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PubMed2002

Shed king cobra and cobra skins as model membranes for in-vitro nicotine permeation studies.

Shed king cobra skin (SKCS) and shed cobra skin (SCS) were investigated for use as barrier membranes, including some pre-hydration factors, for in-vitro nicotine permeation. Inter-specimen variations in nicotine fluxes using shed snake skin were compared with those using human epidermis. Nicotine in the form of 1% w/v aqueous buffer solution at pH 5 and transdermal patches (dose 14 mg day(-1)) were used. The nicotine fluxes across the shed snake skin were not significantly affected (P > 0.05) by temperature and duration of hydration pre-treatment. Scanning electron micrographs of SKCS and SCS revealed a remarkable difference in surface morphology, but the nicotine fluxes using both shed skins were not significantly different (P > 0.05). When compared with the results obtained using human epidermis, there were similarities in fluxes and permeation profiles of nicotine. Using nicotine solution, the nicotine permeation profiles of all membranes followed zero order kinetics. The amount of nicotine permeated provided good linearity with the square root of time over 24 h (R(2) > 0.98) when using nicotine patches. The nicotine fluxes using SKCS and SCS had less inter-specimen variation than those using human epidermis. The results suggest a potential use for SKCS or SCS as barrier membranes for in-vitro nicotine permeation studies.

Animals↗
PubMed2006

An overview of oral contraceptives: mechanism of action and clinical use.

Hormonal contraception is available in oral contraceptive pills and in newer formulations, including the transdermal patch, the vaginal ring, subcutaneous implants, and IM injections. Prevention of pregnancy is achieved by inhibiting ovulation, fertilization, and/or implantation of an egg. Hormonal contraception provides effective, tolerable, and reversible prevention of pregnancy. Efficacy and safety profiles are similar for different formulations and administration routes. Lowest expected failure (i.e., method failure) rates for hormonal contraceptives, regardless of formulation, are <2%. Typical failure rates for oral formulations range from <3% to 5% due to failures in compliance. The most commonly reported adverse effects are weight gain, nausea, variations in menstrual flow, breast changes such as tenderness, discomfort, or swelling, depression or mood disturbances, decreased sexual desire or response, and acne. Rare but serious potential effects include cardiovascular diseases, such as stroke, and an increased risk for breast cancer, liver tumors, and gallbladder disease. Hormonal contraceptive use should be avoided in women at risk for blood clots, by heavy smokers, and in women with breast or other cancers. Use of hormonal contraception in adolescents requires special consideration, in part because of decreased compliance.

Adolescent↗
PubMedDate not supplied

Does nicotine have beneficial effects in the treatment of certain diseases?

Although tobacco smoking has long been associated with diseases of the lungs and cardiovascular system, numerous studies have demonstrated a negative association between tobacco smoking and ulcerative colitis, and the neurodegenerative diseases, Alzheimer's disease (AD) and Parkinson's disease (PD). The evidence suggests that nicotine--the main pharmacologically active ingredient of tobacco--appears to be responsible for this effect. Pure nicotine has no known carcinogenic properties and can be administered in numerous ways including transdermal patches and tablets. As a therapeutic agent, its association with tobacco can be likened to morphine and opium smoking. There is ample clinical evidence to suggest that nicotine could be beneficial in the treatment of some patients with diseases. Pharmacologically, nicotine acts on cholinergic (nicotinic-specific) receptors which are depleted in AD and PD. Nicotinic receptors also interact closely with several neurotransmitters including dopamine, which is implicated in both PD and Gilles de la Tourettes's syndrome. There is no doubt that tobacco smoking can be harmful and no-one should be encouraged to smoke. However, although nicotine has many harmful side-effects, it may have therapeutic value or at the very least be a useful tool for future drug development.

Alzheimer Disease↗
PubMed2005

A placebo controlled, double-blind study of mecamylamine treatment for cocaine dependence in patients enrolled in an opiate replacement program.

