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PubMed1988

Randomized clinical trials of transdermal nitroglycerin systems for the treatment of angina: a meta-analysis.

The efficacy of transdermal nitrate patches at 24 hours after application remains controversial. Definitive evaluation has been limited because most randomized trials have had relatively small sample sizes. Therefore, we performed a meta-analysis and combined the results of 17 trials. We assessed exercise test duration as the primary end point. At 3 to 4 hours after patch application, there was a 77-second increase in exercise duration (p = 0.02) for a 5 mg/24 hour dose and a 114-second increase in exercise duration (p = 0.001) for a 10 mg/24 hour dose. At 24 hours, however, the 29-second increase in exercise duration for a 10 mg/24 hour dose was not significant (p greater than 0.1), despite persistent decreases in systolic blood pressure, an increase in heart rate, and a "therapeutic" plasma nitroglycerin concentration. The findings indicate that the 10 mg/24 hour dose is not efficacious at 24 hours after application and support the hypothesis that nitroglycerin's effect on exercise performance is attenuated by nitrate tolerance even though hemodynamic effects and adequate blood levels persist.

Administration, Cutaneous↗
PubMed1993

Transdermal clonidine as an adjunct to nifedipine-GITS therapy in patients with mild-to-moderate hypertension.

Calcium channel blockers and central alpha-agonists are among the classes of antihypertensive drugs that yield the most favorable overall effects on risk factors for hypertension-related end-organ damage. An open-label prospective trial in 42 patients with a mean baseline blood pressure of 144/102 mm Hg sought to assess the usefulness of adjunctive treatment with transdermal clonidine (0.1 to 0.3 mg/day) in patients responding inadequately to nifedipine--gastrointestinal therapeutic system (GITS) (30 to 60 mg/day) monotherapy. Thirty-nine patients who failed to reach the goal of a seated mean diastolic blood pressure of < 90 mm Hg when treated only with once-a-day nifedipine-GITS entered a transdermal clonidine (once a week) titration phase followed by an 8-week maintenance course of the two drugs combined. The 35 patients completing this last phase responded with a mean seated diastolic blood pressure of 127/87 mm Hg. Only six patients required the highest dose of clonidine for control. A 97% compliance rate with the transdermal medication contrasted with a compliance rate of only 73% for the oral nifedipine. Two of three patients who had contact dermatitis after wearing a transdermal clonidine patch withdrew from the trial prematurely; other minor side effects required no interruption of therapy. The nifedipine-clonidine combination not only achieved blood pressure control in these patients but may prove advantageous in combining the protective effects of the two agents against complications of the hypertensive syndrome.

Administration, Cutaneous↗
PubMed1995

A simplified method of timing frozen embryo transfers.

OBJECTIVE: Our purpose was to compare a simple artificial hormone replacement regimen with two other protocols incorporating pituitary down-regulation with gonadotropin-releasing hormone agonist for frozen embryo transfers. STUDY DESIGN: We performed a retrospective analysis of pregnancy outcomes after 366 frozen embryo transfers timed by one of three hormone replacement regimens. The three regimens used were regimen A, leuprolide acetate and transdermal estradiol patches; regimen B, leuprolide acetate and oral micronized estradiol; regimen C, only oral micronized estradiol. RESULTS: The outcomes of 366 consecutive frozen embryo transfers according to one of the three regimens were compared and analyzed. The clinical pregnancy rates were 13.7%, 11.4% and 13.5% in regimens A, B and C, respectively. No statistical differences were found among the three regimens. The mean age of the patients in the three groups was comparable. The mean number of frozen embryos transferred with regimen B was slightly higher, but it did not have a positive impact on the pregnancy rate in this group. CONCLUSION: Controlled sequential hormone replacement results in an endometrium suitable for frozen embryo transfers. Pituitary down-regulation is not necessary. Therefore this regimen is not only more simple to use but also more economical.

Cryopreservation↗
PubMed1993

Upregulation of nicotinic receptors following continuous infusion of nicotine is brain-region-specific.

