Resting heart rate control and prognosis in coronary artery disease patients with hypertension previously treated with bisoprolol: a sub-group analysis of the BISO-CAD study / 中华医学杂志(英文版)

BACKGROUND@#Resting heart rate (RHR) is considered as a strong predictor of total mortality and hospitalization due to heart failure in hypertension patients. Bisoprolol fumarate, a second-generation beta-adrenoreceptor blockers (β-blocker) is commonly prescribed drug to manage hypertension. The present study was to retrospectively evaluate changes in the average RHR and its association with cardiovascular outcomes in bisoprolol-treated coronary artery disease (CAD) patients from the CAD treated with bisoprolol (BISO-CAD) study who had comorbid hypertension.@*METHODS@#We performed ad-hoc analysis for hypertension sub-group of the BISO-CAD study (n = 866), which was a phase IV, multination, multi-center, single-arm, observational study carried out from October 2011 to July 2015 across China, South Korea, and Vietnam. Multivariate regression analysis was used to identify factors associated with incidence of composite cardiac clinical outcome (CCCO), the results were presented as adjusted odds ratio (OR) along with 95% confidence interval (CI) and adjusted P value.@*RESULTS@#A total of 681 patients (mean age: 64.77 ± 10.33 years) with hypertension from BISO-CAD study were included in the analysis. Bisoprolol improved CCCOs in CAD patients with comorbid hypertension, with RHR <65 and <70 beats/min compared with RHR ≥65 and ≥75 beats/min, respectively, in the efficacy analysis (EA) set. In addition, it lowered RHR in both intent-to-treat (ITT) and EA groups after 6, 12, and 18 months of treatment. Further, RHR 70 to 74 beats/min resulted in significantly higher risk of CCCOs EA set of patients (adjusted OR: 4.34; 95% CI: 1.19-15.89; P = 0.03). Also, events of hospitalization due to acute coronary syndrome were higher when RHR 69 to 74 beats/min compared to RHR <69 beats/min in ITT patients.@*CONCLUSION@#Bisoprolol can effectively reduce RHR in Asian CAD patients with comorbid hypertension and hence, improve CCCO without affecting their blood pressure.

Treatment of Atypical Ulnar Fracture Associated with Bisphosphonate Therapy - A Case Report -

Bisphosphonates can cause atypical fractures when taken for a long time. Atypical fractures appear mainly as femoral subtrochanteric or shaft fractures. On the other hand, reports of atypical fractures in the proximal ulna are relatively rare, with a high proportion of nonunion cases. This paper reports a case of nonunion after fixation for atypical fractures of the proximal ulna.

Efficacy and safety of alirocumab in Korean patients with hypercholesterolemia and high cardiovascular risk: subanalysis of the ODYSSEY-KT study

BACKGROUND/AIMS@#Efficacy and safety data of alirocumab, a fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9 (PCSK9), is not yet well established in the Korean population. We assessed them in ODYSSEY-KT through the pre-specified Korean subanalysis.@*METHODS@#In the ODYSSEY-KT study, South Korean and Taiwanese patients with hypercholesterolemia and high cardiovascular risks were randomized (1:1) to alirocumab or placebo. Alirocumab was self-administered subcutaneously at 75 mg every 2 weeks with a maximally tolerated statin dose with or without other lipid-modifying therapies. Alirocumab dose was increased to 150 mg every 2 weeks at week 12 if low density lipoprotein cholesterol (LDL-C) ≥ 70 mg/dL at week 8. Primary endpoint was percent change in LDL-C from baseline to week 24. Results from Korean cohort (n = 83: 40 for alirocumab and 43 for placebo, respectively) analyses are reported here.@*RESULTS@#In alirocumab group, the least square of mean change percent in LDL-C levels was –65.7% (placebo: 11.1%; p < 0.0001) and 92.0% of them achieved LDL-C < 70 mg/dL (placebo: 12.7%; p < 0.0001) at week 24. Alirocumab also showed significantly greater improvements in high density lipoprotein cholesterol (HDL-C), non-HDL-C, total cholesterol, lipoprotein(a), and apolipoprotein B than placebo (p < 0.05). Two consecutive calculated LDL-C values < 25 mg/dL were observed in 37.5% of alirocumab-treated patients. Overall, 45.0% alirocumab-treated and 51.2% placebo-treated patients experienced treatment-emergent adverse events (TEAEs) without discontinuation of treatment due to TEAEs.@*CONCLUSIONS@#Alirocumab has demonstrated to be effective in improvement of LDL-C and related lipid profiles in Korean cohort. Alirocumab was generally well tolerated with no significant safety signals.