A placebo controlled, double-blind trial of mecamylamine treatment of cocaine dependence was performed in methadone or LAAM maintained subjects who met DSM-IV criteria for cocaine dependence. After an eight-week placebo run-in screening period, 35 subjects were randomly assigned to receive either mecamylamine (6 mg/day) or placebo transdermal patches for a 16-week treatment period. Outcome measures included quantitative urine benzoylecognine (BE) levels, self-report of cocaine use, cocaine craving, global impression scores, mood, retention, and safety. Mecamylamine was well tolerated, and study retention did not differ by treatment group. Evidence for cocaine use, based on urine BE levels and cocaine abstinence rates, did not differ by treatment group. Self reported cocaine use, cocaine craving, and global impression scores showed moderate improvement in both groups, with a significantly greater reduction in cocaine craving (p < 0.05) and self-rated severity of cocaine dependence (p < 0.05) in the placebo group. This pilot study does not support the effectiveness of mecamylamine for the treatment of cocaine dependence in methadone or LAAM maintained patients.

Administration, Cutaneous↗
PubMed2000

Hormone replacement therapy in a postmenopausal woman with epilepsy.

OBJECTIVE: To prospectively evaluate the effects of hormone replacement therapy (HRT) on seizure activity in a postmenopausal woman with epilepsy. BACKGROUND: Postmenopausal women are at an increased risk for cardiovascular disease and osteoporosis secondary to a lack of estrogen's protective effects. As a result, women without known contraindications often take HRT to counteract this risk. Postmenopausal women with epilepsy are at a greater risk for osteoporosis because of the negative effects that certain antiepileptic drugs have on bone density. Clinical studies and experience have shown that hormonal variances across a woman's lifetime play a significant role in seizure activity, but the effects of HRT in postmenopausal women with epilepsy are unknown. CASE SUMMARY: We report the case of a 51-year-old postmenopausal white woman with epilepsy who presented with frequent vasomotor flushing. To determine individual effects of HRT on seizure activity, therapy was initiated in two three-month phases, with monthly evaluation. A weekly transdermal patch of estradiol 0.1 mg/d was initiated for the first three months. During the second three months, the regimen was expanded to include oral medroxyprogesterone acetate 2.5 mg once daily. Antiepileptic medications and their dosages remained constant. HRT was associated with a decreased incidence of seizures, cessation of vasomotor flushing, improved sleep, and a positive impact on the lipid profile. CONCLUSIONS: This case report describing the prospective addition of HRT in a postmenopausal woman with epilepsy suggests that HRT can be initiated in certain women to achieve therapeutic benefits without adversely affecting seizure activity.

Epilepsy↗
PubMed2001

Management of puberty in constitutional delay of growth and puberty.

Constitutional delay of growth and puberty (CDGP) is the most common presenting form of short stature, but no single test can infallibly discriminate CDGP and isolated hypogonadotrophic hypogonadism. Management of puberty in CDGP aims to optimise not only growth maintaining body proportions and improving peak bone mass without impairing growth potential--but also well-being; for example, the distress boys often suffer because of their lack of growth and pubertal progression can affect their school performance and social relationships. Typical sex steroid treatments to induce puberty in boys with CDGP include testosterone (T) enanthate, T undecanoate, mixed T esters, T transdermal patches, and oxandrolone p.o. Compared with other regimens, short-course low-dose depot T i.m. is an effective, practical, safe, well tolerated, and inexpensive regimen. Some unresolved problems in management include optimal timing and dose of sex steroid treatment, the role of GH in CDGP, and the management of CDGP in girls.

Adolescent↗
PubMed2001

Tobacco addiction and pharmacological interventions.

Even though its health consequences are well known, tobacco use continues to kill millions of smokers worldwide every year. In the US alone, tobacco use kills > 430,000 people each year. The global mortality toll is approximately 5 million annually and this is increasing. It is the powerful grip of tobacco addiction that sustains high levels of daily smoke intake and persistent smoking, with > 90% of all cigarette smokers who quit, resuming smoking within 1 year. Tobacco addiction, which places tremendous health and economic burdens on individual societies, is also becoming a global epidemic. Although tobacco addiction is a complex phenomenon, it is treatable and several effective medications are now available. In the mid-1980s, the US FDA approved nicotine gum, the first of these effective pharmacological aids. Other effective medications have subsequently become available, including nicotine transdermal patches, nasal spray, oral vapour inhaler, sublingual nicotine tablets and bupropion. These medications and the potential for development of new medications will be reviewed.