Rats receiving 4 mg nicotine/kg/day via implanted minipumps sustained plasma nicotine concentrations of 40 ng/ml throughout two weeks of nicotine infusion. Numbers of brain [3H]nicotine binding sites were increased by about 50% in cortex and hippocampus whereas numbers of [3H]nicotine binding sites in striatum were unaffected by nicotine treatment at either of the timepoints examined (7, 14 days). Cortical [125I] alpha-bungarotoxin and [3H]QNB binding sites were also unchanged. The regional selectivity of nicotinic receptor modulation may reflect the low dose of nicotine used and the mode of administration. The changes observed may be pertinent to the continuous administration of nicotine in man, via transdermal nicotine patches.

Animals↗
PubMed1994

Studies on a vaginal ring releasing levonorgestrel at an initial rate of 27 micrograms/24 h when used alone or in combination with transdermal systems releasing estradiol.

Vaginal rings releasing levonorgestrel (L-NOG) at an initial rate of 27 micrograms/24h were studied in a group of 24 normally menstruating women during three months (i.e., during three four-week segments). Each segment consisted of three weeks with the vaginal rings in situ followed by a treatment-free period of one week. The women were divided into three groups (8 subjects each). The first group received vaginal rings only, the second and third groups were treated, in addition, with transdermal systems (patches) releasing estradiol at a rate of 50 and 100 micrograms/24h, respectively. Peripheral blood samples were withdrawn three times weekly (Monday, Wednesday and Friday) during a pretreatment cycle and during the following three months of treatment. The levels of L-NOG, estradiol and progesterone were analyzed by radioimmunoassay techniques. In all subjects, endometrial biopsies were taken in a control cycle and during the last days with vaginal rings in situ in segments II and III. The treatment with estradiol did not significantly influence L-NOG levels. Considerable differences in the L-NOG levels between the subjects of the same group were observed. Fluctuation in ovarian reaction within groups was also large. Nevertheless, estradiol noticeably increased the proportion of anovulatory cycles; the total number of anovulatory segments was 5, 9 and 19 (out of 24) in the groups "No estradiol", "50 micrograms/24h estradiol" and "100 micrograms/24h estradiol", respectively. A morphometric study of the endometrium indicated a significant decrease in the diameter of glands. This change was due to L-NOG alone, but it seemed to be accentuated by the exogenous estradiol. The occurrence of glandular mitoses increased in both groups receiving estradiol in a dose-dependent manner, indicating an increased endometrial proliferation. The treatment with estradiol did not significantly alter the bleeding pattern.

Administration, Cutaneous↗
PubMed1990

Unilateral mydriasis caused by transdermal scopolamine.

Contamination of the eye after handling of a transdermal scopolamine patch may cause accidental mydriasis. A simple office test is discussed to identify this pharmacologic blockade and thereby avoid an extensive neurologic workup.

Administration, Cutaneous↗
PubMed1995

Serum lipids and lipoproteins in postmenopausal women receiving transdermal oestrogen in combination with a levonorgestrel-releasing intrauterine device.

OBJECTIVES: To compare the effects of a non-oral combination of a transdermal oestradiol patch (50 micrograms daily) and an intrauterine device (IUD) releasing 20 micrograms of levonorgestrel daily on the serum pattern of lipids and lipoproteins with an established oral regimen of a daily dose of 2 mg of estradiol and 1 mg of noretisterone acetate. METHODS: An open, randomized study comprised of 40 healthy, early postmenopausal women. RESULTS: During 1 year the concentration of total cholesterol decreased 5.0% in the LNg-IUD group and 10.6% in the oral therapy group; HDL cholesterol decreased 10.9% and 12.8%, respectively, and HDL2 cholesterol decreased 18.1% and 26.9%, respectively. LDL cholesterol values did not change in the LNg-IUD group, whereas a 10.3% decrease was observed in the oral therapy group. Triglyceride values did not change in either group. There were no significant differences in the serum lipoprotein changes between the groups during the treatment. CONCLUSIONS: The use of a non-oral regimen of hormone replacement therapy has been advocated to minimize the effect of steroids on the liver. Its effects on the serum pattern of lipids and lipoproteins, however, did not differ significantly from those induced by a continuous oral treatment regimen.

