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Targeting heavy smokers in general practice: randomised controlled trial of transdermal nicotine patches.

OBJECTIVES: (a) To evaluate the efficacy of transdermal nicotine patches as an aid to stopping smoking when used as an adjunct to brief advice and support in a general practice setting; (b) to see whether an increase in nicotine patch dosage enhances the rate of initial cessation. DESIGN: Randomised double blind placebo controlled parallel group study with one year of follow up. SETTING: 30 general practices in 15 English counties. SUBJECTS: 600 dependent heavy smokers (> or = 15 cigarettes daily) who were well motivated to give up. INTERVENTIONS: Brief general practitioner advice, booklet, and 16 hours per day patch treatment for 18 weeks with brief support and follow up at one, three, six, 12, 26, and 52 weeks. MAIN OUTCOME MEASURES: Self reported complete abstinence for up to one year with biochemical validation at all follow up points. RESULTS: Nicotine patches reduced the severity of craving and adverse mood changes in the first weeks of withdrawal and doubled the rate of initial cessation at week 3 (nicotine group 36% of patients (144/400), placebo group 16.5% of patients (33/200)) and of continuous abstinence throughout one year (nicotine group 9.3% (37), placebo group 5.0% (10)). A dose increase at week 1 among patients experiencing difficulty in quitting increased the proportion who achieved abstinence at week 3. There were no adverse systemic effects attributable to nicotine, but the incidence of moderate or severe local irritation or itching at the patch site was 16.4% (63 patients), compared with 3.8% (seven) with placebo. CONCLUSION: Transdermal nicotine patches used as an adjunct to brief advice and support in a general practice setting are an effective aid to long term cessation of smoking in highly dependent smokers.

Administration, Cutaneous↗

Efficacy on climacteric symptoms and safety of low dose estradiol transdermal matrix patches. A randomized, double-blind placebo-controlled study.

Two estradiol (E2) transdermal patches releasing 25 micrograms/day E2 (D-25) or 37.5 micrograms/day E2 (D-37.5) were compared to a placebo patch on 156 patients in natural or surgical menopause suffering from at least 5 hot flushes per day, randomly and blindly assigned to three parallel groups of 52 patients each, to be treated continuously for 12 weeks, without progestin opposition. "Responders" (patients with less than 3 hot flushes per day at the end of treatment), were 82% and 90% under D-25 or D-37.5, respectively, both significantly (p < 0.001) more than under placebo (44%). Comparable efficacy was observed on severity of hot flushes, Kupperman Index and on the self-rated efficacy. Systemic adverse events occurred in 10%, 10% and 8% of patients, respectively, under D-25, D-37.5 or placebo. Occasional mild and transient itching and/or erythema on the site of application was reported by few patients and did never require discontinuation of application. In conclusion D-25 and D-37.5 were significantly more effective than placebo in relieving climacteric symptoms and were systemically and locally as well tolerated as placebo. D-25 (Demestril 25) releasing 25 micrograms/day E2 can therefore be recommended for low-dosed estrogen replacement therapy.

Administration, Cutaneous↗

The prescription of transdermal nicotine patches for tobacco-using dental patients: current status in Indiana.

As Indiana dentists become involved in office-based smoking cessation efforts, they can prescribe the recently-developed Federal Drug Administration (FDA)-approved nicotine transdermal patch delivery systems for their smoking patients who wish to overcome nicotine addiction. This article reviews the evolutionary and scientific development of transdermal nicotine patch systems within an oral health setting. It discusses dental office-based cessation programs which have been designed by faculty members at the Indiana University School of Dentistry and by dentists who work with the National Cancer Institute. Finally, it presents the rationale for patch usage and specific techniques which are utilized in prescribing and monitoring this medication.

Administration, Cutaneous↗

Efficacy, safety and acceptability of a seven-day, transdermal estradiol patch for estrogen replacement therapy.

