Patched therapies

KUlen JD, Fortmann SP, Davis L, Strausberg L, Varady A (1999) Do heavy smokers benefit from higher dose nicotine patch therapy Exp Clin Psychopharm 7 226-233 KUlen JD, Fortmann SP, Schatzberg AF, Hayward C, Sussman L, Rothman M, Strausberg L, Varady A (2000) Nicotine patch and paroxetine for smoking cessation. J Consult Clin Psych 68 883-889... 

Strecher VJ, Shiffman S West R (2005). Randomized controlled trial of a web-based computer-tailored smoking cessation program as a supplement to nicotine patch therapy. Addiction, 100, 682-8... 

When low-dose patch therapy results in breakthrough bleeding it is supposedly more likely to occur in women with large, thin-walled, superficial endometrial vessels (89). If this finding is correct it might also apply to breakthrough bleeding with other forms of hormonal therapy. 

Dalpiaz AS, Lordon SP, Lipman AG. Topical lidocaine patch therapy for myofascial pain. J Pain Palliat Care Pharfnacother. 2004 18 15-34. 

A study investigating the use of atropine for treatment of amblyopia indicated it was as successful as patching therapy. Subjects were less than 7 years old and tolerated 1% atropine daily for 2 years without adverse effects. See Pediatric Eye Disease Investigator Group.A randomized trial of atropine vs patching for treatment of moderate amblyopia in children. Arch Ophthalmol 2002 120 268-278. 

However, subjective and objective analyses of these devices are required to make sure both scientific, regulatory and consumer needs are met. The devices in development are costlier and more complicated when compared with conventional transdermal patch therapies. As such they may contain electrical and mechanical components which could increase the potential safety risks to patients because of poor operator technique or device malfunction. In addition, effects of the device on the skin must be reversible, since any permanent damage to the SC will result in the loss of its barrier properties and hence its function as a protective organ. Regulatory bodies will also require data to substantiate the safety of the device on the skin for either short- or long-term use. Thus, for any of these novel drug delivery technologies to succeed and compete with those already on the market, their safety, efficacy, portability, user-friendliness, cost-effectiveness and potential market have to be addressed. 

Hurt RD, Patten CA, Offord KP, Croghan IT, Decker PA, Morris RA, et al. Treating non depressed smokers with alcohol dependence in sustained full remission Nicotine patch therapy tailored to baseline serum cotinine. J Stud Alcohol 2005 66 506-16. 

Pregnancy Nicotine replacement therapy is a pregnancy category D medication. The effects of nicotine replacement therapy during pregnancy on fetal, neonatal, and maternal outcomes have been reviewed [47 ]. In four studies of pregnancy outcomes after a full course of nicotine gum or patch therapy the use of nicotine replacement therapy significantly reduced the risk of preterm delivery and low birth... 

Habitrol (102), co-developed by Lohmarin Therapie Systeme and Ciba-Geigy Ltd., and marketed by Ciba-Geigy, consists of an impermeable backiag laminate with a layer of adhesive and a nonwoven pad to which a nicotine solution is appHed (103). Multiple layers of adhesive on a release liner are then laminated on the patch. The systems come ia 10, 20, and 30 cm sizes corresponding to 7, 14, and 21 mg/day, respectively, deUvered over 24 hours. 

FIGURE 52-1. This low-dose estrogen transdermal patch, available as the trade name Estraderm (Estradiol Transdermal System), is transparent and about the size of a silver dollar. It releases small amounts of estrogen directly into the bloodstream at a constant and controlled rate to a female requiring estrogen replacement therapy for postmenopausal symptoms. 

Transdermal patches are applied to the skin. The drug is mixed with the adhesive for the patch, and so it lies next to the skin. The skin can readily absorb many chemicals and so can absorb drugs such as nitroglycerin (for heart disease), morphine derivatives (for constant, severe pain), estrogen (for hormone replacement therapy), or nicotine (for easing symptoms that result when a patient stops smoking). 

In general, for smokers with cardiac disease, the benefits of nicotine replacement therapy outweigh the potential risks. In a safety and efficacy study that included veterans with cardiac disease, smoking concurrently with the nicotine patch was not associated with an increase in adverse events (Joseph et al. 1996). Although bupropion SR is generally well tolerated by smokers, it has not been adequately studied in persons with cardiac disease, and definitive conclusions regarding its safety in this patient population cannot currently be made (Society for Research on Nicotine and Tobacco 2003). 

Androgens are important for general sexual function and libido, but testosterone supplementation is only effective in patients with documented low serum testosterone levels. In patients with hypogonadism, testosterone replacement is the initial treatment of choice, as it corrects decreased libido, fatigue, muscle loss, sleep disturbances, and depressed mood. Improvements in ED may occur, but they should not be expected to occur in all patients.23 The initial trial should be for 3 months. At that time, re-evaluation and the addition of another ED therapy is warranted. Routes of administration include oral, intramuscular, topical patches or gel, and a buccal tablet. 

Nicotine is responsible for the highly addictive properties of tobacco products. Addiction occurs in 30% of those who experiment with tobacco products, and more than 80% of those who attempt to quit smoking will relapse within a year. Withdrawal from nicotine produces a syndrome characterized by nicotine craving as well as dysphoria, anxiety, irritability, restlessness and increased appetite. It is treated with nicotine replacement therapies, such as nicotine gum and patches, and/or with buproprion, a drug that is classified as an antidepressant but has multiple and complex effects in brain. Buproprion reduces craving in some smokers. Nicotine addiction has been reviewed recently at cellular and systems levels [38-41]. 

Assessment and reduction in the use of alcohol, tobacco, and other substances prior to pregnancy improve outcomes. For smoking cessation, behavioral interventions are preferred. Intermittent delivery formulations of nicotine replacement therapies are preferred over the patches. If patches are used, 16-hour patches are preferred over 24-hour patches. 

Overactive bladder Anticholinergic agentyantispas-modics Oxybulynin TDS (5.9 mg/day apply one patch twice weekly), tolterodine IR (1-2 mg twice daily), tolterodine LA (2-4 mg daily), trospium chloride (20 mg once or twice daily), solifenacin (5-10 mg daily), darifenacin (7.5-15 mg daily) Anticholinergics are first-line drug therapy (oxybulynin or tolterodine is preferred). 

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