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At least 307 records · Page 17Linked to original sources
PubMed1999

[The effect of transdermal nicotine patches in smoking cessation. A randomized trial in pharmacy customers in Denmark].

The aim of the study was to examine the effect of 24-hour nicotine patches in smoking cessation among over-the-counter customers in Denmark based on a randomized, double-blind, placebo-controlled trial. Participants were consecutive customers to whom nicotine patches were offered free of charge and as the only treatment. Forty-two pharmacies in the areas of Aarhus and Copenhagen in Denmark participated in the trial, and 522 customers who smoked 10 or more cigarettes per day were randomized to either nicotine or placebo patches from January to March 1994. Twenty-four-hour patches were offered for a three-month period. Those smoking 20 or more cigarettes per day started on 21 mg/day patches. Customers who smoked less started on 14 mg/day patches and all the participants were gradually reduced to 7 mg/day patches during the study period. Smoking behaviour and compliance were recorded by means of self-administered question-naires and telephone interviews. Smoking status was recorded following each four-week treatment period, and 26 weeks after inclusion. There was a significant increase in smoking cessations rates, but only among smokers who started on 21 mg/day patches after eight weeks of follow-up. No significant differences in smoking cessation rates were seen among smokers who started with the low dose nicotine or placebo patches.

Administration, Cutaneous↗
PubMed1990

Estrogen replacement therapy and the estraderm transdermal system.

One reliable, controlled and convenient method of delivering parenteral estrogen replacement therapy is by means of a transdermal patch known as the Estraderm Transdermal System, which contains a 17-beta estradiol formulation. The primary side effect appears to be a localized skin irritation in about 15 percent of the women using this route. Most women find this irritation annoying but not enough to necessitate stopping therapy. Studies indicate that the patch provides amelioration of climacteric symptoms that is comparable to the oral estrogens. Preliminary research shows that parenteral estrogen is as effective as oral estrogen in decreasing the risk of osteoporosis. No adverse changes in lipid-lipoprotein levels have been found. A recent Swedish study found an increased relative risk of breast cancer with estradiol and with combined estrogen-progestin use for postmenopausal therapy. Thus, more research on the long-term hormonal replacement effects of the patch is indicated. One advantage of the transdermal delivery system is a first bypass of the liver, thus decreasing the possible risk of renin substrate elevation and the potential increase in blood pressure associated with oral estrogen therapy.

Administration, Cutaneous↗
PubMed2003

Ortho Evra, a new contraceptive patch.

Ortho Evra is the first transdermal patch approved for the prevention of pregnancy. Comparative trials have shown that Ortho Evra has efficacy similar to the oral contraceptives Mercilon (not available in the United States) and Triphasil for the prevention of pregnancy when used as directed. Adverse effects with Ortho Evra are similar to those reported with combined oral contraceptives, with the exceptions of mild-to-moderate application-site reactions and an increased frequency of breast symptoms. The most commonly reported adverse reactions were breast symptoms, headache, application-site reactions, nausea and vomiting, dysmenorrhea, and abdominal pain. Approximately 5% of study subjects had at least one patch that did not stay attached to their skin, and about 2% of women withdrew from clinical trials due to irritation from the patch. In clinical studies, the patch appeared to be less effective in women weighing more than 90 kg than in women with lower body weights. More research is needed on the relationship between body weight and contraceptive patch efficacy. In two clinical trials, compliance was greater with the patch than with oral contraceptives. Whether this will result in reduced pregnancy rates in general use is unknown. Additional studies are warranted to determine if the patch offers any significant efficacy or safety advantages over current methods of hormonal contraception.

Administration, Cutaneous↗
PubMed1999

Transdermal nitroglycerine enhances spinal sufentanil postoperative analgesia following orthopedic surgery.

