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PubMed1998

Two distinct two-step ranks of progesterone stimulation after three different levels of oestrogen priming. Effect on induction of luteinizing hormone surges in young and climacteric women.

Age and menopausal status were evaluated as potential modulators of the progesterone action in the initiation of the mid-cycle luteinizing hormone (LH) surge in women. Three distinct levels of oestradiol priming were used, in combination with two different two-step ranks of progesterone stimulation (10/25 mg and 25/50 mg i.m. injections of progesterone in oil, over 2 consecutive days) in two groups of women, ten premenopausals, aged between 18 and 25 years, and 14 postmenopausals, aged between 48 and 57 years. The low, moderate and high levels of oestradiol priming were defined in the premenopausal group by days 5 and 9 of the cycle, and 0.4 mg transdermal oestradiol applied in the early follicular phase respectively. The corresponding situation in the postmenopausal women was defined by the absence of treatment, 0.1 mg transdermal oestradiol, and 0.4 mg transdermal oestradiol respectively. The oestradiol patches were maintained for 5 days, and the first progesterone dose administered on day 3 of treatment. Unambiguous LH surges, detected in serum and urine, were restricted to the protocols using 0.4 mg oestradiol in both groups, with an onset soon after progesterone administration. The surge was higher in the postmenopausal group in serum and urine. The percentage LH increase above baseline, however, was higher in the premenopausal women. The dose of progesterone did not result in any changes in pituitary LH release. Therefore, the oestradiol threshold for the progesterone stimulatory effect on LH release was similar in both groups. The postmenopausal women did not yield defective LH surges when adequately primed with oestradiol and progesterone.

Adult↗
PubMed1985

Cost-effectiveness of two transdermal nitroglycerin controlled-release systems.

An analysis of the cost-effectiveness of two transdermal nitroglycerin systems utilizing adhesive patches, TDN and ND, was performed by a health-care research and management consulting firm. Better adhesion of TDN produced an estimated 14.5% savings over ND ($22.93 vs $26.82) in wholesale prescription costs for four weeks. Multivariate regression analyses, which controlled for patients' age, sex, body mass index, and study location, did not affect the observed difference in adhesive properties, suggesting that TDN's adhesive superiority is intrinsic to patch function and that it does not depend on other variables.

Adhesiveness↗
PubMedDate not supplied

[Principles and rules of the use of nitrates].

Nitrates, which have been used for more than a century, are the second oldest drug (after digitalis alkaloids) in the cardiological pharmacological arsenal. However, several facets of their mode of use still remain controversial. Their vasodilator and arteriolodilator action (especially in coronary vessels) and their platelet aggregation inhibitory effect make them useful drugs, particularly in all clinical forms of ischaemic heart disease (unstable or stable angina and acute myocardial infarction), for the prevention or treatment of ischaemic episodes (silent or not) and also in heart failure where nitrates are useful not only as symptomatic treatment (alone or associated with diuretics), but also in view of their positive effect on survival (associated with hydralazine: V-Heft I trial). At the present time, nitrates can be administered via the sublingual, oral, intravenous of transdermal routes in the form of nitroglycerin and isosorbide dinitrate or mononitrate (short-acting and sustained-effect forms). Their rare contraindications concern patients suffering from severe hypotension (< 70 mmHg), severe anaemia, glaucoma or intracranial hypertension. The most serious adverse effects are pulsatile headache (which usually disappear after several days), postural hypotension (possibly causing fainting), facial erythema, vertigo, palpitations or nausea and vomiting. Most of these adverse effects can be controlled by dosage adaptation and it is rarely necessary to stop treatment. However, the major problem raised by the use of nitrates concerns the development of a tolerance. The pathophysiology of this multifactorial phenomenon is still unclear. The protagonist role played by loss of SH groups or activation of humoral feedback mechanisms, with an increase of circulating catecholamine levels, activation of the R-A-A system and increased plasma volume, has been postulated. This complication can be avoided by prescribing intermittent treatment, with a drug-free interval of 10-12 hours per day. A single dose of a sustained-release preparation (60 mg of isosorbide dinitrate or 40 to 60 mg of isosorbide mononitrate), or 2 or 3 doses of a short-acting preparation (20-40 mg of isosorbide mononitrate) can be prescribed via the oral route. When the transdermal route is used, the patch should be left in place for 12 hours. Treatment should be started at low doses, which are then gradually increased. The free period is usually at night, which can be covered, when necessary, by other antiischaemic drugs (for example, beta-blockers and/or calcium channel blockers), already usually used in combination with nitrates. This interruption is not accompanied by a rebound phenomenon. It must be remembered that nitrates potentiate the action of other vasodilators and calcium channel blockers and that, in some patients, intravenous nitroglycerin reduces the anticoagulant effect of heparin, while indomethacin can inhibit their vasodilator effect. Nitrates are therefore in very good health despite their advanced age and, when used correctly, they continue to be very useful in the pharmacological treatment of cardiovascular diseases.

