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PubMed2004

17Beta-estradiol/levonorgestrel transdermal system for the management of the symptomatic menopausal woman.

Recent publications of the initial outcomes from the Women's Health Initiative (WHI) study of menopausal management have raised concerns over the safety of hormone therapy [1,2]. Every study, no matter how large or well conducted, has biases and limitations that preclude the ability to apply the outcomes to a larger group of individuals not specifically evaluated in the analysis. In particular, the hormonal arms of the WHI evaluated only a single dose of a daily oral regimen of conjugated equine oestrogen 0.625 mg [1,2], combined with medroxyprogesterone acetate 2.5 mg if the subject had a uterus [1]. The failure to evaluate non-oral regimens prevented the evaluation of hormone delivery systems that have been shown to provide similar symptom relief to oral regimens, but with a considerably different physiological impact. The once-weekly transdermal patch (Climara Pro releasing 17beta-estradiol 0.045 mg/day and levonorgestrel 0.015 mg/day has been shown to be highly effective in rapidly reducing the frequency and intensity of vasomotor symptoms and to significantly improve all categories in the quality of life Women's Health Questionnaire [3]. In addition, this transdermal combination system was not associated with any cases of endometrial hyperplasia, adverse impacts on cholesterol or lipid values and was associated with an increasing rate of amenorrhoea over time [3]. The 17beta-estradiol/levonorgestrel transdermal system is approved in the US for the treatment of moderate-to-severe vasomotor symptoms and the prevention and treatment of urogenital atrophy.

Contraceptive Agents, Female↗
PubMed1986

Comparison of two transdermal nitroglycerin systems.

In a study conducted by office-based cardiologists at eight sites, 115 patients using transdermal nitroglycerin for treatment of angina pectoris participated in a four-week comparison of two transdermal nitroglycerin patches: Transderm-Nitro (TDN) and Nitro-Dur II (ND II). Patients wore two patches, one of each brand, each with half their normal prescribed daily dose of 10 mg (release rate per 24 hours) to compare patch adherence properties, patient preference, and local side effects. More ND II than TDN patches fell off (5% versus 0.1%), and fewer TDN than ND II patches became loose (1.7% versus 8.4%); 98.2% of the TDN and 86.7% of the ND II patches adhered totally. Significantly more patients expressed a preference for TDN over ND II in four of eight assessment variables, including the choice of their next prescription. The frequency of problems at the site of patch application was similar with both patches.

Adhesiveness↗
PubMedDate not supplied

Transdermal fentanyl in postoperative pain.

BACKGROUND AND OBJECTIVES: The aim of this study was to determine the safety and effectiveness of a transdermal fentanyl delivery system for the relief of pain following abdominal surgery. METHODS: In a nonblinded, noncrossover, placebo-controlled study, 40 ASA I and II patients of both sexes, 18-69 years of age, who were scheduled for abdominal surgery under general anesthesia, were randomly divided into two groups of 20 patients each. Patients in group I received a transdermal patch containing 0.16 mg/cm2 of fentanyl, which was applied to the skin over the subclavian area 60 minutes before the induction of anesthesia. For body weight less than 60 kg, a 30 cm2 patch was applied, and for weight greater than 60 kg, a 40 cm2 patch was used. A second group of 20 patients received placebo patches of identical size. Approximately 20 to 30 minutes before the expected end of surgery, 60 mg ketorolac was administered intramuscularly. Patients were observed for 36 hours after placement of the patch. If patients reported their pain at rest as 5 or greater at rest on a 0-10 visual analog scale, they were given 30-mg increments of ketorolac 5 to 7 hours apart. If this regimen did not relieve their pain, they received 1,300 mg acetaminophen between two ketorolac doses. If despite this, they still had pain 30 minutes afterward, intravenous morphine was given, and the patients were excluded from further study. The patch was removed in four patients in the fentanyl group and seven in the placebo group for various reasons, which included, inadequate pain relief requiring additional analgesia postoperatively and more than 1 microgram/kg of sufentanil given intraoperatively or immediately prior to the end of surgery. During the 36-hour observation period, 30 doses of 30 mg ketorolac and 14 doses of 1.3 g acetaminophen were given to 13 patients in the placebo group and 18 doses of ketorolac and 8 doses of acetaminophen were administered to 16 in the fentanyl group. RESULTS: The differences in postoperative analgesic requirements were significant. Plasma fentanyl concentrations at 12 and 24 hours after the application of the fentanyl patch were 0.98 +/- 0.14 ng/mL and 1.22 +/- 0.17 ng/mL, respectively. At 8, 16, 24, and 36 hours after application of the patch, the pain relief, assessed by a VAS at rest and with movement, was similar in the two groups. In the fentanyl and control groups, 12 and 5 patients, respectively, experienced nausea, and 2 and 3 patients, respectively, vomited. CONCLUSIONS: Similar postoperative analgesia was achieved with less parenteral analgesics in patients who received transdermal fentanyl preoperatively than in control patients. Fentanyl, 50-75 micrograms/h, administered in a transdermal delivery system, did not depress respiratory rate or hemoglobin oxygen saturation. Although the exact role of continuously administered opioids in managing acute postoperative pain has yet to be clearly defined, it is concluded that if properly used, this new transdermal device can be effective in providing a background of analgesia, which may assist in the management of acute postoperative pain as well as some chronic pain states.

