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PubMed1996

[Treatment of estrogen deficiency-induced sex disorders].

OBJECTIVE: Is it possible to successfully treat sexual disturbances related to an estrogen deficiency syndrome with estrogens? METHODS: For 4 months, sexual dysfunctions (loss of libido, dyspareunia, difficulties in experiencing orgasm) were treated with a transdermal system-the estrogen patch-in one group cyclically and in a second continually. Women with uterus got 1 mg/day norethisterone acetate for 12 days a month. RESULTS: By estrogen therapy alone, success was seen in 40/41% for loss of libido, in 75/56% for dyspareunia and in 47/25% for difficulties of orgasm. CONCLUSIONS: In spite of the complexity of the biopsychosocial causes of the sexual disturbances in relation with an estrogen deficiency syndrome, the replacement therapy is successful in many cases.

Administration, Cutaneous↗
PubMed2000

Efficacy of anti-anginal drugs in the treatment of angina pectoris associated with silent myocardial ischemia: importance of quantitative Holter ECG data for patient activity.

METHODS: We evaluated the clinical efficacy of transdermal nitroglycerin (NTG-TTS), a patch application of a nitrate, in the treatment of 27 patients with angina pectoris who had asymptomatic myocardial ischemic (SMI) attacks, using a double-blind cross-over method. Evaluation was made using Holter ECG and patient activity data. RESULTS: In frequency and duration of continuation of SMI episodes, no significant differences were noted between the observation and placebo treatment periods, while the values of both these parameters were decreased significantly in the active drug treatment period compared with those in the observation and placebo treatment periods. Critical heart rate, the heart rate at the initiation of ST-segment depression, was significantly higher during the period of active drug treatment than during the placebo treatment and observation periods. In SMI frequency index, which was determined by adjusting the SMI frequency for the number of steps taken, there were no significant differences between the 3 periods. The SMI time index was significantly lower in the active drug treatment period than in the observation period. CONCLUSIONS: These results indicated that the clinical evaluation of the efficacy of anti-anginal drugs against SMI should take into consideration individual patient activity data.

Administration, Cutaneous↗
PubMed2003

Smoking cessation with nicotine replacement therapy among health care workers: randomized double-blind study.

AIM: To assess the smoking prevalence and efficacy of nicotine replacement therapy on the quitting rate after 3 weeks of therapy and after 1- and 5-year follow-up among health care workers with a smoking habit in Split, Croatia. METHODS: Among 311 hospital health professionals included in the study, there were 112 (36%) smokers; 44 (39%) of them were physicians and 68 (61%) nurses. In a randomized double-blind study, 112 smokers were divided in 2 groups, applying daily either a transdermal nicotine system (TNS) or placebo patch over 3 weeks. Abstinence was evaluated via questionnaire and on the basis of carbon monoxide concentration measured in the exhaled breath. RESULTS: The abstinence rates after the 3-week intervention period were 39% in the TNS group and almost 20% in the control group (chi-square test, p=0.038). After one year, these rates declined to 23% and 16%, respectively (p=0.476), and converged to 18% and 14% (p=0.797), respectively, at 5-year follow-up. CONCLUSIONS: Short-term TNS treatment is effective in smoking cessation, although the effects steadily wane over time and the relapse rate is high. Continuous, structured, and composite efforts are needed for the maintenance of the non-smoking behavior.

Administration, Cutaneous↗
PubMed1987

The effect of occlusion of the skin with transdermal therapeutic system on Langerhans' cells and the induction of skin irritation.

Sensitization to drugs in transdermal therapeutic systems is a common unwanted event. We investigated whether prolonged occlusion of the skin causes skin irritation, and in this way might play a role in the possible induction of sensitization to drugs from these systems. Occlusion was effected with a placebo transdermal therapeutic system and silver-patch test in a time span ranging from eight hours to seven days in five groups of five volunteers. Skin irritation was judged on clinical aspects, histopathologic and immunofluorescence findings, and changes in the Langerhans' cell systems. The results indicate that occlusion with the systems used in this experiment provokes only slight or no skin irritation.