Drug Resistance↗
PubMed1999

Case study: accidental clonidine patch overdose in attention-deficit/hyperactivity disorder patients.

The safety and efficacy of the clonidine patch are contingent on the integrity of the transdermal system and the condition of the dermal surface to which it is applied. This article presents the first 2 case reports in the literature of unintentional overdose in pediatric patients with attention-deficit/hyperactivity disorder treated with transdermal clonidine. Appropriate precautions and patient education can help limit toxicity from the clonidine patch in children and adolescents.

Administration, Cutaneous↗
PubMedDate not supplied

Breakthrough strong opioid analgesia prescription in patients using transdermal fentanyl admitted to a hospice.

Durogesic (fentanyl) patches have revolutionized pain relief, but patients still require breakthrough medication. A retrospective analysis of in-patient admission notes at a 25-bed hospice over a six-month period was carried out. Details of analgesia being used on admission for both background and breakthrough pain were obtained, and the appropriateness of the breakthrough dose for those patients using transdermal fentanyl was determined. During the study period 278 patients were admitted to the hospice and 56 (20 percent) were using transdermal fentanyl. Of these, 35 (62 percent) were prescribed strong opioid analgesia--the dose of breakthrough medication prescribed was appropriate in 11 patients (31 percent). Rescue dosing was less than recommended, in relation to prescribed transdermal fentanyl strength in 21 patients (60 percent) and greater than recommended in one patient (3 percent). In this study, short-acting strong opioid analgesia was not always prescribed for patients using transdermal fentanyl, and when they were prescribed, this was in the appropriate dose range in less than a third of patients.

Administration, Cutaneous↗
PubMed1990

Transdermal versus subcutaneous leuprolide: a comparison of acute pharmacodynamic effect.

Transdermal administration of peptides has been limited by the barrier properties of the skin. We compared the acute luteinizing hormone (LH) response to subcutaneous and transdermal administration of an LH-releasing hormone agonist (leuprolide). Eighteen volunteers received 5 mg leuprolide added to electrically powered patches delivering a current of 0.22 microA (transdermally). One week later, they received a 5 mg subcutaneous dose. LH response was measured. The area under the curve for LH response, maximum LH response, and time to maximum LH response were similar. Time to first response was shorter (147 +/- 108 minutes [transdermally] and 73 +/- 74 minutes [subcutaneously]; p less than 0.05), and the area under the curve for the first 150 minutes was greater (3655 +/- 2246 mIU.min/ml [transdermally] and 8666 +/- 4067 mIU.min/ml [subcutaneously]; p less than 0.05) for subcutaneous delivery. No major adverse effects were seen. This electrically powered transdermal technique merits further study.

Administration, Cutaneous↗
PubMed1989

Transdermal delivery of mepindolol and propranolol in normal man. 1st communication: study design, clinical and pharmacodynamic aspects.

