A standardized patch test.
Explore the source record for details and available documents.
Anaphylaxis↗
SEARCH · Search PubMed
Results for “Transdermal Patch”
Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.
Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.
Transdermal nicotine as maintenance therapy for ulcerative colitis.
BACKGROUND: Ulcerative colitis is largely a disease of nonsmokers. Having found previously that treatment with transdermal nicotine patches and mesalamine (5-aminosalicylic acid) has a beneficial effect on active colitis, we examined the value of transdermal nicotine for the maintenance of remission. METHODS: We treated 80 patients with ulcerative colitis in remission with either transdermal nicotine or placebo patches for six months in a randomized, double-blind study. Incremental doses of nicotine were given for the first three weeks to achieve a maintenance dose; most patients tolerated 15 mg for 16 hours daily. All patients were taking mesalamine preparations as maintenance treatment at entry into the study; this treatment was stopped once the maintenance dose of nicotine was achieved. Clinical, sigmoidoscopic, and histologic assessments were made at the beginning and the end of the study, or at relapse. Side effects and serum nicotine and cotinine concentrations were monitored throughout the study. RESULTS: There was no significant difference in the number of relapses between the groups. Twenty-two patients in the nicotine group were prematurely withdrawn from the study, 14 because of relapse and 8 for other reasons, including side effects and protocol violations. In the placebo group, 20 patients were withdrawn prematurely, 17 because of relapse and 3 for other reasons. Among patients using 15-mg nicotine patches, serum nicotine and cotinine concentrations were lower than expected and may reflect poor compliance. Side effects were reported by 35 patients--21 in the nicotine group and 14 in the placebo group--the most common of which were nausea, lightheadedness, and itching. CONCLUSIONS: Transdermal nicotine alone was no better than placebo in the maintenance of remission of ulcerative colitis, and premature withdrawal due to side effects was more common in the nicotine group.
Administration, Cutaneous↗
Patient-reported utilization patterns of fentanyl transdermal system and oxycodone hydrochloride controlled-release among patients with chronic nonmalignant pain.
BACKGROUND: Although use of long-acting opioid analgesics has increased for chronic nonmalignant pain management, little is known about patient-reported utilization patterns. OBJECTIVE: To assess patient-reported utilization patterns of fentanyl transdermal system and oxycodone hydrochloride (HCl) controlled-release among patients with chronic nonmalignant pain and to compare these patterns to standard dose administration guidelines recommended in the manufacturers. prescribing information (PI). METHODS: Cross-sectional, observational, multicenter study of English-speaking patients who were seeking chronic nonmalignant pain management from 6 outpatient pain clinics. The inclusion criteria for the study were (1) diagnosis of chronic nonmalignant pain, (2) prescription for and current use of either transdermal fentanyl or oxycodone HCl controlled-release, and (3) duration of use for either transdermal fentanyl or oxycodone HCl controlled-release of at least 6 weeks. Patients completed either an oxycodone HCl controlled-release or transdermal fentanyl utilization questionnaire. A conversion table was used to standardize opioid analgesic doses from transdermal fentanyl or oxycodone HCl controlled-release to daily oral morphine equivalents. The principal outcome measures were the average interval between oxycodone HCl controlled-release administrations, the number of days the current transdermal fentanyl patch would be worn, and the percentage of oxycodone HCl controlled-release and transdermal fentanyl patients whose administration frequency exceeded the standard recommendation in the manufacturer.s PI (every 12 hours for oxycodone HCl controlled-release or every 72 hours for transdermal fentanyl). Other outcome measures included the number of oxycodone HCl controlled-release tablets per administration, the daily dose of long-acting opioid, the duration of adequate pain relief, and the difference in daily oral morphine equivalents between transdermal fentanyl and oxycodone HCl controlled-release patients, after adjusting in a multivariate regression model for demographic and clinical characteristics. RESULTS: A total of 690 patients were enrolled in this study; 437 (63.4%) received oxycodone HCl controlled-release and 253 (36.6%) received transdermal fentanyl. Oxycodone HCl controlled-release patients reported taking a median of 1 tablet 3 times per day or a median of 3 tablets per day. A mean of 1.6 tablets per administration and 4.6 tablets per day were taken. The average interval between administrations of oxycodone HCl controlled-release was 7.8 hours, and the median daily dose was 80.0 mg (mean 155.6 mg). Among oxycodone HCl controlled-release patients, 17.5% had an average interval between administrations of 12 or more hours, whereas 1.9% reported the duration of pain relief as 12 or more hours. Transdermal fentanyl patients reported wearing the patch, on average, for 2.5 days (median 2.5),and 41.2% reported wearing the patch for at least 3 days, whereas 14.1% reported the duration of pain relief as at least 3 days. The median daily dosage strength of transdermal fentanyl was 75.0 mcg/hour. In the multivariate regression analysis, oxycodone HCl controlled-release patients had, on average, roughly 22 mg additional oral morphine equivalents per day relative to transdermal fentanyl patients (not statistically significant); the probability that oxycodone HCl controlled-release patients had higher oral morphine equivalents was 82.6%, which suggests a trend toward higher oral morphine equivalents per day in the oxycodone HCl controlled-release group. CONCLUSION: Transdermal fentanyl and oxycodone HCl controlled-release both appear to be used by patients in a manner that is inconsistent with the standard recommendation in the manufacturers' PI;however, the difference between patient-reported utilization and the PI recommendation is more pronounced with oxycodone HCl controlled-release.
