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PubMed1991

Transderm scopolamine for the control of perioperative nausea.

A randomized prospective study of 201 patients in two institutions was performed to evaluate the efficacy of a transderm scopolamine patch in the control of postoperative nausea. Of 201 patients, 180 successfully completed the protocol. Demographically, the groups were similar in age, sex, and surgical procedures. Adverse effects were noted in both treatment and control groups. Forty-seven per cent of the placebo and 49 per cent of the transderm scopolamine group did not experience postoperative side effects. The most common adverse reactions were urinary retention, dry mouth, agitation, nausea, and vomiting. There was a reduction in the number of vomiting episodes in the transderm scopolamine treatment group from the control group (21% transderm scopolamine vs. 36% placebo). These differences became more significant among the subgroups in surgery, especially after orthopedic procedures. Thirty-five per cent of the transderm scopolamine group experienced nausea compared with 65 per cent from the placebo, 11 per cent of the transderm scopolamine experienced vomiting compared to 26 per cent. Transderm scopolamine was effective in reducing but not eliminating postoperative nausea.

Administration, Cutaneous↗
PubMed2003

Transdermal buprenorphine.

Buprenorphine is a low molecular weight, lipophilic, opioid analgesic. Recently, a transdermal matrix patch formulation of buprenorphine has become available in three dosage strengths designed to release buprenorphine at 35, 52.5 and 70 micro g/h over a 72-hour period. At least satisfactory analgesia with minimal requirement for rescue medication (</=0.2 mg/day sublingual buprenorphine) was achieved by 34-50% of patients with chronic pain treated with transdermal buprenorphine 35, 52.5 or 70 micro g/h and 31% of placebo recipients, in one double-blind, placebo-controlled, randomised trial. In one trial involving patients unsuccessfully treated with weak opioids or morphine, 36.6% and 47.5% of buprenorphine 35 micro g/h and 52.5 micro g/h recipients, respectively, experienced at least satisfactory analgesia and received </=0.2 mg/day of sublingual buprenorphine compared with 16.2% of placebo recipients (both p </= 0.032). The requirement for rescue medication was reduced from baseline in >50% of patients treated with transdermal buprenorphine, in two trials. Furthermore, despite the availability of rescue medication to all patients, those receiving transdermal buprenorphine tended to experience greater pain relief, reduced pain intensity and longer pain-free sleep. Transdermal buprenorphine was generally well tolerated. Systemic adverse events were typical of opioid treatment or were attributable to the underlying disease.

Administration, Cutaneous↗
PubMedDate not supplied

A comparison of transdermal fentanyl versus epidural morphine for analgesia in dogs undergoing major orthopedic surgery.

Postoperative analgesia provided by transdermal fentanyl was compared with that provided by epidural morphine in dogs undergoing major orthopedic surgery. Dogs randomly were assigned to receive either a 100 microg per hour transdermal fentanyl patch 24 hours prior to surgery (n=8) or epidural morphine (0.1 mg/kg body weight) administered following induction of anesthesia (n=10). Temperature, heart rate, respiratory rate, and pain score were recorded prior to surgery and zero, six, 18, 30, and 42 hours after surgery. Blood samples were collected from the dogs in the transdermal fentanyl group beginning 24 hours preoperatively to 42 hours postoperatively. Fentanyl concentrations were determined by radioimmunoassay. When all time periods after surgery were combined, dogs in the transdermal fentanyl group were experiencing significantly less pain after surgery than dogs given epidural morphine. The transdermal fentanyl provided analgesia after major orthopedic surgery greater than or equivalent to that of epidural morphine.

Administration, Cutaneous↗
PubMed1995

A comparison of the effects of oral and transdermal estrogen replacement on insulin sensitivity in postmenopausal women.

