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PubMed2003

Benefit-risk assessment of transdermal fentanyl for the treatment of chronic pain.

Transdermal fentanyl is effective and well tolerated for the treatment of chronic pain caused by malignancy and non-malignant conditions when administered according to the manufacturer's recommendations. Compared with oral opioids, the advantages of transdermal fentanyl include a lower incidence and impact of adverse effects (constipation, nausea and vomiting, and daytime drowsiness), a higher degree of patient satisfaction, improved quality of life, improved convenience and compliance resulting from administration every 72 hours, and decreased use of rescue medication. Transdermal fentanyl is a useful analgesic for cancer patients who are unable to swallow or have gastrointestinal problems. Transdermal fentanyl forms a depot within the upper skin layers before entering the microcirculation. Therapeutic blood levels are attained 12-16 hours after patch application and decrease slowly with a half-life of 16-22 hours following removal. Patients with chronic pain should be titrated to adequate relief with short-acting oral or parenteral opioids prior to the initiation of transdermal fentanyl in order to prevent exacerbations of pain or opioid-related adverse effects. Transdermal fentanyl can then be initiated based on the 24-hour opioid requirement once adequate analgesia has been achieved. The prolonged elimination of transdermal fentanyl can become problematic if patients develop opioid-related adverse effects, especially hypoventilation. Adverse effects do not improve immediately after patch removal and may take many hours to resolve. Patients who experience opioid-related toxicity associated with respiratory depression should be treated immediately with an opioid antagonist such as naloxone and closely monitored for at least 24 hours. Because of the short half-life of naloxone, sequential doses or a continuous infusion of the opioid antagonist may be necessary. Transdermal fentanyl should be administered cautiously to patients with pre-existing conditions such as emphysema that may predispose them to the development of hypoventilation. Transdermal fentanyl is indicated only for patients who require continuous opioid administration for the treatment of chronic pain that cannot be managed with other medications. It is contraindicated in the management of acute and postoperative pain, as pain may decrease more rapidly in these circumstances than fentanyl blood levels can be adjusted, leading to the development of life-threatening hypoventilation. Cognitive and physical impairments such as confusion and abnormal co-ordination can occur with transdermal fentanyl. Therefore, patients should be instructed to refrain from driving or operating machinery immediately following the initiation of transdermal fentanyl, or after any dosage increase. Patients may resume such activities once the absence of these potential adverse effects is documented.

Administration, Cutaneous↗
PubMed2003

Buprenorphine TDS: use in daily practice, benefits for patients.

In Germany and many other countries, buprenorphine has been used for a long time for the management of pain in both cancer and non-cancer patients. Although a transdermal delivery system for buprenorphine (Transtec) has recently been introduced, the clinical experience in daily practice with this drug, delivered in a matrix patch, is only now being evaluated. In preliminary data from a survey of 3,255 patients with chronic pain, 26% had cancer pain, while the most common diagnoses of the other respondents included back pain (33%), osteoarthritis (22%), osteoporosis (17%), and neuropathic pain (10%, multiple entries). Before being switched to the buprenorphine patch, most patients had been pretreated with World Health Organization (WHO) Step II opioids (47%) or WHO Step III opioids (18%), including tramadol (in 35% of patients) and a tilidin/naloxone combination (15%); 9% had not been prescribed any opioids in advance of receiving transdermal buprenorphine. Most patients (77%) in the survey had been started on the lowest dose of the buprenorphine patch (35 microg/h), and nearly half (49%) were placed on adjuvant analgesics, including tramadol or tilidin/naloxone. Pain relief was rated as good or very good by 81% of the respondents. Adverse effects were similar to those seen on other opioids, although their intensity was mild in most cases. Local side effects, including erythema (4% of cases) and pruritus (1%), were transitory. Based on the survey results, transdermal buprenorphine is considered an effective opioid treatment for patients with stable cancer and non-cancer pain; it may prove particularly useful in patients who have experienced side effects taking oral analgesic preparations, as well as in those who are taking extensive co-medications.