Administration, Cutaneous↗
Disposition of transdermally administered fentanyl in dogs.
OBJECTIVE: To evaluate the disposition of fentanyl after i.v. and transdermal administrations. The hypothesis was that transdermal administration of fentanyl would result in a measurable plasma opioid concentration. DESIGN: Each dog received 2 treatments in a randomized, crossover design. ANIMALS: 6 clinically normal Beagles. PROCEDURE: 2 treatments consisting of i.v. fentanyl (50 micrograms/kg of body weight) and transdermal fentanyl (50 micrograms/h) administrations. Plasma fentanyl concentrations were measured at fixed times, and pharmacokinetic values were calculated. RESULTS: Intravenous pharmacokinetics of fentanyl was similar to those previously described in dogs and provided the distribution and clearance data necessary to calculate the rate of absorption of the transdermally administered opioid. The transdermal fentanyl patch produced average steady-state concentrations of 1.6 ng/ml. The actual rate of delivery of transdermal fentanyl was 35.7 (range, 13.7 to 49.8) micrograms/h, which represented 71.48% (range, 27.45 to 99.56%) of the theoretical rate of delivery. The mean elimination half-life of fentanyl after patch removal was 1.39 hours. CONCLUSIONS: Transdermally administered fentanyl resulted in fairly constant plasma concentrations, in the range generally considered to be analgesic, from 24 to 72 hours after application of the patch. The rate of drug delivery was less than expected, and there was substantial individual variation. CLINICAL RELEVANCE: Transdermally administered fentanyl has the potential to be a clinically useful analgesic regimen in dogs, and further evaluation of its analgesic actions and potential side effects warranted
Absorption↗
Use and effectiveness of transdermal nicotine in primary care settings.
OBJECTIVE: To assess the use and effectiveness of transdermal nicotine patches by smokers receiving care in primary care settings. DESIGN: Telephone survey of a convenience sample of patients. SETTING: Primary care settings in western New York. SUBJECTS: Two hundred eighty-four adult members of an independent practice association health maintenance organization who received a prescription for transdermal nicotine between January 1, 1992, and June 30, 1992. MAIN OUTCOMES: Patient reports regarding advice received from physicians about the use of the nicotine patch, cessation methods used in addition to the patch, usual daily use of the patch, side effects experienced while wearing the patch, and smoking behavior while using the patch and after discontinuing therapy. RESULTS: Most patients reported getting proper advice from their physician about how to use the nicotine patch and possible side effects. The majority of those who used the patch said they used it every day for 24 hours. Side effects associated with using the patch were common but did not cause many subjects to discontinue therapy. Half of the patients who had completed patch therapy were not smoking, including 43% of patients who had not been using the patch for 4 months or longer. CONCLUSION: Transdermal nicotine patches appear to be an effective cessation aid for smokers receiving care outside specialized smoking cessation programs. Proper pretreatment screening to identify patients who are motivated to stop smoking is critical to the success of nicotine patch therapy.
Administration, Cutaneous↗
Application and maintenance habits do make a difference in adhesion of Alora transdermal systems.