In the present study the beta-adrenoreceptor blocking effects of acute and repeated transdermally delivered mepindolol (20 mg/9.8 cm2 patch) and propranolol (40 mg/9.8 cm2 patch) on supine and stimulated circulatory function (isoprenaline infusion, isometric hand grip, delayed auditory feed-back) in nine healthy male volunteers were assessed. The study was conducted in a placebo-controlled double-blind cross-over fashion, with three one-week treatment courses randomly allocated in a period-balanced fashion. Treatment phases were separated by a one-week wash-out phase. The placebo and mepindolol patch were well tolerated, whereas the propranolol patch caused skin irritation and itching in most subjects, and even vesicular lesions in 3/9 subjects. Acute and repeated 24 h application of the propranolol patch caused only small and clinically not relevant changes of heart rate and blood pressure. Acute application of the mepindolol patch induced only mild blunting of the diastolic blood pressure and heart rate responses to isoprenaline i.v. infusion at 8 h. However, the isoprenaline responses were nearly abolished after one week repeated 24 h application of the mepindolol patch, in a stable and protracted fashion. The circulatory responses to isometric handgrip and delayed auditory feedback tended to be reduced, but to a smaller extent than for the isoprenaline test. Repeated application of mepindolol via the investigational device for transdermal drug delivery (BIO TSD) thus resulted in stable and protracted beta-adrenoreceptor blockade.

Administration, Cutaneous↗
PubMed2003

Estradiol effects on the growth hormone/insulin-like growth factor-1 axis in amenorrheic athletes.

Disruption of the growth hormone/insulin-like growth factor-1 (GH/IGF-1) axis has been reported and studied in menopause, hypothalamic amenorrhea, and anorexia nervosa, but not in weight-stable amenorrheic athletes. We investigated the effects of short-term transdermal estradiol on basal and exercise-stimulated serum GH, IGF-1, and associated binding proteins (IGFBP-1 and IGFBP-3) in seven weight-stable female amenorrheic athletes with percentage body fats greater that 12%. Each subject received a 72 h placebo patch followed by 144 h of transdermal estradiol. Serum samples for GH, IGF-1, IGFBP-1, and IGFBP-3 were obtained at baseline (t1), 72 hr (t2), 144 hr (t3), and during three 90-minute trials of aerobic exercise. Basal, and exercise GH, IGF-1, and IGFBP-1 were not different between trials. Baseline IGFBP-3 decreased from t1 to t2 (p = 0.04) and serum free fatty acids increased from t1 to t2, and t1 to t3 (p = 0.04, and 0.02 respectively). These findings differ from postmenopausal women, and women having weightloss-associated amenorrhea, suggesting that estrogen, exercise, and nutritional deficiencies may have independent effects on the GH/IGF-1 axis.

Administration, Cutaneous↗
PubMed1995

Transdermal nicotine and gastroesophageal reflux.

OBJECTIVES: Studies have shown that cigarette smoking acutely increases gastroesophageal reflux (GER). Patients prescribed transdermal nicotine often complain of pyrosis. The purpose of this study was to ascertain the effect of transdermal nicotine on GER. METHODS: Twenty volunteers (12 smokers and eight nonsmokers) were studied with a 24-h pH/motility apparatus while wearing a placebo patch for 24 h and a nicotine patch for a subsequent 24-h period. Each subject completed the entire 48-h monitoring session. RESULTS: A significant increase in the total acid score (p = 0.005), duration of acid exposure (p = 0.010), and supine duration of acid exposure (p = 0.004) were noted with transdermal nicotine versus placebo. There were no significant differences in esophageal motility after transdermal nicotine. CONCLUSIONS: Whether enhanced supine reflux is related to lower esophageal sphincter dysfunction, increased acid secretion, or defective acid clearance is not clear. Nonetheless, it may be prudent to recommend removal of the transdermal nicotine patch at night in the patient with symptomatic nocturnal GERD.

Administration, Cutaneous↗
PubMed1992

Transdermally administered fentanyl for pain management.

The physicochemical properties, pharmacology, pharmacokinetics, serum concentrations and clinical effects, adverse effects and contraindications, and dosage of transdermally administered fentanyl are described, and clinical studies evaluating the use of a transdermal fentanyl system in the treatment of postoperative pain and chronic cancer-associated pain are reviewed. After application of a transdermal system, fentanyl is absorbed into the skin beneath the patch, where a depot forms in the upper skin layers. Plasma fentanyl concentrations are barely detectable for about two hours after patch placement. Eight to 12 hours after patch placement, concentrations approximate those achieved with equivalent i.v. doses of fentanyl. Some studies comparing transdermally administered fentanyl with placebo in postoperative patients showed that the patients who received fentanyl required fewer supplementary analgesics and reported less pain than the patients who received placebo. However, the overall efficacy and safety of the transdermal fentanyl system for the treatment of postoperative pain have not been adequately evaluated. Studies of cancer patients showed that transdermally administered fentanyl appears to be effective in the management of chronic, cancer-related pain. Dermatological reactions to the fentanyl patch are generally transient and mild. Other adverse effects are those that are commonly associated with narcotic analgesics. The 25-micrograms/hr patch should be used for initial treatment in patients not previously treated with narcotics. The dosage may be gradually increased until effective analgesia is obtained. Although experience with the product is limited, transdermally administered fentanyl appears to be effective for the long-term management of cancer-related pain.