OBJECTIVES: To evaluate the efficacy, safety and acceptability of a seven-day, transdermal estradiol patch, in the treatment of menopausal symptoms. DESIGN: Open-label trial. SETTING: Hat Yai Regional Hospital, Thailand. SUBJECTS: Hysterectomized women with surgical or natural menopause. METHOD: The clients received a 12.5 cm2 matrix patch, containing 3.9 mg of estradiol delivering 0.05 mg/day, once a week for six months. The efficacy, safety, and acceptability were evaluated at the end of 1-, 3- and 6-months. RESULTS: Six-month responses were analyzed among 50 enrolled patients. The mean estradiol level/Follicle Stimulating Hormone/Lutienizing Hormone were 27.88/70.03/31.19, 44.08/53.37/26.86, and 42.43/48.53/24.39 pg/ml, mIU/L, mIU/L at admission, 1- and 3-months, respectively. The average climacteric score was 27.18, 16.60, 12.78, and 12.18 at admission, 1-, 3- and 6-month, respectively. At least 94 per cent of patches were not dislodged more than one quarter. The most common skin irritation was itching, followed by erythema, vesicle, and burning sensation. The patches were generally well tolerated, and acceptability was satisfactory. CONCLUSION: Transdermal estradiol patch effectively reduced the severity of menopausal symptoms, measured by modified climacteric score. Adhesion was found to be excellent. In actual clinical practice, the transdermal patch should be appropriately introduced to tolerant users.

Adult↗

Analgesic effect of the transdermal fentanyl patch during and after feline ovariohysterectomy.

OBJECTIVE: To evaluate the efficacy of the transdermal fentanyl patch in relieving perioperative pain and stress associated with ovariohysterectomy in cats. STUDY DESIGN: Prospective laboratory trial. ANIMALS: Twenty-four female, purpose-bred cats. METHODS: Each cat was randomly assigned to groups 1-3. Group 1 received a 25-microg/h transdermal fentanyl patch only. Group 2 received the patch and anesthesia. Group 3 received anesthesia only. Patches were left in place for 72 hours. Rectal temperature, heart rate, respiratory rate, indirect blood pressure, blood glucose, serum cortisol concentration, plasma fentanyl concentration, pain score, and excitement/sedation score were monitored at prescribed intervals over an 81-hour period. Cats from groups 1-3 were reassigned to groups 4 and 5. Group 4 received the patch, anesthesia, and an ovariohysterectomy. Group 5 received anesthesia and an ovariohysterectomy only. The study period and monitored parameters were the same as for groups 1-3. RESULTS: Serum cortisol concentrations were significantly lower in group 4 than group 5 during the surgical and early postsurgical time periods. A similar effect was noted in blood glucose concentrations during the surgical period. Rectal temperature was significantly higher in group 2 when comparing all anesthetized groups during the early postsurgical period. Pain scores were significantly higher in groups 4 and 5 than in groups 2 and 3 during the early postsurgical period. There was no significant difference in pain scores between groups 4 and 5 during this period, however. CONCLUSIONS: The transdermal fentanyl patch affects biochemical markers of perioperative pain and stress associated with ovariohysterectomy in cats, attenuating rises in serum cortisol and blood glucose concentrations during the surgical and early postsurgical periods. CLINICAL RELEVANCE: The transdermal fentanyl patch is effective in alleviating perioperative pain and stress associated with ovariohysterectomy in cats as evidenced by attenuated rises in cortisol and blood glucose concentrations in cats that were operated on and treated with the patch.

Administration, Cutaneous↗

Self-poisoning among adults using multiple transdermal nicotine patches.

OBJECTIVE: To investigate the characteristics and outcomes of poisoning cases involving the dermal application of multiple transdermal nicotine patches. DESIGN: Case series; prospective postmarketing surveillance over a 24 month period. SETTING: Telephone reports from 34 participating US poison centers. PATIENTS: Human poisonings involving more than one transdermal nicotine patch applied simultaneously. RESULTS: Nine cases of dermal exposure to 2-20 transdermal nicotine patches were reported. Cases resulted from either intentional misuse or suicide attempts and included concomitant exposure to other drugs in 7 of 9 cases. Mean age was 45 years; seven of nine patients were female. All suffered medical complications including seizures (3 subjects), other central nervous system changes (8 subjects), cardiovascular effects (6 subjects), and respiratory failure (4 subjects). Eight patients were hospitalized; all recovered. Plasma nicotine/cotinine concentrations did not correlate with the severity of illness. CONCLUSIONS: This case series demonstrated that simultaneous application of several transdermal nicotine patches can be implicated in adult suicide attempts. While signs of toxicity included gastrointestinal complaints, changes in level of consciousness, seizures and parasympathetic effects typical of nicotine poisoning, the frequent presence of co-intoxicants complicated the clinical course. As the accessibility of transdermal nicotine patches increases, increasing misuse of these products by suicidal adults is likely.

Administration, Cutaneous↗

Efficacy of transdermal nitroglycerin patches evaluated by dipyridamole-induced myocardial ischemia in patients with coronary artery disease. Comparison between continuous and intermittent schedule.