OBJECTIVES: To explore and evaluate Alora placebo patch application and maintenance habits of women in order to identify the factors that influence adhesion success. METHODS: This single-center, open-label, placebo, randomized, multiple-application, parallel-group study involved 99 healthy naïve users of transdermal patches. Participants applied and wore an Alora placebo patch for ten consecutive applications of approximately 3.5 days each and evaluated adhesion of the patches twice-daily. Three subgroups comprising participants achieving low, moderate or high adhesion success took part in focus groups to discuss their wear habits, practices and attitudes regarding transdermal patches. RESULTS: There was a significant behavioral component involved in patch adhesion. The habits, practices and attitudes of high achievers were clearly different from the other two subgroups. The three most important issues identified to improve adhesion were: mastering the removal of the patch liner, identifying the best site of application, and developing and implementing techniques to maintain patch adhesion. The Alora placebo patch was well tolerated throughout the study. CONCLUSION: The data showed that there is a learning curve involved in achieving maximal adhesion with a transdermal patch. During the study, a novel patch application method ('press, fold and slide') was demonstrated for the participants. This method was very well received by all participants and was more easily executed than the previous method. An adaptation of this method was incorporated into the Alora patient information leaflet, together with several other changes to help improve adhesion success.
Adhesiveness↗
Haemodynamic studies with a phasic release nitroglycerin patch system.
The use of transdermal nitroglycerin (GTN) patches in patients with coronary artery disease is of uncertain value as numerous investigators have failed to confirm clinical efficacy for more than 8h. This relatively short duration of action is an indication of rapidly developing tolerance due to the relatively constant GTN plasma levels following GTN patch application. We investigated the efficacy of a newly developed GTN patch with a discontinuous release profile in 28 patients with coronary heart disease. Two hours after initial administration, pulmonary capillary wedge (PCW) pressure decreased by 25.7% at rest and by 25.1% during exercise. Cardiac index at rest decreased by 12.2%. No significant changes were observed in systemic blood pressure and heart rate. No significant haemodynamic effects were apparent after 24h. Following renewed GTN patch application, a decrease in PCW pressure occurred, similar to that observed after acute administration. After 1 week of daily therapy, similar changes were observed: 24h after patch application, PCW was similar to baseline values but showed a significant decrease 2h after patch re-application. These data suggest that the phasic release GTN patch is not associated with tolerance to the haemodynamic effects during sustained once daily therapy.
Administration, Cutaneous↗
[The survival indications of skin patch grafts].
Explore the source record for details and available documents.
Humans↗
Intermittent transdermal nitroglycerin therapy in angina pectoris. Clinically effective without tolerance or rebound. Minitran Efficacy Study Group.
BACKGROUND: The objectives of this study were to assess the antianginal and anti-ischemic effects of three dose levels of transdermal nitroglycerin patches applied for 12 hours daily for 30 days. The study also assessed the development of tolerance and rebound. Intermittent transdermal nitroglycerin therapy with a patch-free period of 10 to 12 hours each day has documented clinical benefits during the period of patch application, but studies have failed to clearly document prolonged exercise duration for the entire period of patch application. This study was designed to evaluate the efficacy and duration of action of a range of doses of nitroglycerin. The study also permitted the assessment of the maintenance of initial effects, the development of tolerance, and the presence of rebound. METHODS AND RESULTS: This study was a multicenter, randomized, double-blind, placebo-controlled parallel design trial with treadmill exercise tests at days 0, 1, 7, 15, and 30. Tests were carried out up to 12 hours after patch application. There was a statistically significant treatment effect with increases in treadmill walking time to moderate angina in each nitroglycerin patch group compared with placebo at various time points up to 12 hours throughout the 30-day study period. Secondary efficacy parameters, including the consistent increase in time to 1-mm ST-segment depression, supported the primary efficacy results. There was no evidence of tolerance or rebound. CONCLUSIONS: Intermittent transdermal nitroglycerin therapy increases exercise duration and maintains anti-ischemic effects for 12 hours after patch application, throughout 30 days of therapy, without significant evidence of nitrate tolerance or rebound phenomena.
Administration, Cutaneous↗
Predicting smoking cessation. Who will quit with and without the nicotine patch.