Administration, Cutaneous↗
PubMed2001

Efficacy and safety of a transdermal contraceptive system.

OBJECTIVES: To evaluate the efficacy, cycle control, compliance, and safety of a transdermal contraceptive system that delivers norelgestromin 150 microg and ethinyl estradiol 20 microg daily. METHODS: In this open-label, 73-center study, 1672 healthy, ovulatory, sexually active women received ORTHO EVRA/EVRA for six (n = 1171) or 13 cycles (n = 501). The treatment regimen for each cycle was three consecutive 7-day patches (21 days) followed by 1 patch-free week. RESULTS: The overall and method-failure probabilities of pregnancy through 13 cycles were 0.7% and 0.4%, respectively. The incidence of breakthrough bleeding was low throughout the study. Perfect compliance (21 consecutive days of dosing, followed by a 7-day drug-free interval; no patch could be worn for more than 7 days) was achieved in 90% of subject cycles; only 1.9% of patches detached completely. Adverse events were typical of hormonal contraception, and most were mild-to-moderate in severity and not treatment limiting. The most common adverse events resulting in discontinuation were application site reactions (1.9%), nausea (1.8%), emotional lability (1.5%), headache (1.1%), and breast discomfort (1.0%). CONCLUSIONS: The transdermal contraceptive patch provides effective contraception and cycle control, and is well tolerated. The weekly change schedule for the contraceptive patch is associated with excellent compliance and wearability characteristics.

Administration, Cutaneous↗
PubMed1996

Menorest: technical development and pharmacokinetic profile.

Transdermal application of oestradiol enables the use of lower doses than with the oral drug and avoids first-pass metabolism in the liver. First-generation transdermal delivery systems were of reservoir design. Menorest is one of a new generation of patches, in which oestradiol is dispersed in a micronized suspension throughout the adhesive matrix. This design results in a very thin patch with good cosmetic acceptability. Pharmacokinetic studies indicate that Menorest allows transdermal release of oestradiol at a constant and reproducible rate at doses from 25-100 micrograms/day. There is a linear relationship between the dose of oestradiol administered (which is determined by the surface area of the patch) and the plasma concentration of oestradiol. In contrast to the standard reference reservoir patch, Estraderm, Menorest maintains plasma oestradiol concentrations at or above the target level of 40 pg/ml throughout the 84-h dosing interval.

Administration, Cutaneous↗
PubMed2003

Direct demonstration of nitric oxide formation in organs of rabbits treated by transdermal glyceryl trinitrate using an in vivo spin trapping technique.

Glyceryl trinitrate (GTN) is commonly delivered by a patch for the treatment of angina pectoris. The idea is now generally accepted that GTN requires a biotransformation process that activates the drug, in particular through nitric oxide (NO) generation. However, the pharmacokinetics of NO delivery from GTN still remains obscure. The objective of this study was to assess GTN-derived NO formation in vascular tissues and organs in rabbit given GTN patches. NO levels were evaluated in rabbits after 3 h of treatment with a 10 mg GTN patch (GTN group; n = 7) or a placebo patch (CTL; n = 7). Nitrosylhaemoglobin (HbNO) was evaluated by electron spin resonance (ESR) spectroscopy in red cell suspension. In vivo spin trapping technique using FeMGD as a spin trap, associated with ESR was used to quantify NO in tissues. The NO-spin trap complex, which is a relatively stable product, has been measured in several tissues. The ESR spectrum corresponding to HbNO was not found in red cell of GTN or CTL rabbits. The spectrum corresponding to the NO-spin trap complex was observed in all analysed tissues of CTL rabbits. The signal was significantly increased in liver, renal medulla, heart left ventricle and spleen of GTN-treated rabbits, and to a lesser extent in right ventricle and lung. No difference was shown between NO-spin trap levels measured in aorta or inferior vena cava from GTN or CTL rabbits. These data suggest that GTN patch treatment induced NO release, and that tissue-specific differences in transdermal GTN-derived NO exist. The GTN-NO pathway appears to be largely involved in organs such as the liver, kidney and heart.

