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PubMed2005

Transdermal estrogen patches for aggressive behavior in male patients with dementia: a randomized, controlled trial.

OBJECTIVES: To investigate the efficacy and tolerability of transdermal estrogen patches for the adjunctive treatment of aggressive behavior in male patients with advanced dementia. METHODS: The study was designed as an 8-week, randomized, controlled trial in acute aged psychiatry inpatient units and specialized nursing homes in Melbourne, Australia, between 1998 and 1999. The participants were 27 men with established dementia, identified as displaying aggressive behavior not responding to treatment for at least 2 weeks prior to referral. The instruments used to measure aggressive behavior were the Rating Scale for Aggressive Behavior in the Elderly (RAGE), the Cornell Scale for Depression in Dementia (CSDD) and the Mini-mental State Examination (MMSE). Physical examination was performed and biochemistry and serum hormone concentrations were measured at baseline and at 8 weeks. Concomitant psychotropic medication use was recorded and analyzed. RESULTS: There was no significant difference in aggressive behavior at 8 weeks, but significant "rebound" in aggressive behavior (change in scores between week 8 and week 10, p < 0.009) and benzodiazepine use in the estrogen group (p < 0.03), following removal of the patches. Only behavioral items of the CSDD improved in the experimental group (p = 0.031). The use of patches was associated with a significant rise in serum estrogen (p < 0.001) but not with a significant decrease in serum testosterone (p = 0.077). There were no adverse effects associated with their use. CONCLUSIONS: The use of transdermal estrogen yielding up to 100 microg per day was not associated with discernable improvement in aggressive behavior in men with advanced dementia. Small subject numbers, multiple variables and a lack of statistical power impair interpretation of these results. However, the tolerability and apparent rebound effect on removal of patches indicate the need for larger studies in this area.

Activities of Daily Living↗
PubMed1996

Cost-effectiveness of the transdermal nicotine patch as an adjunct to physicians' smoking cessation counseling.

OBJECTIVE: To determine the incremental cost-effectiveness of the transdermal nicotine patch. DESIGN: Decision analytic model that evaluated the incremental cost-effectiveness of the addition of the nicotine patch to smoking cessation counseling. Costs were based on physician time and the retail cost of the nicotine patch, and benefits were based on quality-adjusted life years (QALYs) saved. PATIENTS: Male and female smokers aged 25 to 69 years receiving primary care. INTERVENTION: Addition of the nicotine patch to physician-based smoking cessation counseling. MAIN OUTCOME MEASURE: Costs (1995 dollars) per QALYs save discounted by 3% annually. RESULTS: The use of the patch produced 1 additional lifetime quitter at a cost of $7332. The incremental cost-effectiveness of the nicotine patch by age group ranged from $4390 to $10 943 per QALY for men and $4955 to $6983 per QALY for women. A clinical strategy involving limiting prescription renewals to patients successfully abstaining for the first 2 weeks improved the cost-effectiveness of the patch by 25%. CONCLUSIONS: The findings provide support both for the routine use of the nicotine patch as an adjunct to physicians' smoking cessation counseling and for health insurance coverage of nicotine patch therapy.

Administration, Cutaneous↗
PubMed1996

Effects of transdermal nicotine patches on ambulatory ECG monitoring findings: a double-blind study in healthy smokers.