BACKGROUND: Sufentanil is a potent but short-acting spinal analgesic used to manage perioperative pain. This study evaluated the influence of transdermal nitroglycerine on the analgesic action of spinal sufentanil in patients undergoing orthopedic surgery. METHODS: Fifty-six patients were randomized to one of four groups. Patients were premedicated with 0.05-0.1 mg/kg intravenous midazolam and received 15 mg bupivacaine plus 2 ml of the test drug intrathecally (saline or 10 microg sufentanil). Twenty to 30 min after the spinal puncture, a transdermal patch of either 5 mg nitroglycerin or placebo was applied. The control group received spinal saline and transdermal placebo. The sufentanil group received spinal sufentanil and transdermal placebo. The nitroglycerin group received spinal saline and transdermal nitroglycerine patch. Finally, the sufentanil-nitroglycerin group received spinal sufentanil and transdermal nitroglycerine. Pain and adverse effects were evaluated using a 10-cm visual analog scale. RESULTS: The time to first rescue analgesic medication was longer for the sufentanil-nitroglycerin group (785+/-483 min) compared with the other groups (P<0.005). The time to first rescue analgesics was also longer for the sufentanil group compared with the control group (P<0.05). The sufentanil-nitroglycerin group group required less rescue analgesics in 24 h compared with the other groups (P<0.02) and had lesser 24-h pain visual analog scale scores compared with the control group (P<0.005), although these scores were similar to the sufentanil and nitroglycerin groups (P>0.05). The incidence of perioperative adverse effects was similar among groups (P>0.05). CONCLUSIONS: Transdermal nitroglycerine alone (5 mg/day), a nitric oxide generator, did not result in postoperative analgesia itself, but it prolonged the analgesic effect of spinal sufentanil (10 microg) and provided 13 h of effective postoperative analgesia after knee surgery.

Analgesics, Opioid↗
PubMed2000

Transdermal nitroglycerine enhances spinal neostigmine postoperative analgesia following gynecological surgery.

BACKGROUND: Intrathecal neostigmine causes analgesia by inhibiting the breakdown of acetylcholine. Experimental data suggest that the production of endogenous nitric oxide is necessary for tonic cholinergic inhibition of spinal pain transmission. The purpose of this study was to determine whether association of transdermal nitroglycerine would enhance analgesia from a low dose of intrathecal neostigmine in patients undergoing gynecologic surgery during spinal anesthesia. METHODS: Forty-eight patients were randomized to one of four groups. Patients were premedicated with use of 0.05-0.1 mg/kg intravenous midazolam and received 15 mg bupivacaine plus 1 ml test drug intrathecally (saline or neostigmine, 5 microgram). Twenty to 30 min after the spinal puncture, a transdermal patch of either 5 mg nitroglycerin or placebo was applied. The control (Con) group received spinal saline and transdermal placebo. The neostigmine group received spinal neostigmine and transdermal placebo. The nitroglycerin group received spinal saline and a transdermal nitroglycerine patch. Finally, the neostigmine-nitroglycerin group received spinal neostigmine and transdermal nitroglycerine. Pain and adverse effects were evaluated using a 10-cm visual analog scale. RESULTS: Patients in the groups were similar regarding age, weight, height, and American Society of Anesthesiologists status. Sensory level to pin prick at 10 min, surgical duration, anesthetic duration, and visual analog scale score for pain at the time of administration of first rescue medication were statistically the same for all groups. The time to administration of first rescue analgesic (min) was longer in the neostigmine-nitroglycerin group (550 min; range, 458-1,440 min; median, 25-75th percentile) compared with the other groups (P < 0.001). The neostigmine-nitroglycerin group required fewer rescue analgesics in 24 h than did the control group (P < 0.0005), whereas the neostigmine group required less analgesics compared with the control group (P < 0.02). The incidence of perioperative adverse effects (nausea, vomiting, headache, back pain) was similar among groups (P > 0.05). CONCLUSION: Although neither intrathecal 5 microgram neostigmine alone nor transdermal nitroglycerine alone (5 mg/day) delayed the time to administration of first rescue analgesics, the combination of both provided an average of 14 h of effective postoperative analgesia after vaginoplasty, suggesting that transdermal nitroglycerin and the central cholinergic agent neostigmine may enhance each other's antinociceptive effects at the dose studied.

