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PubMed1992

[A double-blind trial of nicotine patches in smoking cessation].

The use of nicotine chewing gum combined with psychological support improves the success rate in stopping smoking. We studied the safety and efficacy of a transdermal nicotine patch in stopping smoking. We conducted a double-blind randomized study comparing the effect 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. The rates of sustained abstinence were significantly better with active treatment than with the placebo: 53, 41, 24 and 17% 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% 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 withdrew from the study because of side effects. The nicotine skin patch proved to be safe and effective, as demonstrated by a higher rate of abstinence than with the placebo.

Administration, Cutaneous↗
PubMed1987

[Discontinuous drug release as an alternative to interval therapy in the treatment of coronary heart disease with nitroglycerin patches].

In ten patients with angiographically-documented coronary artery disease, according to a double-blind, placebo-controlled protocol, the antiischemic and antianginal actions of a new transdermal nitroglycerin patch system with discontinuous drug release (7.5 mg/24 hours, two-thirds of which is released within the first twelve hours) were assessed on three consecutive days to determine whether effective longterm treatment is possible (Figure 1). At 2.5 hours after initial application, as compared with placebo, the active drug led to a reduction in exercise-induced ST-segment depression of 55.9% (p less than 0.001; Figure 2), the exercise capacity to onset of 1 mm ST-segment depression increased 129% (p less than 0.05; Figure 3), angina pectoris during exercise was incurred in only 20% of the patients (Figure 4). At twelve hours, the corresponding effects were attenuated at -44%, +114% and +60%. 24 hours after patch application, an appreciable effect could no longer be detected. After renewed patch application on the second day, as compared with the initial application, the actions on ST-segment depression and exercise capacity were diminished about 20%. Similarly, there was an increase in the number of patients who developed angina during exercise. At twelve hours, there was more marked attenuation of the effects on all three parameters than that which had already been observed on the first day. At 24 hours, there were no significant effects. At 2.5 hours after renewed patch application on the third day, the effects on ST-segment depression, exercise capacity and incurrence of angina pectoris were essentially similar those seen after the second application.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Cutaneous↗
PubMed2006

[No potentiation of fentanyl by use of transdermal buprenorphine in patients undergoing fast-track anesthesia for open-heart surgery].

OBJECTIVE: Simultaneous use of opioids with a different pharmacological profile may lead to unexpected prolongation of effects. In an open label study possible overhang in post-operative respiratory effects and vigilance was determined in a group of patients (n = 22) carrying a transdermal buprenorphine patch for at least 2 months for treatment of chronic pain, undergoing a fentanyl-based fast-track enflurane anesthetic technique for open-heart operation. Data was compared with another randomised group (n = 21) undergoing similar open-heart procedures with no other opioid than fentanyl on board. METHODS AND RESULTS: Following induction with fentanyl and a barbiturate, depth of anesthesia with enflurane (Fi 0.5) was guided using the bispectral index (BIS). Additional doses of fentanyl were given when blood pressure and/or heart-rate increased 20% above pre-induction levels. Early postoperative extubation was initiated once the cardiovascular system was stable and there were no signs of respiratory impairment. Following a similar time of operation and anesthesia and a similar total dose of fentanyl (0.69 mg +/- 0.23 SD versus 0.67 mg +/- 0.16 SD), postoperatively, there were no significant differences between the buprenorphine- and the control group regarding the time till extubation (25.2 min +/- 6.1 versus 33.3 min +/- 5.0) and the arterial blood gases under oxygen inhalation (paO2 136 torr +/- 48 SD versus 128 torr +/- 35 SD; paCO2 43.3 torr +/- 3.3 SD versus 41.9 torr +/- 1.2 SD and the post-anesthetic vigilance and recovery score (6.8 +/- 1.0 versus 7.5 +/- 0.8) 60 minutes after end of anesthesia. Contrary to the control group, there was a lower and significant (p < 0.01) incidence of PONV in patients with transdermal buprenorphine. CONCLUSION: Patients using a buprenorphine patch for the relief of chronic pain cannot be regarded as opioid naïve. Due to adaptive mechanisms and the development of tolerance, there is no prolongation of the respiratory depression induced by intraoperative fentanyl. Long-term use of transdermal buprenorphine does not lead to potentiation or prolongation of opioid effects in cardiac surgery patients.