The cardiovascular effects and safety of transdermal nicotine patches were assessed in 50 healthy smokers using repeated 48 hour ambulatory electrocardiographic monitoring as a part of a smoking cessation program. Following baseline measurements, subjects were randomized to active (n = 25) or placebo (n = 25) treatment groups for a period of 2 weeks. Twenty-two patients in each group completed the trial. During the treatment period, subjects also received behavioral supportive therapy. Heart rate and blood pressure were significantly reduced relative to baseline both groups. In the active treatment group, mean values at baseline and after 2 weeks of double-blind treatments were as follows: heart rates, 74.0 and 71.3 beats/min, respectively; systolic blood pressure, 108.9 and 106.9 mmHg; and diastolic blood pressure, 69.7 and 68.2 mmHg, respectively. Values for the placebo group were as follows: heart rate, 73.2 and 69.6 beats/min; systolic blood pressure, 110.6 and 105.3 mmHg; diastolic blood pressure, 71.4 and 70.5 mmHg. The confidence intervals of the mean for the differences between the groups are as follows: heart rate, -4.0 +8.2; systolic blood pressure, -6.7, +10.1; diastolic blood pressure, -7.9, +3.9. There were no changes in the frequency of atrial or ventricular arrhythmia as documented by repeated 48 hour ambulatory ECG recordings from baseline period before stopping smoking compared with the treatment period in the active as well as in the placebo groups. No ischemic events were detected in any of the volunteers during either the baseline or treatment periods. As a measure of smoking abstinence, we assessed the level of carbon monoxide in expired air; in the active group, the mean levels fell from 14.2 to 4.4 ppm after smoking cessation and in the placebo group from 13.2 to 4.2 ppm. The mean urine cotinine level fell from 8.18 mmol/l at baseline to 5.74 mmol/l after 2 weeks of treatment in the active group and from 8.78 to 3.93 mmol/l in the placebo group. The number of cigarettes smoked per week in both treatment groups was significantly reduced: from 175.2 to 8.4 for the active group and from 136 to 8.6 for the placebo group. Eleven out of 22 subjects in each group quit smoking completely. Smoking withdrawal symptoms during the first week of treatment were more severe in the placebo group than in those on active treatment. There were no significant side effects in either the placebo or the active treatment groups. These results indicate that nicotine delivered by transdermal system is free of cardiac adverse effects in healthy volunteers.

Administration, Cutaneous↗
PubMedDate not supplied

Caffeine demethylation monitoring using a transdermal sweat patch.

Caffeine and two metabolites (paraxanthine and theobromine) were quantitated by high-performance liquid chromatography (HPLC) using extracts from transdermal sweat patches that continuously collected and stored analytes lost through the skin. Following caffeine consumption, remarkably clean chromatograms were obtained with minimal sample preparation. Caffeine and paraxanthine accumulated in the patch at comparable rates, and theobromine accumulated more slowly. A major urinary metabolite, 1-methylxanthine, was notably absent in sweat-patch and plasma extracts, a finding which favors a renal source for this metabolite. A simple, noninvasive approximation of N-demethylation can be made by calculating the paraxanthine/ caffeine and theobromine/caffeine ratios in the patch extract. These ratios were significantly reduced in high-dose (600 mg) versus low-dose (200 mg) subjects, possibly reflecting a decreased clearance of caffeine. Because the sweat patches can be worn for several days, the technique gives a multiday historical record which reflects the fluctuating systemic concentration of caffeine and its hepatic metabolites and thus might be useful to noninvasively monitor compliance by caffeine-restricted patients or to assess drug-metabolizing status.

Caffeine↗
PubMed2004

Plasma fentanyl concentrations and analgesic effects during full or partial exposure to transdermal fentanyl patches in cats.

OBJECTIVE: To compare plasma fentanyl concentrations and analgesic efficacy during full or partial exposure to 25-microg/h transdermal fentanyl patches (TFPs) in cats undergoing ovariohysterectomy. DESIGN: Randomized controlled clinical trial. ANIMALS: 16 client-owned cats. PROCEDURE: Cats were randomly assigned to receive full or partial exposure to a TFP; patches were applied approximately 24 hours prior to ovariohysterectomy. Rectal temperature, heart rate, respiratory rate, blood glucose concentration, and blood pressure were measured and pain severity was assessed periodically for 72 hours after patch application. Venous blood samples were collected for determination of plasma fentanyl concentration 0, 6, 12, 18, 24, 36, 48, 60, and 72 hours after patch application. RESULTS: Mean +/- SD steady state plasma fentanyl concentration in cats in the full TFP exposure group (1.78 +/- 0.92 ng/mL) was significantly greater than concentration in cats in the partial exposure group (1.14 +/- 0.86 ng/mL). Steady state plasma fentanyl concentrations were evident between 18 and 72 hours after patch application. Subjective scores used to evaluate analgesic efficacy were not significantly different between treatment groups. CONCLUSIONS AND CLINICAL RELEVANCE: Results suggest that delivery of fentanyl from TFPs can be reduced by decreasing the amount of exposed surface area. In cats weighing < 4 kg (9 lb), exposure to half a 25-microg/h TFP appears to provide adequate analgesia following ovariohysterectomy.