Administration, Cutaneous↗
PubMed1985

Use of transdermal glyceryl trinitrate to reduce failure of intravenous infusion due to phlebitis and extravasation.

Self-adhesive patches which release glyceryl trinitrate at a slow continuous rate or placebo patches were applied to the skin of patients distal to intravenous infusion sites in a double-blind manner. The frequency of infusion failure was three times lower with the glyceryl trinitrate than with placebo patches. The decrease was of similar magnitude whether failure was due to extravasation or phlebitis. Headaches were more common in patients with active patches but were relieved by simple analgesics.

Administration, Topical↗
PubMed1993

Dermal patch anaesthesia: comparison of 10% lignocaine gel with absorption promoter and EMLA cream.

The analgesic effects of transdermally applied 10% lignocaine aquagel containing 3% glycyrrhetinic acid monohemiphthalate disodium (as an absorption enhancer) and EMLA cream were compared on the forearms of 34 adult volunteers in a double-blind fashion. The mean pinprick pain scores (graded by noting the number of painful pinpricks out of five) at 30, 60 and 90 min after application and 30 min after removal of the anaesthetics were 3.3 (0.3) (mean SE), 1.2 (0.3), 0.3 (0.1) and 0.3 (0.1) respectively, in the lignocaine gel group. Corresponding scores were 3.5 (0.3), 1.5 (0.3), 0.7 (0.2) and 0.1 (0.1) respectively, in the EMLA group. Insertion of a 26-gauge needle into the treated skin to a depth of 1 mm at 90 min after application was not painful in 91% of the volunteers in the lignocaine gel group and 88% of those in the EMLA group. There was no significant difference in any of the corresponding pain scores between the two groups.

Administration, Cutaneous↗
PubMed1986

[Transdermal nitroglycerin in the treatment of pulmonary hypertension].

In 10 patients with pulmonary hypertension, glycerol trinitrate in patch form (DEPONIT 10) effected a statistically significant drop in pulmonary artery pressure, pulmonary capillary pressure and right atrial pressure within 24 hours following drug application. This pressure reduction was also recorded after 4 weeks of continuous therapy. The reduction of pulmonary artery pressure and pulmonary vascular resistance is not only a consequence of improved pre- and afterload, but also of a decrease in respiratory tract resistance and a direct influence on arteriolar constriction in the pulmonary vascular bed. Beneficial effects upon pulmonary haemodynamics were also recorded several months later.

Administration, Cutaneous↗
PubMed1985

[High-dose transdermal nitroglycerin therapy: loss of effect within 24 hours?].

Within a relatively short period of time, nitroglycerin patches have come into widespread use for treatment of coronary artery disease in the absence of sufficient clinical data in support of their efficacy. Presently, there is still considerable controversy regarding the extent and duration of action as well as the dosage requirements. Accordingly, a study was carried out in six patients with angiographically-documented coronary artery disease, stable exercise-induced angina pectoris and reproducible ST-segment depression to analyze the effects of nitroglycerin patches, formulated to deliver 5 mg, 10 mg, 20 mg as well as 30 mg per 24 hours, respectively, on the extent of ST-segment depression. In a further study, the extent and duration of antianginal and anti-ischemic effects of nitroglycerin patches delivering 30 mg/24 hours were investigated in ten patients according to a randomized, double-blind, crossover placebo-controlled protocol. In seven of these patients, testing was again performed at 2.5 hours after repeated application (second application at 24 hours) (Figure 1). Nitroglycerin patches delivering 5 mg, 10 mg, 20 mg as well as 30 mg/24 hours, respectively, led to significant reductions in ST-segment depression at 2.5 hours of 59% (range 25 to 100%; p less than 0.025), 63% (0 to 100%, p less than 0.01), 77% (50 to 100%, p less than 0.001) as well as 82% (50 to 100%, p less than 0.005) as compared with control values (Figure 2).(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Topical↗
PubMed2003

Attenuation of nitrate tolerance and oxidative stress by an angiotensin II receptor blocker in patients with coronary spastic angina.