Prognostic Factors after Arthroscopic Treatment of Infectious Knee Arthritis / 대한정형외과학회잡지

PURPOSE: This study examined the effects of gender, age, underlying disease, duration after onset of symptoms, preoperative invasive procedures, bacterial culture of joint fluid, and stage of infection by the Gächter classification on the prognosis of patients with infectious knee arthritis who underwent arthroscopic surgery. MATERIALS AND METHODS: From June 2014 to December 2016, 51 patients who underwent arthroscopic surgery for infective knee arthritis were enrolled in this study. The average follow-up period was 14.2±2.1 months (range, 12–20 months). The subjects were 27 men (52.9%) and 24 women (47.1%), with an average age of 55.1±17.6 years (range, 13–84 years). A preoperative evaluation of the joint aspiration with a count of more than 50,000 leukocytes and a polymorphonuclear leukocyte count of 95% or more was performed. All patients underwent arthroscopic surgery and postoperative continuous joint irrigation. RESULTS: The initial mean value of the C-reactive protein decreased from 9.55±6.76 mg/dl (range, 1.51–31.06 mg/dl) to a final mean of 0.74±1.26 mg/dl (range, 0.08–6.77 mg/dl); the mean duration of C-reactive protein normalization was 27.6±18.9 days (range, 8–93 days). Among the 51 patients who received arthroscopic surgery and antibiotics, 44 patients (86.3%) with infectious knee arthritis completed treatment with improved clinical symptoms, such as fever, pain, and edema, and the C-reactive protein decreased to less than 0.5 mg/dl. Finally, 5 cases were treated with two or more arthroscopic operations, and 2 cases were converted to arthroplasty after prosthesis of antibiotic-loaded acrylic cement. CONCLUSION: The duration of surgery after the onset of symptoms and the stage according to the Gächter classification are important prognostic factors for predicting the successful treatment of infectious knee arthritis. On the other hand, the other factors were not statistically significant. Nevertheless, patients with bacteria cultured from the joint fluids appear to reflect the treatment period because the period of normalization of the C-reactive protein is shorter than that of the control group.

Erratum: Addition of a Co-Author: Etiology of Invasive Bacterial Infections in Immunocompetent Children in Korea (2006–2010): a Retrospective Multicenter Study

The authors regret that one co-author (Kyung-Hyo Kim) was missing in the article.

Overview of the Management of Chronic Non-Cancer Pain in Patients with Spinal Disease / 대한척추외과학회지

STUDY DESIGN: Cross-sectional, multi-center survey study. OBJECTIVES: The objective of this study was to investigate the pain status, pain management methods, and pain experience after treatment among patients suffering from chronic non-cancer pain due to spinal disease. SUMMARY OF LITERATURE REVIEW: No thorough investigation of the current status of chronic non-cancer pain management in patients with spinal disease has recently been reported. MATERIALS AND METHODS: We surveyed 330 patients with chronic non-cancer pain who visited spine clinics in Korea. RESULTS: Prior to treatment, 86.7% of the patients had severe pain and 99.4% of the patients had taken oral analgesics for pain control. After treatment, the percent of patients with severe pain was reduced to 42.1%, and 52.4% of patients responded that they experienced intermittent pain. End of dose failure was experienced by 29.1% of patients, and 41.7% of patients experienced pain again 3–6 hours after taking analgesics. Furthermore, 8.2% of patients experienced breakthrough pain, and 29.1% of patients experienced pain that interfered with sleeping. CONCLUSIONS: Many patients with chronic pain reported experiencing pain due to end of dose failure after medication. As the causes of chronic pain are complex, appropriate analgesics should be considered and selected for effective pain management.

A Comparison between Open Reduction/Internal Fixation and Minimally Invasive Plate Osteosynthesis Using a 3-Dimensional Printing Model for Displaced Clavicular Fractures / 대한정형외과학회잡지

PURPOSE: This study was performed to compare between open reduction/internal fixation (ORIF) and minimally invasive plate osteosynthesis (MIPO) using a 3-dimensional printing model for displaced clavicular fractures. MATERIALS AND METHODS: In a retrospective study, we compared the outcomes of 21 patients treated with MIPO (Group A) with those of 22 patients treated with ORIF (Group B) between January 2013 and December 2015. After the operation, bone union was evaluated using X-ray every 4 weeks. The radiologic outcome (bone union), functional outcome (Korean shoulder scale [KSS], The University of California Los Angeles [UCLA] score), scar length, and degree of satisfaction were evaluated. RESULTS: The mean time to union was 12.1 weeks in Group A and 12.8 weeks in Group B (p=0.524). There was no significant difference in the KSS score and UCLA score between the two groups (p=0.478, p=0.698). The mean length of scar was 4.9 cm (medial 2.6 cm, lateral 2.3 cm) in Group A and 9.7 cm in Group B (p=0.001), and Group A was more satisfied than Group B with respect to scarring (p=0.001). Nonunion developed in one case in each group. Five patients in Group B had skin numbness (1 in Group A, p=0.038). CONCLUSION: There were no significant differences in the radiologic and functional results between the two groups with respect to displaced clavicle shaft fracture. However, scar satisfaction was higher in MIPO than in ORIF.