Administration, Cutaneous↗
PubMed1999

Cotinine replacement levels for a 21 mg/day transdermal nicotine patch in an outpatient treatment setting.

This study examined plasma cotinine replacement levels of 56 outpatient smokers administered a 21 mg/day transdermal nicotine patch (Nicoderm CQ ). The percentage of cotinine replacement ranged from 35 to 232% (mean 107%; median 90.5%). Four subject variables were found to be significantly correlated with percentage of cotinine replacement-baseline cotinine level, prior quit attempts, gender, and the Fagerström Tolerance Questionnaire score. A two-variable model consisting of baseline cotinine level and gender provided the most powerful predictor combination. The percentage of cotinine replacement was not predictive of post-treatment smoking. The relatively high levels of cotinine replacement obtained using the Nicoderm CQ 21 mg/day patch suggest cautious use of higher dose treatment with this particular patch.

Administration, Cutaneous↗
PubMed2000

Dose-response efficacy of a new estradiol transdermal matrix patch for 7-day application: a randomized, double-blind, placebo-controlled study. Italian Menopause Research Group.

New estradiol (E2) transdermal matrix patches developed for once-a-week application, releasing 25 micrograms E2 (7D-25) or 50 micrograms E2 (7D-50) daily, were investigated in comparison with a placebo patch and the twice-weekly parent patch releasing 50 micrograms E2 (Derm-50) daily. Three hundred and eleven postmenopausal patients suffering at least seven hot flushes daily were randomly assigned to the four parallel groups and treated continuously for 12 weeks without progestin opposition. The daily number of hot flushes significantly decreased in all groups. At the 12th week the decrease from a base-line average of eight to nine episodes per day was 78% with 7D-25, 93% and 97% respectively with 7D-50 and Derm-50, and significantly (p < 0.001) lower with placebo (59%). Comparable efficacy was observed in terms of severity of hot flushes, Kupperman Index and patient self-rated overall efficacy. Minor systemic adverse events occurred in 10.0%, 8.8%, 16.9% and 13.5% patients in the placebo, 7D-25, 7D-50 and Derm-50 groups respectively. Occasional mild and transient itching and/or erythema at the site of application was reported by a few patients, with no difference between groups or between once-weekly or twice-weekly application. In conclusion all E2 patches were significantly more effective than placebo in relieving climacteric symptoms in a dose-dependent fashion and all were well tolerated.

Administration, Cutaneous↗
PubMed1984

Clinical experience with rate-controlled delivery of antihypertensive therapy by a transdermal system.

The efficacy of transdermal clonidine, alone and in combination with diuretics, has been demonstrated in several studies involving patients with mild to moderate essential hypertension. In one 3-month open study, 64% of patients (wearing one to three 3.5 cm2 transdermal patches) achieved sustained blood pressure reductions throughout the treatment period. In this large study, side effects requiring discontinuation of drug were not observed. Transdermal clonidine reduced plasma renin activity and urinary aldosterone excretion to the same extent as that reported for oral clonidine. Renal function or serum electrolytes were not affected during therapy with transdermal clonidine. Another study showed that patients receiving oral clonidine and hydrochlorothiazide experienced comparable blood pressure reductions when switched to transdermal patches. Plasma drug concentrations measured during treatment with the transdermal patches were similar to the trough levels observed during treatment with oral clonidine. The equipotency of oral and transdermal therapy in combination with hydrochlorothiazide was also demonstrated in two remaining studies. In one of these studies it was suggested that daily variations in blood pressure induced by the peak and trough drug levels of the oral form were minimized by the stable drug levels characteristics of the transdermal device.