BACKGROUND: Nitrates are widely used to treat coronary artery disease, but their therapeutic value is compromised by the rapid development of tolerance. Recently, the renin-angiotensin system has been suggested to play an important role in the development of nitrate tolerance. METHODS AND RESULTS: Sixty-four patients with coronary spastic angina were investigated to clarify the effect of angiotensin II type 1 receptor blocker (ARB) therapy on nitrate tolerance. Transdermal nitroglycerin (10 mg/d) and an ARB (candesartan, 8 mg/d) were administered to 21 patients (GTN+ARB group) for 3 days, whereas transdermal nitroglycerin and placebo were administered to 19 patients (GTN group). Another 18 patients were treated with placebo skin patches and placebo tablets for 3 days (control group). The brachial artery response to incremental doses of intravenous nitroglycerin (0.01, 0.1, and 1.0 micro;g/kg) was measured by ultrasound before and after transdermal nitroglycerin therapy. Before treatment, the arterial diameter was increased by nitroglycerin injection in each group. After treatment, the increase of arterial diameter was significantly suppressed in the GTN group but not in the control or GTN+ARB groups. The plasma level of thioredoxin (a marker of oxidative stress) was increased in the GTN group after treatment (P<0.01) but not in the control or GTN+ARB groups. CONCLUSIONS: An ARB suppressed the development of nitrate tolerance during transdermal nitroglycerin therapy. These results suggest that increased oxidative stress induced by activation of angiotensin II may play an important role in the development of nitrate tolerance.

Administration, Cutaneous↗
PubMed1997

"Cloniderm" toxicity: another manifestation of clonidine overdose.

We present a case of accidental transdermal clonidine toxicity in a six-year-old child who was applying a clonidine patch intermittently to her dermis in the mistaken assumption that it was an adhesive bandage. Although the child appeared to be drug toxic, she repeatedly denied ingestion of any substances to family, paramedics, and hospital staff but was not initially questioned regarding dermal exposure. In dealing with drug toxic states in which the differential diagnosis includes drugs available as transdermal delivery systems, the evaluation should include questions regarding possible dermal exposure and a thorough skin examination.

Administration, Cutaneous↗
PubMed1992

Transdermal fentanyl for postoperative pain management in patients recovering from abdominal gynecologic surgery.

The current placebo-controlled double-blinded study was undertaken to assess the safety and efficacy, as well as the potential clinical role, of the transdermal therapeutic system (TTS) of fentanyl delivery in the postoperative setting. TTS patches releasing 25 micrograms.h-1 or 50 micrograms.h-1 or placebo were applied to 95 women 1 h before abdominal gynecologic surgery during general anesthesia. Postoperatively, patients self-administered intravenous morphine as required using patient-controlled analgesia with a 1-mg incremental dose and a 6-min lockout interval. Each was assessed upon admission to the postanesthesia care unit and at intervals over the following 72 h with respect to vital signs, visual analogue scale pain and satisfaction scores, side effects, and cumulative morphine use. Data were analyzed using analysis of variance, Kruskal-Wallis, and chi-square. P less than 0.05 was considered significant. There were no demographic differences among groups. Beginning 32 h after TTS application, a statistically significant morphine-sparing effect was seen with the 50 micrograms.h-1 patch. There were no significant differences among groups with regard to visual analogue scale pain scores at rest, patient satisfaction, or the incidence of side effects; a significant reduction in pain upon movement was noted at 24 h in patients treated with TTS 50 micrograms.h-1. This finding constituted the only benefit noted with this form of analgesic therapy in the present investigation.

Abdomen↗
PubMed1986

Comparison of transdermal nitrate and isosorbide dinitrate in chronic stable angina.