Nitrate tolerance remains a problem despite an enormous number of studies on this phenomenon. The aim of the present study was to compare the efficacy of nitroglycerin transdermal patches intermittently or continuously administered to patients with myocardial ischemia evaluated by the echocardiography dipyridamole stress test. We prospectively studied 34 coronary patients with stable myocardial ischemia. A double-blind, randomized, crossover study technique was used. After a run-in period (1 week) they underwent a dipyridamole stress test to evaluate nitrate responsiveness and then were randomized to 1 week of transdermal nitroglycerine 20 mg/24 h (two patches of 10 mg/24) administered either intermittently or continuously for 1 week. During the following week all patients were given placebo. In the final week, therapy was crossed over the alternate regimen. No significant changes in heart rate, systolic and diastolic blood pressure and rate-pressure product were observed at basal conditions and at peak of dipyridamole infusion among patients after placebo run-in period, after acute, 1 week of intermittent and 1 week of continuous nitroglycerine administration. At peak of dipyridamole infusion after acute administration of nitrate we observed a significant decrease in wall motion score index with respect to placebo. This pattern was similar during intermittent, but not continuous, patch therapy (p < 0.001). Our results suggest that transdermal nitroglycerin patches are an effective anti-ischemic medication, in reducing transient myocardial ischemia induced by dipyridamole. This anti-ischemic effect is lost when an overnight nitrate free dose interval is not used. Moreover the dipyridamole echocardiographic stress test, besides evaluating myocardial ischemia-induced wall motion abnormalities, is adequate to assess both the efficacy and the tolerance of transdermal nitrate therapy.

Administration, Cutaneous↗

Hemodynamic effects of transdermal nitroglycerin patches in patients with acute myocardial infarction.

Transdermal nitroglycerin patches are used mainly in the therapy of angina pectoris. However, the magnitude and duration of their effects are still controversial. In this study, transdermal discs with nitroglycerin were given to 14 patients with acute myocardial infarction (AMI) and mild hemodynamic impairment. Seven patients received Nitroderm TTS, and seven patients Deponit 5 (in this case 2 patches), the nitroglycerin dose being 10 mg. Hemodynamic measurements were made 19-24 h after application of the patch and 1 h after its removal. Comparing with the values obtained 1 h after removal of the patch, 19-24 h after the application of the patch heart rate was significantly higher (90.2 +/- 3.8 vs. 85.6 +/- 4.0 min-1; p less than 0.01), mean right atrial pressure was significantly lower (10.8 +/- 1.0 vs. 12.7 +/- 1.3 mm Hg; p less than 0.01), and so were the pulmonary artery pressure: systolic (36.9 +/- 3.0 vs. 43.0 +/- 3.1 mm Hg; p less than 0.001), mean (26.8 +/- 2.1 vs. 31.4 +/- 2.0 mm Hg; p less than 0.001) and the capillary wedge pressure (19.2 +/- 1.8 vs. 23.0 +/- 1.9 mm Hg; p less than 0.01). These findings revealed that in patients with AMI hemodynamic effects persist for at least 19 h after single application of a nitroglycerin patch of 10 mg. The therapy is safe and the risk of side effects is small.

Administration, Cutaneous↗

An evaluation of the use of the transdermal contraceptive patch in adolescents.

PURPOSE: To evaluate the acceptability and feasibility of using the new transdermal contraceptive patch in adolescents. METHODS: A 3-month longitudinal trial using the Ortho Evra transdermal contraceptive patch in 50 adolescent girls. All healthy girls aged 15-18 years were invited to participate from two San Francisco Bay Area teen clinics. Participants were followed after 1 month and 3 months of treatment. Data were collected on patch detachments, perceived advantages and disadvantages, side effects, and compliance. Data were analyzed using Student's t-test (SPSS). RESULTS: Forty participants (80%) completed 1 month of treatment and 31 (62%) completed all 3 months of the study. There were no pregnancies during treatment. At the 3-month follow-up, 87.1% of participants reported perfect compliance. Ease of use, the fact that it does not require daily attention, and the ease of concealment were among the main reported advantages. Roughly 77% of participants who completed the study were planning to continue using the patch. The 35.5% rate of complete or partial detachment of at least one patch was considerably higher than reported in previous studies of adults. As in adults, the most commonly reported complaints were application site reactions and breast discomfort. CONCLUSIONS: This evaluation found an overall positive impression of the new transdermal contraceptive patch, with good rates of short-term compliance and few side effects among adolescents. However, the high degree of detachment unique to this sample of adolescents is concerning and requires further evaluation.