Administration, Cutaneous↗
PubMed2006

Efficacy of estradiol topical patch in the treatment of symptoms of depression following mini-gastric bypass in women.

BACKGROUND: Obesity is associated with elevated levels of estrogen. Gastric bypass causes rapid weight loss and decreased levels of estrogen. Patients after gastric bypass can suffer from anxiety and depression out of proportion to the surgical outcome. This study reports the efficacy of a short-term empiric trial of topical estradiol for the treatment of mild to moderate depression and anxiety following mini-gastric bypass (MGB) in women. METHODS: Postoperative MGB women were surveyed for the presence of depressive symptoms before and after MGB. The results of an empiric trial of transdermal patches of estradiol-17beta were assessed. Outcome measures were the self-reported efficacy of the patch. RESULTS: 711 women who had undergone MGB and had functioning e-mail addresses made up the study. 62% of patients reported depression prior to surgery. 156 patients (22%) reported depression after the operation. 130 women were treated empirically with the patch, and remission of depression was observed in 92 (71%). In response to the question "Did the estrogen patch help?", subjects reported responses of 1) Yes, fantastic, 2) Yes, somewhat, 3) Hard to say, 4) No, in 36%, 31%, 20%, 13% of respondents respectively. Patients treated with estradiol sustained antidepressant benefit of treatment after the patch was discontinued. Treatment lasted <1 month, 1-3 months, and >3 months, in 48%, 32% and 20% respectively. Treatment was well-tolerated and adverse events were rare. CONCLUSION: Depression is common in obese patients and remains a problem in a subset following the MGB operation. Transdermal estradiol replacement appears to be an effective treatment of symptoms of depression in women following MGB.

Administration, Cutaneous↗
PubMed1996

Transdermal fentanyl in the management of cancer pain in ambulatory patients: an open-label pilot study.

We performed an open-label pilot study to define analgesic efficacy, acceptability, and toxicity of transdermal fentanyl in an ambulatory population of patients with cancer pain. Our 7-day study included 35 patients, all of whom had failed a trial of an opioid analgesic conventionally used for moderate pain. Patients received either a 25 micrograms/hr or 50 micrograms/hr fentanyl transdermal patch depending on prior opioid dose. Pain was measured daily utilizing visual analogue (VAS) and categorical (CAT) scales. Hours of nighttime sleep, quality of life, toxicities, and use of rescue medication were also assessed. There was a 24%-29% reduction in mean VAS and CAT pain scores as compared with the baseline and a 25% increase in mean hours of nighttime sleep. Fifty-nine percent of those patients responding (46% of all study patients) were satisfied to very satisfied with the analgesia provided by transdermal fentanyl. Six percent of all study patients were not at all satisfied with the pain relief obtained. Toxicities were similar to those seen with other opioids. No patient developed severe sedation or respiratory depression. The 25-50 micrograms/hr patch appears to be a safe starting dosage in ambulatory patients previously receiving opioids conventionally used for moderate pain.