The effects of transdermal nitrate (TN) (Transiderm-Nitro TTS, Geigy Pharmaceuticals, one 10 cm2 patch daily) and oral isosorbide dinitrate (ISDN) (Sorbitrate, Stuart Pharmaceuticals, 10 mg three times daily) were compared in a group of 20 patients with chronic stable angina pectoris. Treadmill exercise duration was prolonged from a median time of 365 s to 428 s after ISDN (P less than 0.05), but was unchanged after TN. The difference between the active treatments was not significant. Weekly consumption of glyceryl trinitrate (GTN) increased during treatment with TN from a median value of 5.5 to 6.3 (P less than 0.05). A decrease was observed after ISDN (7.8 to 3.9, P = NS), and the difference between the drugs was significant (P less than 0.01). Systolic arterial pressure was significantly lower during the ISDN than during the TN treatment period in both the supine (135 +/- 5 vs 128 +/- 5 mm Hg; P less than 0.05) and standing positions (134 +/- 5 vs 122 +/- 5 mm Hg; P less than 0.05). No change in weekly attack rate, the degree of ST depression at angina on treadmill testing, or the number of episodes of ST depression recorded during a 24 h period by Holter monitoring was observed after either drug. In this study, an antianginal effect was demonstrated for ISDN but not for TN. It is suggested that the dose of TN may have been inadequate to demonstrate such an effect, and further studies using a higher dose schedule will be required.

Administration, Oral↗
PubMed2006

A Phase III study to assess the clinical utility of low-dose fentanyl transdermal system in patients with chronic nonmalignant pain.

BACKGROUND: The transdermal fentanyl delivery system (fentanyl TTS; Duragesic) is currently widely available in patch strengths of 25, 50, 75, and 100 microg/h. However, a lower dose of 12 microg/h would allow optimal titration and fine tuning of the analgesic effect, and may be beneficial in certain patient populations such as the elderly or opioid-naïve. A 12 microg/h fentanyl TTS patch has been developed, and the clinical efficacy and safety tested in this single-arm, non-randomized, open-label, multicenter, 28-day trial in opioid-exposed and -naïve patients with moderate to severe pain for at least 6 months. PATIENTS: Patients were treated with fentanyl TTS for 28 days in an intent-to-treat manner starting at 12 microg/h (one patch), titrated upwards in increments of 12 mug/h to a maximum dose of 36 microg/h (three patches). RESULTS: A total of 227 patients were enrolled. The majority of patients with a "global assessment of therapy" of fair/poor at baseline (63.4%) improved to good/very good, while 28.9% of patients with an assessment of good/very good at baseline worsened to fair/poor at endpoint. The average pain intensity levels for the efficacy evaluable population steadily decreased over the course of the trial. The adverse event (AE) profile of fentanyl TTS in this trial was generally similar to that identified in previous fentanyl TTS trials, and no unexpected safety issues or AEs were noted. Furthermore, the drop-out rate in this trial was lower than has been noted in previous trials. CONCLUSION: This trial demonstrated that the lower 12 microg/h dose of fentanyl TTS provided a therapeutic benefit in non-malignant chronic pain, with a similar AE rate but a lower drop-out rate than that seen in trials at higher doses. This lower dose may, therefore, be of particular benefit to elderly or opioid-naïve patients.

Administration, Cutaneous↗
PubMedDate not supplied

Fentanyl patches for the treatment of pain in dying cancer patients.

It has been claimed that fentanyl patches are less suitable for elderly patients and for patients who are terminally ill and dying. In a retrospective survey of 205 cancer patients who died within the hospital-based home care in Norrköping, Sweden between January 1997 and June 1998 we identified 34 patients who had used fentanyl patches. 30 patients were possible to evaluate for the analgesic efficacy of transdermal fentanyl. 18 out of 30 patients were treated with fentanyl until time of death. The estimated efficacy was good or moderate in 93% and 88%, respectively, of patients younger or older than 65 years of age.

