Effectiveness of a transdermal nicotine system in smoking cessation studies.

To investigate the effectiveness and tolerability of a transdermal nicotine system (TNS) as an aid towards easing smoking cessation, two double-blind placebo-controlled randomized field studies were performed. The TNS was available in sizes of 10, 20 and 30 cm2, delivering 7, 14 and 21 mg of nicotine per 24 h. A first study was undertaken in general medical practice by a group of 21 doctors (Practitioner Study). This study involved 199 nicotine-dependent cigarette smokers of whom 100 were allocated to the nicotine group and 99 to the placebo group. The second trial was performed in 112 young people, 56 in each treatment group, at the Universities of Basle and Zurich (University Study). The placebo and the nicotine groups were comparable in both studies. Participants smoking more than 20 cigarettes a day were treated with the 30-cm2 system and the others with the 20-cm2 system. When abstinence, as verified by CO measurements, was achieved, the next smaller system was applied. In the Practitioner Study, the double-blind treatment phase lasted for 12 weeks with consultations every month and in the University Study the consultations during the 9-weeks' treatment period took place every 3 weeks. Abstainers in both studies will be followed up until 12 months after treatment was begun. After 1, 2 and 3 months of treatment 41%, 36% and 36% of the participants in the nicotine group of the Practitioner Study were abstinent. The corresponding figures in the placebo group were 19.4%, 20.4% and 22.5%. The differences were statistically significant for all three months (p = 0.001; p = 0.018 and p = 0.043). Body weight did not increase in the TNS group, but did in the placebo group (+ 4.4 kg). The craving for cigarettes and withdrawal symptoms decreased more under nicotine substitution. Abstinence rates in the University Study were initially higher with 51.8% in the nicotine group and 28.6% in the placebo group after 3 weeks of treatment, but then declined to 42.9% after 6 weeks and 39.3% after 9 weeks in the nicotine group and to 25% and 19.6%, respectively, in the placebo group. The differences between the groups were statistically significant on all 3 occasions, with p = 0.012, p = 0.046 and p = 0.023.(ABSTRACT TRUNCATED AT 250 WORDS)

Controlled trial of transdermal nicotine patch in tobacco withdrawal.

A transdermal nicotine patch, which delivers 0.7 mg/cm2 per 24 h and is available in sizes of 10, 20, and 30 cm2 was tested in subjects from 21 general medical practices in a 3-month, placebo-controlled randomised double-blind study. The nicotine group (n = 100) and the placebo group (n = 99) were similar at entry. Participants who smoked more than 20 cigarettes a day were treated with the 30 cm2 patch and the others with the 20 cm2 patch. When abstinence, defined as smoking 0-3 cigarettes per week and verified by CO measurement, was achieved, the next smallest patch was applied. After 1, 2, and 3 months of treatment 41, 36, and 36%, respectively, in the nicotine group were abstinent. The corresponding figures in the placebo group were 19, 20, and 23%. The differences were significant for all 3 months. Body weight did not increase in the nicotine group, but in the placebo group the mean increase was 4.4 kg. Craving and withdrawal symptoms decreased more with nicotine substitution for cigarettes. The patches were generally well tolerated, although 25% of subjects in the nicotine group and 13% in the placebo group had transient local erythema after application of the patch; 5 members of the nicotine group withdrew because of poor cutaneous tolerance.

Impact of smoking on heart attacks, strokes, blood pressure control, drug dose, and quality of life aspects in the International Prospective Primary Prevention Study in Hypertension.

Effects of smoking are highlighted in a posthoc analysis of this randomized, double-blind International Prospective Primary Prevention Study in Hypertension (IPPPSH). At the time of entry, 37% of the men and 23% of the women were smoking cigarettes, and only 537 patients changed their smoking status during the trial. In men and women, smoking doubled cardiac and cerebrovascular event rates. Nonsmoking men had fewer myocardial infarctions and sudden deaths when treated with oxprenolol. Smoking status did not affect in-study blood pressure control, the type of drugs, or the combinations used, but smokers were given higher doses of oxprenolol. For a given blood pressure during antihypertensive treatment, rates for cardiac and cerebrovascular events were higher in smokers. Heart rates were higher in both oxprenolol and non-beta-blocker-treated smokers. Smoking dose dependently increased hematocrit level. Among physician-elicited symptoms, dyspnea and cold extremities were more frequent in smokers, whereas dyspnea, headaches, impotence, dizziness, and anxiety states were common, with unsatisfactory blood pressure control (diastolic blood pressure greater than 95 mm Hg). Quality of life may be more jeopardized by smoking, poor blood pressure control, or diuretic use than by beta-blocker-based therapy. In the IPPPSH, the patient who smoked had double the cardiovascular complication rates without cardiac benefit from the beta-blocker despite higher doses given; the higher heart rate and hematocrit level may have been contributing factors.

Electrocardiographic changes during antihypertensive therapy in the International Prospective Primary Prevention Study in Hypertension.

In the International Prospective Primary Prevention Study in Hypertension, electrocardiographic changes before and during 3- to 5-year antihypertensive treatment were investigated in a cohort of 5819 men and women aged 40 to 64 years with entry diastolic blood pressures of 100 to 125 mm Hg. They were randomly allocated to treatment regimens that either included or excluded the slow-release beta-blocker oxprenolol. Electrocardiograms (ECGs) were assessed using the Minnesota Code and assigned to groups of normal ECGs or ECGs with pressure-related, ischemic, "intermediate," or "other" abnormalities. Antihypertensive treatment was associated with a decrease (mainly in men) of pressure-related and (mainly in women) of intermediate abnormalities. Ischemic abnormalities increased, particularly in men. Inclusion of the beta-blocker resulted in a greater reduction in intermediate abnormalities and in a lesser increase in ischemic abnormalities. Better blood pressure control was associated with a lesser increase in ischemic abnormalities and in a regression of pressure-related abnormalities. The presence of ST segment depression and of a complete left bundle branch block in the entry ECG was associated with a significant risk for sudden death and myocardial infarction. Optimal blood pressure control prevents pressure-induced cardiac target organ damage and, hence, heart failure, and may delay the progression of ischemic abnormalities. This tallies with the lower critical cardiac event rate associated with lower blood pressure that was observed in the same study.

The influence of age, year of birth, and date on mortality from malignant melanoma in the populations of England and Wales, Canada, and the white population of the United States.

The age-adjusted death rates from malignant melanoma of the skin have increased from 1951 to 1975 by about 3% per year in the populations of England and Wales, Canada, and the white population of the US. This is due to large increases in risk of successively later born cohorts. Any effects of earlier diagnosis of improved treatment within the period 1951--1975 have been sufficiently steady to fail to alter these trends. The slope of the log rates with log age is about 3.5. Projections of rates for at least the next decade can be made with some confidence, and provide a basis for evaluating control measures.