Administration, Cutaneous↗
PubMed1997

Effects of transdermal oestrogen therapy in postmenopausal women: a comparative study of an oestradiol gel and an oestradiol delivering patch.

OBJECTIVE: To compare the efficacy, safety and tolerability of an oestradiol gel (1.0 mg of oestradiol daily, Divigel/Sandrena) with those of an oestradiol delivering patch (delivering 50 micrograms oestradiol/24 h, Estraderm TTS) in hormone replacement therapy of postmenopausal women. Dydrogesterone tablets (Terolut), 10 mg daily for the first 12 days of every month, were used as the progestogen component of the therapy. MAIN OUTCOME MEASURES: The effect of treatment on clinical symptoms and on endometrium, total body bone mineral density and lipid metabolism as well as the tolerability of the treatments with special emphasis on skin irritation and compliance were evaluated. DESIGN: An open, randomised, controlled, parallel-group trial of 12 months' duration. SETTING: The Medical Clinic of Kalevankatu, Helsinki, Finland. PARTICIPANTS: One hundred twenty postmenopausal women were treated with transdermal oestradiol combined with dydrogesterone. In addition, 25 women without HRT served as a reference group for the bone mineral density measurements. RESULTS: Both treatment regimens were equally effective in alleviating climacteric symptoms, preserving bone mineral density and were equally safe. A trend towards heavier bleeding was detected in patients treated with the oestradiol delivering patch. A statistically nonsignificant decrease of total cholesterol and triglyceride concentrations but no change in high-density lipoprotein cholesterol concentration was observed in both groups. The acceptability of the treatment was higher in the gel group (96.4%) than in the patch group (90.7%). Only two (3.3%) women using the oestradiol gel complained of skin irritation whereas 28 patients (46.7%, P < 0.001) using the oestradiol delivering patch reported this adverse effect. CONCLUSIONS: Both the oestradiol gel and the oestradiol delivering patch are equally effective in hormone replacement therapy but the gel preparation is less irritative to the skin.

Administration, Cutaneous↗
PubMed2003

New modalities of transdermal testosterone replacement.

Hypogonadism, irrespective of its etiology, has a negative impact on various physiologic parameters. These parameters may improve with testosterone replacement therapy. Before 1990, intramuscular testosterone esters were the principal modality of testosterone replacement in men with hypogonadism. Although effective, they have a non-physiologic pharmacokinetic profile. Recently, transdermal preparations of testosterone have become widely available. These include a scrotal patch, non-scrotal patches and, the most recent development, a gel. Several studies have shown that transdermal testosterone replacement is physiologic, efficacious and has a good safety profile. Transdermal testosterone replacement improves bone mass and lean body mass, decreases fat mass, and improves mood and sexual function. There are no harmful effects on the prostate and lipids. Acne, polycythemia, and gynecomastia are less common with this form of therapy than with the intramuscular esters.

Administration, Cutaneous↗
PubMed2000

Lipid effects of hormone replacement therapy with sequential transdermal 17-beta-estradiol and oral dydrogesterone.

OBJECTIVE: To assess the effects on lipid and lipoprotein levels of a combination therapy of matrix patch and oral sequential dydrogesterone. METHODS: The lipid effects of transdermal estradiol (E2) (80 microg/day continuously) and oral dydrogesterone (10 mg from days 15-28 of each cycle) were assessed in a multicenter, prospective, open, baseline-controlled study. Subjects were 42 healthy, postmenopausal women who had not had hysterectomies. Fasting blood samples were taken at baseline, day 14 of cycle 3 (estrogen alone), and day 25 of cycle 6 (estrogen and progestogen). The main outcome measures were changes from baseline in total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides after six cycles. RESULTS: Thirty-six subjects completed six cycles and in the 28 with complete data, HDL cholesterol increased by 10.6% from 65.25 to 72.2 mg/dL (95% confidence interval [CI] 2.32, 11.58, P = .005) and LDL cholesterol fell by 5.1% from 130.9 to 124.3 mg/dL (95% CI 13.9, 1.16, P = .07). There was a nonsignificant decrease in LDL cholesterol from 130.9 at baseline to 124.3 mg/dL at 6 months and in triglycerides from 110.6 to 107.1 mg/dL. CONCLUSION: Sequential treatment with transdermal E2 and oral dydrogesterone increased HDL cholesterol, without the accompanying increase in triglycerides that occurs with oral estrogen replacement therapy.

