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PubMed2005

Non-nicotine pharmacotherapies for nicotine dependence.

The smoking rate for patients with schizophrenia reaches as high as 90% in clinical samples, 70% for patients with bipolar disorder, and 40% to 50% for patients with major depression and anxiety disorders. Because it is a significant health hazard, smoking should be aggressively discouraged, and, in this group of patients, a combination of behavioral therapy and pharmacotherapy currently offers the best option. Nicotine provides a number of benefits, including anxiety relief, increased alertness, and improved cognitive functioning. It alters a wide range of central nervous system neurotransmitters. Unfortunately, nicotine readily establishes physiological dependence. In cessation efforts, transdermal nicotine patches and nicotine gum are helpful adjuncts. The primary FDA approved non-nicotine pharmacotherapy agent is bupropion (Zyban). Studies summarizing the effectiveness (or lack thereof) of other (off-label) agents, such as tricyclic antidepressants, MAO-Inhibitors, SSRIs, and clonidine, are cited.

Antidepressive Agents↗
PubMed1989

Artificially induced menstrual cycle with natural estradiol and progesterone.

In order to study the feasibility and efficacy of using natural 17 beta-estradiol (E2) and progesterone (P) to induce endometrial changes, a group of patients with history of premature ovarian failure and bilateral oophorectomy, also interested in the embryo transfer program with donor ovum, were given transdermal E2 (Estraderm, Ciba Pharmaceutical Co., Summit, NJ), and vaginal progesterone suppositories. Serial serum E2, P, follicle-stimulating hormone, and luteinizing hormone were determined by radioimmunoassays. The dosages of E2 and P were adjusted according to the levels of E2 and P so that their changes could follow the same pattern as that of a normal spontaneous menstrual cycle. Serial ultrasonic evaluation of the endometrium and endometrial biopsy during the late luteal phase also was performed. Preliminary data indicated that transdermal E2 patches and vaginal P suppositories, while being as effective in inducing endometrial development for the embryo transfer procedure with donor ovum as synthetic steroids, can also provide a more physiologic approach that may conveniently and safely be extended into the second trimester of pregnancy.

Administration, Cutaneous↗
PubMed1989

Chronic effects of transdermal nitroglycerin in stable angina pectoris: a within-patient, placebo-controlled study.

The efficacy of transdermal nitroglycerin patches, releasing 20 mg of active substance over a period of 24 h (TDN 20), was investigated in 10 patients with stable exercise-induced angina pectoris. The study was divided into 3 periods: the first part was an acute, within-patient, crossover, double-blind, placebo-controlled study, in which patients performed a cycloergometric exercise test 4 and 24 h after the application of the patches (TDN 20 or placebo). During the 2nd period, patients were given TDN 20, in single blind conditions, for 4 weeks and another exercise test was performed, on the last day, 4 and 24 h after patch application. Finally, after a one-day placebo wash-out, a second acute study similar to the first was performed. Four h after dosing, exercise duration to 1 mm ST segment depression was 441 s and 314 s (p less than 0.01) for TDN 20 and placebo, respectively (first acute study), 394 s for TDN 20 after chronic treatment (p less than 0.001 vs acute placebo) and 472 and 354 s (p less than 0.001) for TDN 20 and placebo, respectively (second acute study). No difference in exercise duration to 1 mm ST segment depression was found between TDN 20 and placebo, 24 h after administration, in any of the periods. Blood pressure significantly decreased and heart rate significantly increased 4 h after TDN dosing (in comparison with placebo) in both the acute studies, but no difference was observed after chronic TDN treatment. In conclusion, TDN 20 increases exercise tolerance 4 h after the application of both acute and chronic treatments.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Cutaneous↗
PubMed1986

[Avoidance of tolerance development to long term therapy with nitrates through correct dosage].