Antidepressive Agents, Second-Generation↗
PubMed2003

Non-oral drug delivery in Parkinson's disease: a summary from the symposium at the 7th International Congress of Parkinson's Disease and Movement Disorders. 10-14 November 2002, Miami, FL, USA.

This symposium reviewed the issues of non-oral therapy in the late stage Parkinson's disease (PD). The accepted standard treatment of PD is oral levodopa or oral dopamine agonists. However, the long-term complications and limitations of this treatment might be improved by changing therapy from the present pulsatile stimulation to a more constant stimulation of central dopamine receptors. Stimulation of these receptors may be possible with non-oral drug delivery treatments. Many of these non-oral options have been evaluated during the last few decades to find a more continuous drug delivery. The non-oral treatment options include invasive measures such as intraduodenal levodopa, subcutaneous apomorphin and most recently, the non-invasive transdermal (patch) delivery system, with the novel dopamine agonist rotigotine (Aderis Pharmaceuticals Inc.). The benefits of the non-oral, more continuous dopaminergic treatment of PD needs to be demonstrated in clinical trials and long-term clinical practice, before they can be considered as potential replacements of the standard oral therapy.

Antiparkinson Agents↗
PubMed2006

Review of Testim gel.

Hypogonadism is a medical condition characterised by testosterone deficiency in males, accompanied by numerous clinical symptoms, which can negatively affect quality of life and multiple organ systems. Late-onset hypogonadism describes testosterone deficiency or reduced effect seen in ageing men. The conditions are generally managed using testosterone supplementation. Many formulations of testosterone are available, including deep-muscle injections, buccal formulations, transdermal patches and topical gels. Testim gel 1% testosterone gel (Auxilium Pharmaceuticals, Inc. and Ipsen) has been shown to restore serum testosterone concentrations to within the normal range in men with hypogonadism. Two randomised, controlled studies showed that Testim gel significantly improved sexual motivation, desire, performance and function, as well as positive and negative mood scores and body composition after 90 days, compared with baseline. The magnitude of improvement seen with Testim gel was similar to that achieved with testosterone patches, but with fewer application-site reactions. In another study, improvements in mood and sexual function were seen within the first 2 weeks of treatment. Long-term, open-label extension studies of Testim gel suggest that clinical benefits are maintained for < or = 12 months without an additional increase in side effects. Notably, Testim gel treatment for 12 months was associated with a gradual increase in bone mineral density, suggesting that Testim gel may help to prevent osteoporosis. The most common adverse events associated with Testim gel were application-site reactions, increased haematological parameters, and moderately increased prostate-specific antigen levels that remained within the normal range in 96% of subjects. Men on any testosterone therapy will require careful monitoring, including serial digital rectal examination and prostate-specific antigen testing. Overall, the clinical evidence so far indicates that Testim gel is a safe and effective treatment option for daily use in the management of male hypogonadism.

Administration, Topical↗
PubMed2006

Treating tobacco use and dependence in clinical practice.

Physicians are in a unique position to advise smokers to quit by the ability to integrate the various aspects of nicotine dependence. This review provides an overview of the intervention strategies for smokers presented in a primary care setting. The strategies that are used for smoking cessation counselling differ according to the patient's readiness to quit. For smokers who do not intend to give up smoking, physicians should inform about tobacco use and the benefits of cessation. For smokers who are dissonant, physicians should use motivational strategies, such as discussing the barriers to successful cessation and their solutions. For smokers who are ready to quit, the physician should show strong support, help set a date to quit, prescribe pharmaceutical therapies for nicotine dependence, such as nicotine replacement therapy (i.e., gum, transdermal patch, nasal spray, mouth inhaler, lozenges, and micro and sublingual tablets) and/or bupropion (an atypical antidepressant thought to work by blocking the neural re-uptake of dopamine and/or noradrenaline), with instructions for use, and suggest behavioural strategies to prevent relapse. The efficacy of all of these pharmacotherapies is comparable, roughly doubling the cessation rates over control conditions.