Adult↗
PubMed2005

[In vitro transdermal permeation of lidocaine-dodecanol binary eutectic system].

AIM: To study the effect of lidocaine-dodecanol binary eutectic system on the transdermal permeation of lidocaine. METHODS: Binary eutectic mixture of different proportions of lidocaine and dodecanol were prepared and the patch containing the binary eutectic mixture was developed. The solubilities of pure lidocaine and lidocaine from the binary eutectic system were determined in pH 7.9 phosphate buffer. The transdermal flux of lidocaine from the patches containing the binary eutectic system and pure lidocaine were measured using Franz-type single diffusion cell. RESULTS: The melting point of the lidocaine-dodecanol binary eutectic system was markedly lower than that of pure lidocaine. The steady state transdermal flux of lidocaine from the patch of the binary eutectic system was six times as much as that of pure lidocaine patch. CONCLUSION: The lidocaine-dodecanol binary eutectic system could produce high thermodynamic activity of the drug and the high driving force for transdermal permeation of lidocaine.

Administration, Cutaneous↗
PubMed1997

Effect of preoperative transdermal ketoprofen on post-hysterectomy pain.

BACKGROUND: In an attempt to reduce central sensitization after tissue injury, the concept of "pre-emptive analgesia" was evolved. The aim of the present study was to evaluate the analgesic effect of pre-incisional transdermal ketoprofen on post-hysterectomy pain. METHODS: Sixty patients scheduled for elective trans-abdominal total hysterectomy were divided into three groups. The day before surgery, patients in Group 1 received transdermal ketoprofen 30 mg over the proposed surgical area twice; patients in Group 2 received a placebo patch under a similar design; patients in Group 3 received transdermal ketoprofen 30 mg over right thigh twice. Operations were performed under general anesthesia. Postoperatively, patients received patient-controlled analgesia with morphine for pain relief, and pain was assessed by visual analogue pain scale (VAS). Hemodynamic parameters, respiratory rate, sedation scale, morphine consumption and associated side effects were also recorded. RESULTS: There was no significant difference among groups with respect to VAS, sedation scale, blood pressure, respiratory rate or morphine consumption within 24 hours postoperatively. The mean time for first morphine demand was significantly delayed in Group 1 patients (p < 0.05). The incidence of nausea and vomiting among the three groups showed no significant difference. CONCLUSIONS: It seems that pre-incisional transdermal ketoprofen (30 mg, twice the day before surgery) has only a limited pre-emptive effect on post-hysterectomy pain as indicated by delayed first morphine request. Further, it had no effect on postoperative VAS, morphine consumption or incidence of nausea and vomiting.

Administration, Cutaneous↗
PubMed1994

Lack of tolerance in forearm blood vessels in man to glyceryl trinitrate.

1. Nitrate tolerance is a clinical problem. The cause is not known but it has been suggested that tolerance to organic nitrates occurs within the blood vessels to reduce sensitivity to the drug. We have determined the sensitivity of human forearm resistance vessels and veins to glyceryl trinitrate (GTN) at the beginning and end of a 7 day period of GTN administration in healthy volunteers using a clinically relevant dose of transdermal drug. 2. Eight healthy volunteers completed the study which entailed measurement of change in forearm venous compliance and change in forearm blood flow following intraarterial infusions of two doses of glyceryl trinitrate (0.5 and 2.0 micrograms min-1) before, after 2 h and after 7 days of transdermal GTN administration using one 10 mg patch each 24 h. 3. Changes in venous compliance and blood flow were measured by venous occlusion plethysmography using a basal infusion of noradrenaline (1 microgram min-1) to increase venous tone. 4. Noradrenaline produced the expected decrease in forearm blood flow and venous compliance. The effect of locally infused GTN on venous compliance and forearm blood flow was similar on the three study days. In particular there was no significant difference in the response to GTN following 7 days transdermal administration compared with that after 2 h. 5. We conclude from this study that local vascular tolerance to GTN is unlikely to explain the clinical problem of nitrate tolerance, and that other mechanisms such as neurohumoral activation may be important.