Administration, Oral↗
PubMed2000

Nicotine replacement therapy for smoking cessation.

BACKGROUND: The aim of nicotine replacement therapy (NRT) is to replace nicotine from cigarettes. This reduces withdrawal symptoms associated with smoking cessation to help resist the urge to smoke cigarettes. OBJECTIVES: The aims of this review were to determine the effectiveness of the different forms of nicotine replacement therapy (chewing gum, transdermal patches, nasal spray, inhalers and tablets) in achieving abstinence from cigarettes; to determine whether the effect is influenced by the clinical setting in which the smoker is recruited and treated, the dosage and form of the NRT used, or the intensity of additional advice and support offered to the smoker; and to determine whether combinations of NRT are more effective than one type alone. SEARCH STRATEGY: We searched the Cochrane Tobacco Addiction Group trials register. SELECTION CRITERIA: Randomized trials in which NRT was compared to placebo or no treatment, or where different doses of NRT were compared. We excluded trials which did not report cessation rates, and those with follow-up of less than six months. DATA COLLECTION AND ANALYSIS: We extracted data in duplicate on the type of subjects, the dose and duration and form of nicotine therapy, the outcome measures, method of randomisation, and completeness of follow-up. The main outcome measure was abstinence from smoking after at least six months of follow-up. We used the most rigorous definition of abstinence for each trial, and biochemically validated rates if available. Where appropriate, we performed meta-analysis using a fixed effects model. MAIN RESULTS: We identified 49 trials of nicotine gum, 32 of transdermal nicotine patch, four of intranasal nicotine spray, four of inhaled nicotine and two of nicotine sublingual tablet. Three trials compared combinations of two forms of nicotine therapy with one form alone. The odds ratio for abstinence with NRT compared to control was 1.72 (95% confidence interval 1.60 to 1.84), The odds ratios for the different forms of NRT were 1.63 for gum, 1.77 for patches, 2.27 for nasal spray, 2.08 for inhaled nicotine and 1.73 for nicotine sublingual tablet. These odds were largely independent of the intensity of additional support provided or the setting in which the NRT was offered. Eight weeks of patch therapy was as effective as longer courses and there was no evidence that tapered therapy was better than abrupt withdrawal. Wearing the patch only during waking hours (16 hours/day) was as effective as wearing it for 24 hours/day. The odds ratio for abstinence in the trials which directly compared 4 mg versus 2 mg gum in highly dependent smokers found a significant benefit in favour of 4 mg gum (odds ratio 2.67, 95% confidence interval 1.69 to 4.22). There is no strong evidence that combinations of forms of NRT are more effective. Only one study directly compared NRT against another pharmacotherapy (bupropion) and found that the latter was significantly more effective either alone or used in combination with nicotine patch than if nicotine patch was used alone. REVIEWER'S CONCLUSIONS: All of the commercially available forms of NRT (nicotine gum, transdermal patch, and in some countries, the nicotine nasal spray, nicotine inhaler and nicotine sublingual tablets) are effective as part of a strategy to promote smoking cessation. They increase quit rates approximately 1.5 to 2 fold regardless of setting. The effectiveness of NRT appears to be largely independent of the intensity of additional support provided to the smoker. Since all the trials of NRT reported so far have included at least some form of brief advice to the smoker, this represents the minimum which should be offered in order to ensure its effectiveness. Provision of more intense levels of support, although beneficial in facilitating the likelihood of quitting, is not essential to the success of NRT. There is promising evidence that bupropion may be more effective than NRT (either alone or in combination). (ABSTRACT

Administration, Cutaneous↗
PubMed1991

[Weaning of young smokers using a transdermal nicotine patch].