Tolerance development to organic nitrates, with respect to blood pressure reduction and precipitation of headache, had been assumed for almost a century but it was not until 1980 that the anti-ischemic effect was proven to be subject to this phenomenon, in a placebo-controlled, double-blind study carried out by our group exemplarily employing long-term treatment with isosorbide dinitrate (ISDN) in sustained-release form. Subsequent studies showed that tolerance development was also incurred during administration of ISDN, nonsustained-release form, 40 mg q.i.d. and on application of transdermal nitroglycerin patch systems. Both changes in the pharmacokinetics and activation of counter-regulatory mechanisms can be excluded as meaningful etiologic factors for the development of nitrate tolerance. It must be assumed that intracellular changes in the target organ which are associated with a diminished responsiveness for guanylate cyclase activation are at the basis of tolerance development. Prerequisite, according to laboratory experiments and clinical observations, are high concentrations of nitrates. After development of tolerance, on allowing a nitrate-free interval to intervene, the attenuated effects rapidly resume. Consequently, we investigated the hypothesis that tolerance could be avoided by an intermittent administration of nitrates which prevented accumulation of high serum concentrations. This was confirmed in two placebo-controlled, double-blind studies. Both during treatment with 20 mg ISDN in the morning and at midday as well as with the once-daily administration of 120 mg ISDN sustained-release form in the morning, there was an unequivocal anti-ischemic effect without tolerance development together with a significant reduction in the rate of anginal attacks and nitrate consumption.(ABSTRACT TRUNCATED AT 250 WORDS)

Angina Pectoris↗
PubMed1985

The effects of swallowing frequency and transdermal scopolamine on esophageal acid clearance.

Fourteen volunteers were studied on two occasions to assess the effect of swallowing frequency on acid clearance time. The experimental protocol consisted of two trials of infusion of 15 ml of 0.1 N HCl into the distal esophagus. One trial required swallowing every 30 s for 10 min. The other trial involved an initial rapid swallowing rate (seven swallows in the 1st min) with a gradual predetermined decline in rate. This procedure was repeated 12 h after application of a transdermal scopolamine patch. Baseline clearance times for rapid and slow swallowing were not significantly different. The anticholinergic drug significantly prolonged the clearance times for both rapid and slow swallowing. Under baseline conditions, sequential swallows (after the first three to four swallows) produced a significant rise in pH until the clearance criterion of pH 4.0 was reached. This effect was abolished with the anticholinergic drug. These results support a two-stage model of acid clearance with initial volume clearance and subsequent salivary buffering of residual intraesophageal acid.

Administration, Topical↗
PubMedDate not supplied

Management of pain in the cancer patient.

Pain is the most common symptom experienced in patients with advanced cancer. This pain may be acute, chronic, or intermittent, and often has a definable origin, usually related to tumor recurrence and treatment. The goal of therapy is to provide patients with enough pain relief to enable them to tolerate diagnostic and therapeutic manipulations and allow them freedom of movement and choice, while limiting medication-induced adverse effects. Morphine is the medication of choice, and is available in a sustained-release oral formulation with convenient around-the-clock administration every 8 to 12 hours. Morphine can also be administered subcutaneously, intravenously, and rectally, which provides enhanced flexibility for dosing patients unable to take oral medications. The transdermal fentanyl patch may provide a convenient dosage-form alternative if oral morphine preparations are not tolerated. Some patients with advanced cancer may require other adjunctive medications such as nonsteroidal anti-inflammatory agents, tricyclic antidepressants, steroids, or benzodiazepines, as well as psychologic techniques, to assist in pain management.

Acetaminophen↗
PubMedDate not supplied

The vestibulo-ocular reflex (VOR) under the influence of cinnarizine.

In a double-blind, placebo controlled, crossover study, we evaluated the effects of cinnarizine on the VOR of 55 healthy young subjects. VOR was evaluated by the Sinusoidal Harmonic Acceleration (SHA) test at frequencies of 0.01, 0.02, 0.04, 0.08 and 0.16 Hz. There was a reduction in VOR gain in 16 of the 20 SHA trials performed under the influence of cinnarizine alone (25 mg and 50 mg) and cinnarizine 25 mg in combination with 10 mg domperidone or 1 transdermal scopolamine patch. This decrease in VOR gain was significant in only a few SHA trials. Phase lead was not consistently affected by cinnarizine. No notable side effects were found for any of the drug groups. Our findings are in accord with the contention that increased resistance to seasickness produced either by drugs, or by the natural process of habituation to sea conditions, may be reflected by a decrease in VOR gain.