OBJECTIVE: To identify predictors of smoking cessation success or failure with and without transdermal nicotine patch treatment. DESIGN: Two independent randomized, double-blind, placebo-controlled studies using the nicotine patch assessing outcome at the end of treatment and at 6-month follow-up; each study used a different mode of adjuvant counseling. PATIENTS: Subjects were daily smokers (> or = 15 cigarettes per day), aged 21 to 65 years with expired air carbon monoxide levels of at least 10 ppm, and motivated to quit. Eighty-eight subjects participated in study 1, and 112 subjects participated in study 2. INTERVENTION: Study 1 consisted of 8 weeks of 22-mg nicotine patch therapy with intensive group counseling. Study 2 consisted of 4 weeks of 22-mg nicotine patch therapy and 2 weeks of 11-mg nicotine patch therapy with brief individual counseling. MAIN OUTCOME MEASURES: The prediction of smoking cessation (at end of treatment and after 6 months) based on pretreatment and intratreatment measures in smokers using active or placebo nicotine patches. RESULTS: Pretreatment markers, such as the Fagerstrom Tolerance Questionnaire score, number of cigarettes smoked per day, years smoked, expired air carbon monoxide level, or baseline blood nicotine and cotinine levels, showed no consistent relationship with successful smoking cessation across both studies. Of the intratreatment markers examined, withdrawal severity and nicotine replacement levels also were not consistently predictive of cessation success. However, any smoking during the second week of treatment was a consistent and powerful predictor of failure at the end of treatment and after 6 months. Among active nicotine patch patients who smoked at all during week 2 after quitting, 83% and 97% (studies 1 and 2, respectively) were smoking at 6-month follow-up. Conversely, abstinence during the second week of treatment predicted successful smoking cessation. Among active nicotine patch patients who were totally abstinent during week 2 after quitting, 46% and 41% (studies 1 and 2, respectively) were abstinent at 6-month follow-up. Of all nicotine patch patients in both studies who were smoking at 6-month follow-up, 74% began smoking during week 1 or 2. Among all placebo patch patients who were smoking at 6-month follow-up, 86% began smoking during week 1 or 2. CONCLUSIONS: Smoking status (abstinent or smoking) during the first 2 weeks of nicotine patch therapy, particularly week 2, was highly correlated with clinical outcome and can serve as a powerful predictor of smoking cessation. Early smoking behavior also predicted outcome among placebo patch users. Traditional measures of dependence are not consistently predictive of cessation success. Clinicians are advised to emphasize the importance of total abstinence after a quit attempt and to follow-up with patients within the first 2 weeks of quitting; smoking during this critical time should be assessed and treatment may be altered as appropriate.
Administration, Cutaneous↗
Transfer of transdermally applied testosterone to clothing: a comparison of a testosterone patch versus a testosterone gel.
AIM: To assess the amount of testosterone transferred from the abdominal application sites of a transdermal testosterone patch and a transdermal testosterone gel to cotton T-shirts worn for 24 hours during each treatment. METHODS: During a crossover study comparing the pharmacokinetics of a testosterone patch versus a testosterone gel in 28 hypogonadal men, subjects wore fresh cotton T-shirts for 24 hours on the seventh and fourteenth days of each treatment and during a 24-hour baseline period. At the end of each evaluation, the abdominal section of the shirt was carefully cut out, extracted in alcohol, and analyzed for testosterone by a direct radioimmunoassay. The minimum quantifiable amount of testosterone was 0.03 microg per T-shirt sample. RESULTS: The median amounts of extracted testosterone were 0.44 microg for the baseline samples, 25.4 microg for the average of the two patch samples, and 6,762.7 microg for the average of the two gel samples (all comparisons P < 0.0001). Significant correlations were observed between the day 7 and day 14 data for both the patch (R = 0.4982; P < 0.01) and the gel (R = 0.8383; P < 0.0001). No significant correlations were found between the baseline, patch, or gel data, or between these and any demographic or pharmacokinetic parameters. A quantitative interpretation of the findings suggests that the baseline results are consistent with the transfer of testosterone in sweat; the patch results are probably due to the transfer of a small amount of residual testosterone left on the abdominal skin from the prior day's patches; and the gel results reflect the desquamation of stratum corneum containing a portion of the abdominally applied testosterone. CONCLUSIONS: There are large differences in the amount of testosterone that can be transferred from the application sites of transdermal patches and gels. The latter should be covered with clothing to minimize transfer through intimate skin-to-skin contact.
Abdomen↗
Intranasal versus transdermal matrix oestrogen replacement in Australasian women.