Previous studies have shown that oral, but not transdermal, administration of estrogen stimulates GH secretion in postmenopausal women. Because GH impairs insulin action, the impact of estrogen replacement therapy on carbohydrate metabolism may be influenced by the route of administration. The aim of this study was to prospectively compare the effects of oral and transdermal estrogen replacement on glucose tolerance and insulin sensitivity in postmenopausal women. In an open label, randomized, cross-over study, nine postmenopausal women were randomized to transdermal estrogen patches (Estraderm-TTS 100) or oral conjugated estrogen (Premarin, 1.25 mg) daily for 12 weeks and then crossed over to receive the alternative treatment for a further 12 weeks. An oral glucose tolerance test and hyperinsulinemic euglycemic clamp (HEC) were performed before treatment and at the end of 10 weeks of treatment. Oral and transdermal estrogen both significantly reduced LH to the same degree. Mean GH did not significantly change with transdermal estrogen, but rose significantly during oral estrogen therapy. Peak and mean glucose and insulin levels during the oral glucose tolerance test were not altered by estrogen therapy and were not significantly different between treatments. Mean glucose and insulin levels were maintained at an identical level during the HEC performed at pretreatment and during estrogen therapy. The mean glucose infusion rate required to maintain euglycemia during the HEC (mean +/- SEM, pretreatment, 40.4 +/- 4.8 mumol/kg.min) was unaltered by oral (39.8 +/- 4.6 mumol/kg.min) or transdermal estrogen treatment (42.1 +/- 4.2 mumol/kg.min). However, during the transdermal estrogen phase (60 +/- 10 mumol/L), the mean nonesterified free fatty acid concentration was suppressed to a significantly lower level during the HEC than during the oral estrogen phase (120 +/- 20 mumol/L; P < 0.05). We conclude that compared to the oral route, transdermal estrogen therapy is associated with a slight, but significant, improvement of insulin action on lipid metabolism. However, in the short term, the route of estrogen replacement therapy does not have a major impact on glucose metabolism in postmenopausal women.

Administration, Cutaneous↗
PubMed2003

New advances in the treatment of hypogonadism in the aging male.

The signs and symptoms of low testosterone in the aging male include erectile dysfunction, decreased libido, mood disturbances such as depression, loss of muscle mass, osteoporosis, and increase in body fat. Many of these signs and symptoms were previously believed to be part of the normal aging process, and only recently has treatment of low testosterone in the aging male been shown to provide long-term physical and mental improvement. In the past, oral and injectable testosterone delivery methods had disadvantages that limited their use, but the introduction of transdermal testosterone patches has allowed testosterone to be delivered into the circulation in a consistent fashion. Long-term use of these patches over the last 3 to 10 years has been effective in maintaining sexual function and bone and muscle mass, and from short-term studies it does not appear that testosterone treatment puts men at risk for the development of prostate cancer. A new topical gel formation (Testim) has been designed to provide consistent transdermal absorption of testosterone over 24 hours after a single dose.

Journal Article↗
PubMed2004

Ethinylestradiol + norelgestromin: new preparation. Transdermal contraception: no tangible progress.

(1) The reference hormone-based contraceptive for women is an oral contraceptive combining ethinylestradiol (about 30 micrograms) and a well-known progestin such as levonorgestrel or norethisterone. (2) A transdermal contraceptive patch delivering 20 micrograms of ethinylestradiol and 150 micrograms of norelgestromin over 24 hours, and designed to be left in place for a whole week, three weeks a month, has recently been marketed in France. (3) Norelgestromin is the active metabolite of norgestimate, which is already available in combined contraceptives but is less well evaluated than some other progestins. Norelgestromin is metabolised by the liver, notably into norgestrel. (4) The clinical evaluation dossier of the new transdermal contraceptive contains data from two comparative unblinded trials, one versus a triphasic combination of oral ethinylestradiol + levonorgestrel, and the other versus oral ethinyl estradiol (20 micrograms) + desogestrel. A third, non comparative trial offers weaker evidence. These three trials included about 3300 women in total, and lasted between 6 and 13 cycles. The patch was about as effective as the comparator contraceptives. (5) In the three main clinical trials, 4.7% of patches had to be replaced because they became unstuck, either completely (1.8%) or partially (2.9%). (6) More women dropped out of the groups using patches (19.9% of the patch group compared with 14.5% of the group taking oral contraceptives in one trial, 29.6% versus 24.3% in the other trial). Women using the patch were more likely than other women to stop their treatment because of adverse events (about 12% versus 5%). (7) Breast discomfort, breast tenderness or pain were reported by 22% of women using the patches and by 9% and 6% of women in the two comparator groups. Women using the patches had slightly longer menstrual periods (5.6 days versus 4.7 days). Reactions at the patch site were reported by 17% of women. (8) There is no evidence that the patch is any less likely than reference oral contraceptives to cause thromboembolism. The true thromboembolic risk associated with the new patches is unknown. (9) Used patches still contain large amounts of active substances, and must be placed in sachets (provided in the packet) and taken to a pharmacy for disposal. (10) In practice, the reference combined contraceptive for women is still oral ethinylestradiol (about 30 micrograms) plus a well-known progestin such as levonorgestrel or norethisterone. Ethinylestradiol + norelgestromin patches offer women no real benefits: they are probably less convenient and may be less safe.