Administration, Cutaneous↗

Clinical and pharmacokinetic properties of a transdermal nicotine patch.

We examined the pharmacokinetics of a transdermal nicotine patch and evaluated the usefulness of such a patch in a pilot smoking-cessation program. Use of the patch was associated with plasma nicotine concentrations that were comparable to smoking or to the use of other smoking-cessation devices. However, these plasma concentrations were maintained for 24 hours, and the patch appeared to be suitable for use once a day. Its use in a 6-week placebo-controlled double-blind study resulted in a significant degree of smoking cessation or in reduction of smoking activity. The findings suggest that it may be valuable to extend investigations to a larger population and that transdermal nicotine may have a useful role in smoking-cessation therapy.

Administration, Cutaneous↗

The impact of advertising on nicotine replacement therapy demand.

While much is known about the economic determinants of tobacco use, very little is known about the economic determinants of nicotine replacement therapy (NRT) use. This paper is the first econometric study to examine the impact of advertising on NRT demand. Pooled cross-sectional time-series scanner-based data for 50 major metropolitan markets in the USA covering the period between the second quarter of 1996 and the second quarter of 2002 are used in the analysis. Fixed-effects modeling is employed to estimate the NRT demand equation. The estimates indicate that increased advertising of Nicoderm CQ transdermal patches and Nicotrol transdermal patches increases per-capita sales of established Nicoderm CQ and Nicotrol products, respectively. However, increased advertising of Nicorette polacrilex (gum) was found not to significantly increase sales of established Nicorette products. Moreover, decreases in the price of NRT and increases in the price of cigarettes were found to increase per-capita sales of NRT products. Given the documented efficacy of NRT, measures to increase peoples' awareness of NRT products through advertising, measures to decrease the price of NRT, and measures to increase the price of cigarettes would be effective means to increase the use of NRT, likely leading to decreased cigarette smoking and reductions in the future public health burden caused by tobacco use.

Administration, Cutaneous↗

Transdermal nicotine maintenance attenuates the subjective and reinforcing effects of intravenous nicotine, but not cocaine or caffeine, in cigarette-smoking stimulant abusers.

The effects of transdermal nicotine maintenance on the subjective, reinforcing, and cardiovascular effects of intravenously administered cocaine, caffeine, and nicotine were examined using double-blind procedures in nine volunteers with histories of using tobacco, caffeine, and cocaine. Each participant was exposed to two chronic drug maintenance phases (21 mg/day nicotine transdermal patch and placebo transdermal patch). Within each drug phase, the participant received intravenous injections of placebo, cocaine (15 and 30 mg/70 kg), caffeine (200 and 400 mg/70 kg), and nicotine (1.0 and 2.0 mg/70 kg) in mixed order across days. Subjective and cardiovascular data were collected before and repeatedly after drug or placebo injection. Reinforcing effects were also assessed after each injection with a Drug vs Money Multiple-Choice Form. Intravenous cocaine produced robust dose-related increases in subjective and reinforcing effects; these effects were not altered by nicotine maintenance. Intravenous caffeine produced elevations on several subjective ratings; nicotine maintenance did not affect these ratings. Under the placebo maintenance condition, intravenous nicotine produced robust dose-related subjective effects, with maximal increases similar to the high dose of cocaine; nicotine maintenance significantly decreased the subjective and reinforcing effects of intravenous nicotine. The results of the present study demonstrate that chronic nicotine maintenance produces tolerance to the effects of intravenous nicotine, but does not affect the subjective or reinforcing effects of cocaine or caffeine.

Administration, Cutaneous↗

Comparison of plasma fentanyl concentrations by using three transdermal fentanyl patch sizes in dogs.

