Current status and characteristics of hypertension treatment by primary physicians in Korea: data from Korean epidemiology study on hypertension (KEY study).

BACKGROUND: This study was designed to investigate the characteristics, control rate, and factors affecting BP control in hypertensive patients treated by primary physicians in Korea. METHODS: The study was a multicenter, nationwide, cross-sectional, population-based survey conducted to identify the current status of hypertension treatment in Korean patients. A direct mail survey was sent to a random sample of 800 primary-care clinics across the nation. A total of 529 physicians in 510 clinics agreed to participate in this study (63.8%). Among the recruited 13,452 patients, 13,184 were included in the analysis. RESULTS: BP was controlled in 6,723 patients (51.0%). However, the control rate was lower in patients with diabetes (21.6%) or chronic kidney disease (CKD) (19.9%). Furthermore, the mean systolic and diastolic BP levels were higher in patients with diabetes and/or CKD. The mean BP level was higher in patients undergoing combination therapy than those undergoing single-drug therapy. Male gender, cardiovascular comorbidities, long duration of hypertension, and unhealthy lifestyle were associated with poor control of hypertension. In multivariate analysis, diabetes (odds ratio: 5.57; 95% confidence interval: 5.05-6.13) and CKD (odds ratio: 3.40; 95% confidence interval: 2.54-4.54) were the most significant independent factors related to poor BP control. CONCLUSION: BP control is still largely unsatisfactory, especially in patients with diabetes and kidney disease, who could benefit the most from effective BP control. The reasons for poor BP control and high BP levels in those patients need to be investigated to improve BP control in Korea.

Rash in adult patients receiving lamotrigine to treat bipolar I disorder in Korea: a multicenter, prospective, naturalistic, open-label trial.

The goal of this study was to assess the incidence of rash occurring in patients received lamotrigine to treat bipolar I disorder in a real world setting in Korea. We included a heterogeneous sample with multiple medications and medical comorbidities. Lamotrigine was added to the current therapy regime for DSM-IV bipolar I patients on an open-label basis for 12 weeks. The incidences of rash and other adverse events were assessed. The primary outcome measure was the incidence of rash. A total of 237 adult patients were included in the present study and 173 patients (73.0%) completed the 12 weeks of treatment. Thirty patients (12.7%) developed a rash, of whom 2 (0.8%) developed a serious rash. There were no patients who developed Stevens-Johnson syndrome or toxic epidermal necrolysis. The median time of rash onset was 16 days. As a group, patients who did not experience rash were significantly heavier than those who did. Our findings suggest that the incidence of serious rash associated with lamotrigine is low. The prescription of lamotrigine should be undertaken with appropriate consideration of the potential risk of adverse events including rash to the patient in relation to potential benefit from improvement of bipolar disorder.

Natural menopause and risk of stroke in elderly women.

Although early natural menopause has been postulated to increase stroke risk, studies have not produced convincing results. We examined the associations between stroke risks and age at natural menopause or time since natural menopause. 5,731 naturally postmenopausal women more than 65 yr of age were followed from 1993 to 1998. Information on age at menopause and risk factors were obtained using mailed questionnaires. 186 cases of stroke occurred over a total 27,936 person-years. After adjusting for age, hypertension, and physical activity, age at menopause was not found to be significantly associated with stroke or cerebral infarction. However, adjusted relative risks (aRRs) showed a significant increasing tendency of hemorrhagic stroke versus age at menopause (aRRs, 0.66, 0.48, 1.00 and 2.33 for the following age groups at menopause; 40-44, 45-49, 50-54 [reference group], and > or =55 yr). Time since menopause (11-20, 21-30, and > or =31 yr) was not found to be significantly associated with cerebral infarction, or hemorrhagic stroke. Late menopause (menopause age > or =55 yr) showed a tendency of a lower risk of cerebral infarction (aRR, 0.79) and a higher risk of hemorrhagic stroke (aRR, 2.33). Further study is warranted to determine stroke risk in women during the decade following menopause.

Nonsteroidal Anti-inflammatory Drugs Utilization Patterns among the Elderly with Osteoarthritis at Primary Ambulatory Care Units in Busan Metropolitan City, Korea.

OBJECTIVE: To investigate the utilization patterns of non-steroidal anti-inflammatory drugs (NSAIDs) among the elderly with osteoarthritis (OA) undergoing primary ambulatory care in Busan metropolitan city, Korea. METHODS: OA patients, aged 65 years and over, were identified from the Korean National Health Insurance Review Agency drug prescription database. The subjects had at least one episode of claim for OA (ICD-10-CM: M15-M19) between August 1, 2000 and February 28, 2002. Trends in the determinations of NSAIDs utilization were identified using chi-squared tests for trend. RESULTS: There were 47, 711 osteoarthritic patients. The total number of visits by these patients was 177, 443, with a total frequency for NSAID prescriptions of 214, 952. Seventy-nine percent of the OA patients were female. NSAIDs were prescribed on 133, 284 visits (75.1%) and the proportion of prescriptions was significantly increased with age. Only the proportion of visit when NSAIDs were prescribed decreased, from 65.1 to 43.5%, during the study period (p< 0.001). However, the proportion of combined treatments with anti-ulcer drugs was increased. The use of NSAIDs injections was decreased. Of the individual NSAIDs, diclofenac (28.7% of total frequency of NSAID prescriptions), piroxicam (15.0%) and talniflumate (8.7%), were the most frequently prescribed. Among the NSAIDs prescribed OA visits, 45.7% used two or more NSAIDs. CONCLUSIONS: The total proportion of NSAIDs prescribed to the osteoarthritic patients was higher than in other studies. The decline in the use of NSAIDs during the study period, and the frequent selection of safer medications, such as combination therapy with anti-ulcer drug, may reflect the risk awareness of the use of NSAIDs.

