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PubMed2003

Effects of patch or gel estrogen therapies on auditory brainstem response in surgically postmenopausal women: a prospective, randomized study.

OBJECTIVE: To study the effects of gonadal steroids on the nongenital audiological target in surgically postmenopausal women treated with patch or gel transdermal estrogen therapy (ET). DESIGN: Prospective randomized study. SETTING: Research Group for Sexology, University of Catania, Italy. PATIENT(S): One hundred twenty-two surgically postmenopausal women. INTERVENTION(S): Transdermal E(2) by patch or gel, and evaluation of auditory brainstem response by auditory-evoked potentials for waves I, III, and V latencies, and for interpeak I-III, I-V, and III-V intervals. MAIN OUTCOME MEASURE(S): Changes in auditory wave latencies and in interpeak intervals during treatment with ET with respect to baseline levels. RESULT(S): One hundred two women completed the study. Forty-eight subjects used E(2) patches and 54 E(2) gel. No significant difference was observed in plasma E(2) improvement and in auditory brainstem response values with the two estrogen (E) formulations. The wave latencies and the interpeak intervals showed lower values during the E treatment than at baseline. CONCLUSION(S): Auditory brainstem response seems to depend on the type of E given. Our data suggest that fluctuating E levels act on waves, even if the exact mechanism of the gonadal steroids is not clear. However, we believe that E could influence neuronal plasticity, the metabolic levels of neurotransmitters, and thus, the neuronal conduction time into the audiological system.

Administration, Cutaneous↗
PubMedDate not supplied

A comparative evaluation of two transdermal nitroglycerin delivery systems: Nitro-Dur versus Transderm-Nitro. The Collaborative Investigation Group.

A paired-comparison, multicenter study examined differences in patient and physician preferences for two transdermal nitroglycerin delivery systems, Nitro-Dur Transdermal Infusion System and Transderm-Nitro Transdermal Therapeutic System. For two weeks, 72 patients with angina pectoris wore both transdermal nitroglycerin patches simultaneously, each patch delivering half of each patient's need for nitroglycerin. (Each patch delivers nitroglycerin to the skin at a rate of about 0.02 mg/cm2 of patch per hour.) The patients and their physicians were then asked to rate the patches and to express their preferences with respect to eight patch characteristics: size, color, comfort, ease of application, adhesiveness, ease of removal, appearance, and associated redness/irritation. On each of the patch characteristics, significantly more of the patients expressed a preference for Nitro-Dur. Of the 67 patients who rated the patches overall, significantly more preferred Nitro-Dur (47 patients) than Transderm-Nitro (17 patients). Physician evaluations were also significantly biased in favor of Nitro-Dur. Treatment side effects included headache in 17 patients, application-site reactions in seven, nausea in four, dizziness in three, and fatigue in two. It is concluded that Nitro-Dur has greater patient acceptance than Transderm-Nitro and thus treatment compliance may be higher with Nitro-Dur than with Transderm-Nitro.

Administration, Cutaneous↗
PubMed1985

[Therapy of coronary heart disease with nitroglycerin patches. Behavior of anti-ischemic effectiveness in continuous administration and following patch free interval].

Subsequent to the finding of a rapidly attenuated anti-ischemic effect on use of high-dose nitroglycerin patch treatment in patients with coronary artery disease as well as contradictory results obtained with low-dose patch treatment, there are still no reliable guidelines for the use of transdermal nitroglycerin patch therapy. Accordingly, this study was carried out in ten patients with angiographically-documented coronary artery disease, stable exercise-induced angina pectoris and reproducible ST-segment depression, to assess the extent and duration of antianginal and anti-ischemic action of nitroglycerin patch treatment at an intermediate dosage of 15 mg/24 hours after the initial application, after renewed patch application on the second day and after patch application on the third day which had been preceded by a ten-hour patch-free interval in the night. At 2.5 hours after initial application of the nitroglycerin patch there was a 64% reduction in exercise-induced ST-segment depression from 2.6 mm +/- 0.21 (SEM) to 0.93 mm +/- 0.29 (p less than 0.001) (Figures 1 and 2). The exercise capacity to onset of 1 mm ST-segment depression was increased 132% from 191 watt X min +/- 15 (SEM) to 442 watt X min +/- 47 (p less than 0.001), (Figure 3). Eight hours after the initial patch application, exercise-induced ST-segment depression was reduced 37% from 2.6 mm +/- 0.19 to 1.65 mm +/- 0.18 (p less than 0.01); the exercise capacity to onset of 1 mm ST-segment depression was increased 39% from 178 watt X min +/- 18 to 245 watt X min +/- 19 (p less than 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Topical↗
PubMed2000

Efficacy and tolerability of fully transdermal hormone replacement in sequential or continuous therapy at two doses of progestogen in postmenopausal women.