Administration, Cutaneous↗
PubMed1991

The use of transdermal scopolamine to control drooling. A case report.

Drooling is a serious social handicap experienced by some neurologically impaired patients. No one method has been identified to control drooling for all patients, however, anticholinergic drugs recently have been utilized. In the case study described, transdermal scopolamine patches were found to be effective for controlling drooling in a traumatic brain-injured patient for whom more conservative methods failed. From a baseline saliva flow rate, saliva flow decreased an average of 30% with one-patch and 59% with two-patch dosing. No significant side effects were observed with treatment, and the decrease in drooling was maintained for a 4-month period. Although transdermal scopolamine may represent one acceptable facet of long-term treatment, it must be stressed that efficacy is variable across patient populations and that treatment approaches must be individualized.

Administration, Cutaneous↗
PubMed1996

Transdermal modification of platelet function: an aspirin patch system results in marked suppression of platelet cyclooxygenase.

Aspirin inhibits platelet cyclooxygenase and prevents thromboxane A2 (TXA2) production. Although it is an effective antithrombotic, even at a low doses aspirin may induce gastrointestinal toxicity. We examined the feasibility of delivering aspirin transdermally using two patch systems, one without (type A) and one with (type B) the permeation enhancer limonene. Daily application of two type A patches that had a total surface area of 100 cm2 and contained 84 mg/patch resulted in 85% +/- 6% reduction in serum TXB2 in six male subjects by day 14. Suppression of serum TXB2 was less marked in females (32% +/- 16%). Analysis of the residual drug in the patch showed that each patch delivered 18 +/- 3 mg on day 1 and 17 +/- 4 mg on day 14, with no difference between males and females. Daily application of a single patch B that had a surface area of 50 cm2 and contained 120 mg aspirin resulted in 60% +/- 11% suppression of serum TXB2 by day 14 in nine male subjects and 84% +/- 9% suppression by day 21. Analysis of the applied patches showed that patch B delivered 33 +/- 3 mg of aspirin daily. Plasma aspirin and salicylate were determined by gas chromatography, mass spectrometry. No aspirin was detected, whereas plasma salicylate was 157 +/- 38 ng/ml and 133 +/- 20 ng/ml by day 14 with patch A and patch B, respectively. Analysis of aspirin applied by patch to the skin in three subjects showed marked hydrolysis to the inactive product, salicylic acid. Aspirin can be delivered transdermally by patch in a dose that suppresses platelet cyclooxygenase. The delivery rate is low reflecting hydrolysis of the drug in the skin. Delivery is improved by the permeation enhancer limonene. This novel route of delivery may be applicable to other antithrombotics and may limit the risk of gastrointestinal toxicity.

Administration, Cutaneous↗
PubMed2001

Three-year follow-up of the use of transdermal 17beta-estradiol matrix patches for the prevention of bone loss in early postmenopausal women.

OBJECTIVE: A total of 325 of 569 postmenopausal women who were initially recruited into two 2-year, double-blind, placebo-controlled, dose-ranging studies of a matrix transdermal formulation of 17beta-estradiol (Menorest) participated in open-label extensions for a third year. STUDY DESIGN: Those patients originally randomly assigned to receive 17beta-estradiol continued active treatment with dosages of 25, 50, 75, or 100 microg/d, whereas those originally randomly assigned to receive a placebo patch were switched to an active patch of identical size that delivered 17beta-estradiol at 25, 50, 75, or 100 microg/d. Follow-up was conducted, and bone density and other parameters were compared. RESULTS: Overall, gains in bone mass were maintained in patients who received 3 years of active treatment. In patients originally randomly assigned to receive placebo, initial losses in bone mass during the first 2 years were reversed and replaced with marked increases after the switch to active treatment. All patients who had initially received placebo showed significant, dose-related, clinically relevant increases (2.77% +/- 0.99%; P =.0048; to 7.36% +/- 0.74%; P =.0001) in lumbar spine bone mineral density relative to the end of the second year of the original study; smaller final-year increases were noted among the patients who had been actively treated for all 3 years. Similar trends were reported for femoral, trochanter, and total hip bone mineral densities. Mean total body bone mineral density either increased or remained unchanged in all dosage groups. These results were accompanied by parallel changes in levels of serum and urinary markers of bone turnover, with all markers approaching or returning to premenopausal levels by month 36. The high tolerability of this formulation during years 1 and 2 was maintained during year 3; 5.5% of patients withdrew from treatment because of adverse events in the final year. CONCLUSION: The Menorest formulation of transdermal 17beta-estradiol maintained bone mineral density gains in postmenopausal women and was well tolerated through a 3-year treatment period. It was also effective in reversing the initial bone loss associated with late commencement of therapy.