To assess efficacy and tolerance of a transdermal nicotine system (TNS) as adjuvant to tobacco withdrawal, 112 young, nicotine-dependent cigarette smokers were treated for nine weeks with TNS (n = 56) or placebo (n = 56). Initial doses of nicotine (21 or 14 mg/24 h) were based on previous smoking habits and stepwise reduced to 7 mg/24 h if abstinence was achieved during medication. After treatment, 39.3% of the TNS users were abstinent versus 19.6% on placebo (p less than 0.05). The craving for cigarettes diminished steadily, but not more significantly on TNS medication. Tenseness, difficulty in concentration and feelings of hunger were consistently and in part significantly lessened in the TNS group. The other withdrawal symptoms were not influenced by TNS treatment. Nine-month follow-up cotinine-verified abstinence rates were 12.5% in the TNS and 3.6% in the placebo group (n. s.). Transient mild or moderate erythema at the application site appeared in 20% of the TNS and 6.3% of the placebo group, and 7.1% of the TNS users dropped out because of severe localized erythema. Other mild, transient, systemic side effects reported by 33.9% of the TNS and 26.8% of the placebo users (n. s.) did not lead to drop-outs.

Administration, Cutaneous↗
PubMed1997

Respiratory depression in a child unintentionally exposed to transdermal fentanyl patch.

A 2-year-old boy was found unresponsive after sleeping in bed with his grandmother. After the patient was intubated and ventilated, paramedics discovered a transdermal fentanyl patch on the victim's back. Removal of the patch and treatment with naloxone resolved symptoms. This is the first reported case of secondary exposure to a fentanyl patch causing clinically significant respiratory depression in the pediatric population, and it emphasizes a new hazard of such drug use.

Administration, Cutaneous↗
PubMed1993

Transdermal nicotine in smoking cessation. A meta-analysis.

A systematic search of the literature was made to identify relevant reports of clinical trials of transdermal nicotine, followed by detailed statistical analysis of the results to calculate a pooled estimate of the rate of smoking cessation. Both a fixed effect and a random effects model were used to calculate pooled estimates. The pooled odds ratio (OR) for short-term smoking cessation in favour of the transdermal patches was OR = 3.10. Using a random effects model, the risk difference (RD) in favour of the transdermal patches was RD = 0.25. The corresponding values for long-term cessation were OR = 2.26 and RD = 0.11. Skin irritation was a common adverse effect with incidence rates ranging up to about 70%. Nicotine transdermal patches were effective in promoting smoking cessation both in the short-term, with assessments at 3 to 10 weeks, and in the long-term, with assessment at 24 to 52 weeks. Long-term abstinence rates in subjects treated with nicotine patches for a few weeks remained higher than in subjects treated with placebo patches. Adverse effects were usually minor and transient, although subjects with a sensitive skin may find the applications intolerable. Further studies are required to confirm the value of nicotine patches in promoting smoking cessation in the absence of professional medical support and in general medical practices in the community.

Administration, Cutaneous↗
PubMed1989

Prophylactic transdermal scopolamine patches reduce nausea in postoperative patients receiving epidural morphine.

To evaluate the efficacy of prophylactic transdermal scopolamine in reducing nausea associated with postoperative epidural analgesia, we studied 32 healthy adult women undergoing major gynecologic surgery. The patients were randomized in a double blind fashion to receive either a cutaneous scopolamine patch or a visually identical cutaneous placebo patch. Postoperative analgesia was provided solely with epidural morphine. Nausea was treated with metoclopramide and droperidol. At 24 hours postoperatively, the mean nausea score was significantly lower with scopolamine than with placebo (1 +/- 2 vs 51 +/- 42, respectively, P less than 0.05). The number of patients reporting "zero nausea" was significantly greater with scopolamine patches than with placebo patches (13 vs 1, P less than 0.01). The mean number of times antiemetic drugs were administered per patient was lower with scopolamine than with placebo patches (0.2 +/- 0.4 vs 2.8 +/- 2.6, P less than 0.05). It is concluded that prophylactic transdermal scopolamine patches reduce nausea in postoperative patients receiving epidural morphine.

Administration, Cutaneous↗
PubMed1998

Transdermal nitroglycerin patch therapy improves left ventricular function and prevents remodeling after acute myocardial infarction: results of a multicenter prospective randomized, double-blind, placebo-controlled trial.