Administration, Cutaneous↗
PubMed1991

Transdermal glyceryl trinitrate to allow peripheral total parenteral nutrition: a double-blind placebo controlled feasibility study.

Seventy-two consecutive patients requiring total parenteral nutrition (TPN) were randomized to two groups. Group A received daily a peripheral intravenous regimen which provided 10 g nitrogen and 1400 non-nitrogen kcal (5.9 MJ). Group B received daily a peripheral intravenous regimen which delivered 9.4 g nitrogen and 1900 non-nitrogen kcal (8.0 MJ). Each group was further randomized to receive a self-adhesive patch of transdermal glyceryl trinitrate (GTN) or an identical placebo. Infusion survival was the main end-point. For group A, the median time of infusion survival was 74 h (range: 58-100) in the control group compared with 108 h (range: 68-156) in the group that received transdermal GTN (P less than 0.001). For group B, the median infusion survival was 67 h (range: 46-92) in the control group compared with 103 h (range: 66-151) in the treatment group (P less than 0.001). TPN is feasible via peripheral veins and the incidence of infusion failure can be effectively reduced by transdermal GTN.

Administration, Cutaneous↗
PubMed1994

Long-term effects of oral and transdermal hormone replacement therapies on serum lipid and lipoprotein concentrations.

OBJECTIVE: To see whether the short-term changes in serum lipid and lipoprotein concentrations induced by postmenopausal estrogen-progestin therapy are maintained in the long term. METHODS: Sixty-one healthy postmenopausal women were randomized to either oral therapy (continuous conjugated equine estrogens at 0.625 mg/day with sequential dl-norgestrel at 0.15 mg/day for 12 days each cycle) or transdermal therapy (patches delivering continuous 17 beta-estradiol [E2] at 0.05 mg/day with sequential norethindrone acetate at 0.25 mg/day for 14 days each cycle). Twenty-nine healthy postmenopausal women who did not request therapy served as a reference group. Fasting serum lipid and lipoprotein concentrations were monitored for 3 years. RESULTS: Studied in the estrogen-progestin phase, oral and transdermal therapies reduced serum total cholesterol concentrations by 12.1% (P < .001) and 8.4% (P < .001), respectively, and those of low-density lipoprotein (LDL) by 14.2% (P < .001) and 6.6% (P < .01), respectively. These changes, apparent at 3 months, were maintained over 3 years. Serum triglyceride concentrations fell by 2.5% (P < .05) and 16.4% (P < .01), respectively. These decreases were evident after 6 months in both groups but were maintained over 3 years only in the transdermal group. High-density lipoprotein (HDL) concentrations fell in women given oral therapy (7.8%, P < .05) and transdermal therapy (10.7%, P < .001), as well as in untreated women (7.0%, P < .05). CONCLUSIONS: The potentially beneficial effects of estrogen-progestin therapy on serum total and LDL cholesterol and on triglycerides were maintained over 3 years. Interpretation of the potentially detrimental effects on HDL concentrations was hindered by the changes seen in untreated women.

Administration, Cutaneous↗
PubMed1987

A controlled clinical trial of the addition of transdermal scopolamine to a standard metoclopramide and dexamethasone antiemetic regimen.

A randomized prospective clinical trial was conducted to evaluate the potential utility of adding transdermal scopolamine to a standard regimen of metoclopramide and dexamethasone for the prevention of cisplatin-induced emesis. Thirty-one patients who were about to receive their first cycle of chemotherapy, using a combination regimen including cisplatin at a dose greater than or equal to 60 mg/m2 were randomized to receive an antiemetic regimen of either metoclopramide and dexamethasone alone, or these two drugs plus transdermal scopolamine patches. The mean number of episodes of emesis was .63 +/- 1.31 in the 16 scopolamine-treated patients, and 2.27 +/- 2.66 in the 15 patients who did not receive scopolamine (P less than .01). The scopolamine appeared to inhibit extrapyramidal reactions to the metoclopramide, but the number of cases was too small for statistical significance. We conclude that the addition of transdermal scopolamine to a standard metoclopramide and dexamethasone antiemetic regimen provides additive benefit in the control of cisplatin-induced emesis.