OBJECTIVE: To compare plasma fentanyl concentrations attained after the application of three transdermal fentanyl patch sizes (50, 75, and 100 micrograms/hour) in dogs. DESIGN: Repeated Latin square controlled study. ANIMALS: Six intact, mixed-breed adult dogs (2 males, 4 females) weighing 19.9 +/- 3.4 kg. METHODS: Each dog was randomly assigned to receive each of three treatments: 50 (P50), 75 (P75), or 100 (P100) micrograms/hour transdermal patches. Patches were left in place for 72 hours. Jugular venous blood was collected at 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours after patch application and for 1, 2, 4, 8, and 12 hours after patch removal. Plasma fentanyl concentrations were measured using a radioimmunoassay technique. After a 96-hour washout period, each dog was moved to another treatment group and received a different patch size. RESULTS: The following results were obtained (mean +/- SD): average plasma fentanyl concentration from 24 to 72 hours, 0.7 +/- 0.2 ng/mL (P50), 1.4 +/- 0.5 ng/mL (P75), 1.2 +/- 0.5 ng/mL (P100); the total area under the concentration versus time curve (0 hours to infinity), 46 +/- 12.2 ng/h/mL (P50), 101.2 +/- 41.4 ng/h/mL (P75), 80.4 +/- 38.3 ng/h/mL (P100); and the apparent elimination half-life, 3.6 +/- 1.2 hours (P50), 3.4 +/- 2.7 hours (P75), and 2.5 +/- 2.0 hours (P100). There was a high degree of variability in plasma fentanyl concentrations achieved. Plasma fentanyl concentrations declined rapidly after patch removal. CONCLUSIONS: The attainment of steady-state plasma concentrations takes up to 24 hours, and there is a great deal of variability in the final concentrations reached in different individuals. In this study, the 100 micrograms/hour patches did not provide statistically increased plasma concentrations when compared with the 50 micrograms/hour patches. CLINICAL RELEVANCE: Because of the interindividual and intraindividual variation in plasma fentanyl concentrations, patches should be applied 24 hours before the anticipated time that analgesia will be required. Adequacy of analgesia and potentially deleterious side effects, such as sedation and respiratory depression, should be monitored while the patches are in place. Skin reactions may occur, and the patches should be removed if such skin irritation is seen. After the patch is removed, it is expected that analgesia will wane rapidly because of the brief elimination half-life.

Administration, Cutaneous↗

Pharmacokinetics of estradiol and of estrone during repeated transdermal or oral administration of estradiol.

The estradiol (CAS 50-28-2, E2) and estrone (CAS 53-16-7, E1) concentrations in blood were investigated during a 3-week twice weekly application of an E2 transdermal patch, or daily oral administration of E2 tablets. The transdermal patch (Dermestril 50, hereinafter called "Patch") contains 4 mg E2 and delivers daily 50 micrograms E2. The E2 tablets (hereinafter called "Tablet") contains 2 mg micronized E2. The study was performed on 32 healthy postmenopausal women randomly assigned to two parallel groups, each of 16 subjects, one treated with Patch and the other with Tablet. During the first transdermal Patch application, E2 reached effective concentrations of 30 pg/ml of more 12 h after application. During the following 5 applications the concentrations of E2 remained rather constant (fluctuation = 0.65). The study state was reached with the second Patch, with an average concentration (Cav) of 35 pg/ml. After removal of the last Patch, the E2 concentrations returned to the basal levels within 12 h. The E1 concentrations reached the maximum concentration (Cmax) of 48 pg/ml 41 h after the first Patch application and then remained rather constant (fluctuation = 0.28), with a Cav at steady state of 47 pg/ml. During the oral administration of the first Tablet, E2 reached the peak of 1084 pg/ml 49 min after administration and then decreased rapidly in the following 3 h. There was a progressive cumulation of E2 until steady state, which was reached after the 5th Tablets with a Cav of 418 pg/ml i.e. 12.0 times greater than during Patch, and very large pulses of E2 (fluctuation = 3.68). The E1 concentrations reached the peak of 334 pg/ml 4.28 h after the first administration. The steady was reached with the 14th daily administration. There were Large pulses of E1 (fluctuation = 1.15). The Cav was 441 pg/ml, i.e. 9.4 times greater than during Patch. In conclusion the twice weekly application of the transdermal Patch elicits rather constant and therapeutically effective blood concentrations of E2 and E1. In contrast, the daily oral administration of E2 Tablets elicits large pulses of E2 and E1, and exposes the subjects to high concentrations of E2 and of E1, which are 12.0 and 9.4 times greater, respectively, than those elicited by the Patch. Both treatments were fairly well tolerated, and no withdrawal of the medications during the study was necessary.

Administration, Cutaneous↗

Thrombophilia and lipid profile in post-menopausal women using a new transdermal oestradiol patch.