Administration, Cutaneous↗
PubMed2005

Effects of different nicotine replacement therapies on postcessation psychological responses.

Transdermal nicotine patch (TN) and nicotine nasal spray (NS) are both efficacious forms of smoking cessation treatment, but have different pharmacokinetic properties and modes of action. To understand better psychological responses to treatment, we investigated the effects of TN versus NS on positive affect, negative affect, and withdrawal symptoms during treatment. Participants were randomly assigned to receive TN (n=172) or NS (n=163) plus seven sessions of behavioral counseling, and completed self-report questionnaires at pretreatment and during treatment. TN participants, but not NS participants, reported significant increases in positive affect during treatment. Increases in negative affect and withdrawal were observed, independent of treatment. Only changes in negative affect predicted relapse by the end of the treatment phase. These findings indicate that, although TN may enhance positive affect for smokers in treatment compared with NS, only changes in negative affect predict treatment outcome.

Administration, Cutaneous↗
PubMed2005

Therapeutic effects of progestins, androgens, and tibolone for menopausal symptoms.

Therapeutic strategies using progestins, androgens, and synthetic steroids such as tibolone are based on the understanding that estrogen, progesterone, and androgen receptors are localized to reproductive target tissues, brain, and bone. Unfortunately, these sex steroid receptors are widely distributed and localized to other tissues, often resulting in unintended effects. Progestins at high doses have been shown to be effective at reducing hot flashes by approximately 80% to 90%. Side effects include weight gain, mastalgia, fluid retention, vaginal discharge, and dry mouth. Dehydroepiandrosterone (DHEA), an adrenal-derived androgen, can be considered a prohormone that is peripherally converted to more potent androgens and estrogens. In studies with small numbers of subjects, DHEA has been reported to reduce vasomotor symptoms, increase sexual arousal, and improve cognitive performance. With regard to use of other androgens, there are no current testosterone preparations approved by the US Food and Drug Administration (FDA) for use in menopausal women. In phase 3 trials, a testosterone transdermal matrix patch has been shown to be effective in treatment of hypoactive sexual desire disorder in menopausal women on estrogen therapy. Tibolone, a synthetic steroid with estrogenic, androgenic, and progestational properties has been shown to be effective in the treatment of vasomotor symptoms and in preserving bone density, and it may provide positive effects on sexual function. The beneficial effects of these compounds in the menopausal woman for treatment of vasomotor symptoms, general well-being, cognitive deficits, bone loss, mood disorders, and sexual function are discussed. The overall clinical trial evidence for benefits and side effects also is presented.

Androgens↗
PubMed2005

Same-day initiation of the transdermal hormonal delivery system (contraceptive patch) versus traditional initiation methods.

INTRODUCTION: Published comparisons of oral contraceptive pill (OCP) initiation methods demonstrate that OCP initiation at the office visit ("Quick Start") resulted in higher continuation rates into the second cycle. This trial was performed to investigate whether Quick Start with the contraceptive patch would provide similar results. MATERIALS AND METHODS: Sixty women were randomized to initiate use of the contraceptive patch using Quick Start (Group 1, n=30) or on the first day of their next menses (Group 2, n=30). Telephone contact at 6 weeks occurred to ensure that the second cycle had been initiated. A single follow-up visit was scheduled after completion of the third patch cycle. RESULTS: Continuation rates for Groups 1 and 2 were 97% and 93% (p=1.0), respectively, into the second cycle, and 93% and 90%, respectively, into the third cycle (p=1.0). Only approximately half of the subjects planned to continue using the patch after the study. CONCLUSION: Quick Start for the contraceptive patch did not improve continuation rates into the second or third cycle.

Administration, Cutaneous↗
PubMed2005

Simultaneous determination of piroxicam, meloxicam and tenoxicam in human plasma by liquid chromatography with tandem mass spectrometry.