Humans↗
PubMed2006

The effects of nicotine on the metabolic and hormonal responses during acute cold exposure.

OBJECTIVE: To examine the effects of nicotine on the metabolic and hormonal responses during acute cold exposure. METHODS: Participants in this study included 6 men and 5 women between the ages of 19 and 25 years. Each subject performed 2 cold-air trials (CATs) consisting of a 30-minute baseline (BASE) period and a 120-minute exposure to 10 degree C air. One CAT was performed after a nicotine (NIC) dosing using a 21-mg transdermal patch, whereas the other CAT was performed after a placebo (PL) treatment. Blood samples for metabolic and hormonal measurements were obtained at the end of BASE and immediately after the cold exposure. RESULTS: When examining the sexes separately, there was no difference in norepinephrine between PL and NIC (P = .066). There was also no difference in epinephrine between PL and NIC in either sex (P = .634). From BASE to 120 minutes of the CAT, there was a significant decrease in cortisol (P = .036), but this response was similar between the 2 treatments (P = .077). Glucose and glycerol concentrations were not different between the PL and NIC treatments. At BASE, nonesterified fatty acid (NEFA) concentration was lower during PL compared with NIC (P = .021); however, at 120 minutes of the CAT, NEFA was greater during PL compared with NIC (P = .035). CONCLUSIONS: During 120 minutes of cold exposure, NIC resulted in alterations in the responses in NEFA, whereas the other blood measurements were not significantly different between the 2 groups.

Adult↗
PubMed2006

Rotigotine for the treatment of Parkinson's disease.

Dopaminergic therapies, including levodopa and dopamine agonists, are the mainstays of therapy in Parkinson's disease. With the exception of the injectable short-acting dopamine agonist apomorphine, there is no other widely available non-oral dopaminergic therapy. Rotigotine is a lipid-soluble, non-ergot, D3, D2, D1 dopamine receptor agonist that has demonstrated efficacy as an alternative therapeutic option in both early and advanced Parkinson's disease. More importantly, it is uniquely formulated as a transdermal patch delivery system allowing for continuous, once-daily administration and better patient compliance. Preclinical and clinical trials have shown rotigotine to be a well-tolerated and effective treatment for early-stage Parkinson's disease. Rotigotine has also shown promise as adjunctive therapy with levodopa for the treatment of advanced Parkinson's disease.

Antiparkinson Agents↗
PubMed2002

Fentanyl-associated syndrome of inappropriate antidiuretic hormone secretion.

A 43-year-old woman with advanced pulmonary blastoma was admitted for worsening back pain. Her drug regimen included hydromorphone and benazepril. On admission, hydromorphone patient-controlled analgesia (PCA) was started for acute pain control and dexamethasone for possible cord compression. Baseline laboratory tests were unremarkable, but magnetic resonance imaging revealed T3 and L3 lesions. Irradiation was started with improvement in her pain. In anticipation of discharge, a fentanyl transdermal patch was given, and PCA was tapered. Two days later, the patient became progressively confused and fell. Neurologic examination and computed brain tomography were normal. Her serum sodium was 119 mEq/L (normal 136-144 mEq/L) and was confirmed on repeat testing, urine sodium was 194 mEq/L, and urine and serum osmolalities were 554 mOsm/kg (normal 300-900 mOsm/kg) and 245 mOsm/kg (normal 280-300 mOsm/kg), respectively, consistent with the syndrome of inappropriate antidiuretic hormone secretion (SIADH). Fluids were restricted, hydromorphone PCA was started again, and fentanyl was discontinued. After 36 hours, her serum sodium increased to 136 mEq/L. Because we were unsure whether the fentanyl or her cancer was causative and were unable to find any published reports of fentanyl-associated SIADH, we readministered the fentanyl patch 2 days later. Within 48 hours, serum sodium dropped to 123 mEq/L. Fentanyl was discontinued, fluids were restricted, and 3% saline was started. Her serum sodium increased to 132 mEq/L in 48 hours. The patient was prescribed oral hydromorphone and benazepril and was discharged. The repeated temporal relationship between the administration of fentanyl and the onset of SIADH strongly implicates fentanyl as the causative agent in this case. To our knowledge, this is the first report of fentanyl-associated SIADH.