Adult↗
PubMed2000

Structure-activity relationship of chemical penetration enhancers in transdermal drug delivery.

Transdermal drug delivery (TDD) is the administration of therapeutic agents through intact skin for systemic effect. TDD offers several advantages over the conventional dosage forms such as tablets, capsules and injections. Currently there are about eight drugs marketed as transdermal patches. Examples of such products include nitroglycerin (angina pectoris), clonidine (hypertension), scopolamine (motion sickness), nicotine (smoking cessation), fentanil (pain) and estradiol (estrogen deficiency). Since skin is an excellent barrier for drug transport, only potent drugs with appropriate physicochemical properties (low molecular weight, adequate solubility in aqueous and non-aqueous solvents, etc) are suitable candidates for transdermal delivery. Penetration enhancement technology is a challenging development that would increase significantly the number of drugs available for transdermal administration. The permeation of drugs through skin can be enhanced by physical methods such as iontophoresis (application of low level electric current) and phonophoresis (use of ultra sound energy) and by chemical penetration enhancers (CPE). In this review, we have discussed about the CPE which have been investigated for TDD. CPE are compounds that enhance the permeation of drugs across the skin. The CPE increase skin permeability by reversibly altering the physicochemical nature of the stratum corneum, the outer most layer of skin, to reduce its diffusional resistance. These compounds increase skin permeability also by increasing the partition coefficient of the drug into the skin and by increasing the thermodynamic activity of the drug in the vehicle. This review compiles the various CPE used for the enhancement of TDD, the mechanism of action of different chemical enhancers and the structure-activity relationship of selected and extensively studied enhancers such as fatty acids, fatty alcohols and terpenes. Based on the chemical structure of penetration enhancers (such as chain length, polarity, level of unsaturation and presence of some special groups such as ketones), the interaction between the stratum corneum and penetration enhancers may vary which will result in significant differences in penetration enhancement. Our review also discusses the various factors to be considered in the selection of an appropriate penetration enhancer for the development of transdermal delivery systems.

Administration, Cutaneous↗
PubMed1997

Improvement in accuracy of delayed recall in aged and non-aged, mature monkeys after intramuscular or transdermal administration of the CNS nicotinic receptor agonist ABT-418.

ABT-418 was evaluated for its ability to enhance accuracy on a delayed matching-to-sample (DMTS) task by aged monkeys following intramuscular administration, and in non-aged mature monkeys following transdermal application. Aged monkeys were impaired in their performance of the DMTS task such that the longest delay intervals performed at above-chance levels extended only to 20 s. In contrast, for non-aged, mature animals, delay intervals extended to 140 s. In aged monkeys, the response to ABT-418 was highly individualized with animals responding to one or more doses in the range of 2-259 nmol/kg. A systematic dose-dependent enhancement of DMTS accuracy was not observed. When the individualized "best dose" was administered on a separate occasion, overall DMTS accuracy was increased by 12.6%. By 24 h after administration, accuracy was at control levels. In young monkeys, a significant dose-dependent enhancement of DMTS performance (an overall increase of 11.25% above baseline accuracy) was observed 5 h after application of a transdermal patch designed to maintain steady-state plasma levels of ABT-418 of 40-60 ng/ml over a 24-h period. Again there was some individual responsiveness to one of the three doses. When data included only the individualized best doses of ABT-418 for each animal, a similar enhancement of accuracy was observed for both the 5-h and 24-h test intervals. In neither the aged nor the young cohorts was enhancement of performance associated with altered response latencies or with any overt side effects of ABT-418. Thus, these data are consistent with the ability of ABT-418 to improve DMTS performance in both young and aged monkeys. In aged monkeys, this response was observed only after administration of individualized optimal doses for different monkeys. In young monkeys, a more systematic enhancement of DMTS accuracy was observed. Further, transdermal delivery of ABT-418 in non-aged monkeys demonstrated prolonged performance enhancement compared with IM injection to at least 24 h after patch administration.