OBJECTIVES: Two randomized open-label studies were performed to evaluate fully transdermal hormone replacement therapy (HRT) with oestradiol (E2) and norethisterone acetate (NETA) in postmenopausal women. METHODS: Both hormones were delivered by transdermal matrix patches changed twice weekly. Subjects received E2, 50 microg/day and NETA, 170 microg/day or 350 microg/day, either continuously or sequentially. A one-year study (13 cycles of 28 days), including a reference regimen of transdermal E2 and sequential oral progestogen, was followed by a continuation study for a further year in 367 women. RESULTS: All regimens were highly and equally effective in the prevention of hot flushes. The fully transdermal regimens were associated with beneficial changes in the lipid profile. The sequential regimens provided effective scheduling of bleeding around the end of the progestogen phase. The continuous regimens were associated with irregular bleeding, which was rarely severe, and a gradually increasing incidence of amenorrhoea. With sequential or continuous therapy, bleeding was less severe at the lower dose of progestogen than at the higher dose. No endometrial hyperplasia was detected by biopsy in any treatment group. One serous endometrial carcinoma and one endometrial adenocarcinoma were detected. An endometrial thickness >5 mm did not predict the presence of hyperplasia at biopsy. Hormone-related adverse events were typical of those expected for HRT and dermal tolerability of the patches was good. CONCLUSIONS: Fully transdermal sequential or continuous HRT is effective and well tolerated in postmenopausal women. The lower dose of NETA may be preferable, because it confers adequate endometrial protection at a lower dose of progestogen.

Administration, Cutaneous↗
PubMed1991

Stable isotope method for studying transdermal drug absorption: the nicotine patch.

A stable isotope-labeled drug method was used to determine the absolute bioavailability and absorption kinetics of a transdermal nicotine-delivery system (TTS). TTSs are being developed as an adjunct to smoking-cessation therapy. Deuterium-labeled nicotine was infused for 24 hours simultaneously to TTS application in cigarette-abstinent smokers. In 11 subjects with good patch adhesion, an average systemic dose of 19 mg nicotine was delivered, with average absolute bioavailability of 82%. The rate of nicotine absorption was maximal between 6 and 12 hours after TTS application and declined thereafter, plateauing between 16 and 24 hours at 62% of the maximal rate. Ten percent of nicotine was absorbed after the TTS was removed, demonstrating a reservoir for nicotine in the skin. Our study demonstrates the applicability of stable isotope methods in understanding the clinical pharmacology of transdermal drugs.

Administration, Cutaneous↗
PubMed2003

Transdermal testosterone for women: a new physiological approach for androgen therapy.

Transdermal testosterone patches and topically applied gels have become well accepted for the treatment of testosterone deficiency in men and are currently being developed in appropriate dosage strengths for androgen therapy in women. The furthest developed among these products is an investigational testosterone matrix patch which is now in phase III clinical trials for the treatment of sexual dysfunction in oophorectomized and naturally menopausal women. This review article discusses the biopharmaceutical rationale for the transdermal delivery of testosterone to women, illustrates and quantitatively analyzes the pharmacokinetics and metabolism of the testosterone matrix patch and a recently investigated testosterone gel, and summarizes the efficacy and safety data that have been reported in phase II studies of the testosterone matrix patch in surgically menopausal women with sexual dysfunction and HIV-infected women with the AIDS wasting syndrome. The different effects of oral and transdermal estrogen therapy (ET) on the concentrations of total and free testosterone attained with the testosterone matrix patch are contrasted. Although still in development, transdermal testosterone therapy appears to be a promising new approach for providing physiologically based androgen therapy to women.

Administration, Cutaneous↗
PubMedDate not supplied

Nicotine patches improve mood and response speed in a lexical decision task.

The effects of smoking a cigarette or wearing a transdermal nicotine patch on mood and lexical decision-making were tested in eight smokers. Each participant was tested after 4 hours of smoking abstinence, under 4 conditions: placebo (very low nicotine) cigarette, nicotine cigarette, placebo patch, and nicotine patch. Relative to placebo, wearing the nicotine patch reduced Profile of Mood States (POMS) Total Mood Disturbance and Fatigue/Inertia scores, while increasing the speed of some types of lexical decisions. Smoking a nicotine cigarette did not affect reaction times, but unexpectedly decreased the accuracy of Word/ Nonword lexical decisions. Thus, transdermal nicotine may improve mood and facilitate longterm memory search and/or attentional processes in nicotine-deprived smokers.

Administration, Cutaneous↗
PubMed2001

Transdermal nicotine and haloperidol in Tourette's disorder: a double-blind placebo-controlled study.