Administration, Cutaneous↗
PubMed2001

Transdermal fentanyl: little absorption in two patients with systemic sclerosis?

Two patients suffering from systemic sclerosis (SSc) were treated with the 25 micro/hr transdermal fentanyl patch for pain from either deltoid muscle tendinitis of the left arm or from ischemia of the left-hand thumb. When the medication was changed to either oral morphine or oral methadone, the effects did not correspond to the drug conversion table. These findings suggest that patients with SSc and other systemic skin diseases may be at risk for limited absorption of transdermal fentanyl. In contrast, no restriction of the absorption of transdermal testosterone was observed.

Journal Article↗
PubMed2007

Association of the mu-opioid receptor gene with smoking cessation.

We investigated the association of the OPRM1 genotype with long-term smoking cessation and change in body mass index (BMI) following a smoking cessation attempt among smokers who attempted to quit using the nicotine replacement therapy (NRT) patch or placebo in a randomized controlled trial, and were followed-up over an 8-year period following their initial cessation attempt. We also investigated possible sex differences in these relationships, given evidence for sex differences in smoking cessation and central opioid mechanisms, as well as some evidence for sex differences in response to NRT. Our results indicate that OPRM1 genotype may moderate the effect of transdermal nicotine patch compared to placebo during active treatment, with a benefit of active NRT treatment evident in the OPRM1 AA genotype group only and those carrying one or more copies of the G allele demonstrating no benefit of active NRT versus placebo patch. Our results also indicate a sex difference in change in BMI at 8-year follow-up following a smoking cessation attempt, with ex-smokers demonstrating an increase in BMI, and this increase being greater in female subjects than in male subjects. We did not observe any association of OPRM1 genotype with change in BMI, although there was a trend for genotype to influence the observed sex difference in change in BMI over time. Future studies should attempt to replicate these findings, and investigate the relationship between both short- and long-term weight gain and smoking cessation and investigate possible mechanisms that may underlie these processes. Future studies should also investigate the role of OPRM1 genotype and smoking cessation on other appetitive and reward behaviours such as alcohol consumption.

Administration, Cutaneous↗
PubMed2006

Endometrial safety, overall safety and tolerability of transdermal continuous combined hormone replacement therapy over 96 weeks: a randomized open-label study.

OBJECTIVES: To establish whether transdermal continuous hormone replacement therapy (HRT) with estrogen/progestogen provides adequate long-term endometrial protection in postmenopausal women over a period of 96 weeks. METHODS: This multicenter, randomized, open-label, parallel-group study evaluated the endometrial effects and overall safety and tolerability of a transdermal matrix patch delivering estradiol (E2) 50 microg/day and norethisterone acetate (NETA) 140 microg/day (Estalis; patches applied twice weekly without intermediate breaks) and a once-daily oral comparator (Kliogest; one tablet containing E2 2 mg/NETA 1 mg) in postmenopausal women. A total of 406 women with an intact uterus, aged 44-69 years, were randomized in the 48-week core phase of the study, and 239 continued into the 48-week extension phase. Subjects were randomized in the ratio 3 : 1 to transdermal or oral E2/NETA treatment. RESULTS: No cases of endometrial hyperplasia or endometrial cancer were reported with either treatment during the core or extension phase. Both treatments were generally well tolerated, with most adverse events (>90%) being mild to moderate, although minor differences in the tolerability profile were observed between treatments. CONCLUSIONS: Continuous combined transdermal HRT with E2/NETA shows no evidence of an increased endometrial hyperplasia or endometrial cancer risk over a 96-week period.

Administration, Cutaneous↗
PubMed2003

Differential effects of oral and transdermal estradiol treatment on circulating estradiol fatty acid ester concentrations in postmenopausal women.