Administration, Cutaneous↗
PubMedDate not supplied

Long-term, continuous treatment with both oral and transdermal nitrates increases cardiac events in healed myocardial infarction patients.

This study was performed to investigate the effects of continuous dosing of oral, transdermal (patch), and a combination of the two with nitrate treatments on cardiac events in patients with healed myocardial infarction. In total, 1,291 patients with healed myocardial infarction were assigned 2 groups: treatment with nitrates (n=713) or nontreatment (n=578). Nitrate treatment was subdivided into 3 groups: patch group (n=149), oral group (n=504), and combination group (n=60). The mean observation period was 17.4 +/- 21.1 months. Primary end points were nonfatal and fatal recurrent myocardial infarction, death from congestive heart failure, and sudden death. Baseline characteristics were also compared among the 4 groups to determine any effects on outcome. Among the patients with patch, oral, and combination groups, cardiac events occurred 3.4%, 6.7%, 10.0%, respectively, whereas only 2.9% of the patients treated without nitrates had cardiac events. The incidence of cardiac events was significantly greater in patients with oral nitrates and combination groups compared to patients without nitrates (p<0.01, respectively). Continuous dosing of long-term treatment with both oral and transdermal nitrates increased cardiac events in healed myocardial infarction patients.

Administration, Cutaneous↗
PubMed2002

Intranasal estradiol: new formulation. Intranasal oestrogen delivery system: just a gimmick.

(1) Many oral and transdermal (patch and gel) estradiol preparations are already available for controlling menopausal symptoms due to oestrogen deficiency. (2) Marketing authorization has now been granted in Europe for an intranasal delivery system, which produces a high, brief plasma estradiol peak. (3) According to two clinical trials, the symptomatic effects of 300 micrograms of estradiol daily by the intranasal route is similar to that of 50 micrograms /day transdermally (unblinded trial) and 2 mg/day orally (double-blind trial). (4) The most frequent side effects are intranasal reactions (in approximately 50% of patients), breast pain (30-40% of patients), and metrorrhagia (approximately 7% of cycles). (5) The long-term consequences of such high plasma estradiol peaks, including the risk of breast cancer, are unknown. (6) Intranasal estradiol is not reimbursed in France, unlike other oestrogen preparations for use in menopausal women. (7) In practice, oral and transdermal delivery systems, with which we have lengthy experience, are adequate for relieving menopausal symptoms. The intranasal route offers no proven advantage, and its long-term risks are unknown.

Administration, Cutaneous↗
PubMed1997

Comparison of continuous and sequential transdermal progestogen with sequential oral progestogen in postmenopausal women using continuous transdermal estrogen: vasomotor symptoms, bleeding patterns, and serum lipids.