BACKGROUND: Nitrates are widely used in the treatment of angina in patients with acute myocardial infarction (AMI). Short-term administration prevents left ventricular (LV) dilation and infarct expansion. However, little information is available regarding their long-term effects on LV remodeling in patients surviving Q-wave AMI. METHODS AND RESULTS: This was a randomized, double-blind, placebo-controlled trial designed to investigate the long-term (6-month) efficacy of intermittent transdermal nitroglycerin (NTG) patches on LV remodeling in 291 survivors of AMI. Patients meeting entry criteria had baseline gated radionuclide angiography (RNA) followed by randomization to placebo or active NTG patches delivering 0.4-, 0.8-, or 1.6-mg/h. RNA was repeated at 6 months and 6.5 days after withdrawal of double-blind medication. The primary study end point was the change in end-systolic volume index (ESVI). Both ESVI and end-diastolic volume index (EDVI) were significantly reduced with 0.4-mg/h NTG patches (-11.4 and -11.6 mL/m2, respectively, P<.03). This beneficial effect was observed primarily in patients with a baseline LV ejection fraction < or =40% (deltaESVI, -31 mL/m2; deltaEDVI, -33 mL/m2; both P<.05) and only at the 0.4-mg/h dose. After NTG patch withdrawal, ESVI significantly increased but did not reach pretreatment values. CONCLUSIONS: Transdermal NTG patches prevent LV dilation in patients surviving AMI. The beneficial effects are limited to patients with depressed LV function and only at the lowest (0.4-mg/h) dose. Continued administration is necessary to maintain efficacy. Whether these remodeling effects confer a clinical or survival advantage will need to be addressed in an adequately powered cardiac event trial.

Administration, Cutaneous↗
PubMed1991

A double-blind trial of a 16-hour transdermal nicotine patch in smoking cessation.

BACKGROUND: The use of nicotine chewing gum combined with psychological support improves the success rate in quitting smoking. We studied the safety and efficacy of a transdermal nicotine patch in smoking cessation. METHODS: We conducted a double-blind randomized study comparing the effects of a 16-hour nicotine patch (15 +/- 3.5 mg of nicotine in 16 hours) with those of a placebo patch. Of the 289 smokers (207 women and 82 men) enrolled in the study, 145 were treated with nicotine patches and 144 with placebo patches for 16 weeks. RESULTS: Rates of sustained abstinence were significantly better with active treatment than with placebo: 53, 41, 24, and 17 percent of those in the nicotine-patch group were abstinent after 6, 12, 26, and 52 weeks, respectively, as compared with 17, 10, 5, and 4 percent of those in the placebo-patch group (P less than 0.0001). Only two subjects with the nicotine patch and one with the placebo patch had to withdraw from the study because of side effects. CONCLUSIONS: The nicotine skin patch proved to be safe and effective, as demonstrated by a higher rate of abstinence than with placebo. However, the absolute rate of abstinence after one year was only 17 percent, which is lower than the rate in studies that have combined the use of nicotine chewing gum with behavioral therapy.

Administration, Cutaneous↗
PubMed1996

Bioequivalence Comparison of Two Drug-in-Adhesive Transdermal Nitroglycerin Patches.

Plasma concentrations of nitroglycerin, 1,2-dinitroglycerin and 1,3-dinitroglycerin in 50 healthy male subjects who received single 24-h applications of two 0.6 mg/h drug-in-adhesive transdermal nitroglycerin patch formulations were compared for the purpose of establishing bioequivalence. The rates of appearance and elimination of nitroglycerin and both dinitro metabolites were the same for both patch treatments. The pharmacokinetic and statistical analyses indicated that the 20-cm(2) test patch met the current two one-sided t-test criteria for bioequivalence with the 30-cm(2) reference patch for nitroglycerin and both dinitro metabolites, even though the reference patch was 50% larger in size and contained 120% more nitroglycerin than the test patch. A likely explanation for the equivalence in drug delivery with a smaller patch is that the test patch maintained more intimate skin contact than did the reference patch. This study shows that strict bioequivalence criteria can be met with a highly variable drug such as nitroglycerin.