Absorptiometry, Photon↗
PubMed1993

Effectiveness of a nicotine patch in helping people stop smoking: results of a randomised trial in general practice. Imperial Cancer Research Fund General Practice Research Group.

OBJECTIVE: To assess the effectiveness of 12 weeks' treatment with a 24 hour transdermal nicotine patch in helping heavy smokers to stop smoking; also to assess the value of a specially written support booklet about smoking cessation and patch use compared with a simple advice pamphlet. DESIGN: Double blind placebo controlled randomised trial with a 2 x 2 factorial design. SETTING: 19 general practices in Oxfordshire. SUBJECTS: 1686 heavy smokers aged 25-64 (mean cigarette consumption 24/day; mean duration of smoking 25 years). MAIN OUTCOME MEASURE: Sustained cessation for the last four weeks of the 12 week treatment period, confirmed by saliva cotinine estimation (226/262 cases; 86.3%) or expired carbon monoxide concentration (36/262; 13.7%). Patients lost to follow up (155/1686; 9%) were assumed to have continued to smoke. RESULTS: Cessation was confirmed in 163 patients (19.4%) using the nicotine patch and 99 patients (11.7%) using the placebo patch (difference 7.6% (95% confidence interval 4.2% to 11.1%); p < 0.0001). There was no significant advantage in using the more detailed written support material. The most important adverse effect of the patch was local skin irritation, which occurred in 15.8% (133/842) and 5.1% (43/844) of patients using the nicotine and placebo patches respectively, was graded as severe in 4.8% (40) and 1.1% (nine), and was stated as a reason for withdrawal from the trial in 9.5% (80) and 2.8% (24). CONCLUSION: Nicotine patches are effective in a general practice setting with nursing support, but the extent to which this effect is sustained cannot be assessed until the results of longer term follow up are known.

Administration, Cutaneous↗
PubMed2001

Transdermal fentanyl therapy for pains in children with infantile neuronal ceroid lipofuscinosis.

We used infantile neuronal ceroid lipofuscinosis (INCL), in which deterioration of the central nervous system is extremely rapid, to study constant release of an opioid for pains of central origin in a metabolic disease. The effect of a transdermal fentanyl patch was studied in five children with INCL. In two of them, measurements of 17 fentanyl serum concentrations and also visual analogue pain scale were obtained during a 15-day study period. Low doses of transdermal fentanyl usually provided good pain relief for the first two days, but not for the third day, of the three-day patch change interval. Pain relief of this type seems mandatory for pains mostly of central origin.

Administration, Cutaneous↗
PubMed2005

Transdermal delivery of naloxone: skin permeation, pharmacokinetic, irritancy and stability studies.

The current investigation aims to evaluate ex vivo, in vivo performance, stability and irritancy potential of a transdermal formulation of naloxone (NLX) developed at our laboratory at different concentrations (10, 20 and 30mg/g of gel) in a transdermal reservoir patch. Ex vivo permeation studies were performed by employing porcine and rat skins. In vivo performance was assessed in Sprague-Dawley rats by single and multiple application of the patch. Further stability of the formulation was established for 3 months at accelerated stability conditions as per ICH guidelines. Amongst the barriers used the rat skin was found to be more permeable than the porcine epidermis and the flux across each barrier increased with increasing thermodynamic activity of drug in the gel. Based on ex vivo data, the surface area (SA) of the patch was predicted to be 39.6 cm(2) in order to achieve therapeutic blood levels. Upon single dose administration, the steady-state levels were maintained from 4-48 h, which proves the clear advantage of transdermal delivery system over the current mode of administration, i.e., intravenous (i.v.) bolus which is effective upto a maximum of 1.5h. Upon multiple dose administration, the sustained steady state for 12h, even after patch removal proves the formation of drug depot in the skin. The formulations were found to be stable with respect to NLX assay and penetration enhancer efficacy upto 3 months under accelerated stability conditions. The alteration of penetration barrier function, as evidenced by increased trans epidermal water loss (TEWL) was not accompanied by any significant amount of skin irritation measured using laser doppler velocimetry (LDV). The developed transdermal delivery system of NLX is efficacious, stable and safe upon single and multiple dose applications each lasting for 48 h.