BACKGROUND: Preclinical animal and open-trial clinical trials using nicotine gum and the transdermal nicotine patch found that treatment with nicotine potentiates the effects of neuroleptics in reducing the dyskinetic symptoms of Tourette's disorder. We sought to verify and expand these findings in a prospective double-blind placebo-controlled trial. METHOD: Seventy patients with DSM-IV Tourette's disorder were treated with either transdermal nicotine (7 mg/24 hours) or placebo patches in a 33-day, randomized, double-blind study. Each patient received an individually based optimal dose of haloperidol for at least 2 weeks prior to random assignment to nicotine or placebo treatment. A new patch was worn each day for the first 5 days. On the sixth day, the dose of haloperidol was reduced by 50%. Daily patch applications were then continued for an additional 2 weeks (through day 19), at which time the patch was discontinued, but the 50% dose of haloperidol was continued for an additional 2 weeks (through day 33). Clinical and safety assessments were made at each visit. RESULTS: Patients who completed all 19 days of nicotine (N = 27) or placebo (N = 29) patch treatment were used in efficacy analyses. As documented by the Clinician- and Parent-rated Global Improvement scales, transdermal nicotine was superior to placebo in reducing the symptoms of Tourette's disorder. The Yale Global Tic Severity Scale was less sensitive in detecting a placebo/drug difference than were the global improvement scores, suggesting that some of the improvement may not have been related to treatment-related changes in tic severity, but to the emotional and behavioral symptoms. The side effects of nausea and vomiting were significantly more common in the nicotine group (71% [N = 25] and 40% [N = 14]) than in the placebo group (17% [N = 6] and 9% [N = 3]) (nausea, p = .0001; vomiting, p = .004). CONCLUSION: Transdermal nicotine was superior to placebo in reducing behavioral symptoms when patients were receiving an optimal dose of haloperidol, when the dose of haloperidol was reduced by 50%, and when the patch had been discontinued for 2 weeks. These findings confirm earlier open-label findings and suggest that combining nicotinic receptor modulation and neuroleptics could be a therapeutic option for the treatment of Tourette's disorder. While side effects limit chronic use of nicotine, it may be useful on a p.r.n. basis. Further clinical research is warranted to investigate the use of novel nicotinic receptor modulating agents with improved safety profiles over nicotine.

Administration, Cutaneous↗
PubMed1997

Nicotine for the treatment of Tourette's syndrome.

Recent evidence has demonstrated that nicotine may obtund the symptoms of Tourette's syndrome (TS). TS is a neuropsychiatric disorder characterized by motor and vocal tics, obsessions and compulsions, and frequently with impulsivity, distractibility, and visual-motor deficits. While neuroleptics, such as haloperidol, are most effective for treatment of the motor and vocal tics of TS, these medications have many side effects. In this article, we review the evidence, consistent with findings in animals, that administration of nicotine (either 2 mg nicotine gum or 7 mg transdermal nicotine patch) potentiates the therapeutic properties of neuroleptics in treating TS patients and that a single patch may be effective for a variable number of days. These findings suggest that transdermal nicotine could serve as an effective adjunct to neuroleptic therapy for TS.

Adolescent↗
PubMed2006

Performance of contraceptive patch compared with oral contraceptive pill in a high-risk population.

OBJECTIVE: To evaluate the potential benefit of the transdermal contraceptive patch compared with the oral contraceptive pill for its acceptability and compliance in a population at high risk for future unintended pregnancies and abortions. METHODS: Assessment of the contraceptive patch and pill was prospective. We gathered information on women undergoing contraceptive counseling at three Planned Parenthood clinics. Discontinuation, adverse effects, and pregnancy outcomes were catalogued. The primary outcome was time to discontinuation of the patch or pill. Survival analyses with life tables and Cox proportional hazards were used to assess acceptability and compliance. Pearl indices were calculated for both the pill and patch. RESULTS: A total of 1,230 contraceptive-naïve women were identified. Subjects were a racially diverse group of primarily single women. Eighty-nine percent of the study population met our definition of being at high risk for a future unintended pregnancy or pregnancy termination. Loss to follow-up was higher among patch users (45.2% versus 29.5%, P<.001). Verified continued use beyond the first three cycles was lower with a patch (67% versus 89%, P<.001). Skin irritation and site reactions were the treatment-limiting factor for 3.3% of patch users. The 3,206 cycles captured in this study resulted in a Pearl index of 3.62 for the pill and 14.84 for the patch. Differences in the baseline demographic and contraceptive practices may account for this discrepancy although, in multivariate analysis, patch users continued to do worse. CONCLUSION: In this high-risk population, we found the contraceptive patch to have lower continuation and effectiveness rates. Further research should investigate factors contributing to poorer real-world performance by the patch.

Administration, Cutaneous↗
PubMed1986

Accidental mydriasis from scopolamine patches.