OBJECTIVE: The efficacy, bleeding patterns, and safety of continuous transdermal and sequential transdermal progestogen therapy were compared with those of oral progestogen therapy in postmenopausal women receiving transdermal estrogen. METHODS: In an open-label, 1-year (13 treatment periods, 28 days each), randomized study, 774 postmenopausal women were assigned to receive 50 micrograms/day of continuous trans dermal estradiol with either continuous or sequential transdermal norethisterone acetate (NETA) in daily doses of 170 or 350 micrograms in a single transdermal patch or sequential oral progestogen (1 mg norethisterone [NET] or 20 mg dydrogesterone/day). RESULTS: The average number of hot flushes/day decreased from prestudy by over 90% (P < .001), and this reduction was unaffected by different progestogen regimens. With sequential progestogen, bleeding incidence and the number of bleeding days did not change over the course of the study but were lower in the low-dose transdermal progestogen group. With continuous progestogen, the incidence of bleeding decreased in both the low- and high-dose groups, from 35% and 45% in treatment period 1 to 25% and 15%, respectively, at the end of treatment. Adverse event incidence was similar in all groups, with 23% to 36% of subjects reporting events possibly or probably related to HRT (excluding vaginal bleeding). Two cases of simple hyperplasia were reported (one in each low-dose progestogen group). Beneficial effects on coronary heart disease risk factors, such as reductions in total cholesterol and low-density lipoprotein cholesterol and increases in high-density lipoprotein-2 cholesterol levels, were measured in all treatment groups. Lipoprotein (a) was reduced in all but the oral progestogen group. CONCLUSIONS: Continuous and sequential transdermal estrogen/progestogen treatments with estradiol/NETA appear to be effective and safe alternatives to continuous transdermal estrogen and oral sequential progestogen for the treatment of menopausal symptoms. Continuous transdermal therapy with estradiol/NETA may be more acceptable for a majority of patients, i.e., those who wish to avoid monthly bleeds, whereas the sequential regimen may be preferable when the clinician and/or patient believes monthly bleeding to be appropriate.

Administration, Cutaneous↗
PubMed2000

Short-term effects of intramuscular and transdermal testosterone on bone turnover, prostate symptoms, cholesterol, and hematocrit in men over age 70 with low testosterone levels.

The objective of the study was to determine whether short-term testosterone administration to older men with low bioavailable testosterone would have any immediate adverse effects, especially on the symptoms of benign prostate hyperplasia, preliminary to embarking on a long-term study of testosterone treatment. Transdermal and intramuscular testosterone were compared to determine whether there were any rapid changes in markers of bone formation or resorption with either testosterone administration. We undertook a non-randomized trial of 9 weeks intervention with either intramuscular testosterone, transdermal testosterone or neither followed by a 9-week observation period. Twenty-seven men over age 70 years with no medical conditions known to affect bone turnover and total testosterone levels below 350 ng/dl (normal range 350-1230 ng/dl) or bioavailable testosterone levels below 128 ng/dl (normal range 128-430 ng/dl) received either testosterone via transdermal patch (TP; two 2.5 mg patches/d), intramuscular testosterone enanthate (IM; 200 mg every 3 weeks) or no testosterone for 9 weeks of treatment followed by a 9 week observation period. Nine men were enrolled in each group. The mean age of the men was 74 +/- 3 years (range 70-83 years). While all men receiving testosterone treatment increased levels above their own baseline, only 6 of 9 men receiving transdermal testosterone achieved bioavailable testosterone levels in the normal range for young men. Neither treatment group demonstrated changes in estradiol levels. No side effects were reported using the intramuscular testosterone while 5/9 men using transdermal testosterone developed a rash. There were no significant changes in markers of bone resorption or formation in either testosterone treatment group. There were no ill effects on prostate size, symptoms or prostate specific antigen level. PSA levels of 1.5 +/- 0.7 ng/dl and 1.6 +/- 0.7 ng/dl in the TP and IM groups, respectively. were 2.0 +/- 1.0 ng/dl and 1.8 +/- 0.9 ng/dl following treatment. Cholesterol profiles were also not affected by either transdermal or intramuscular testosterone. Similarly hemoglobin and hematocrit remained unchanged in men receiving either testosterone preparation.

Administration, Cutaneous↗
PubMed2003

Evidence for lymphatic transport of insulin by topically applied biphasic vesicles.