Administration, Cutaneous↗
PubMed1995

[Non-oral administration of progesterone: experiences and possibilities of the transvaginal route].

Recent development of transdermal therapy permits application of estrogen, usually produced in the ovaries, in physiological dosage by means of continuous release from either an epidermal patch or dermal application of a gel. Transdermal therapy with progesterone, however is impossible due to poor dermal absorption and high dose requirements (release from corpora lutea: 25 mg/24 hours). Two other possibilities have been proposed. On one hand it is possible to apply norethisterone-acetate (NETA), another gestagen, epicutaneously. This mode of administration carries the same problems as oral application thus allowing for a dose reduction. On the other hand progesterone can be applied vaginally. This mode leads to significantly higher plasmatic concentrations of progesterone and has effects on the uterine mucosa similar to those in a normal cycle. This modality thus permits application of estradiol and progesterone in a physiological manner by a non oral route. It appears particularly interesting in patients at cardiovascular risk.

Administration, Intravaginal↗
PubMed1992

Transdermal clonidine versus placebo in painful diabetic neuropathy.

In a randomized, double-blind, 2-period crossover study, 24 patients with pain due to diabetic polyneuropathy received transdermal clonidine, 0.3 mg/day, and placebo patches, each for 6 weeks. Pain was assessed daily by a 13-word descriptor list. Mean daily pain scores for the 6th week, the primary outcome variable, averaged 13% lower with clonidine than with placebo (95% conf. lim. for clonidine effect: 29% reduction to 3% increase in pain), which was not statistically significant (P = 0.11, 2-tailed paired t test). After this study, however, 9 patients who wished to continue clonidine had single (3 patients) or multiple (6 patients) cycles of clonidine withdrawal and rechallenge. Seven of 9 patients consistently reported return of pain with patch withdrawal followed by relief upon retreatment. One patient had an equivocal response, and the other patient had no relief upon retreatment. The 7 responders appeared similar to the other 17 patients in pain quality and neurological exam. We conclude that there may be a subset of patients with diabetic polyneuropathy who respond to transdermal clonidine. Further research is needed to identify features of neuropathic pain that predict drug response and to develop study designs that are more sensitive to a response in a subset of patients.

Administration, Cutaneous↗
PubMed1998

Increasing nitroglycerin release from patches enables circumvention of early nitrate tolerance.

Continuous treatment with transdermal nitroglycerin leads to tolerance development within the first day of application. Effective long-term therapy can be provided by interval treatment with nightly patch removal, but even during the hours of intermittent patch application there is rapid attenuation of initial effects. To assess whether an unattenuated antiischemic and antianginal efficacy during the hours of intermittent dosing can be maintained, a modified drug-release profile with increasing plasma concentrations was evaluated using a double-blind, placebo-controlled crossover protocol. Eleven patients with documented coronary artery disease received, in a randomized order, a total of four low-dose nitroglycerin patches (5 mg/24 h each) or placebo, respectively, at intervals of 3 hours. After a treatment interval of 12 hours, all patches were removed for an equally long patch-free interval prior to renewed application of one patch the next morning. At a comparable workload, reductions of ST-segment depression of 65%, 63%, and 56% were found at 2.5 hours, 8 hours, and 12 hours after application of the first patch on day 1, respectively (all significant vs. placebo; 2.5 hours vs. 12 hours, n.s.). On day 2, the comparable reduction of 63% at 2.5 hours after renewed application indicates prevention of tolerance development during subchronic treatment. Effects on exercise capacity and angina pectoris paralleled those on exercise-induced ST-segment depression. Plasma concentrations of nitroglycerin increased from 223 pg/mL to 558 and 803 pg/mL on day 1 and amounted to 205 ng/mL at 2.5 hours on day 2. Thus, interval therapy with increasing nitroglycerin concentrations provides unattenuated antiischemic and antianginal efficacy during the hours of treatment and circumvention of early tolerance during subchronic application. This modified pharmacokinetic profile can be regarded as a model for an improved dosage regimen in nitrate interval therapy.