Administration, Cutaneous↗
PubMed1994

Scopolamine improves autonomic balance in advanced congestive heart failure.

BACKGROUND: Sympathetic hyperactivity and parasympathetic withdrawal in patients with congestive heart failure correlate closely with disease severity and overall survival. The modulating effects of drugs on the autonomic dysfunction may contribute to improve survival. Low-dose scopolamine has a vagomimetic effect in normal subjects and patients after acute myocardial infarction. We assessed whether transdermal scopolamine would increase vagal activity in patients with congestive heart failure. METHODS AND RESULTS: Heart rate variability was assessed at baseline, 24 hours after one patch of transdermal scopolamine, and 48 hours after scopolamine withdrawal in 21 patients with moderate to severe heart failure. Scopolamine increased both time- and frequency-domain parameters of heart rate variability. Specifically, the mean RR interval and its SD increased by 5.5% (P < .001) and 45% (P < .001), respectively. The change remained significant when corrected for mean heart rate with a 39% (P < .01) increase of the coefficient of variation. The absolute power of the high-frequency component was also significantly augmented. All the parameters returned to baseline after scopolamine withdrawal. Individual analysis showed that in the 7 patients in whom scopolamine did not increase mean RR interval, heart rate variability did not change. CONCLUSIONS: Transdermal scopolamine increases vagal activity as assessed by heart rate variability in patients with congestive heart failure. This autonomic modulation does not occur in all patients and can be predicted by RR interval changes. Whether such restoration of the autonomic balance might have beneficial effects in the long-term management of patients with congestive heart failure remains to be determined.

Administration, Cutaneous↗
PubMed1999

Differential effect of transdermal estrogen plus progestagen replacement therapy on insulin metabolism in postmenopausal women: relation to their insulinemic secretion.

OBJECTIVE: To evaluate the impact on glucose and insulin metabolism of transdermal estrogen patches before and after the addition of cyclic dydrogesterone in postmenopausal women. DESIGN: We studied 21 postmenopausal women seeking treatment for symptomatic menopause. All patients received transdermal 50 micrograms/day estradiol for 24 weeks. After 12 weeks of treatment, 10 mg/day dydrogesterone were added. METHODS: During both regimens, insulin and C-peptide plasma concentrations were evaluated after an oral glucose tolerance test (OGTT); insulin sensitivity was evaluated by a hyperinsulinemic euglycemic clamp technique. Insulin and C-peptide response to OGTT were expressed as area under the curve (AUC) and as incremental AUC; insulin sensitivity was expressed as mg/kg body weight. Fractional hepatic insulin extraction (FHIE) was estimated by the difference between the incremental AUC of the C-peptide and insulin divided by the incremental AUC of the C-peptide. Plasma hormone and lipid concentrations were assessed at baseline and at 12 and 24 weeks of treatment. RESULTS: Nine patients proved to be hyperinsulinemic and 12 were normoinsulinemic. Transdermal estrogen treatment significantly decreased the insulin AUC (P < 0.05) and the insulin incremental AUC in hyperinsulinemic patients; addition of dydrogesterone further decreased both the AUC and incremental AUC of insulin. Estrogen alone and combined with dydrogesterone evoked a significant increase in C-peptide AUC in hyperinsulinemic (79.2%) and normoinsulinemic (113%) patients. The treatment increased the values for FHIE and insulin sensitivity in all patients (P < 0.04) and in the hyperinsulinemic group (P < 0.01), whereas it did not affect such parameters in normoinsulinemic patients. CONCLUSIONS: Transdermal estrogen substitution alone and combined with cyclical dydrogesterone may ameliorate hyperinsulinemia in a selected population of postmenopausal women.

Administration, Cutaneous↗
PubMed2005

Clinical efficacy and safety of transdermal tulobuterol in the treatment of stable COPD: an open-label comparison with inhaled salmeterol.