Adult↗
PubMed1995

[Smoking and peripheral vascular disorders].

Smoking is a major risk factor for peripheral arterial occlusive disease (PAOD) and plays a crucial role in the pathogenesis of the thrombangiitis obliterans (TAO), nicotine and carboxyhemoglobin cause functional disturbances and structural damage of the endothelial cells which may initiate arteriosclerosis. Additional effects of smoking are hyperfibrinogenemia, lowering of HDL-cholesterol and increased oxidation of LDL-cholesterol. By these mechanisms, smoking influences other primary risk factors for arteriosclerosis. Patients with PAOD, who continue to smoke, have a worse clinical prognoses with higher amputation and mortality rates than those who quit smoking. The most urgent goal in the therapy of PAOD and TAO should be an immediate and complete smoking cessation. However most patients continue to smoke despite the knowledge of the hazards to their health. An appropriate approach to this addiction may be an alternative application of nicotine temporarily (transdermal by patches or chewing gum) and behavioral treatment. This combined therapy results in better success rates in terms of smoking cessation.

Arterial Occlusive Diseases↗
PubMed1996

Transdermal nicotine compared with oral prednisolone therapy for active ulcerative colitis.

BACKGROUND: Ulcerative colitis is largely a disease of non-smokers. Previous controlled trials have shown benefit with transdermal nicotine when given with 5-aminosalicylic acid in active disease but not when given alone as maintenance therapy. OBJECTIVE: To examine nicotine alone compared with prednisolone in active disease. PATIENTS AND METHODS: Sixty-one patients with active ulcerative colitis were treated with either transdermal nicotine patches or 15 mg prednisolone for 6 weeks in a randomized, double-blind study. Incremental doses of nicotine were given for the first 9 days; patients tolerated between 15 and 25 mg daily. Most patients were taking mesalazine at entry which was discontinued at day 10; a few were taking topical steroids which were discontinued at the onset. Clinical, sigmoidoscopic and histological assessments were made at baseline and 6 weeks, or at premature withdrawal. Symptoms were recorded on a diary card, and the clinician made a global clinical assessment. Side effects and serum nicotine and cotinine concentrations were monitored throughout the study. RESULTS: Forty-three patients completed the 6-week trial; of these, 6 of 19 in the nicotine group achieved full sigmoidoscopic remission compared with 14 of 24 with prednisolone (P = 0.08). In those who completed the 6-week study, there was significant improvement within both the nicotine and prednisolone group for the St Mark's score (P < 0.05 and P < 0.01, respectively), Global Clinical Grade (P < 0.01 for both), blood in the stool (P < 0.05 and P < 0.01), abdominal pain (P < 0.05 and P < 0.01) and sigmoidoscopic score (P < 0.01 and P < 0.001); differences between groups tend to favour prednisolone, but none reach statistical significance. However, on intention-to-treat analyses there is little clear evidence of improvement in either group apart from sigmoidoscopic score in which prednisolone was associated with a significantly greater improvement than nicotine (P < or = 0.05). The nicotine group had more withdrawals than the prednisolone group, 11 versus 7, respectively (P = 0.23), both for deterioration (6 vs. 5) and side effects (5 vs. 2, P = 0.15). Side effects were more frequently reported in the nicotine group (average 1.47 episodes per person) than the prednisolone group (average 0.61; P = 0.03), the most common of which were nausea, light-headedness and tremor. CONCLUSION: In those who managed to complete the 6-week study, nicotine alone appeared to be of only very modest benefit in acute colitis and was not as effective as 15 mg of prednisolone daily.

Administration, Cutaneous↗
PubMedDate not supplied

Smoking cessation techniques.