Although scopolamine is rarely intentionally applied directly to the eye, accidental contamination can occur after touching or handling a transdermal scopolamine patch, worn behind the ear to prevent motion sickness, and then rubbing one's eyes or handling contact lenses. An acute episode of prolonged cycloplegia with no admission of use of any medication by the patient was only resolved after direct questioning as to the use of a scopolamine patch revealed its removal within a 36 hour period.

Administration, Topical↗
PubMed1993

Effects of low dose transdermal scopolamine on heart rate variability in acute myocardial infarction.

OBJECTIVES: We hypothesized that by enhancing parasympathetic activity, low dose transdermal scopolamine would increase heart rate variability after myocardial infarction. BACKGROUND: Low heart rate variability is associated with increased mortality after acute myocardial infarction. METHODS: Conventional time domain heart rate variability was measured from 24-h Holter recordings of 61 consecutive male patients (mean age 58 +/- 10 years, left ventricular ejection fraction 44.7 +/- 15.5%) 6 days (median) after acute myocardial infarction. Patients were then randomly assigned to wear one patch of transdermal scopolamine or a matching placebo patch for 24 h, during which their 24-h heart rate variability was remeasured. RESULTS: Compared with placebo, transdermal scopolamine caused a significant increase in time domain measures of 24-h heart rate variability by 26% to 35% above baseline. Transdermal scopolamine was well tolerated. CONCLUSIONS: Low dose transdermal scopolamine safely increases cardiac parasympathetic activity and short-term heart rate variability after acute myocardial infarction. Whether the effect of transdermal scopolamine on heart rate variability is a reasonable surrogate for improvement of long-term morbidity and mortality requires an appropriate designed investigation.

Administration, Cutaneous↗
PubMed2000

The use of nicotine patches with minimal intervention.

BACKGROUND: This paper describes a natural, prospective, open-label study designed to evaluate the impact of free nicotine patches with minimal support for smoking cessation. METHODS: Surveys were administered to 223 participants who received nicotine patches from the American Lung Association. All participants received a 6-week supply of 15-mg/16-h transdermal nicotine patches, a self-help book Freedom from Smoking, and information about area smoking cessation classes. Follow-up telephone surveys were administered 6 weeks after the patches were distributed. Abstinence was measured through self-report exclusively. RESULTS: The overall quit rate at 6-weeks was 21% (47/223). Among nonquitters, the mean number of cigarettes smoked per day dropped from 25 at baseline to 14 at 6 weeks. There was a significant difference in the average number of patches used by quitters and nonquitters (26 versus 11, P < 0.001). CONCLUSIONS: Nicotine patches with minimal support can be effective in smoking cessation and smoking reduction. The availability of patches may have motivated participants to quit. Efforts to increase access to and use of nicotine patches may result in increased attempts to quit and successful quitting.

Administration, Cutaneous↗
PubMed1985

Transdermal hyoscine (Scopolamine). A preliminary review of its pharmacodynamic properties and therapeutic efficacy.

Hyoscine (scopolamine) is a competitive inhibitor of the muscarinic receptors of acetylcholine and it has been shown to be one of the most effective agents for preventing motion sickness. However, a relatively high incidence of side effects and a short duration of action has restricted the usefulness of this agent when administered orally or parenterally, and to counter this a novel transdermal preparation of hyoscine has been developed. Pharmacokinetic studies indicate that this new method for administering hyoscine controls the absorption process and the rate of drug entry into the systemic circulation over an extended period (72 hours), providing a means of delivery which is similar to a slow intravenous infusion. However, recent evidence suggests that the response to transdermal hyoscine treatment is variable and this may reflect pharmacokinetic differences between individuals. Controlled therapeutic trials have indicated that a single transdermal hyoscine patch is significantly superior to placebo and oral meclozine (meclizine) in preventing motion sickness. Trials comparing transdermal hyoscine with oral dimenhydrinate have failed to establish any significant differences in efficacy between the 2 drugs in small numbers of subjects, although there was always a more favourable trend towards the transdermal system. In patients with acute vertigo, transdermal hyoscine and oral meclozine were equally efficacious and both were significantly better than placebo in reducing the number of attacks of vertigo. Although transdermal hyoscine has been associated with a lower incidence of side effects than orally or parenterally administered hyoscine hydrobromide, adverse systemic effects have still been frequently reported. Most commonly cited have been dry mouth, drowsiness and impairment of ocular accommodation, including blurred vision and mydriasis (some ocular effects reported may be due to finger-to-eye contamination). Adverse central nervous system (CNS) effects, difficulty in urinating, rashes and erythema have been reported only occasionally. Thus, preliminary evidence suggests transdermal hyoscine may offer an effective and conveniently administered alternative for the prevention of motion-induced nausea and vomiting in certain situations. However, the duration of its clinical effectiveness, and its relative efficacy and tolerability compared with other agents needs to be confirmed in a few additional well-designed studies.

Administration, Topical↗