Administration, Cutaneous↗
PubMed1999

Experience with transdermal testosterone replacement therapy for hypogonadal men.

BACKGROUND: None of the existing options for long-term testosterone replacement therapy (TRT) for hypogonadal men are ideal. Depot replacement at frequent intervals and implants are effective but invasive and inconvenient for the patient. Oral therapy results in poor hormone levels. Both are associated with undesirable metabolic changes. A transdermal formulation therefore represents a potential therapeutic advance for testosterone replacement. OBJECTIVE: To carry out a clinical audit of the acceptability and efficacy as a treatment for hypogonadism of the first transdermal testosterone therapy available in the UK (Andropatch, SmithKline Beecham) compared with existing androgen replacement options. PATIENTS AND MEASUREMENTS: Serum testosterone and questionnaire data on treatment efficacy, side-effects, therapy preference, sexual dysfunction and partner's attitudes to therapy were obtained from 50 hypogonadal men prescribed long-term testosterone replacement. RESULTS: Eighty per cent of the men returned analysable questionnaires. Eighty-four per cent experienced adverse effects with transdermal therapy, most commonly dermatological problems; 22% of the sample elected to continue with transdermal therapy, 72% returned to depot and 5% returned to oral therapy. The reservoir patches were judged to be too large, uncomfortable, visually obtrusive and noisy. Testosterone levels were comparable to those obtained with depot replacement with the added advantage of a more physiological pharmacokinetic profile. Men taking oral preparations were consistently under-replaced. CONCLUSIONS: Adverse events were substantially higher than reported from clinical trials but in keeping with the spectrum of yellow card reports received by the Committee on Safety of Medicines. The pharmacokinetic advantages are thus largely outweighed by low patient acceptability. In its present form transdermal therapy remains an expensive option for those who cannot tolerate depot testosterone replacement.

Administration, Cutaneous↗
PubMed1992

Transdermal nicotine replacement and smoking cessation.

Transdermal nicotine systems are a useful adjunct to smoking cessation. The larger-sized nicotine patches provide steady-state replacement of approximately 50 percent of the average serum nicotine level obtained by smoking one to one and one-half packs of cigarettes a day. This level is sufficient to prevent many symptoms of nicotine withdrawal, including physical craving, irritability, anxiety, restlessness, hostility, hunger and difficulty concentrating. In double-blind, placebo-controlled trials, transdermal nicotine systems have been about twice as successful as placebo in helping patients stop smoking.

Administration, Cutaneous↗
PubMed1995

Pharmacokinetics of physostigmine in man following a single application of a transdermal system.

1. The pharmacokinetics of physostigmine were investigated in a three-way cross-over design in six healthy, male volunteers comparing a physostigmine transdermal system (PTS), an oral solution and an i.v. infusion. 2. A single application of the patch over 24 h produced detectable plasma drug concentrations after a mean lag-time of 4 h. Thereafter, the drug was absorbed continuously from the PTS and putative therapeutic plasma concentrations were measured over approximately 18 h. 3. A mean absolute bioavailability of 36% was determined for the transdermal system and 3% for the oral solution. In comparison with the oral solution, interindividual variability of pharmacokinetics was less with the PTS. 4. The mean amount of physostigmine released from the transdermal system after 24 h was 5.7 mg. Because of extensive metabolism, only 2.2 mg of physostigmine were detected systemically. 5. After removing the PTS, the mean apparent half-life of elimination was 4.9 h, compared with 0.5 h for the i.v. infusion. This indicates continued drug absorption from a skin depot. 6. Physostigmine was well tolerated by the volunteers. With the PTS, a mild erythema was observed at the area of application, disappearing within a few hours.

Administration, Cutaneous↗
PubMed1986

Transdermal clonidine in mild hypertension. A randomized, double-blind, placebo-controlled trial.