A key responsibility for all health care professionals is to advise patients to quit smoking, which means being knowledgeable about smoking cessation programs and methods. This article considers both assisted and self-help methods of smoking cessation and their application to female smokers. The most effective assisted programs employ multiple interventions, primarily behavioral, but also pharmacologic, in the form of nicotine replacement. Smoking cessation products have not generally proven effective with the exception of nicotine polacrilex gum and the transdermal nicotine patch. Use of nicotine replacement, especially the patch, in smokers who are pregnant or nursing is controversial. In addition to pregnant women, those with young children and those of color and low socioeconomic status represent important high-risk target populations. Very little work has been done with female adolescents.

Administration, Cutaneous↗
PubMed1997

Usefulness of markers in managing tobacco withdrawal.

To evaluate the usefulness of tobacco markers in dependent smokers being treated with transdermal nicotine patches, a study was conducted at the Tobacco Withdrawal Consultation Centre at the Hôpital Laennec, Paris, France. 125 patients were included in the study and, in a first time, carbon monoxide in exhaled air, carboxyhaemoglobin, urinary nicotine and cotinine, Fagerström index, were measured and correlated to the amount of nicotine inhaled per day. The most significant value was observed for cotinine. In a second time, 25 patients were followed clinically and biologically with urinary continine monitoring (group FC) and 73 were followed up only clinically (group FC). The success rate of therapy 12 weeks after the end of treatment was 72% in group FB and 28% in group FC. The nicotine patch dose was positively correlated (p < 0.01) with successful outcome. The lower the urinary cotinine level at 4 weeks, the more likely was successful outcome (p < 0.05). If psychological factors remain important, urinary cotinine monitoring in the course of nicotine patch treatment thus favours successful withdrawal.

Administration, Cutaneous↗
PubMed1998

[Application of ultrasound energy as a new drug delivery system].

Ultrasound is frequently used in medicine for diagnostic purposes. Recently, there have been numerous reports on application of ultrasound energy for controlling drug release or targeting. This new concept of therapeutic ultrasound combined with drugs has induced excitement in various areas. Ultrasound energy can enhance effects of thrombolytic agents as urokinase. Ultrasound emitting catheters are currently being developed for cardiovascular diseases. Device with ultrasound transducers implanted in transdermal drug patches are also being evaluated for possible delivery of insulin through the skin. Chemical activation of drugs by ultrasound energy for treatment of cancers is another new field recently termed as "Sonodynamic Therapy". Various examples of application of ultrasound for drug delivery systems are discussed.

Animals↗
PubMed1998

Knowledge about smoking, reasons for smoking, and reasons for wishing to quit in inner-city African Americans.

OBJECTIVE: To determine knowledge about smoking, reasons for smoking, and reasons for wishing to quit and the association of these variables with abstinence at ten weeks and six months. DESIGN: Descriptive study and longitudinal intervention. SETTING: Inner-city public hospital clinics. PARTICIPANTS: 410 African-American cigarette smokers interested in quitting were surveyed at baseline and subsequently enrolled into a double-blind, placebo-controlled, randomized trial of the transdermal nicotine patch. MAIN OUTCOME MEASURES: Descriptive information about smoking knowledge, reasons for smoking, and reasons for wishing to quit, and association of these variables with abstinence at 10 weeks and 6 months. RESULTS: Among the 410 patients randomized, mean age was 48 years, 61% were female, 41% had less than a high school education, 51% had an annual household income less than $8,000, and the average number of cigarettes smoked a day was twenty. The average number of questions answered correctly was nine out of eleven (84%). The most cited reason for smoking was relaxation/tension reduction and the least cited were stimulation and handling of the cigarette. Ninety-nine percent of patients stated they wished to quit for health reasons. Knowledge, reasons for smoking, and reasons for wishing to quit were not significantly associated with 10-week or 6-month abstinence. CONCLUSIONS: In this group of inner-city African-American smokers, knowledge about cigarette smoking was high. Reasons for smoking were related to relaxation, craving, and pleasure, and reasons for wishing to quit were largely health-related. Knowledge, reasons for smoking, and reasons for wishing to quit were not associated with 10 week or 6 month abstinence. Since knowledge about smoking is already high, future efforts should be directed at promoting cessation through proven behavioral and pharmacological approaches, rather than didactic patient education.