Administration, Cutaneous↗
PubMed1996

Transdermal estroprogestins versus transdermal estrogen plus oral dihydrogesterone replacement in menopause.

We studied 18 early (6 to 36 months) postmenopausal patients with a mean age of 51 years (47-53), who had never undergone hormone replacement therapy before and had no contraindications to hormone replacement. All cases of menopause were spontaneous. The treatment consisted in the continuous transdermal administration of 17-beta-estradiol (50 microg/daily) by skin patch to be replaced every 84 hours. The patients were further treated with a two-week progestogen administration every fortnight. This consisted of transdermal norethisterone acetate (0.25 mg/daily) combined with estradiol in the same patch in the first year, and oral dihydrogesterone (10 mg/daily) in the second year, without wash-out period. Before treatment (T0), and at the 12th (T1) and 24th (T2) month we measured the body mass index, the arterial blood pressure (AP), lipoproteins, coagulation parameters and bone metabolism parameters. The systolic pressure presented mean values (+/-SD) equal to 128.5+/-10.2 mmHg (T0), 131.1+/-7.4 mmHg (T1) and 130.4+/-7.5 mmHg (T2). Diastolic pressure values showed mean value ranging from 85.4+/-8.7 mmHg (T0) to 83.9+/-5.3 (T1) and 83.4+/-5.8 mmHg (T2). The detailed analysis of values of triglycerides, HDL cholesterol, apolipoprotein A1, apolipoprotein B and coagulation parameters at different times of therapy showed no statistically significant changes. With regard to bone metabolism, no statistically significant changes from baseline values were observed in parathormone, alkaline phosphatase, calcitonin, urinary calcium/creatinine ratio, and bone mineral content expressed by the bone density.

20-alpha-Dihydroprogesterone↗
PubMed1985

Hemodynamic and hormonal effects of high-dose transdermal nitroglycerin in patients with chronic congestive heart failure.

The hemodynamic effect of a large dose of nitroglycerin (NTG) (90 mg) given transdermally using a reservoir system was studied in 10 patients with severe, long-standing congestive heart failure. Serial hemodynamic measurements over 24 hours revealed a mild decrease in mean pulmonary artery wedge pressure. However, the change from baseline was significant only at 2 hours (19 +/- 9 vs 27 +/- 6 mm Hg). Mean right atrial pressure fell 1 hour after initiation of therapy, from 12 +/- 7 to 8 +/- 5 mm Hg. However, the change from control was not statistically significant. No significant changes were noted in heart rate, mean blood pressure, cardiac index, and systemic and pulmonary vascular resistance. Individual analysis of the effect of transdermal NTG on pulmonary artery wedge pressure demonstrated at 20% or greater reduction in 8 of 10 patients. However, persistent effect (longer than 8 hours) was seen in only 4 patients. Removal of NTG patches at 24 hours did not result in hemodynamic rebound. Serum catecholamine levels and renin concentration did not change 2 hours and 24 hours after initiation of NTG therapy or after removal of NTG patches. Thus, a large dose (90 mg) of transdermal NTG using a reservoir system results in mild and mostly statistically insignificant hemodynamic effect in patients with chronic severe congestive heart failure. Although a reduction in pulmonary artery wedge pressure is seen in most patients, rapid attenuation of this response is found in many patients and the effect only rarely lasts for 24 hours.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Topical↗
PubMed2004

In vitro transdermal delivery of the major catechins and caffeine from extract of Camellia sinensis.