A rapid, sensitive and selective liquid chromatography-tandem mass spectrometric (LC-MS/MS) method for the determination of piroxicam, meloxicam and tenoxicam in human plasma was developed. Piroxicam, meloxicam, tenoxicam and isoxicam (internal standard) were extracted from human plasma with ethyl acetate at acidic pH and analyzed on a Sunfire column with the mobile phase of methanol:ammonium formate (15 mM, pH 3.0) (60:40, v/v). The analytes were detected using a mass spectrometer, equipped with electrospray ion source. The instrument was set in the multiple-reaction-monitoring (MRM) mode. The standard curve was linear (r=1.000) over the concentration range of 0.50-200 ng/ml. The coefficient of variation (CV) and relative error (RE) for intra- and inter-assay statistics at three QC levels were 1.0-5.4% and -5.9 to 2.8%, respectively. The recoveries of piroxicam, meloxicam and tenoxicam ranged from 78.3 to 87.1%, with that of isoxicam being 59.7%. The lower limit of quantification for piroxicam, meloxicam and tenoxicam was 0.50 ng/ml using a 100 microl plasma sample. This method was successfully applied to a pharmacokinetic study of piroxicam after application of transdermal piroxicam patches to humans.

Administration, Cutaneous↗
PubMed2006

Prostate cancer risk in testosterone-treated men.

Men with classical androgen deficiency have reduced prostate volume and blood prostate-specific antigen (PSA) levels compared with their age peers. As it is plausible that androgen deficiency partially protects against prostate disease, and that restoring androgen exposure increases risk to that of eugonadal men of the same age, men using ART should have age-appropriate surveillance for prostate disease. This should comprise rectal examination and blood PSA measurement at regular intervals (determined by age and family history) according to the recommendations, permanently revisited, published by ISSAM, EAU, Endocrine Society.... Testosterone replacement therapy is now being prescribed more often for aging men, the same population in which prostate cancer incidence increases; it has been suggested that administration in men with unrecognised prostate cancer might promote the development of clinically significant disease. In hypogonadal men who were candidates for testosterone therapy, a 14% incidence of occult cancer was found. A percentage (15.2%) of prostate cancer has been found in the placebo group (with normal DRE and PSA) in the prostate cancer prevention study investigating the chemoprevention potential of finasteride. The hypothesis that high levels of circulating androgens is a risk factor for prostate cancer is supported by the dramatic regression, after castration, of tumour symptoms in men with advanced prostate cancer. However these effects, seen at a very late stage of cancer development, may not be relevant to reflect the effects of variations within a physiological range at an earlier stage. Data from all published prospective studies on circulating level of total and free testosterone do not support the hypothesis that high levels of circulating androgens are associated with an increased risk of prostate cancer. A study on a large prospective cohort of 10,049 men, contributes to the gathering evidence that the long standing "androgen hypothesis" of increasing risk with increasing androgen levels can be rejected, suggesting instead that high levels within the reference range of androgens, estrogens and adrenal androgens decrease aggressive prostate cancer risk. Indeed, high-grade prostate cancer has been associated with low plasma level of testosterone. Furthermore, pre-treatment total testosterone was an independent predictor of extraprostatic disease in patients with localized prostate cancer; as testosterone decreases, patients have an increased likelihood of non-organ confined disease and low serum testosterone levels are associated with positive surgical margins in radical retropubic prostatectomy. A clinical implication of these results concerns androgen supplementation which has become easier to administer with the advent of transdermal preparations (patch or gel) that achieve physiological testosterone serum levels without supra physiological escape levels. During the clinical development of a new testosterone patch in more than 200 primary or secondary hypogonadal patients, no prostate cancer was diagnosed.

Androgens↗
PubMed2004

Acute effects of nicotine on serum glucose insulin growth hormone and cortisol in healthy smokers.