Administration, Cutaneous↗
PubMed2001

Risks and benefits of nicotine to aid smoking cessation in pregnancy.

Cigarette smoking during pregnancy is the single largest modifiable risk for pregnancy-related morbidity and mortality in the US. Addiction to nicotine prevents many pregnant women who wish to quit smoking from doing so. The safety and efficacy of nicotine replacement therapy (NRT) for smoking cessation during pregnancy have not been well studied. Nicotine is classified by the US Food and Drug Administration as a Pregnancy Category D drug. Animal studies indicate that nicotine adversely affects the developing fetal CNS, and nicotine effects on the brain may be involved in the pathophysiology of sudden infant death syndrome (SIDS). It has been assumed that the cardiovascular effects of nicotine resulting in reduced blood flow to the placenta (uteroplacental insufficiency) is the predominant mechanism of the reproductive toxicity of cigarette smoking during pregnancy. Short term high doses of nicotine in pregnant animals do adversely affect the maternal and fetal cardiovascular systems. However, studies of the acute effects of NRT in pregnant humans indicate that nicotine alone has minimal effects upon the maternal and fetal cardiovascular systems. Cigarette smoking delivers thousands of chemicals, some of which are well documented reproductive toxins (e.g. carbon monoxide and lead). A myriad of cellular and molecular biological abnormalities have been documented in placentas, fetuses, and newborns of pregnant women who smoke. The cumulative abnormalities produced by the various toxins in cigarette smoke are probably responsible for the numerous adverse reproductive outcomes associated with smoking. It is doubtful that the reproductive toxicity of cigarette smoking is primarily related to nicotine. We recommend the following. Efficacy trials of NRT as adjunctive therapy for smoking cessation during pregnancy should be conducted. The initial dose of nicotine in NRT should be similar to the dose of nicotine that the pregnant woman received from smoking. Intermittent-use formulations of NRT (gum, spray, inhaler) are preferred because the total dose of nicotine delivered to the fetus will be less than with continuous-use formulations (transdermal patch). A national registry for NRT use during pregnancy should be created to prospectively collect obstetrical outcome data from NRT efficacy trials and from individual use. The goal of this registry would be to determine the safety of NRT use during pregnancy, especially with respect to uncommon outcomes such as placental abruption. Finally, our review of the data indicate that minimal amounts of nicotine are excreted into breast milk and that NRT can be safely used by breast-feeding mothers.

Animals↗
PubMed2004

Depression in aging men: the role of testosterone.

Age-related decline in testosterone levels is associated with a number of mild, nonspecific symptoms, including depressive symptoms. The relationship between depressive symptoms and testosterone levels is confounded by numerous factors, including medical illness, obesity, smoking, alcohol use, diet and stress, and is thus complex. Studies have not consistently supported an integral role of reduced testosterone levels in major depressive disorder, although levels may often be reduced in men with treatment-refractory depression and older men with dysthymia. Low testosterone levels may also increase the risk of incident depression in older males, although this may depend upon androgen receptor genetic polymorphisms. Testosterone replacement has demonstrated short-term tolerability and efficacy in augmenting antidepressants to alleviate treatment-refractory depression in adult males. Case studies support the potential need for maintenance therapy to maintain response. In a placebo-controlled trial, testosterone monotherapy was not effective in treating major depressive disorder in men with hypogonadism. However, in an open-label, noncomparative study, testosterone monotherapy appeared effective in treating late-onset but not early-onset major depressive disorder in older males. Testosterone therapy is not without potential for adverse effects, the most worrisome of which is the worsening of pre-existing prostate carcinoma. Oral, short- and long-acting parenteral, and transdermal patch and gel formulations are available. Testosterone has demonstrated usefulness in the treatment of a number of depressed populations, but further studies are needed to fully elucidate its role in the treatment of depressive syndromes in the aging male.

