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Purpose: The effect of peripheral arterial disease (PAD) among young and middle-aged adults can be significant, but no previous study has examined the prognosis and the associated health care cost of the disease in this population. We evaluated the clinical and economic burden of PAD in patients from a large claims database to clarify the effect of the disease on a relatively young working Japanese population. Methods: Patients aged ≥ 4 5 and ≤ 6 4 years with first PAD diagnosis between 2005 and 2011 comprised the PAD cohort (n = 362); an age- and sex-matched non-PAD comparison cohort (n = 362) was also identified. Rates of cardiovascular events/interventions, health care utilization, and costs were compared. Findings: The mean (SD) age of the cohort was 52.8 (5.6) years and 40.8% were women. Baseline Charlson comorbidity index was significantly higher in the PAD cohort than in the non-PAD cohort (1.90 [2.19] vs 1.16 [1.99]; P < 0.001). The PAD cohort had significantly higher first-year event rates than did the non-PAD cohort for myocardial infarction (2.2% vs 0.2%; P = 0.019) and ischemic stroke (4.1% vs 0.5%; P = 0.001). Health care utilization was significantly greater for the PAD cohort for all parameters assessed (number of hospitalization, inpatient days, and outpatient visits) in the first year (all, P < 0.001). Total annual costs for health care were significantly higher in the PAD cohort than in the non-PAD cohort in the first year (P < 0.001). Among patients with diabetes, patients with PAD (n = 98) had significantly greater first-year event rates (myocardial infarction, ischemic stroke, coronary artery bypass surgery, peripheral arterial revascularization, percutaneous coronary intervention, and limb amputation; all, P < 0.001), significantly greater number of clinic visits (P = 0.023), and total cost burden than did patients without PAD (n = 63). Implications: Even in a relatively young working Japanese population, PAD is associated with substantial clinical and economic burden. [ABSTRACT FROM AUTHOR]

Background: The efficacy of the smoking-cessation agent varenicline has been reported in Asian smokers; however, few studies have investigated factors that contribute to lapse and relapse. Objective: This post hoc analysis aimed to identify predictors of smoking lapse and relapse. Methods: This was a post-hoc analysis based on a double-blind, placebo-controlled, randomized, parallel- group study in which Japanese smokers (aged 20--75 years) who smoked ≥10 cigarettes/day and were motivated to quit were randomized to receive varenicline (0.25 mg twice daily [BID], 0.5 mg BID, 1 mg BID) or placebo for 12 weeks followed by a 40-week non-treatment follow-up. For inclusion in this analysis, participants must have been nicotine dependent (Tobacco Dependence Screener score ≥5) and must have successfully quit smoking continuously for 4 weeks (weeks 9--12). Lapse was defined by answering yes to ≥1 question in the Nicotine Use Inventory. Relapse was defined by participants having smoked for ≥7 days during follow-up measured by the Nicotine Use Inventory. Results: Of the 619 randomized individuals, 515 had a Tobacco Dependence Screener score of ≥5, and 277 quit smoking continuously from weeks 9 to 12. Approximately 75% were male, with a mean (SD) BMI of 23.0 (3.0) kg/m2. Maximum length of continuous abstinence (CA) during treatment and age (both P < 0.0001) were significant predictors of lapse. Maximum CA (P < 0.0001), age (P = 0.0002), Minnesota Nicotine Withdrawal Scale (MNWS) score for urge to smoke (P = 0.0019), and having made ≥1 serious quit attempt (P = 0.0063) were significant predictors of relapse. For participants with a maximum CA of 4 to 6 weeks versus those with a maximum CA of 10 to 11 weeks, the ORs for lapse and relapse were 4.649 (95% CI, 2.071--10.434) and 3.337 (95% CI, 1.538--7.239), respectively. In participants aged 21--34 years versus those aged 47--72 years, the ORs for lapse and relapse were 3.453 (95% CI 1.851, 6.441) and 3.442 (95% CI 1.795, 6.597), respectively. Participants with a MNWS urge to smoke score of 2 to 4 versus 0 had an OR for relapse of 3.175 (95% CI, 1.166--8.644). Participants having made ≥1 versus no serious quit attempts had an OR for relapse of 2.108 (95% CI, 1.168–3.805). Conclusion: Shorter maximum CA and younger age at quit attempt were associated with increased risk of lapse and relapse. Higher MNWS urge to smoke score and having made ≥1 serious quit attempt were associated with increased relapse risk. ClinicalTrials.gov identifier: NCT00139750. [ABSTRACT FROM AUTHOR]