Cigarette smoking impairs glucose tolerance and alters serum levels of hormones involved in glucose metabolism, but the role of nicotine in such hormonal alterations is not well understood. In order to isolate the effects of transdermal nicotine on serum glucose, insulin, growth hormone, and cortisol in smokers, we conducted a randomized double-blind placebo-controlled cross-over study involving 34 healthy volunteer smokers between 18 and 55 years of age. Administration of a 14-mg transdermal nicotine patch resulted in nonsignificantly lowered fasting quantitative insulin-sensitivity index (P =.11) and a nonsignificant 9.3-mg/dL mean increase in serum glucose levels during a 75-g oral glucose tolerance test (OGTT) at time 60 minutes (P =.12). There were no substantial differences between groups in the areas under the curve (AUCs) for glucose (P =.33) or insulin (P =.79) during the OGTT. Levels of insulin and cortisol also were not significantly altered by nicotine. A secondary finding observed in the overall study group (primarily in females) was that nicotine caused a 29% median decrease in serum growth hormone (P =.02). We conclude that nicotine patches may lead to mild hyperglycemia and lowered insulin sensitivity. Further research is needed to determine the clinical implications of the unexpected finding that nicotine decreased growth hormone levels in female smokers.

Administration, Cutaneous↗
PubMed2004

Visual-spatial attention in alcoholics and illicit stimulant abusers: effects of nicotine replacement.

Reports of alcohol or illicit drug-related cognitive impairments have frequently disregarded the potentially confounding effects of smoking status and nicotine withdrawal on these measures. This study addressed this issue by measuring visual-spatial attention via an adaptation of the Posner paradigm in three groups of tobacco smokers: controls without a history of alcoholism or illicit drug use (n=27; 20 male), chronic alcoholics (n=22; 18 male), and illicit stimulant abusers (n=36; 21 male). Throughout testing, nicotine levels were stabilized by the double-blind administration of a high (14 or 21 mg) or low (7 mg) dose transdermal nicotine patch. A significant effect of group was observed for number of correct responses to restriction trials (F=5.48, 2/79 df; p=.006). Performance was normalized in the illicit stimulant group, and alcoholic participants exhibited superior performance relative to both illicit stimulant abusers (p=.002) and controls (p=.01). These findings support the hypothesis that nicotine may have a compensatory or normalizing effect on attentional functions in substance abusers. Whether these results reflect the central nervous system-activating effects of nicotine or merely alleviation of nicotine withdrawal is a topic of ongoing research.

Administration, Cutaneous↗
PubMed2003

Effect of transdermal nitroglycerin on inflammatory mediators in patients with peripheral atherosclerotic vascular disease.

OBJECTIVE: To demonstrate that nitroglycerin improves biological markers of arterial inflammation in patients with peripheral vascular disease. BACKGROUND: Atherosclerosis is an inflammatory disease in which there is an increase in active inflammation markers such as C-reactive protein and other factors released by endothelial cells. Nitroglycerin acts by a chemical liberation of nitric oxide. We have previously published the results from several controlled clinical trials confirming an anti-inflammatory action of nitroglycerin. METHODS: Forty patients with peripheral vascular disease entered a randomized, double-blind, placebo-controlled pilot study for 6 weeks. Twenty-one patients were treated with continuous application of a transdermal nitroglycerin patch (15 mg/24 hours) on the anterior face of the thigh. Venous blood samples were obtained before treatment and 2 and 6 weeks after. We measured plasma levels of C-reactive protein, cGMP (also intraplatelet cGMP), E-selectin, ICAM, VCAM-1, IL-6, and nitrites/nitrates. RESULTS: No biological parameter was modified in the placebo group. On the contrary, nitroglycerin significantly reduced plasma levels of C-reactive protein and sE-selectin and increased the levels of intraplatelet cGMP. CONCLUSIONS: The results of this preliminary study show that nitroglycerin has an anti-inflammatory action in patients with peripheral vascular disease. This may provide a new therapeutic approach to understanding the efficacy of nitrovasodilators in the improvement of atherosclerotic syndromes.

Administration, Cutaneous↗
PubMed1998

Design of a randomized, placebo-controlled multicenter trial on the long-term effects of intermittent transdermal nitroglycerin on left ventricular remodeling after acute myocardial infarction. Transdermal Nitroglycerin Investigators Group.