OBJECTIVES: To compare the efficacy and patient acceptability of intranasal and transdermal 17beta-oestradiol delivery systems for postmenopausal symptoms in Australasian women. METHODS: Symptomatic postmenopausal women were randomly assigned to treatment with either intranasal 17beta-oestradiol, 300 microg daily (n = 66) or transdermal matrix patch 17beta-oestradiol, 50 microg/day (n = 66) for 12 weeks, followed by a 4-week period with the alternate treatment. Efficacy was compared between groups using the modified Greene climacteric scale, the menopause quality of life (MENQOL) questionnaire and vasomotor symptoms at week 12. Patient acceptability was compared by a satisfaction questionnaire at week 16 and patient preference at week 16. RESULTS: Intranasal and transdermal therapy produced significant reductions in both the Modified Greene and MENQOL scores, and in the occurrence of hot flushes and night sweats at week 12. The overall rate of reported vasomotor symptoms was lower on patients treated with the nasal spray. Both therapies were well tolerated with similar adverse event rates. Satisfaction and preference were similar for both modes of drug delivery. CONCLUSIONS: Intranasal oestradiol therapy route has comparable efficacy and safety to that of transdermal oestradiol matrix patch therapy with no difference in patient preference or satisfaction.
Administration, Cutaneous↗
[Bioavailability of 17 beta-estradiol after transdermal administration--dependence on the patch system].
The objective of this study was to compare the pharmacokinetics of serum estradiol concentrations after application of two different transdermal estradiol delivery systems. Ten postmenopausal women (E2 < or = 30 pg/ml; follicle-stimulating hormone > or = 30 mIE/ml) were prospectively randomized to a crossover treatment protocol separated by a 7-day wash out period. The absorption of estradiol was measured after application of a patch either containing 4.0 mg of E2 in a reservoir system or 1.8 mg of E2 in a specially designed matrix system. Although the increase of serum estradiol concentrations after application of the patches with the matrix system was slightly delayed, mean E2 levels over the whole observation period of 80 hours were significantly higher than those achieved with the reservoir system (difference of mean values: 5.1 pg/ml; p < 0.05). This observation was most striking at the end of the observation period and after removal of the patches. Yet, fluctuations of hormone concentrations were greater with the matrix system patches, and the areas under the E2 concentration-time curves were slightly but not significantly increased as compared to these of the patches with the reservoir system (3211 +/- 584 vs. 2556 +/- 249 pg/ml x h). In conclusion, both transdermal estradiol delivery systems are well suited for postmenopausal hormone substitution providing stable serum estradiol concentrations at about 50 pg/ml, with the matrix system possibly increasing the life span of the patch and thus the recommended application period.
Administration, Cutaneous↗
Transdermal clonidine compared with hydrochlorothiazide as monotherapy in elderly hypertensive males.
Sixteen of 22 elderly male patients (aged 60-74 years) who had previously taken only hydrochlorothiazide 50 mg completed a study evaluating the safety, efficacy, and tolerability of 12-20 weeks of transdermal clonidine (Catapres TTS) as monotherapy for mild hypertension. Thirteen of the sixteen patients (81%) responded to transdermal clonidine which was begun after 28 days of placebo. Five patients discontinued transdermal clonidine therapy because of intolerable skin irritation, and one because of daytime fatigue. Clonidine caused none of the metabolic effects we observed with hydrochlorothiazide: no change in serum potassium, uric acid, cholesterol, or triglyceride. Eleven of the 22 patients (50%) who began the study experienced a skin reaction under the transdermal clonidine patch. The incidence of dry mouth and fatigue in patients using transdermal clonidine was dose-related and similar to reports of dry mouth and fatigue in patients taking oral clonidine tablets. Rebound hypertension occurred in one patient upon withdrawal of transdermal clonidine. There was no effect of transdermal clonidine or hydrochlorothiazide on cognitive function or emotional state tested with three questionnaires. Overall, transdermal clonidine, in various doses, was as effective as hydrochlorothiazide in elderly male hypertensive patients. The effectiveness of both was inversely proportional to the level of untreated blood pressure. The high incidence of skin reactions limited prolonged use of transdermal clonidine in our patients.
Administration, Cutaneous↗
The route of administration influences the effect of estrogen on insulin sensitivity in postmenopausal women.