OBJECTIVE: To assess the changes, over a 6-month period, in serum lipoproteins, apoproteins and coagulation factors, induced in post-menopausal women treated by a new transdermal oestradiol patch. METHODS: Fifty-three hysterectomised, healthy, post-menopausal women were treated by a new transdermal patch designed to deliver 50 micrograms of 17 beta oestradiol per day (Gynaderm, Shire Developments). One patch was applied twice weekly. RESULTS: Forty-two patients completed the study. There was no significant change in the level of total cholesterol, triglycerides, HDL or LDL. There was a significant rise in the level of ApoAI after 3 months on therapy but this was not sustained after 6 months; there was also a significant drop in the level of ApoAII after 6 months on treatment. The changes in ApoB and Lp(a) were not statistically significant. There was a significant drop in the level of antithrombin III and of protein S, and a significant rise in factor VII. The drop in the level of fibrinogen and of protein C were not statistically significant. CONCLUSION: The transdermal route of oestradiol administration causes minimal changes in lipoprotein metabolism. The statistically significant changes in the thrombophilia profile parallel those observed with oral HRT, but, similarly, may not reflect clinical significance. The potential of transdermal oestrogens as cardioprotective agents is yet to be determined.

Administration, Cutaneous↗

The transdermal contraceptive patch: a new approach to hormonal contraception.

The transdermal contraceptive patch delivers ethinyl estradiol and norelgestromin (17-deacetylnorgestimate) at a rate over seven days that results in efficacy paralleling that achieved with oral contraceptives. Due to the pharmacokinetics of the system, adequate steroid levels are maintained for two days beyond the recommended duration of use of an individual patch, with resulting maintenance of efficacy. With perfect use, the failure rate is 0.70 pregnancies per 100 woman-years and for typical use, the rate is 0.88 pregnancies per 100 woman-years. Body weight above 90 kilograms (198 pounds) is associated with lower efficacy. Cycle control is similar to that achieved by oral contraceptives. With the exception of a transient increase in breast tenderness, the side effect profile is similar to that noted by oral contraceptive users. A major advantage of this method compared to oral contraceptives is a nearly 90% perfect adherence to the dosing schedule across all age groups. Partial or total detachment of the patch occurs at an overall rate of 3.8%. This rate is not affected by warm humid climates, vigorous exercise, or exposure to saunas or water baths.

Adhesiveness↗

Some issues concerning transdermal nitroglycerin patches.

There is sufficient evidence to suggest that the duration of action of transdermal nitroglycerin patches is between 20 and 26 hours, as measured by exercise testing. At 24 hours there may be some patient variability, particularly with lower doses; however, the majority of patients show an increase in exercise time at 24 hours. In studies of the same patients, higher doses of transdermal nitroglycerin resulted in greater increases in exercise time, suggesting that higher doses may be more effective and that titration to higher doses is desirable. However, there is insufficient information from the chronic studies reported in the literature to draw any definitive conclusions. In the only crossover comparative studies reported in the literature to date, transdermal nitroglycerin appears to be as effective as isosorbide dinitrate and nifedipine. While transdermal nitroglycerin patches appear to be an effective mode of therapy, further studies are needed to confirm these findings.

Administration, Topical↗

Transdermal nicotine patch enhances type I collagen synthesis in abstinent smokers.

Cigarette smokers deposit less collagen, expressed as hydroxyproline, in granulation tissue than nonsmokers. We studied the effect of abstinence from smoking and transdermal nicotine patches on deposition of hydroxyproline, proline, type I procollagen, and total proteins. Fifty-four healthy smokers were studied during 10 days of smoking and again from days 10 to 20 following smoking cessation. After the first 10 days of abstinence they were randomized to double-blind treatment with transdermal nicotine patches of 25 mg/day or placebo for a period of 10 days. During this period and during smoking, an expanded polytetrafluoroethylene tube was implanted into the subcutis. Following removal of the implant, total amino acids and peptides were extracted. Hydroxyproline and proline were analyzed by high-pressure liquid chromatography, type I procollagen was analyzed by enzyme-linked immunoassay, and total proteins were determined colorimetrically. In the 39 subjects who complied with the study protocol, abstinence from smoking did not affect the deposition of hydroxyproline, proline, type I procollagen, or total protein in the implants. During abstinence, the type I procollagen level increased by 18% in the transdermal nicotine patches group and decreased by 10% in the placebo group (p<0.05). We conclude that 20 days of abstinence from smoking does not affect collagen deposition in granulation tissue. However, in abstinent smokers, transdermal nicotine patches appears to increase type I collagen synthesis.

Administration, Cutaneous↗