Administration, Cutaneous↗
PubMed2003

Fentanyl use, misuse, and abuse: a summary of 23 postmortem cases.

We report the rapidly increasing finding of fentanyl in medical examiner cases in southwestern Virginia. During the past 3 years, fentanyl cases have increased from 3 in 2000 to 12 in 2002. The first medical examiner case of 2003 was a fentanyl poisoning. Nineteen of 23 cases were attributed to fentanyl misuse or abuse of fentanyl transdermal patches. Routes of administration were transdermal, transmucosal/oral, intravenous, and combinations of routes of administration. Fentanyl was identified using a solid-phase extraction basic drug screen in blood and/or urine followed by full scan gas chromatography-mass spectrometry (GC-MS) in the electron impact ionization mode. Fentanyl quantitation was performed using selected ion monitoring GC-MS. The method was linear from 1 to 50 microg/L with a limit of quantitation of 1 microg/L. Fentanyl blood concentrations ranged from 2 to 48 microg/L with a mean concentration of 18 microg/L. The age range of the decedents was 16-53 with an average age of 37. Southwestern Virginia is currently a "hot spot" for misuse and abuse of oxycodone and methadone. The rapid rise in the number of fentanyl cases over the past three years, the increasing availability of fentanyl patches, and the large number of case histories indicating misuse or abuse suggest that fentanyl is rapidly becoming an additional desired opioid similar to oxycodone and methadone.

Adolescent↗
PubMed2001

The effect of transdermal nitroglycerin on spinal S(+)-ketamine antinociception following orthopedic surgery.

STUDY OBJECTIVES: To determine whether combination of transdermal nitroglycerine (a nitric oxide generator) would enhance analgesia from epidural S(+)-ketamine (a N-methyl-D-aspartate antagonist) in patients undergoing orthopedic surgery with combined spinal anesthesia. DESIGN: Randomized, double-blind study. SETTING: Orthopedic surgery unit of a teaching hospital. PATIENTS: 60 ASA physical status I and II patients scheduled for minor orthopedic knee surgery. INTERVENTIONS: Patients were randomized to one of five groups (n = 12) to receive combined epidural/intrathecal anesthesia. A 10-mL epidural injection was first administered to all patients (study drug or normal saline). Intrathecal anesthesia consisted of 15 mg bupivacaine. Twenty to 30 minutes after the spinal puncture, a transdermal patch of either nitroglycerin 5 mg or placebo was applied. The control group (CG) received epidural saline and transdermal placebo. The nitroglycerin group (NG) received epidural saline and transdermal nitroglycerine patch. The 0.1 mg/kg S(+)-ketamine epidural group (1 KG) received 0.1 mg/kg epidural S(+)-ketamine and transdermal placebo. The 0.2 mg/kg S(+)-ketamine epidural group (2 KG) received 0.2 mg/kg epidural S(+)-ketamine and transdermal placebo. Finally, the nitroglycerin/0.1 mg/kg S(+)-ketamine epidural group (1 NKG) received 0.1 mg/kg epidural S(+)-ketamine and transdermal nitroglycerin. Pain and adverse effects were evaluated using a 10-cm visual analog scale (VAS). MEASUREMENTS AND MAIN RESULTS: The groups were demographically the same. Sensory anesthetic level and VAS score for pain at the time of first rescue medication were similar among groups. The time to first rescue analgesic (min) was less in both the CG and the NG groups compared with the other groups (p < 0.05). Epidural S(+)-ketamine resulted in analgesia to both groups (1 KG < 2 KG; p < 0.05). The 1 NKG and the 2 KG displayed similar analgesia (p > 0.05). The CG required more rescue analgesics in 24 hours compared with the patients who received epidural S(+)-ketamine (p < 0.02). CONCLUSIONS: Epidural S(+)-ketamine resulted in antinociception, which was enhanced by transdermal nitroglycerin.