Stomach Cancer Incidence, Mortality and Survival Rate in Korean Elderly Pharmacoepidemiologic Cohort (KEPEC) in 1994~1998.

PURPOSE: This study was conducted to estimate the incidence, mortality and survival rate of stomach cancer in elderly people in Korea. MATERIALS AND METHODS: The source population was a Korean Elderly Phamacoepidemiologic Cohort (KEPEC), who were 65 years of age or older and living in Busan metropolitan city and Gyeongsangnam province, Korea. A subcohort of 38, 443 persons without stomach cancer were identified before enrolling the KEPEC. The stomach cancer incidence cases were detected from three different sources, the medical claims database of the Korea Medical Insurance Corporation (KMIC), the Korea Central Cancer Registry (KCCR), and the Busan Cancer Registry (BCR). A hospital survey for abstracting the relevant information to confirm the final diagnosis of the potential cases from the medical claims database was conducted. A medical oncologist reviewed the data to confirm the final diagnoses and the date of onset. The mortality cases due to stomach cancer were detected from the mortality database at the National Statistical Office. The incidence rate, the survival rate and the mortality rate of stomach cancer and their 95% confidence intervals were estimated using SAS Windows ver. 8.1. RESULTS: There were 338 confirmed stomach cancer cases in the KEPEC between 1 January 1994 and 31 December 1998. The age-standardized incidence rate of stomach cancer in the Korean elderly population was estimated to be 351.4 per 100, 000 person-years in males and 122.6 per 100, 000 person-years in females. In addition, 272 stomach cancer death cases were detected in the KEPEC between 1 Jan. 1994 and 31 Dec. 1998. The age-standardized mortality rate of stomach cancer to the Korean elderly population was estimated to be 268.5 per 100, 000 person-years in males and 93.7 per 100, 000 person-years in females. The one-year survival rate was 62.1% in males and 63.0% in females, which was considered to be statistically similar. The three-year survival rate was 38.9% in males and 40.9% in females. The five-year survival rate was 34.8% in males and 34.7% in females. CONCLUSION: The age-standardized male stomach cancer incidence rate and mortality rate to the Korean population were approximately three times higher than in female. However, there was little significant difference between males and females in terms of the overall survival rates. These results may be useful for planning a health policy for preventing and managing stomach cancer in Korea.

Analysis of Repeated Measured VAS in a Clinical Trial for Evaluating a New NSAID with GEE Method.

OBJECTIVE: To compare the efficacy between SKI306X and Diclofenac by using generalized estimating equations (GEE) methodology in the analysis of correlated bivariate binary outcome data in Osteoarthritis (OA) diseases. METHODS: A randomized, double-blind, active comparator controlled, non-inferiority clinical trial was conducted at 5 institutions in Korea with the random assignment of 248 patients aged 35 to 75 years old with OA of the knee and clinical evidence of OA. Patients were enrolled in this study if they had at least moderate pain in the affected knee joint and a score larger than 35mm as assessed by VAS (Visual Analog Scale). The main exposure variable was treatment (SKI 306X vs. Diclofenac) and other covariates were age, sex, BMI, baseline VAS, center, operation history (Yes/No), NSAIDS (Y/N), acupuncture (Y/N), herbal medicine (Y/N), past history of musculoskeletal disease (Y/N), and previous therapy related with OA (Y/N). The main study outcome was the change of VAS pain scores from baseline to the 2nd and 4th weeks after treatment. Pain scores were obtained as baseline, 2nd and 4th weeks after treatment. We applied GEE approach with empirical covariance matrix and independent (or exchangeable) working correlation matrix to evaluate the relation of several risk factors to the change of VAS pain scores with correlated binary bivariate outcomes. RESULTS: While baseline VAS, age, and acupuncture variables had protective effects for reducing the OA pain, its treatment (Joins/Diclofenac) was not statistically significant through GEE methodology (ITT: aOR=1.37, 95% CI= (0.8200, 2.26), PP: aOR=1.47, 95% CI= (0.73, 2.95) ). The goodness-off it statistic for GEE (6.55, p=0.68) was computed to assess the adequacy of the fitted final model. CONCLUSIONS: Both ANCOVA and GEE methods yielded non statistical significance in the evaluation of non-inferiority of the efficacy between SKI306X and Diclofenac. While VAS outcome for each visit was applied in GEE, only VAS outcome for the fourth visit was applied in ANCOVA. So the GEE methodology is more accurate for the analysis of correlated outcomes.