OBJECTIVE: To determine the effect of transdermal estrogen on insulin sensitivity in postmenopausal women and to compare this effect with changes observed with oral conjugated equine estrogens. DESIGN: Fourteen postmenopausal women were randomized to receive a transdermal E2 patch, 0.1 mg, for 25 days each month (n = 7) or transdermal E2 with added medroxyprogesterone acetate (MPA), 10 mg, from days 16 to 25 each month (n = 7). An insulin tolerance test (ITT) was performed at baseline and between days 23 and 25 during the 2nd month of treatment to assess insulin sensitivity. Values for the disappearance of glucose (K(itt)) were calculated and compared with values obtained from women receiving 1.25 mg of oral equine estrogens (n = 8). SETTING: University Clinical Research Center. PATIENTS: Healthy postmenopausal women not receiving hormonal replacement. INTERVENTION: Insulin tolerance tests before and after treatment. MAIN OUTCOME MEASURE: Disappearance of glucose and insulin (K(itt)) before and after treatment. RESULTS: Women receiving transdermal E2 alone demonstrated improved insulin sensitivity. The K(itt) glucose values increased by 13.2%, compared with a 23.9% decrease in K(itt) values observed with 1.25 mg of conjugated equine estrogen. The group treated with transdermal E2 and MPA had a reduction in insulin sensitivity. Insulin clearance was enhanced only with transdermal estrogen and was significantly delayed (blunted clearance) with the addition of MPA to transdermal E2 and with oral estrogen. CONCLUSION: We previously demonstrated a bimodal effect of oral equine estrogens on insulin sensitivity with an improvement occurring with the lower dose of 0.625 mg but with a deterioration with the dose of 1.25 mg. Here we suggest that this effect may be related to a first-pass hepatic-portal effect in that transdermal E2 (0.1 mg), which may be equated more closely with the larger dose of oral estrogen (1.25 mg), improved insulin sensitivity. Progestin, however, appeared to attenuate the beneficial effects of transdermal estrogen and may alter the clearance of insulin.
Administration, Cutaneous↗
[An unusual case of psychosis caused by long-term administration of a scopolamine membrane patch. Paranoid hallucinogenic and delusional symptoms].
We report on a psychosis caused by application of a transdermal scopolamine patch for over 15 days. In the literature there is no mention of a case in which scopolamine had such an influence nor are any cases reported in which paranoid-hallucinatory symptoms continued 11 days after removing the patch.
Administration, Cutaneous↗
Acute feasibility and safety of a smoking reduction strategy for smokers with schizophrenia.
The authors examined whether smoking while wearing a transdermal nicotine patch over 32 h was well-tolerated and led to smoking suppression in heavy smokers with schizophrenia. In a crossover design, 10 male veteran smokers with schizophrenia were admitted for two brief inpatient stays to smoke while wearing a transdermal nicotine or placebo patch. Carbon monoxide in expired air, self-reported cigarettes per day, nicotine plasma levels, and psychiatric ratings were measured. Nicotine levels increased during active patch treatment, without evidence of nicotine toxicity. Psychiatric symptoms, carbon monoxide and cigarettes per day did not change, although eight subjects had a decrease in expired carbon monoxide on the active patch. Dyskinesias showed a small, but significant, increase during smoking plus active patch. The heaviest smokers (identified by placebo phase nicotine plasma level or CO level above group median; n = 5) had a statistically significant decrease in expired carbon monoxide of at least 20%. Smoking while wearing the nicotine patch over 32 h was well tolerated. Significant decreases in carbon monoxide smoking indices were seen for the heaviest smokers. These findings suggest further investigation of a smoking reduction intervention in this population.
Administration, Cutaneous↗
Clinical benefit of transdermal glyceryl trinitrate when used with an eight hour patch-free period.
The 24-hour application of transdermal nitrate patches has been associated with rapid development of therapeutic tolerance. Recent reports suggest maintenance of clinical benefit by introducing a daily patch-free period. This study investigates, by means of serial treadmill testing, the efficacy of a new transdermal delivery system when used with an eight hour patch-free period in 16 subjects with chronic stable angina. Concomitant antianginal therapy was permitted. After demonstration of exercise test reproducibility and nitrate responsiveness, subjects entered a double-blind randomised placebo-controlled crossover trial comprising one week of active nitroglycerin patches (10mg/24hrs) and one week of an identical placebo patch. Exercise tests were conducted four hours after patch application on the last day of each of the treatment arms. Daily angina frequency and nitroglycerin consumption were also monitored. There was significant improvement in total exercise duration (16.5%), time to onset of angina (26%), time to 1mm ST depression (22%), and peak heart rate blood pressure product with active patch application. Angina frequency was reduced during the week of active therapy. These results demonstrate the additional efficacy of intermittent transdermal nitroglycerin in a group of subjects with continuing angina despite therapy with beta-blockers and calcium antagonists.
Administration, Cutaneous↗