The aim of this study was to investigate the feasibility of the transdermal delivery of catechins and caffeine from green tea extract. Drug-in-adhesive patches containing 1.35, 1.03, 0.68, and 0.32 mg cm(-2) green tea extract were formulated and the dissolution of (-)-epigallocatechin gallate (EGCg), (-)-epigallocatechin (EGC) and (-)-epicatechin (EC) from these was determined. Transdermal delivery was determined across full thickness pig ear skin from saturated solutions of green tea extract in pH 5.5 citrate-phosphate buffer, polyethylene glycol 400 and a 50:50 mixture of the citrate phosphate buffer and polyethylene glycol in addition to patches containing 1.35 mg cm(-2) green tea extract. Dissolution experiments indicated first order release which was dose dependent in respect of the loading level, although the amounts permeated were not always proportional to the amounts in the formulation. The highest percentage permeation of EGCg was found to be from the patch formulation. EGCg, EGC and EC were all successfully delivered transdermally from saturated solutions and adhesive patches containing green tea extract in this study. There was some evidence for the dermal metabolism of EGCg, but after 24 h 0.1% permeated from the patches containing 1.35 mg cm(-2) green tea extract. This was equivalent to the percentage absorbed after intragastric administration of green tea extract in rats. In addition, the concentration of EGCg in the Franz cell receptor chamber after 24 h permeation from the 0.9 cm diameter patch containing 1.35 mg cm(-2) was within the range of Cmax plasma levels achieved after oral dosing of 2.2-4.2 gm(-2) green tea extract. Caffeine was also delivered at concentrations above those previously reported.

Administration, Cutaneous↗
PubMed2001

[Effect of transdermal administration of 17-beta estradiol on the release of growth hormone by growth hormone liberating hormone (GH-RH-1-29) in climacteric women before and after treatment].

BACKGROUND: Great interest has sparked recently the role that plays the changes that the growth hormone undergoes in the menopausal woman, specially its involvement in the central nervous, cardiovascular, genitourinary, digestive and osteomuscular systems. OBJECTIVE: To evaluate the influence of transdermal administration of 17-beta estradiol on growth hormone secretion in menopausal women before and after treatment under the stimulus of growth-hormonereleasing hormone (GH-RH). MATERIAL AND METHODS: We studied 5 patients with a mean age of 51 +/- 4.1 yr. with clinical and biochemical evidence of menopause. Evolution time 5.4 +/- 4.61 (range: 1-13 yr.). We monitored the pulsatility of GH during the first 120 minutes and 3 hours after the administration of the GHRH-1-29-NH2, i.v. bolus (50 micrograms). There were obtained every 15 minutes for the determination of GH levels before and after the stimulus. Immediately thereafter hormone replacement therapy was initiated with transdermal beta-estradiol with 50 micrograms patches twice a week. Clinical evaluations and hormone dynamics with OHRH-1-29 were performed at baseline and at 1,3 and 6 months from the start of therapy as described previously. RESULTS: GH pulsatility before estrogen replacement therapy (ERT) in these 5 patients was: X: 0.48 +/- 0.22, 0.38 +/- 0.17, 0.45 +/- 0.25 and 0.29 (at baseline, 1, 3 and 6 months respectively) and 2.74 +/- o 1.21; 3.48 +/- 1.32 (p > 0.05) 4.91 +/- 1.57 (p < 0.05) and 6.04 +/- 1.69 (p < 0.05) (p in relation to baseline) post stimulus with GH-RH-1-29 at baseline 1, 3 and 6 months respectively after transdermal estrogen therapy. Gonadotrophins basal serum levels fall from X: 54.68 +/- 27 to 33.20 +/- 11.23 and 40.48 +/- 12 to 28.30 +/- 6.70 (FSH and LH respectively). Estradiol serum level were from 1.82 +/- 4.06 to 25.95 +/- 5.96 before and after treatment, respectively. COMMENTS AND CONCLUSIONS: These results demonstrate that transdermal estrogen therapy does not modify the pulsatility of growth hormone but it does increase the magnitude of response to the stimulus with GH-RH-1-29 proportional to the time of treatment. We consider that this tendency to increase the production of growth hormone could be explained by an endogenous deficit of growth hormone releasing hormone due to a number of factors including the lack of adequate estrogen serum levels in menopausal women. More investigations will be needed to support this hypothesis and to bring forth a new understanding of menopause and its treatment.

Administration, Cutaneous↗