Adult↗
PubMed1989

Efficiency of multimodal smoking cessation therapy combining transdermal nicotine substitution with behavioral therapy.

Effects of smoking cessation treatment combining transdermal nicotine substitution with behavioral therapy were investigated in three studies. A total of 535 smokers underwent 9 weeks of behavioral self-control treatment. For 7 weeks, groups with transdermal nicotine substitution received in addition nicotine patches that continuously released nicotine through the skin into the circulatory system. The effects of treatment were measured by daily cigarette consumption. Subjects additionally treated with transdermal nicotine substitution reached significantly higher abstinence rates by the end of treatment and during the follow-up period than control subjects. The results thus indicate enhanced therapeutic effectiveness of transdermal nicotine substitution.

Administration, Cutaneous↗
PubMed1997

Postoperative analgesia with parenteral opioids: does continuous delivery utilizing a transdermal opioid preparation affect analgesic efficacy or patient safety?

STUDY OBJECTIVES: To compare, in patients who underwent major orthopedic surgical procedures, the efficacy of intravenous (IV) patient-controlled analgesia (PCA) with morphine combined with continuous administration of two doses of fentanyl or placebo via transdermal therapeutic system with fentanyl (TTSF) patches. DESIGN: Randomized, double-blind, placebo-controlled study. SETTING: University teaching hospital. PATIENTS: 62 patients aged 18 to 65 years, presenting for elective orthopedic surgery and general anesthesia. INTERVENTIONS: Patients were randomized to one of three groups: group 1 received two placebo patches; group 2 received a 20 cm2 active patch delivering 50 micrograms/hr of fentanyl and a 30 cm2 placebo patch; group 3 received a 30 cm2 active patch delivering 75 micrograms/hr of fentanyl and a 20 cm2 placebo patch. All patches were placed approximately two hours prior to induction of general anesthesia. General anesthesia was induced with thiopental, intubation facilitated by the use of vecuronium or pancuronium, and anesthesia was maintained with isoflurane in an oxygen/nitrous oxide mixture (O2/N2O). Following surgery, IV morphine was provided using IV PCA with 1.5 mg of morphine with a 6-minute lockout and a 4-hour maximum dosage of 30 mg. MEASUREMENTS AND MAIN RESULTS: The time and dosage of morphine administered was recorded. Vital signs, pain intensity at rest, level of sedation, and arterial oxygen saturation (SpO2) were measured at intervals throughout the 72-hour study period and at 6 and 12 hours following patch removal. The presence of side effects was noted. Visual analog pain scores throughout the 72 hours of the study were not significantly different among groups. Patients receiving active TTSF required less IV PCA morphine at all time intervals. However, total opioid consumption was comparable among groups. The incidence of side effects was similar in all groups. CONCLUSIONS: There is no significant advantage to the routine use of continuous transdermal opioid delivery in patients receiving IV PCA after major orthopedic surgery.

Administration, Cutaneous↗
PubMedDate not supplied

Is transdermal nicotine associated with cardiovascular risk?

We had the unique opportunity to study the effects of transdermal nicotine on markers of haemostasis and serum lipids in patients with ulcerative colitis; all were non-smokers and were given transdermal nicotine to assess its value in maintenance therapy for colitis. In a controlled double-blind trial, 45 patients with ulcerative colitis in remission on 5-aminosalicylic acid, were randomly allocated to receive transdermal nicotine (20) or placebo (25) patches. Markers of haemostasis, including platelet activation (platelet volume and surface expression of P selectin), endothelial damage (plasma von Willebrand factor antigen) and plasma fibrinogen were measured at the beginning and after 12 weeks of treatment. The white cell count and serum lipids were also measured. Nicotine significantly lowered plasma fibrinogen but did not affect markers of platelet activation, endothelial damage, white cell count and serum lipids. The possibility that transdermal nicotine may beneficially influence cardiovascular risk factors warrants further exploration.