Adjuvants, Anesthesia↗
PubMedDate not supplied

Performance of a new transdermal nitroglycerin adhesive patch formulation.

This two-period crossover study in 24 healthy men compared the transdermal absorption of nitroglycerin from a new 20-cm2 nitroglycerin adhesive transdermal patch applied for a single 24-hour period (q24hr) with that from one inch of 2% nitroglycerin ointment applied over a 50-cm2 area every eight hours (q8hr) during a single 24-hour period. The observed differences in pharmacokinetic parameters were expected, based on product design (q24hr vs q8hr) and surface area (20 cm2 vs 50 cm2); however, when corrected for surface area, the mean plasma AUC ratios indicated that the patch delivered about 1.5 times more drug than the ointment. The patch delivery of nitroglycerin was confirmed by patch residual results, which indicated nitroglycerin was released at a rate of 0.75 mg/cm2/24 hrs. The patch exhibited good skin adhesion throughout the 24-hour application period.

Administration, Cutaneous↗
PubMed1993

The USA experience with the clonidine transdermal therapeutic system.

Cardiovascular diseases are the leading causes of death in the United States, with hypertension being amongst the most prevalent of the cardiovascular risk factors. Improvement of hypertension management has, in consequence, received much attention. Extensive pre- and post-marketing experience with the transdermal formulation of clonidine marketed in the USA in the mid-1980s has now been accumulated. Transdermal clonidine is effective as monotherapy in mild-moderate hypertension, and in combination with diuretics, calcium antagonists and ACE inhibitors in more resistant cases. It controls blood pressure throughout the 24-h circadian cycle. It is effective and generally well-tolerated in adolescents, the elderly, blacks, diabetics, and subjects with chronic renal insufficiency. It has been used perioperatively and for suppression of adrenergic symptoms in subjects withdrawing from addicting substances. In comparison with oral clonidine, transdermal clonidine reduces the incidence and severity of such symptomatic side-effects as dry mouth, drowsiness, and sexual dysfunction. Minor skin reactions occur at the site of application of the transdermal patch with moderate frequency. Adherence to transdermal clonidine therapy is high, and patients commonly prefer it to oral therapy. Transdermal administration of clonidine is a useful therapeutic advance in the long-term management of hypertension.

Administration, Cutaneous↗
PubMed2005

Physicians' knowledge of transdermal fentanyl.

BACKGROUND: Different opioids for use in the control of moderate to severe cancer pain have become widely available. More recently, sophisticated formulations such as transdermal patches have been developed. One example, transdermal fentanyl (TF), has characteristic pharmacokinetics and along with the other opioids, equivalency conversions are often made when changing from or to other opioids. AIM OF STUDY: To explore the knowledge of general practitioners (GPs), hospital consultants and oncologists about the pharmacology and use of TF in the management of moderate/severe cancer pain. METHOD: During 2001 and 2002 a questionnaire survey was carried out. A randomized selection of GPs, hospital consultants and oncologists (n=1167) from the UK and Ireland were sent a questionnaire and 576 (49%) were returned and evaluated. RESULTS: The results show doctors who had previously prescribed TF are more confident and knowledgeable about the indications and pharmacology of TF than doctors who had never prescribed TF. Overall knowledge and confidence in using TF was poor.

Administration, Cutaneous↗
PubMed2001

Scopolamine: new preparations. Reference treatment for death rattle.

(1) The reference symptomatic drug treatment of death rattle is the use of atropinic agents such as scopolamine or atropine. (2) Marketing authorisation has now been granted in France for scopolamine in this indication, both for a subcutaneous preparation and a transdermal patch. (3) The clinical file on subcutaneous scopolamine delivery mainly comprises non comparative data on 200 patients studied prospectively and 196 patients studied retrospectively. (4) The assessment of transdermal scopolamine patches is limited to a few published cases. (5) Available data show the efficacy of scopolamine, when administered after aspiration of the back of the throat. (6) The main adverse effects are neuropsychological (excitation, hallucinations, delirium). (7) In practice, injectable scopolamine is the reference drug for symptomatic treatment of death rattle.