The cutaneous delivery pathway through the lymphatics of a novel transdermal lipid-based delivery system (biphasic vesicles), which was previously shown to deliver sustained physiological levels of basal insulin in a pain-free manner across the skin, was evaluated in a diabetic rat model. Transdermal patches (one per rat) containing insulin in biphasic vesicles (1-10 mg recombinant human insulin dose) were applied to the shaved abdominal skin of streptozotocin-induced diabetic rats for 73 h. Blood glucose was monitored approximately every 2-10 h using a Lifescan glucose meter. Inguinal lymph node insulin levels were analysed by ELISA. Insulin in the lymph nodes increased in a dose- and time-dependent manner. Maximal transdermal insulin concentrations in the lymph nodes were observed with both 140 IU (5 mg: 43.0 +/- 18.0 microIU mg(-1) (mean +/- s.e.m., n = 4)) and 280 IU (10 mg: 48.0 +/- 19.6 microIU mg(-1) (mean +/- s.e.m., n = 4)) doses of recombinant insulin at t = 73 h. The level of insulin in the lymph nodes after subcutaneous injection of 1 mg insulin at the peak blood glucose response was 35.8 microIU mg(-1) (n = 2), before falling to 0.35 microIU mg(-1) by t = 48 h (n = 2). The lymphatics is involved in the transdermal insulin delivery by biphasic vesicles. This is the first report on the lymphatic transport of a protein after non-invasive topical application on the skin.

Administration, Cutaneous↗
PubMed1992

Enhanced transdermal delivery of testosterone across nonscrotal skin produces physiological concentrations of testosterone and its metabolites in hypogonadal men.

None of the current or experimental androgen treatment modalities for male hypogonadism has been reported to produce physiological concentrations or circadian variations in testosterone (T) and its metabolites, dihydrotestosterone (DHT) and estradiol (E2). This investigation describes a novel transdermal dosage form designed to enhance the delivery of native T across nonscrotal skin. The main objective was to determine whether the nightly application of two experimental transdermal patches to different sites on the body (e.g. back, chest, arms, etc.) would result in normal plasma levels of T, DHT, and E2 for men and mimic the normal circadian variation. Six hypogonadal males (aged 24-66 yr) were studied 4 weeks after stopping T ester treatment. After single application of two patches, T levels increased from a pretreatment baseline of 5.8 +/- 0.94 nmol/L (mean +/- SE; 167 +/- 27 ng/dL) to an average peak concentration of 44.1 +/- 4.8 nmol/L (1273 +/- 138 ng/dL) 5.7 +/- 0.6 h after application and reached a 24-h level of 16.9 +/- 2.9 nmol/L (488 +/- 85 ng/dL). DHT and E2 levels exhibited parallel variations within the normal reference ranges. During 4 weeks of daily evening application to various sites on the torso, the mean delivery of T from two patches was 5.2 +/- 0.1 mg/day (approximately 20% of the patch content), and morning T levels were within the normal limits. On day 28 of treatment, the 24-h plasma profiles of T, DHT, and E2 (obtained with two patches on the back) approximately mimicked the normal circadian variations reported in healthy young men. The time-averaged T level was 21.8 +/- 2.9 nmol/L (629 +/- 84 ng/dL), and the plasma concentration ratios of DHT/T (0.07 +/- 0.01) and E2/T (0.005 +/- 0.001) were within the normal range. SHBG concentrations were not significantly altered over the 4 weeks of treatment. The patches were well tolerated, except for one patient who developed a local reaction to an excipient during the third week of treatment. Two of the patients (one with Klinefelter's syndrome) completed several months of continuous therapy. T, DHT, and E2 have remained in the range of normal, and plasma LH levels in the patient with Klinefelter's syndrome became normal. Subjective improvement in symptoms has continued, and tolerability has been good in both patients. These results indicate that the enhanced transdermal delivery of T across nonscrotal skin is a patient-friendly androgen replacement modality and produces physiological concentrations of T and its metabolites, which are unattainable with other treatment modalities.

Administration, Cutaneous↗
PubMed2004

Electron beam irradiation: a novel technology for the development of transdermal system of isosorbide dinitrate.

