Nicotine patch therapy in adolescent smokers
Smith, T.A.; House, R.F.; Croghan, I.T.; Gauvin, T.R.; Colligan, R.C.; Offord, K.P.; Gomez-Dahl, L.C.; Hurt, R.D.
Pediatrics 98(4 Part 1): 659-667
1996
ISSN/ISBN: 0031-4005 PMID: 8885941 Document Number: 463820
The "Report of the Second Task Force on Blood Pressure Control in Children-1987" developed normative blood pressure (BP) data for children and adolescents. These normative data are used to classify BP levels. Since 1987, additional BP data in children and adolescents, the use of newer classes of drugs, and the role of primary prevention of hypertension have expanded the body of knowledge regarding the classification and treatment of hypertension in the young. To report new normative BP data in children and adolescents and to provide additional information regarding the diagnosis, treatment, and prevention of hypertension in children. A working group was appointed by the director of the National Heart, Lung, and Blood Institute as chair of the National High Blood Pressure Education Program (NHBPEP) Coordinating Committee. Data on children from the 1988 through 1991 National Health and Nutrition Examination Survey III and nine additional national data sets were combined to develop normative BP tables. The working group members produced initial draft documents that were reviewed by NHBPEP Coordinating Committee representatives as well as experts in pediatrics, cardiology, and hypertension. This reiterative process occurred for 12 draft documents. The NHBPEP Coordinating Committee discussed the report, and additional comments were received. Differences of opinion were adjudicated by the chair of the working group. The final report was sent to representatives of the 44 organizations on the NHBPEP Coordinating Committee for vote. It was approved unanimously by the NHBPEP Coordinating Committee on October 2, 1995. This report provides new normative BP tables for children and adolescents, which now include height percentiles, age, and gender. The fifth Korotkoff sound is now used to define diastolic BP in children and adolescents. New charts have been developed to guide practicing clinicians in antihypertensive drug therapy selection. The primary prevention of hypertension in these age groups is discussed. A statement on public health considerations in the treatment of children and adolescents is provided. To evaluate the safety, tolerance, and efficacy of 24-hour nicotine patch therapy in adolescent smokers who were trying to stop smoking. Nonrandomized, open-label, 6-month clinical trial. Five public high schools in the Rochester, MN, area. Twenty-two adolescent smokers, aged 13 through 17 years, with current smoking rate of 20 or more cigarettes per day (cpd). Daily nicotine patch therapy for 8 weeks (22 mg/d for 6 weeks followed by 11 mg/d for 2 weeks). Weekly individual behavioral counseling and group support continued for 8 weeks with follow up visits at 3 and 6 months and a mailed survey at 1 year. Self-reported smoking abstinence verified by expired air carbon monoxide of 8 ppm or less, nicotine withdrawal symptoms, adverse experiences, and blood cotinine levels. Subjects had a mean +/- SD smoking rate of 23.3 +/- 5.0 (range, 20 to 35) cpd at study entry and 2.6 +/- 1.6 years of smoking; the mean age was 15.9 +/- 1.2 (range 13 through 17) years, and 68% were girls. Of the 22 participants, 19 (86%) completed patch therapy, 3 (14%) had biochemically validated smoking cessation at week 8, and 1 continued to be smoke free at 3 and 6 months after patch initiation. There was a significant decrease from baseline in the mean nicotine withdrawal scores for days 4 and 7 of week 1 and the mean for weeks 2 through 8. Skin reactions were the most common adverse event. As the worst skin reactions, 55% had erythema only, 5% had erythema and edema, and 9% had erythema and vesicles, whereas 32% had no skin reactions. Other reported adverse events were headaches (41%), nausea and vomiting (41%), tiredness (41%), dizziness (27%), and arm pain (23%). None of these were considered serious, life threatening, or led to the discontinuation of patch therapy. In adults with comparable smoking rates, we found that the adolescents had lower blood cotinine levels. Those smoking 20 to 25 cpd had cotinine levels of 146 +/- 84 (adolescents) vs 260 +/- 98 (adults) ng/ml, and those smoking 26 to 35 cpd had levels of 169 +/- 73 vs 276 +/- 110 ng/ml, respectively. Nicotine patch therapy seems safe in adolescent smokers. Placebo-controlled trials are needed to establish the efficacy of nicotine patch therapy in adolescents.