Journal Article↗
PubMed1994

Transdermal nitroglycerin patch therapy reduces the extent of exercise-induced myocardial ischemia: results of a double-blind, placebo-controlled trial using quantitative thallium-201 tomography.

OBJECTIVES: This study prospectively evaluated whether transdermal nitroglycerin patches could limit the extent of exercise-induced left ventricular ischemia as assessed by quantitative thallium-201 tomography. BACKGROUND: Although antianginal medications are effective at reducing chest pain symptoms in patients with coronary artery disease, there is limited evidence that these agents can also reduce myocardial ischemia. METHODS: This was a randomized, double-blind, parallel, placebo-controlled trial evaluating nitroglycerin patch therapy in patients in stable condition with angiographic coronary artery disease and no previous myocardial infarction. All patients were weaned from antianginal agents and had a baseline symptom-limited treadmill test followed by thallium-201 tomography. Forty patients with perfusion defects involving > or = 5% of the left ventricle were randomized to receive either intermittent (12 h on/off) active nitroglycerin patch therapy (0.4 mg/h) or placebo. Exercise tomography was repeated a mean (+/- SD) of 6.1 +/- 1.8 days after randomization. RESULTS: Patients randomized to receive active patch therapy had a significant reduction in their total perfusion defect size (-8.9 +/- 11.1%) compared with placebo-treated patients (-1.8 +/- 6.1%, p = 0.04), which was most apparent in those with the largest (> or = 20%) baseline perfusion defects (-11.4 +/- 13.4% vs. 1.0 +/- 3.6%, respectively, p < 0.02). Furthermore, 7 (33%) of 21 patients receiving active therapy had a > or = 10% decrease in their perfusion defects compared with only 1 (5%) of 19 patients randomized to receive placebo (p = 0.002). Nitrate therapy did not significantly reduce heart rate, blood pressure or double product, indicating benefit through enhancement of coronary blood flow. CONCLUSIONS: Short-term, intermittent nitroglycerin patch therapy significantly reduces myocardial ischemia, particularly in patients with large ischemic perfusion defects. Thallium-201 tomography can be used to assess sequential changes in the extent of exercise-induced left ventricular ischemia.

Administration, Cutaneous↗
PubMed2002

Tolerability and safety of sustained-release bupropion in the management of smoking cessation.

Sustained-release bupropion (bupropion SR) was first launched in the US in 1997 as an aid to smoking cessation and has since been launched in many other countries. Adverse events associated with the use of bupropion SR at the recommended dosage of 150mg twice daily in clinical trials most commonly included insomnia, headache, dry mouth, nausea and anxiety; insomnia and anxiety are also recognised as symptoms of nicotine withdrawal. Only insomnia and dry mouth occurred significantly more frequently with bupropion SR than with placebo. Relative to placebo, no significant changes in mean values for heart rate, blood pressure or routine laboratory parameters have been reported in smokers using bupropion SR alone in clinical trials. When bupropion SR was compared with a nicotine transdermal patch in a clinical trial, insomnia predominated in the bupropion SR group, while dream abnormalities were more common in smokers using the nicotine patch. Bupropion SR and the nicotine transdermal patch in combination can be used safely (with appropriate monitoring) as an aid to smoking cessation. Infrequent but clinically important adverse reactions to bupropion SR include seizures and hypersensitivity reactions: in controlled clinical trials of bupropion SR (300 mg/day), where smokers were carefully screened for risk factors for seizure, the incidence of both seizures and severe hypersensitivity reactions was approximately 0.1% for each event. In order to avoid a risk of seizure of greater than 0.1%, smokers should be screened for predisposing risk factors and adhere to the manufacturer's dosage recommendations (maximum daily dose of 300mg). Thus, bupropion SR is generally well tolerated, as seen by the low discontinuation rate due to an adverse event in clinical trials (6 to 12%). The most common adverse events (insomnia and dry mouth) are generally transient and often resolve quickly without therapeutic intervention; they can be managed if necessary by a reduction in bupropion dose.

Bupropion↗