The development of a transdermal delivery system for isosorbide dinitrate (ISDN) using electron beam irradiation was studied. The solid state stability of the drug to irradiation was assessed. The drug was dissolved in 2-ethylhexylacrylate (EHA)-acrylic acid (AA) system and this solution was directly irradiated on a backing membrane (Scotchpak1006) at different doses to get transdermal patches. The developed systems were evaluated for residual monomer content, equilibrium weight swelling ratios (EWSR), differential scanning calorimetry (DSC), weight uniformity, thickness uniformity, drug content and content uniformity, peel strength, in vitro release, skin permeation kinetics and skin irritation potential. The developed system possessed excellent adhesive properties. Increase in the irradiation doses did not have a significant effect on the peel strength values. The systems exhibited promising skin permeation kinetics and no skin irritating potential, both of which are important properties for transdermal drug delivery. The ISDN-EHA-AA system developed at an irradiation dose of 50 kGy showed a higher skin permeation profile as compared to an internationally marketed transdermal matrix system of ISDN.

Administration, Cutaneous↗
PubMed2006

Double blind, randomized controlled trial, to evaluate the effectiveness of a controlled nitric oxide releasing patch versus meglumine antimoniate in the treatment of cutaneous leishmaniasis [NCT00317629].

BACKGROUND: Cutaneous Leishmaniasis is a worldwide disease, endemic in 88 countries, that has shown an increasing incidence over the last two decades. So far, pentavalent antimony compounds have been considered the treatment of choice, with a percentage of cure of about 85%. However, the high efficacy of these drugs is counteracted by their many disadvantages and adverse events. Previous studies have shown nitric oxide to be a potential alternative treatment when administered topically with no serious adverse events. However, due to the unstable nitric oxide release, the topical donors needed to be applied frequently, making the adherence to the treatment difficult. The electrospinning technique has allowed the production of a multilayer transdermal patch that produces a continuous and stable nitric oxide release. The main objective of this study is to evaluate this novel nitric oxide topical donor for the treatment of cutaneous leishmaniasis. METHODS AND DESIGN: A double-blind, randomized, double-masked, placebo-controlled clinical trial, including 620 patients from endemic areas for Leishmaniasis in Colombia was designed to investigate whether this patch is as effective as meglumine antimoniate for the treatment of cutaneous leishmaniasis but with less adverse events. Subjects with ulcers characteristic of cutaneous leishmaniasis will be medically evaluated and laboratory tests and parasitological confirmation performed. After checking the inclusion/exclusion criteria, the patients will be randomly assigned to one of two groups. During 20 days Group 1 will receive simultaneously meglumine antimoniate and placebo of nitric oxide patches while Group 2 will receive placebo of meglumine antimoniate and active nitric oxide patches. During the treatment visits, the medications will be daily administered and the presence of adverse events assessed. During the follow-up, the research group will visit the patients at days 21, 45, 90 and 180. The healing process of the ulcer, the health of the participants, recidivisms and/or reinfection will also be assessed. The evolution of the ulcers will be photographically registered. In case that the effectiveness of the patches is demonstrated, a novel and safe therapeutic alternative for one of the most important public health problems in many countries will be available to patients.

Journal Article↗
PubMed1996

Handling hormone replacement therapy: key issues for the prescriber.

OBJECTIVES: To examine the key considerations for physicians when prescribing hormone replacement therapy (HRT). METHODS: A review of the literature, including some unpublished data. RESULTS: As far as oral HRT is concerned, relatively large doses may have to be given because of the first-pass effect involving metabolism by the liver following absorption from the G1 tract. Alternatives include percutaneous gels, impregnated pessaries, subcutaneous implants and transdermal patches. The last of these offers the possibility of delivering oestrogen accurately in convenient form and many patients regard this as a more 'natural' way of treating the menopause. Provided equivalent doses of hormone are given, all these routes of administration are equally effective in preventing osteoporosis. The situation with respect to cardiovascular disease is more complex and different types of oestrogen or progestogen and different routes of administration can have different effects on metabolic risk factors. Certain oral HRT can adversely affect glucose tolerance and insulin metabolism while transdermal HRT has very little effect. CONCLUSIONS: The first issue for the physician is the choice of route of administration. To some extent this may depend on the patient's other clinical conditions such as raised triglycerides HRT. Patient preference is very important since this will affect compliance. One approach is to start with a fixed combination of oestrogen and progestogen which is usually easier for the patient to remember and use. Side-effects are usually due to the progestogen component. The variety of progestogens available in Europe means that switching to other combinations is not difficult if side effects occur. Patients satisfaction is the ultimate determinant.