Aging↗
PubMed1987

Various administration forms of nitrates and their possibilities.

This article reviews the development and pharmacokinetics of a number of new dosage formulations (e.g. transdermal patches and buccal tablets) and new active substances (e.g. isosorbide 5-mononitrate) which have recently been introduced to overcome some of the problems inherent in conventional formulations of organic nitrates.

Administration, Cutaneous↗
PubMed2000

Economic cost of male erectile dysfunction using a decision analytic model: for a hypothetical managed-care plan of 100,000 members.

OBJECTIVE: This paper examined the economic cost of male erectile dysfunction (ED) for a hypothetical managed-care (MC) model. DESIGN AND SETTING: A prevalence-based cost-of-illness approach was used to estimate the direct medical cost for ED treatment. A treatment plan algorithm was developed from a MC perspective to model the initial treatment selection of various patient groups [vacuum erection device, intracavernosal injection (ICI) therapy, transurethral alprostadil suppository, sildenafil, testosterone replacement therapy, penile prosthesis] and their therapy outcomes during a 3-year period. Overall cost was based on 1998 US dollars. Total direct medical cost of ED considered in this model included the cost of initial physician consultation and evaluation, the cost incurred by patients from various treatment groups (pharmacological and surgical options), as well as the cost related to patients' follow-up for treatment within the 3-year period. Consideration for therapy switches made by patients who failed initial therapy was included as part of the clinical assumptions for this model. Treatment response and expected outcomes (dropouts) were considered for the various treatment options. PARTICIPANTS: A total of 100,000 enrolled members were included in the study. MAIN OUTCOME MEASURES AND RESULTS: The total cost of ED was $US3,204,792 for the 3-year period in the hypothetical MC plan. The treatment portion accounted for approximately 80% of the total cost while the cost of medical services and diagnostic tests were minimal in comparison. The 3 year total cost of nonsurgical treatment was $US2,473,045. Costs associated with each treatment alternative were $US81,866 (testosterone transdermal patch), $US51,930 (vacuum erection device), $US384,624 (ICI therapy), $US226,483 (transurethral alprostadil suppository) and $US1,728,142 (sildenafil citrate). Results from the model showed a noticeable trend of decreasing cost patterns over time and reflected the attrition observed for many of the standard medical therapies for ED. CONCLUSIONS: Sildenafil and the vacuum erection device should be considered as first-line management strategies for ED whereas ICI therapy, transurethral alprostadil suppository and penile prosthesis implant should be reserved for second- or third-line therapy. Because costs associated with switches related to successive treatment failures can be high, treatment considerations should, therefore, focus on achieving long term patient satisfaction. The patient's preferred treatment choice, using goal-directed therapy during the initial consultation and evaluation visit, should be used.

Adult↗
PubMed2001

Combination nicotine replacement therapy for smoking cessation: rationale, efficacy and tolerability.

Currently available nicotine replacement therapy (NRT) medications provide effective treatment for tobacco dependence, typically doubling success rates compared with placebo. A strategy for further improving the efficacy of NRT is to combine one medication that allows for passive nicotine delivery (e.g. transdermal patch) with another medication that permits ad libitum nicotine delivery (e.g. gum, nasal spray, inhaler). The rationale for combining NRT medications is that smokers may need both a slow delivery system to achieve a constant concentration of nicotine to relieve cravings and tobacco withdrawal symptoms, as well as a faster acting preparation that can be administered on demand for immediate relief of breakthrough cravings and withdrawal symptoms. This article reviews 5 published studies that have examined the effectiveness of combination NRT compared with monotherapy in providing withdrawal relief and smoking cessation, and examines other factors relevant to the promotion of combination NRT for treating tobacco dependence. The data show that there are conditions under which combinations of NRT products provide greater efficacy in relieving withdrawal and enabling cessation than monotherapy, but the findings are not robust and additional research is warranted to better understand the magnitude and generality of the benefits of combination therapy. There are also regulatory and commercial obstacles that must be considered. Nonetheless, combination NRT has the potential to provide effective treatment of tobacco dependence in persons whose dependence is refractory to currently available treatments.

Humans↗