherapy. At the end of a 4-week treatment period with 200 mg slow-release metoprolol patients were randomly divided into two groups: one group was given common salt and the other the dietary salt. Both salts were given at table, in double-blind conditions over a period of 4 weeks. The dietary salt group showed a systolic and diastolic blood pressure (BP) reduction (4.2 and 3.0 mmHg, respectively, in the supine position and 4.0 and 2.5 mmHg in the standing position), which was virtually absent in the common salt group. A statistically significant difference between the two groups was found only between the systolic values (P less than 0.05). Twenty-four-hour urinary sodium excretion did not change in either group, while the excretion of 24-h urinary potassium increased significantly in the dietary salt group. It is concluded that in mild or moderately hypertensive patients already receiving a beta-blocker, ancillary treatment with a low-Na/high-K salt can be expected to lead to a further, slight reduction in systolic BP, probably due to the daily potassium load (around 20 mmol).

Blood Pressure↗
PubMed1987

The treatment of angina pectoris with nitroglycerin plasters. A multicenter study involving 6,986 patients.

A multicenter study was carried out in order to evaluate the efficacy and tolerability of 2 doses of a nitroglycerin transdermal system (TTS-NG 5 mg/24 h and TTS-NG 10 mg/24 h) on a large population of patients affected by angina pectoris. Nine hundred and seventy three cardiologists enrolled a total of 6,986 patients, 4,290 males and 2,696 females, mean age 61.7 years (range 26-95), 3,283 with effort-angina, 2,062 with mixed angina and 1,641 with angina at rest. Patients whose angina was not satisfactorily controlled by their previous therapy, were given TTS-NG 5 for 1 week in the morning, while continuing their antianginal treatment, with the exception of nitrates which were gradually withdrawn. At the end of this period, patients who responded to the treatment continued taking the same dose for a further 6 weeks, while poor responders were given a double dose of the study medication over the same period. Six thousand two hundred and sixty patients (90%) completed the study. TTS-NG 5 proved to be effective in 2,091 patients (33%) with a reduction in weekly anginal attacks after only 1 week of treatment (from 5.8 +/- 2.9 to 2.4 +/- 2.3). This reduction improved in the following 2 weeks (from 2.4 +/- 2.3 to 1.2 +/- 1.6) and subsequently remained virtually unchanged. Four thousand one hundred and sixty-nine patients (67%), whose angina was not sufficiently controlled by TTS-NG 5 (from 5.0 +/- 2.4 to 4.3 +/- 2.8), received double the dose at the end of the first week. TTS-NG 10 brought about a reduction in weekly anginal symptoms during the 2nd and the 3rd week (from 4.3 +/- 2.8 to 2.0 +/- 2.2), with a further decrease during the following 2 weeks (from 2.0 +/- 2.2 to 1.1 +/- 1.7). The reduction in anginal attacks was of the same extent both during the day and the night, thus suggesting that the drug is effective throughout 24 hours. A similar pattern was observed in the reduction of the number of anginal attacks weighted by their severity, the severity of attacks weighted by their number and the number of trinitrine pills taken. Tolerability was good in the majority of cases. In conclusion, this study confirms the efficacy of TTS-NG in the treatment of angina pectoris, thus supporting some recently published data obtained by using more standardized protocols and rigorous evaluation criteria.

Administration, Cutaneous↗
PubMed1986

[Hemodynamic and anti-angina effects of transdermal nitroglycerin after acute and chronic administration. Additive effect of sublingual isosorbide dinitrate].

To evaluate the acute and chronic anti-anginal efficacy of a Transdermal Therapeutic System, releasing 10 mg of nitroglycerin over 24 hours (TTS 10), and possible additional effects of isosorbide dinitrate 5 mg (ISDN) sublingually (s.l.), ten patients with stable exercise-induced angina pectoris and pathological coronary angiography were studied. The protocol of the trial consisted of an initial acute study, carried out in double-blind conditions and following a cross-over design, to compare TTS 10 and placebo. Cycloergometric exercise tests were performed on the first and second day, 3 hours after dosing. After a 30 minute rest period, a sublingual 5 mg dose of ISDN was given and 15 minutes later a further exercise test was carried out. Subsequently, patients received TTS 10 in single-blind conditions for 16 days. On the 15th and 16th day, stress test was repeated, 3 hours after the application of active plasters and, 30 minutes later, a further exercise test was performed, 15 minutes after a sublingual dose of ISDN 5 mg or placebo, given in double-blind conditions and in randomized sequence. After acute and chronic administration, TTS 10 significantly improved exercise tolerance in comparison with placebo. During the first acute study, ISDN 5 mg s.l., led to a significant reduction in systolic BP, a reflex increase in heart rate and a further improvement in exercise tolerance, whether patients were on placebo or TTS.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Cutaneous↗
PubMed1985

Effect of a new transdermal therapeutic system containing nitroglycerin on exercise capacity in patients with angina pectoris.

In a double-blind, within-patient, randomized, placebo-controlled, acute study, the effects at rest and on exercise capacity of two doses of a new transdermal therapeutic system (TTS), releasing respectively 10 and 20 mg of nitroglycerin (NTG) over 24 hours, were assessed in 15 outpatients with stable exercise-induced angina pectoris. A symptom-limited exercise test was performed 4 and 24 hours after the application of each system. In comparison with placebo, both TTS-NTG doses induced a statistically significant (p less than 0.01) increase in total duration of exercise, in exercise duration to 1 mm ST segment depression, in maximal workload and in total work performed, at both 4 and 24 hours after dosing. Furthermore, both TTS-NTG doses induced a significant rise in the pressure-rate product, both 4 and 24 hours after dosing (p less than 0.01 and p less than 0.05, respectively). No statistical difference was found between the two doses of active drug in any of the above-mentioned evaluation parameters. The only unpleasant side effect was the typical nitrate headache, which occurred in 11 of 15 patients. In conclusion, a single application of TTS-NTG, 20 cm2 or 40 cm2, may improve exercise capacity over a 24-hour period in patients with stable exercise angina due to atherosclerotic heart disease.

Administration, Topical↗