Administration, Cutaneous↗
PubMed2002

Hemodynamic effect of transdermal glyceryl trinitrate on newly constructed arteriovenous fistula.

Transdermal glyceryl trinitrate (GTN) administration may have a beneficial effect in the creation of an arteriovenous fistula (AVF) by increasing blood flow through the access and by inhibiting platelet aggregation. We evaluated the hemodynamic effects of transdermal GTN administration on newly constructed arteriovenous fistula. Radiocephalic fistula at the wrist (Brescia fistula) was constructed as the initial vascular access in 31 uremia patients (study = 16, control = 15). The patient demographics and the etiology of chronic renal disease were similar in the two groups. None of the patients had severe vasculitis. The mean duration of chronic renal disease was 8 months (1-24 months). The diameter, blood flow rate, and blood output at the drainage vein and the subclavian vein were measured by duplex ultrasonography 24 hours after the procedure. The measurements were performed again with transdermal GTN (10 mg/24 hours adhesive patch) administration in the study group and, without any medication, in the control group 4 hours after the initial measurements were taken. In the study group, all of the hemodynamic parameters were significantly increased over the initial measurements (p <0.05) whereas in the control group all hemodynamic parameters were unchanged, except the diameter of the subclavian vein (p <0.05). The actual change in hemodynamic parameters was significant in the study group when compared to the control group (p <0.05). Our data showed that transdermal GTN administration at the forearm increases flow through the Brescia fistula.

Administration, Cutaneous↗
PubMed2003

Modulation by progestogens of the effects of oestrogen on hepatic endocrine function in postmenopausal women.

OBJECTIVE: Oral but not transdermal oestrogen administration reduces IGF-I, and increases GH binding protein (GHBP) reflecting effects on hepatic endocrine function in postmenopausal women. As progestogens attenuate the effects of oestrogen on circulating lipid levels according to their androgenic properties, we have investigated the impact of progestogen types on the hepatic endocrine effects of oestrogen. DESIGN: Four progestogens differing in androgenicity were co-administered in a monthly cyclical regimen in random order to postmenopausal women receiving either oral (n = 9, premarin 1.25 mg) or transdermal (n = 10, Estraderm 100 microg patches twice weekly). The four progestogens were cyproterone acetate (CA 5 mg, antiandrogenic), dydrogesterone (20 mg, neutral), medroxyprogesterone acetate (MPA 10 mg, mildly androgenic), norethisterone (2.5 mg, androgenic). PATIENTS: Nineteen postmenopausal women (age 57 +/- 3 years, mean +/- SE) were studied. MEASUREMENTS: The effects of oestrogen alone and the combined effects with each progestogen type on IGF-I, GHBP, SHBG, cholesterol, triglycerides and lipoprotein(a) were investigated. RESULTS: Mean IGF-I fell while GHBP and SHBG levels increased with oral (P < 0.01) but not transdermal oestrogen administration. When the combined effects were examined, progestogens did not affect IGF-I, GHBP and SHBG during oral oestrogen treatment, while they significantly increased (P < 0.01) mean IGF-I levels during transdermal therapy. Among the progestogen types, only norethisterone prevented the fall in IGF-I induced by oral oestrogen. During transdermal therapy, MPA and norethisterone but not CA or dydrogesterone significantly increased (P < 0.005) IGF-I. The rise in GHBP induced by oral oestrogens tended to be lower during co-administration of MPA and norethisterone. The increase in SHBG induced by oral oestrogen was attenuated (P < 0.05) by norethisterone which was the only progestogen that lowered SHBG (P < 0.05) during transdermal oestrogen treatment. Mean IGF-I was higher (P < 0.001), GHBP and SHBG lower during co-administration of androgenic progestogens (MPA and norethisterone). CONCLUSIONS: Oestrogen effects on IGF-I, GHBP and SHBG are dependent on the route of administration with progestogens having variable effects. Among the progestogen types, norethisterone, the most androgenic, had the greatest effect, particularly on IGF-I. Progestogens modulate the effects of oestrogen on hepatic endocrine function in relation to their intrinsic androgenic properties. The modulatory effects of progestogens on IGF-I during oestrogen therapy may have long-term implications for lean body mass.

Analysis of Variance↗