BACKGROUND: Long-acting bronchodilators are recommended for the management of stable COPD to relieve symptoms and improve quality of life. The tulobuterol patch (Hokunalin) is a transdermal patch preparation of the beta2-adrenoceptor agonist (beta2-agonist) tulobuterol designed to yield sustained beta(2)-agonistic effects for 24 hours when applied once daily. OBJECTIVE: To compare the effectiveness of tulobuterol patch and inhaled salmeterol (Serevent Diskus) in the treatment of stable COPD. STUDY DESIGN: Clinically stable COPD patients (age > or = 40 years, postbronchodilator FEV1/FVC <70%, and postbronchodilator FEV1 <80% predicted) were enrolled in a multicenter, open-label randomized study. After a 2-week run-in period, patients were administered either tulobuterol (2mg once-daily applied as a patch) or salmeterol (50 microg per inhalation, twice a day) for 12 weeks. RESULTS: Data for 92 patients (46 each for each treatment group) were analyzed. There were no significant differences in baseline characteristics in the tulobuterol versus salmeterol groups: age, 69.2 +/- 7.4 vs 71.6 +/- 7.3 years; male, 91% versus 96%; and patients with stage II (III) COPD, 32.6% (67.4%) versus 50% (50%). FEV1, FVC, and PEF improved during treatment in both groups compared with baseline, with no significant between group differences. The total St George's Respiratory Questionnaire (SGRQ) score was significantly improved relative to baseline in the tulobuterol group at 8 weeks (-4.7 units [U]), but not in the salmeterol group at all timepoints. Domain analysis of the SGRQ scores revealed significant improvement in the symptom score relative to baseline in the tulobuterol group at weeks 4 (-6.9U), 8 (-12.0U), and 12 (-11.7U), but not in the salmeterol group in any of the domains tested. Medical Research Council dyspnea scale score improved during treatment in both groups, with no significant differences between groups. Compliance with the treatment regimen was significantly better in the tulobuterol than in the salmeterol group (98.5% vs 94.1%; p < 0.05). CONCLUSION: These findings indicate that once-daily transdermal sustained-release tulobuterol is as effective or better than the inhaled long-acting beta2-agonist salmeterol in the management of stable COPD, with significant effects on quality of life.

Administration, Cutaneous↗
PubMed2002

Nicotinic treatment for cognitive dysfunction.

Nicotinic medications may provide beneficial therapeutic treatment for cognitive dysfunction such as Alzheimer's disease, schizophrenia and attention deficit hyperactivity disorder (ADHD). For development of nicotinic treatments we are fortunate to have a well characterized lead compound, nicotine. Transdermal nicotine patches offer a way to deliver measured doses of nicotine in a considerably safer fashion than the more traditional means of administration, tobacco smoking. We have found that transdermal nicotine significantly improves attentional function in people with Alzheimer's disease, schizophrenia or ADHD as well as normal nonsmoking adults. To follow-up on this proof of principal that nicotinic treatment of cognitive dysfunction holds promise, it is important to use animal models to determine the critical neurobehavioral bases for nicotinic involvement in cognitive function so that more selective nicotinic analogues that improve cognitive function with fewer side effects can be developed. We have found with local infusion in rat studies that the hippocampus and amygdala are important substrates for nicotinic effects on working memory function. Both alpha7 and alpha4beta2 nicotinic receptors are involved in working memory. Nicotinic interactions with dopaminergic and glutaminergic systems are also important in the basis of cognitive function. Studies of the neural nicotinic mechanisms underlying cognitive function are key for opening avenues for development of safe and effective nicotinic treatments for cognitive dysfunction.

Alzheimer Disease↗
PubMed1990

The influence of microwave radiation on transdermal delivery systems.

It has been alleged that the exposure of a transdermal delivery system to leakage of microwave radiation from a domestic microwave oven can result in the user receiving a second-degree burn in the area of the patch. Several transdermal delivery systems were exposed to microwave radiation from an Electro Medical Supplies Microtron 200 microwave diathermy unit. Temperature rises of up to 2.2 degrees C were recorded at a maximum power density of 800 W/m2. These temperature rises were considered insignificant compared to that required to produce a burn. The exposure of transdermal delivery systems to a microwave diathermy field or lower level leakage radiation from a microwave oven is unlikely to cause direct thermal injury to the wearer.

Administration, Cutaneous↗