Carbohydrate Metabolism↗
PubMed1998

Hemodynamic and metabolic effects of transdermal clonidine in patients with hypertension and non-insulin-dependent diabetes mellitus.

The aim of this study was to evaluate the effect of transdermal clonidine on hemodynamic and metabolic parameters in patients who have elevated blood pressure and non-insulin-dependent diabetes mellitus (NIDDM). After a 2-week run in placebo period, 20 NIDDM patients who had diastolic blood pressure in the range of 90 to 105 mm Hg underwent a randomized, single blind, placebo controlled, cross-over study of 4 week treatment with clonidine (transdermal patch 2.5 mg/week) or placebo (inactive patch). Compared with placebo, clonidine significantly reduced systolic (153 +/- 6 v 163 +/- 8) and diastolic (88 +/- 2 v 98 +/- 3.5 mm Hg, P = .001) blood pressure, left ventricular mass (94 +/- 11 v 99 +/- 12 g/m2, P < .01) and fasting glucose levels. Total glucose disposal (glucose clamp) was 6.5 +/- 1.5 with placebo and 7.1 +/- 1.6 mg/kg/min with clonidine (P < .01). Oxidative glucose disposal (indirect calorimetry) was also greater after clonidine. Plasma glucose, insulin, and C-peptide responses following oral glucose (75 g) were significantly lower after clonidine, as well as urinary albumin excretion. Transdermal clonidine is effective in reducing blood pressure in hypertensive NIDDM patients and is well tolerated. It may be useful to reduce the cardiovascular impact of hypertension in diabetes mellitus.

Administration, Cutaneous↗
PubMed2003

A safe and effective method for converting patients from transdermal to intravenous fentanyl for the treatment of acute cancer-related pain.

BACKGROUND: The delayed effects (12-16 hours) of transdermal fentanyl make dose titration difficult during acute exacerbations of cancer pain. Patients at the authors' institution routinely are switched from transdermal to intravenous (IV) fentanyl using a 1:1 (transdermal:IV) conversion during severe episodes of pain. METHODS: The authors evaluated nine consecutive hospitalized patients with cancer who had severe pain for up to 6 days following the conversion from transdermal to IV fentanyl. Pain intensity was rated using an 11-point (0-10) verbal numeric rating scale (NRS). All 9 patients initially reported their pain intensity with movement as >or= 8 during treatment with transdermal fentanyl. Eight patients initially reported their pain at rest as >or= 8. In each patient, all transdermal patches were removed, and a continuous infusion (CI) delivering IV fentanyl at the same hourly rate was initiated simultaneously. Demand boluses of IV fentanyl equivalent in dosage to 50-100% of the CI rate remained available by patient-controlled analgesia (PCA). Pain intensity (0-10), sedation (0-3), and hourly fentanyl requirements (micrograms per hour) were assessed and recorded immediately prior to patch removal and at least once daily after the initiation of IV fentanyl. The CI and demand boluses were titrated whenever necessary on the basis of pain intensity and supplemental PCA use. RESULTS: All 9 patients reported mild levels (<or= 4) of pain at rest within 5 days. The median time to achieve mild levels of pain at rest was 1.5 days. Six patients achieved mild levels of pain with movement within 3 days. Three patients never achieved mild levels of pain with movement while receiving IV fentanyl. No serious side effects were reported. CONCLUSIONS: The conversion from transdermal to IV fentanyl can be accomplished safely and effectively using a 1:1 (transdermal:IV) conversion during acute exacerbations of cancer pain.

Administration, Cutaneous↗