Administration, Cutaneous↗
PubMed2001

Transdermally-delivered oxybutynin (Oxytrol(R) for overactive bladder.

(1) The oxybutynin patch is a transdermal delivery system, which releases the drug oxybutynin through the skin for the management of overactive bladder. (2) Limited evidence suggests that transdermal delivery of oxybutynin over a short period of time may have efficacy comparable to oral oxybutynin. (3) Recent phase II and III clinical trials supported by the manufacturer suggest a potentially reduced incidence of dry mouth compared to oral oxybutynin. Itching, however, is present in 18% of patients, and the patients' withdrawal rate due to adverse events after 12 weeks is significant (10%). (4) More studies are required to determine the long-term efficacy and safety of the oxybutynin patch for overactive bladder. (5) A New Drug Application for transdermal oxybutynin (Oxytrol(R)) is currently under review at the U.S. Food and Drug Administration. As of October 2001, the oxybutynin patch has not been approved in Canada.

Administration, Cutaneous↗
PubMed2002

Effects of transdermal estradiol delivered by a matrix patch on bone density in hysterectomized, postmenopausal women: a 2-year placebo-controlled trial.

This 2-year, double-masked, randomized, placebo-controlled trial was designed to evaluate the safety and efficacy in preventing bone loss in postmenopausal women of two doses of transdermal 17betaestradiol (estradiol) delivered by a matrix patch, compared with placebo. One hundred and sixty healthy, hysterectomized postmenopausal volunteers aged 40-60 years with serum estradiol levels < 20 pg/ml were started on treatment at four centers in The Netherlands. Every 6 months, bone mineral density (BMD) was measured by dual-energy X-ray absorptiometry (DXA) at the lumbar spine, non-dominant wrist and left hip, and markers of bone turnover were assessed in urine and serum. The treatment arms were: estradiol, 100 microg/day (E-100, n = 53), oestradiol, 50 microg/day (E-50, n = 54), placebo (P-100, placebo to E-100, n = 27 or P-50, placebo to E-50, n = 26). Treatment was continued for up to 2 years. After 24 months, BMD of the lumbar spine in the E-100 group differed by 7.7% [5.8-9.5%] (mean [95% confidence interval]) from the placebo group and showed a mean (s.e.m.) increase in BMD from baseline of 5.9% (0.69%). For the E-50 group the difference compared with placebo was 6.2% [4.4-8.0%] and the absolute increase was 4.5% (0.62%); in the placebo group, the absolute change was -2.3% (0.48%). In the total wrist, the changes were: E-100: difference compared with placebo 2.5% [1.5 3.6%], absolute increase 0.6% (0.3%); E-50: difference compared with placebo 2.9% [1.8-3.9%], absolute increase 0.7% (0.25%); and absolute change on placebo: -2.5% (0.35%). In the total hip, the changes were: E-100: difference compared with placebo 3.7% [2.2-5.2%], absolute increase 2.8% (0.5%); E-50: difference compared with placebo: 3.2% [1,8-4.7%], absolute change 2.4% (0.36%); and absolute change on placebo -1.4% (0.66%). Three markers of bone turnover--serum bone-specific alkaline phosphatase, serum osteocalcin and urinary CTX--fell significantly during the trial. Breast pain was reported by 8% of women on placebo, by 6% of women on E-50 and by 17% of women on E-100. Estradiol delivered by the E-50 matrix patch effectively reversed bone loss in hysterectomized postmenopausal women with few side-effects. The marginal additional gain in BMD with the higher dose may be offset by a more important side effect profile.

Administration, Cutaneous↗
PubMed1998

Transdermal delivery of isosorbide 5-mononitrate from a new membrane reservoir and matrix-type patches.