In 30 patients with mild essential hypertension, clonidine hydrochloride was delivered from a skin patch reservoir designed to release medication at a constant rate for seven days. After a four-week washout period, patients were randomized (double-blind) into a clonidine- or a placebo-treated group. Clonidine or placebo was then given for five weeks, followed by a two-week washout period to assess withdrawal from treatment. Blood pressure was controlled in 11 of 15 clonidine-treated patients but in only four of 15 placebo-treated patients. The clonidine-treated group evidenced larger decreases in both systolic and diastolic blood pressures. In the clonidine-treated group, blood pressures and plasma clonidine levels were stable throughout a representative seven-day period. Besides mild skin irritation with both clonidine and placebo patches, few side effects were observed. After discontinuation of clonidine administration, plasma levels declined in a non-log linear manner. There was no rebound hypertension. The results suggest that clonidine delivered transdermally is safe and effective for control of mild essential hypertension.

Administration, Cutaneous↗
PubMed1994

Application of a Stable Isotope Technique for the Bioequivalency Study of Two Transdermal Nitroglycerin Systems.

A bioequivalency study of an experimental transdermal nitroglycerin system relative to the commercial Transderm-Nitro 0.4 mg/h system was performed on eight healthy volunteers by using an innovative stable isotope technique. Plasma clearance changes for nitroglycerin (NTG) during patch application were corrected with simultaneously administered intravenous infusion of (15)N-labeled nitroglycerin ((15)N-NTG) solution. The total amount of NTG transdermally absorbed (AUC x CL) during a 22-h application for the experimental system was not statistically different from that for the commercial system (9.7 plus minus 3.3 versus 8.1 plus minus 2.6 mg; p = 0.41). The analysis of residual drug content in the used system revealed that the difference in amounts of NTG delivered from the experimental and commercial systems were not significant (12.2 plus minus 3.1 versus 10.8 plus minus 3.1 mg; p = 0.29). With the isotope-labeled method, the absorption rate was evaluated at each time interval during the system application. The peak concentration values were 0.52 plus minus 0.21 mg h(minus sign1) at 1 h for the experimental system and 0.41 plus minus 0.15 mg h(minus sign1) at 2 h for commercial systems. After the peak concentrations, the absorption rates remained constant for both systems over the 16-h period. There was no statistical difference in absorption between the two systems at any sampling time. In this study, substantial fluctuations in the plasma concentrations of both NTG and (15)N-NTG were observed within and between subjects. In addition, the variability in plasma concentrations of NTG correlated well with that of (15)N-NTG for all participating subjects. The momentary changes of clearance, estimated from (15)N-NTG plasma data, were found to be responsible for the fluctuation of NTG in plasma.

Journal Article↗
PubMed2001

Treatment of cancer pain with transdermal fentanyl.

Pain is a feature of many cancers, particularly in the advanced stages at which the palliative care approach to symptom control achieves the best outcomes. The holistic approach generally dictates that any treatment of the cancer per se has symptom control as the primary objective at this advanced stage. Pain, which invariably increases with disease progression, is treated with opioids and adjuvant analgesic drugs together with physical therapies. Orally administered opioid drugs are used preferentially because of cost and convenience, but other routes of administration (subcutaneous, rectal, spinal) are also possible. More recently, transdermal fentanyl has been evaluated in the treatment of moderate to severe cancer pain. The rate of fentanyl absorption is constant (after a lag period), and the dose is altered by increasing or decreasing the area of skin covered by the patch (size and/or number of patches). The dosing interval for these systems is generally 3 days. The extent of pain relief provided by transdermal fentanyl and sustained release morphine formulations is similar, with quality-of-life instruments showing no consistent preference for either formulation. Open studies have suggested a lower risk of constipation. Transdermal fentanyl is effective in the treatment of severe cancer pain, particularly when the oral route is unavailable.

Administration, Cutaneous↗