Estradiol fatty acid esters are potent lipophilic estrogens with antioxidant properties, transported by lipoproteins in blood. We investigated effects of oral and transdermal estradiol replacement therapy on concentrations of estradiol fatty acid esters in serum in postmenopausal women in a double-blind, randomized fashion. The first group (n = 9) received oral (2 mg/d); the second (n = 10), transdermal estradiol (patch delivering 50 microg/d); and the third group (n = 7), placebo treatment for 12 wk. After extraction of serum and separation of esterified estradiol from nonesterified estradiol, the concentration of saponified estradiol esters was measured by time-resolved fluoroimmunoassay. In the oral estradiol group, the median serum estradiol fatty acid ester concentration rose by 27%, from 77 to 98 pM (P = 0.028) but remained unchanged in the transdermal estradiol and placebo groups. The median concentrations of serum nonprotein-bound estradiol increased similarly in the oral and transdermal estradiol groups. The change in serum estradiol ester concentrations during treatment, but not that of nonesterified estradiol, correlated positively with enhanced forearm blood flow responses in vivo. These data raise the possibility that an increase in serum estradiol fatty acid esters may contribute to beneficial effects of oral estradiol treatment, compared with an equipotent dose of transdermal estradiol.

Administration, Cutaneous↗
PubMed1992

Transdermal fentanyl use in hospice home-care patients with chronic cancer pain.

In this study, 11 cancer patients who experienced severe pain were treated with transdermal fentanyl. Of the 11 patients, 7 completed the 4-wk protocol. Of the 4 patients who did not complete the study, 3 died due to disease progression, and 1 was withdrawn by the primary physician. Patients' pain level, mood, and quality of life were evaluated before starting the transdermal fentanyl patch system and again at 2 and 4 wk. Data from the 7 patients who completed the study showed no statistical differences in pain level, mood, or quality of life at any of the three time points. Starting doses ranged from 25 micrograms/hr to 325 micrograms/hr, with increases from 0% to 300%. There were no significant adverse reactions to the medication. The hospice patients chose to continue with the transdermal fentanyl system for pain control after completing the study.

Administration, Cutaneous↗
PubMed2004

The impact of improved compliance with a weekly contraceptive transdermal system (Ortho Evra) on contraceptive efficacy.

OBJECTIVE: The contraceptive efficacy of perfect dosing cycles and imperfect dosing cycles has not been described previously. Method compliance determines the proportion of perfect and imperfect dosing cycles, and together can form the basis for evaluating differences in efficacy based on differences in compliance. MATERIALS AND METHODS: The transdermal contraceptive delivery system (Ortho Evra) has been studied in a North American randomized trial vs. an oral contraceptive (OC) and in total has been evaluated in 3319 women in contraceptive clinical trials. This article explores the impact of perfect vs. imperfect compliance with the contraceptive method on contraceptive efficacy. Previously published data for a transdermal system (Patch, n = 812) and OC (Triphasil, n = 605) users from the North American comparative study were reanalyzed to determine the effect of imperfect use on the contraceptive efficacy of the different methods. RESULTS: Contraceptive efficacy was significantly better (p = 0.007) in cycles with perfect dosing (Pearl Index = 0.83) compared to those with imperfect dosing (Pearl Index = 6.32) for both methods. This difference is homogeneous (p = 0.62) across the Patch and OC groups. Pooled data for all Patch users confirm that perfect dosing cycles are associated with significantly better efficacy than imperfect dosing cycles (p = 0.047). In addition, compliance did not vary by age in the pooled Patch data, which are in agreement with the previously published Patch data from the comparative study. In the comparative study, the percentage of cycles with perfect dosing was significantly higher with the Patch than with the OC (88.7% vs. 79.2%, p < 0.001), and was consistently high in all age groups (range, 89.6-91.8%). By contrast, among OC users, the percentage of cycles with perfect dosing increased with increasing age (p < 0.001) from 67.7% in users aged 18-20 years to more than 80% in those aged 30 years and older. CONCLUSION: In conclusion, deviations from perfect use (whether corrected or not) of a transdermal contraceptive system and of an OC increase contraceptive failures by approximately 5-10-fold when compared to perfect use. The weekly change schedule of the transdermal contraceptive delivery system is associated with a significantly greater proportion of cycles in which there is perfect dosing compared to an OC.