Nitrates are widely used in the treatment of patients with ischemic heart disease and in those with angina following acute myocardial infarction. Short-term studies indicate that the administration of nitrates may prevent left ventricular (LV) dilation and infarct expansion. Animal models suggest that prolonged nitroglycerin use after infarction may limit LV remodeling similar to that observed with angiotensin-converting enzyme inhibitors. However, to date there have been no trials evaluating the effects of nitrates on LV volumes in patients surviving acute myocardial infarction. We therefore performed a randomized double-blind, placebo-controlled trial designed to investigate the long-term (6 month) efficacy of intermittent transdermal nitroglycerin patches on LV remodeling in 291 survivors of acute myocardial infarction. Patients were randomized to receive either placebo or a nitroglycerin patch that delivered 0.4, 0.8, or 1.6 mg/hour. Gated radionuclide angiography was used to assess serial changes in LV ejection and cardiac volumes. The baseline characteristics of the study population were similar in all 4 treatment groups. The study protocol and the main design-related issues are described.

Administration, Cutaneous↗
PubMed1995

High reproducibility of myocardial perfusion defects in patients undergoing serial exercise thallium-201 tomography.

The purpose of this study was to define the reproducibility of sequential quantitative exercise thallium-201 tomography. This was an ancillary study of a randomized, double-blind, placebo-controlled trial evaluating the short-term efficacy of transdermal nitroglycerin patches in stable patients with angiographic coronary artery disease and no prior myocardial infarction. All 18 patients had a baseline tomographic perfusion defect involving > or = 5% of the left ventricle after treadmill exercise. At a minimum of 3 days (mean 6.1 +/- 1.8) after double-blind randomization to placebo, exercise thallium-201 tomography was repeated (study 2) using the same exercise protocol as in the baseline study (study 1). No significant differences in exercise parameters were observed from studies 1 to 2. Seventeen of 18 patients (94%) had an abnormal repeat exercise perfusion scan and 96% of initially abnormal vascular territories remained abnormal. The mean tomographic perfusion defect size was not significantly different from studies 1 (17.4 +/- 13.3%) to 2 (16.6 +/- 15.3%), nor were the components defined as scar and ischemia. A > or = 10% change in total perfusion defect size in an individual patient defined the 95% confidence interval for exceeding the variability of the tomographic technique. Quantitative exercise thallium-201 tomography is highly reproducible and can be used to accurately interpret temporal changes in myocardial perfusion in individual patients.

Administration, Cutaneous↗
PubMed2000

An animal model of adolescent nicotine exposure: effects on gene expression and macromolecular constituents in rat brain regions.

Nearly all smokers begin tobacco use in adolescence, and approximately 25% of US teenagers are daily smokers. Prenatal nicotine exposure is known to produce brain damage, to alter synaptic function and to cause behavioral anomalies, but little or no work has been done to determine if the adolescent brain is also vulnerable. We examined the effect of adolescent nicotine exposure on indices of cell damage in male and female rats with an infusion paradigm designed to match the plasma levels found in human smokers or in users of the transdermal nicotine patch. Measurements were made of DNA and protein as well as expression of mRNAs encoding genes involved in differentiation and apoptosis (p53, c-fos) in cerebral cortex, midbrain and hippocampus. Following nicotine treatment from postnatal days 30-47.5, changes in macromolecular constituents indicative of cell loss (reduced DNA) and altered cell size (protein/DNA ratio) were seen across all three brain regions. In addition, expression of p53 showed region- and gender-selective alterations consistent with cell damage; c-fos, which is constitutively overexpressed after gestational nicotine exposure, was unaffected with the adolescent treatment paradigm. Although these measures indicate that the fetal brain is more vulnerable to nicotine than is the adolescent brain, the critical period for nicotine-induced developmental neurotoxicity clearly extends into adolescence. Effects on gene expression and cell number, along with resultant or direct effects on synaptic function, may contribute to increased addictive properties and long-term behavioral deficits.

Adolescent↗