BACKGROUNDA trial involving adults 50 years of age or older showed that the herpes zoster subunit vaccine (HZ/su) containing recombinant varicella-zoster virus glycoprotein E and the AS01 B adjuvant system was associated with a risk of herpes zoster that was 97.2% lower than that associated with placebo. A second trial was performed concurrently at the same sites and examined the safety and efficacy of HZ/su in adults 70 years of age or older . METHODSThis randomized, placebo-controlled, phase 3 trial was conducted in 18 countries and involved adults 70 years of age or older. Participants received two doses of HZ/su or placebo (assigned in a 1:1 ratio) administered intramuscularly 2 months apart. Vaccine efficacy against herpes zoster and postherpetic neuralgia was assessed in participants from ZOE-70 and in participants pooled from ZOE-70 and ZOE-50. RESULTSIn ZOE-70, 13,900 participants who could be evaluated (mean age, 75.6 years) received either HZ/su (6950 participants) or placebo (6950 participants). During a mean follow-up period of 3.7 years, herpes zoster occurred in 23 HZ/su recipients and in 223 placebo recipients (0.9 vs. 9.2 per 1000 person-years). Vaccine efficacy against herpes zoster was 89.8% (95% confidence interval [CI], 84.2 to 93.7; P<0.001) and was similar in participants 70 to 79 years of age (90.0%) and participants 80 years of age or older (89.1%). In pooled analyses of data from participants 70 years of age or older in ZOE-50 and ZOE-70 (16,596 participants), vaccine efficacy against herpes zoster was 91.3% (95% CI, 86.8 to 94.5; P<0.001), and vaccine efficacy against postherpetic neuralgia was 88.8% (95% CI, 68.7 to 97.1; P<0.001). Solicited reports of injection-site and systemic reactions within 7 days after injection were more frequent among HZ/su recipients than among placebo recipients (79.0% vs. 29.5%). Serious adverse events, potential immune-mediated diseases, and deaths occurred with similar frequencies in the two study groups. CONCLUSIONSIn our trial, HZ/su was found to reduce the risks of herpes zoster and postherpetic neuralgia among adults 70 years of age or older. ( 1020T h e ne w e ngl a nd jou r na l o f m e dicine H erpes zoster, or shingles, results from the reactivation of latent varicellazoster virus (VZV) and typically manifests as a vesicular, painful dermatomal rash.

Clinicaltrials.gov registry number: NCT00296829.

RZV reduced the HZ burden of illness significantly, particularly due to its very high VE in preventing HZ. For breakthrough HZ cases, the results suggest that RZV mitigated severity of HZ-related pain, burden of interference with ADLs and recipients' utility loss.

Pharyngitis (sore throat) is usually caused by viral infections; therefore, antibiotics are generally not warranted. Flurbiprofen 8.75 mg spray (maximum five doses/day, for three days) provides effective symptomatic relief. ABSTRACTBackground: Viral infections cause most cases of pharyngitis (sore throat); consequently, antibiotics are generally not warranted. However, a treatment targeting pain and inflammation, e.g. a topical non-steroidal anti-inflammatory spray, may be helpful for patients. Objective: To evaluate the efficacy and safety of flurbiprofen 8.75 mg spray. Methods: This randomised, double-blind, parallel group study was conducted at six communitybased clinical research centres in Australia and two in New Zealand. Adults with sore throat due to upper respiratory tract infection (onset four days) took one dose of flurbiprofen (n ¼ 249) or placebo spray (n ¼ 256); after six hours, they could re-dose every three-six hours as required, for three days (max. five doses/day). The primary endpoint was the area under the change from baseline curve in throat soreness from zero-two hours (AUC 0-2h ). The change from baseline in other sore throat symptoms also assessed efficacy. Results: The mean AUC 0-2h for throat soreness was significantly greater with flurbiprofen spray (À1.82; 95% CI: À1.98 to 1.65) compared with placebo (À1.13; 95% CI: À1.27 to 0.99) (P < 0.0001). Significantly greater reductions from baseline were observed with flurbiprofen spray compared with placebo from the first time-points assessed (five minutes for throat soreness/difficulty swallowing, 20 minutes for sore throat pain intensity and 30 minutes for swollen throat) for up to six hours (P < 0.05 for all). There was no significant difference in adverse events between treatment groups during the three-day study. Conclusion: Flurbiprofen spray provides rapid and long-lasting relief from sore throat symptoms, and is well-tolerated over three days.

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ObjectiveThis study evaluates the impact of a number of demographic, biological, behavioural and lifestyle health risk factors on the incidence of hypertension in Thailand over a 4-year period.DesignA 4-year prospective study of health risk factors and their effects on the incidence of hypertension in a national Thai Cohort Study from 2005 to 2009.SettingAs Thailand is transitioning from a developing to a middle-income developed country, chronic diseases (particularly cardiovascular disease) have emerged as major health issues. Hypertension is a major risk factor for heart attack and stroke and cross-sectional studies have indicated that the prevalence is increasing.Study participantsA total of 57 558 Sukhothai Thammathirat Open University students who participated in both the 2005 and 2009 questionnaire surveys and who were normotensive in 2005 were included in the analysis.MeasuresAdjusted relative risks associating each risk factor and incidence of hypertension by sex, after controlling for confounders such as age, socioeconomic status, body mass index (BMI) and underlying diseases.ResultsThe overall 4-year incidence of hypertension was 3.5%, with the rate in men being remarkably higher than that in women (5.2% vs 2.1%). In both sexes, hypertension was associated with age, higher BMI and comorbidities but not with income and education. In men, hypertension was associated with physical inactivity, smoking, alcohol and fast food intake. In women, hypertension was related to having a partner.ConclusionsIn both men and women, hypertension was strongly associated with age, obesity and comorbidities while it had no association with socioeconomic factors. The cohort patterns of socioeconomy and hypertension reflect that the health risk transition in Thais is likely to be at the middle stage. Diet and lifestyle factors associate with incidence of hypertension in Thais and may be amenable targets for hypertension control programmes.

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Background:Surveys for chronic diseases, and large epidemiological studies of their determinants, often acquire data through self-report since it is feasible and efficient. We examined validity and associations of self-reported hypertension, as verified by physician telephone interview among participants in a large ongoing Thai Cohort Study (TCS).Methods:The TCS investigates the health-risk transition among distance learning Open University students living all over Thailand. It began in 2005 and at 4-year follow-up, 60 569 self-reported having or not having doctor diagnosed hypertension. Two hundred and forty participants were randomly selected from each of the “hypertension” and “normotension” self-report groups. A Thai physician conducted a structured telephone interview with the sampled participants and classified them as having hypertension or normotension. The sensitivity, specificity, positive and negative predictive value (PPV and NPV) and overall accuracy of self-report were calculated.Results:The sensitivity of self-reported hypertension was 82.4% and the specificity was 70.7%. As true prevalence was simulated to vary from 1% to 50% the overall accuracy of self-report varied little from 71% to 75%. High sensitivity and negative predictive value related to female gender, younger age (≤40 years), higher education attainment and not visiting a physician in the last 12 months. High specificity and positive predictive value related to female gender, older age, higher education attainment and visiting a doctor in the previous year.Conclusion:Self-report of hypertension had high sensitivity and good overall accuracy. This is acceptable for use in large studies of hypertension, and for estimating its population prevalence to help formulate health policy in Thailand.