Administration, Cutaneous↗
PubMedDate not supplied

Low dose transdermal estradiol/norethisterone acetate treatment over 2 years does not cause endometrial proliferation in postmenopausal women.

OBJECTIVE: We investigated the effects of 2-year transdermal continuous combined estradiol (0.025 mg/day) and norethisterone acetate (0.125 mg/day) (Estragest TTS) on bleeding and on the endometrium. DESIGN: This double-blind, randomized, multicenter, parallel, 1-year trial enrolled 266 healthy women at least 2 years past menopause with intact uteri. Patients received a transdermal patch delivering either 0.025 mg estradiol and 0.125 mg norethisterone acetate daily or placebo. Of the 266 women initially included, 135 (96 Estragest TTS, 39 placebo) completed a second year open follow-up, where all women had the estradiol/norethisterone patch. Endometrial biopsies were performed at weeks 0, 48 (n = 171), and 96 (n =109). Effects on endometrial morphology and uterine bleeding were studied. RESULTS: The overall incidence of endometrial hyperplasia after treatment with the estradiol/norethisterone acetate patch for one year was 0.8% with only one case of atypical hyperplasia. There were no clinically significant changes in endometrial thickness in either treatment group. The proportion of bleed-free patients with the estradiol/norethisterone acetate transdermal system increased from 55% in cycles 1-3 to 83% in cycles 10-12. By the 12th cycle, 92% of patients receiving estradiol/norethisterone acetate patches were bleed-free. No additional hyperplasia was seen during the second year follow-up. CONCLUSIONS: A continuous combined transdermal patch delivering 0.025 mg estradiol/day and 0.125 mg norethisterone acetate/day provided good endometrial protection. The dose maintained a consistently high rate of amenorrhea in postmenopausal women.

Administration, Cutaneous↗
PubMed2000

Cost-benefit analysis of sustained-release bupropion, nicotine patch, or both for smoking cessation.

BACKGROUND: The nicotine transdermal patch (NTP) has been shown previously to be a cost-effective smoking cessation intervention. This is the first economic analysis comparing the NTP with the only non-nicotine-containing pharmacological intervention, bupropion HCl. METHODS: Decision-tree analysis, based on a previously published cost-benefit smoking-cessation model, was used to determine the optimal treatment from the standpoint of costs versus benefits, from the employer's perspective. Base-case probabilities of successful quitting in our model came from clinical trial point-prevalence data at the end of a 1-year follow-up study (N = 893) comparing placebo, bupropion, NTP, and bupropion/NTP in combination, administered along with minimal counseling. Sensitivity analyses were performed to determine the effects of variations in base-case assumptions regarding the monetary benefits that would accrue if an intervention were successful, probabilities of quitting, drug costs, cost of lost work time for a health care provider visit, and cost of the visit itself. RESULTS: The analysis showed that bupropion is more cost-beneficial than either NTP or bupropion/NTP, with a net benefit in the first post-quit year of up to $338 per employee who attempts to quit compared with $26 for NTP, $178 for the two in combination, and $258 for placebo. These results were robust to most plausible variations in the assumptions used in the model. One exception was the monetary benefit of successful intervention (assumed in the base-case to be $1,654). If this benefit were actually less than $1, 112, placebo (i.e., minimal counseling with no pharmacological intervention) would be more cost-beneficial than any of the active treatments. CONCLUSION: From an employer's perspective, bupropion 300 mg/day for 9 weeks is a more cost-beneficial smoking cessation intervention than the nicotine patch, and under most scenarios, bupropion is also more cost-beneficial than placebo.

Administration, Cutaneous↗