Isosorbide 5-mononitrate (5-ISMN) has a direct relaxing effect on vascular smooth muscle. In the present study we developed matrix and reservoir-type transdermal patches of 5-ISMN. We investigated the usefulness of a new film-forming material isolated from the roots of Salacia macrosperma to serve as rate-controlling membrane for the reservoir-type patches. Matrix-type patches were formulated using polyvinyl chloride. Permeation studies through rat skin were conducted on both types of patches using Teflon cells. The mean +/- SD flux values from the matrix- and reservoir-type patches were 99.55 +/- 22.89 and 31.82 +/- 8.31 micrograms/cm2.hr, respectively.

Administration, Cutaneous↗
PubMed1999

17Beta-estradiol delivered by three different matrix patches 50 microg/day: a three way cross-over study in 21 postmenopausal women.

The aim of this study was to investigate the systemic bioavailability and plasma profiles of 17beta-estradiol (E2) after the application of three matrix patches for the transdermal delivery of E2: Menorest, Tradelia, and Estraderm MX claiming to deliver a dosage of 50 microg E2/day. All three patches were each worn randomly by 21 postmenopausal women volunteers over a 4-day period (i.e. 96 h). Each of the three treatment periods were separated by an at least 7 day wash out period according to a randomized, 3-way crossover design. Blood samples were taken from the antecubital vein before and 3, 6, 9, 12, 24, 28, 33, 48, 57, 72, 81, and 96 h after application. E2 plasma values were determined by a specific direct radioimmunoassay method. The following pharmacokinetic parameters were evaluated: AUC0-96h, Cmax, Tmax, Cmin, C(average). The time to reach the maximal E2 value of 32 h was the only pharmacokinetic parameter which was identical for all three patches. Menorest produced the highest E2 bioavailability judged by the AUC0-96h = 3967.8 +/- 1651.8 pg/ml, C(average) = 41.3 +/- 21.3 pg/ml, Cmin = 36.8 +/- 8.6 pg/ml. Tradelia showed statistically not significantly smaller C(average) = 38.9 +/- 17.0 pg/ml, AUC0-96h = 3737.9 +/- 1637.6 pg/ml x per h, and Cmin = 33.8 +/- 26.7 than Menorest. Estraderm MX showed lowest E2 plasma profiles Cmax = 38.9 +/- 25.1 pg/ml, C(average) = 33.2 +/- 17.1 pg/ml, AUC0-96 = 3192.1 +/- 1646.0 pg/ml per x h. Menorest showed the smallest fluctuation over the entire test period, similar to Estraderm MX, while Tradelia showed the highest E2-fluctuation (P < 0.01): Tradelia exhibited the highest Cmax = 48.0 +/- 20.3 pg/ml. When E2 baseline levels, prior to patch application are subtracted individually from the produced E2 plasma level, Estraderm MX is not bioequivalent to Menorest (P < 0.05). A circadian curve pattern of the E2 plasma level was observed for all patches: in the evening higher E2 plasma level were always detected compared with the morning, however, less pronounced with Estraderm MX. Individual comparison of AUC0-96h of each patch exhibited a large interindividual variability of 2000-8000 pg/ml per h for all three patches but relatively small individual variability: women with high E2 bioavailability (high responders) maintained high bioavailability in all applied patches, women identified as low and medium responders remained the same regardless of the applied patch. Menorest produced in 2/3 of all postmenopausal women with the highest E2 bioavailability (AUC0-96h), Tradelia was found in less than 1/3 (28.6%), and Estraderm MX in only one postmenopausal woman. Menorest only produced the highest reduction in postmenopausal symptoms together with Tradelia. Estraderm MX produced a smaller reduction in postmenopausal symptoms compared to Menorest and Tradelia. The observed side-effects were approximately equal in all three patches, with a maximum value after 72 h. It can be concluded that the three patches for the transdermal delivery of E2 claiming to deliver 50 microg E2/day differed from each other in their pharmacokinetic performance, although statistically not significant: Menorest exhibited the highest C(average), AUC and Cmin, and the lowest fluctuation, followed by Tradelia and Estraderm MX.

Administration, Cutaneous↗