Administration, Cutaneous↗
PubMed2001

Effects of chronic clonidine administration on sympathetic nerve traffic and baroreflex function in heart failure.

Congestive heart failure is characterized by a sympathetic activation that is coupled with a baroreflex impairment. Whether these alterations are affected by clonidine is unknown. In 26 normotensive patients age 58.0+/-1.1 years (mean+/-SEM) affected by congestive heart failure (New York Heart Association functional class II or III) and treated with furosemide and enalapril, we measured mean arterial pressure, heart rate, venous plasma norepinephrine, and muscle sympathetic nerve traffic (microneurography) at rest and during baroreceptor stimulation and deactivation caused by stepwise intravenous infusions of phenylephrine and nitroprusside, respectively. Measurements were repeated after a 2-month administration of transdermal clonidine patch (14 patients) or placebo (12 patients) according to a double-blind, randomized sequence. Clonidine caused a slight, nonsignificant reduction in mean arterial pressure and heart rate without affecting exercise capacity and echocardiographically determined left ventricular ejection fraction. In contrast, both plasma norepinephrine and sympathetic nerve traffic were significantly reduced (-46.8% and -26.7%, respectively; P<0.01 for both). This reduction was coupled with no change in cardiac and sympathetic baroreflex responses. Transdermal placebo administration for a 2-month period did not affect any of the above-mentioned variables. Thus, in congestive heart failure patients who are undergoing conventional drug treatment, chronic clonidine administration exerts marked sympathoinhibitory effects without adversely affecting cardiac functions and clinical state. Whether this leads to further therapeutic benefits remains to be tested.

Baroreflex↗
PubMed1990

The effect of ketoconazole and transdermal estradiol on serum sex steroid hormones levels.

In this randomized, open-label trial, 24 subjects were studied. There were 12 subjects with essential hypertension and 12 normotensive controls who received, after an initial control period, 48 h of treatment with a transdermal estradiol patch or ketoconazole tablets every 8 h for six doses, or in combination. LHRH (100 micrograms) and ACTH (250 micrograms) were given at 48 h of each treatment. Each treatment was one week apart. In both normotensive and hypertensive men ketoconazole reduced adrenal and gonadal androgens, raised 11-deoxycortisol and 17 alpha-hydroxyprogesterone levels; blunted the rise of cortisol to ACTH and had no effect on the response of LH to LHRH. Transdermal estradiol raised serum estradiol levels, blunted the time to peak plasma concentration of LH to LHRH and produced a normal response to ACTH. Although baseline level of total and free testosterone and DHEA-S were lower in hypertensive men, the response of the pituitary (LH) to LHRH and adrenal axis with ACTH were similar in both normotensive and hypertensive men. Blood pressure was unaffected by any of the treatment interventions in either normotensive or hypertensive men. Although ketoconazole or transdermal estradiol reduce androgens, there was no evidence that this reduction in androgens was involved with the short term regulation of blood pressure in hypertensive men.

Administration, Cutaneous↗
PubMed1995

The hemodynamic and hematologic effects of cigarette smoking versus a nicotine patch.

Patients who smoke have higher complication rates than nonsmokers in the postoperative period. The authors designed an experimental protocol for habitual smokers (n = 30) to determine the specific hemodynamic and hematologic adverse effects possibly caused by nicotine and whether the method of nicotine delivery and systemic nicotine levels achieved might influence these adverse effects. During the 5-day study, subjects were asked to refrain from smoking, and testing sessions were conducted as follows: on day 1, the subjects smoked two cigarettes immediately before testing; on day 3 (control day), testing was done after not smoking for 48 hours and then the subjects were instructed to wear a transdermal nicotine patch (PROSTEP 22 mg/day) for 24 hours and replace it with another so that, on day 5, testing took place after the subjects had worn the patch for approximately 34 hours. At each testing session, digital artery pulse amplitude and a number of clinical and serum blood level parameters were measured. Relative digital blood flow after smoking (69.2 +/- 5.8%) and with the patch (80.4 +/- 7.6%) was lower than on the control day (100.0 +/- 0.0%). The nicotine patch, unlike smoking, had no effect on vasopressin or fibrinogen concentrations, hematocrit, or white cell or platelet counts; both smoking and the patch resulted in elevated norepinephrine levels.

Administration, Cutaneous↗