Variants in the Gene EBF2 Are Associated with Kawasaki Disease in a Korean Population

PURPOSE: Kawasaki disease (KD) is a mucocutaneous lymph node syndrome. It is mainly seen in young children under the age of five. KD is a multifactorial disorder that includes genetic variants. The present study investigated the association between KD and single nucleotide polymorphisms (SNPs) in the candidate gene early B cell factor 2 (EBF2), which is associated with inflammation markers. MATERIALS AND METHODS: An SNP analysis was performed by whole exon sequencing of the EBF2 gene. Our study comprised a total of 495 subjects (295 KD patients and 200 unrelated normal controls) from a Korean population. Tag SNPs were discovered using the Haploview program. Genotyping of the EBF2 gene was performed with the TaqMan® assay with real-time PCR methods. RESULTS: Polymorphism of rs10866845 showed a significant difference in allele frequency between KD patients and controls (p=0.040). The EBF2 gene polymorphisms were significantly associated with KD on logistic regression analysis. CONCLUSION: EBF2 gene variants can contribute to KD in the Korean population.

Clinical Outcomes of Low-Dose Methotrexate Therapy as a Second-Line Drug for Intravenous Immunoglobulin-Resistant Kawasaki Disease

PURPOSE: Intravenous immunoglobulin (IVIG) is the standard treatment for Kawasaki disease (KD). However, there is still no standard treatment for IVIG-resistant KD. This study aimed to evaluate the efficacy of low-dose methotrexate (MTX) as a treatment for IVIG-resistant KD. MATERIALS AND METHODS: We retrospectively analyzed 10-year data for patients with IVIG-resistant KD who were administered MTX at Severance Children's Hospital. RESULTS: The subjects included 75 patients with KD aged 5 months to 9.2 years who had been administered MTX. Their maximum body temperatures decreased significantly within 24 h of therapy. The patients' C-reactive protein levels were significantly lower 1 week after administering the first dose of MTX than those before treatment. No adverse effect for MTX was observed. CONCLUSION: MTX treatment of IVIG-resistant KD resulted in rapid defervescence, improvement of clinical symptoms, and normalization of acute-phase reactants in all patients. Thus, MTX could be a candidate treatment for IVIG-resistant KD.

ITPKC and SLC11A1 Gene Polymorphisms and Gene-Gene Interactions in Korean Patients with Kawasaki Disease

PURPOSE: Kawasaki disease (KD) is an acute systemic vasculitis. Both the etiology of KD and the erythema of Bacille Calmette-Guérin (BCG) injection sites observed in the disease are poorly understood. We investigated the association between KD and single nucleotide polymorphisms (SNPs) in two candidate genes: inositol 1,4,5-triphosphate 3-kinase (ITPKC), a well-studied KD-associated gene, and solute carrier 11a1 (SLC11A1), which is associated with the hypersensitive reaction to the BCG strain in Koreans. MATERIALS AND METHODS: Associations between KD and SNPs in two genes were evaluated. Potential associations between BCG injection site erythema and SNPs in two genes were also evaluated. Gene-gene interactions between ITPKC and SLC11A1 in KD and BCG injection site erythema were also analyzed. RESULTS: Three tagging SNPs in ITPKC and five tagging SNPs in SLC11A1 were genotyped in 299 KD patients and 210 control children. SNP rs28493229 in ITPKC was associated with KD and coronary artery complications. SNP rs77624405 in SLC11A1 was associated with KD. Comparisons of KD patients with and without BCG injection site erythema revealed that SNP rs17235409 in SLC11A1 was associated with erythema; no erythema-associated SNPs in ITPKC were identified. Interactions between ITPKC rs28493229_GG and SLC11A1 rs17235409_GA and between ITPKC rs10420685_GG and SLC11A1 rs17235409_AA were strongly associated with BCG injection site erythema. CONCLUSION: This study identified several important polymorphisms in the ITPKC and SLC11A1 genes in Koreans. The genetic variants identified in this study affected KD and erythema of BCG injection sites independently and through gene-gene interactions. Also, the effects of the polymorphisms were age-dependent.

Etiology of Invasive Bacterial Infections in Immunocompetent Children in Korea (2006–2010): a Retrospective Multicenter Study

BACKGROUND: Invasive bacterial infections in apparently immunocompetent children were retrospectively analyzed to figure causative bacterial organisms in Korea. METHODS: A total of 947 cases from 25 university hospitals were identified from 2006 to 2010 as a continuance of a previous 10-year period study from 1996 to 2005. RESULTS: Escherichia coli (41.3%), Streptococcus agalactiae (27.7%), and Staphylococcus aureus (27.1%) were the most common pathogens in infants < 3 months of age. S. agalactiae was the most prevalent cause of meningitis and pneumonia and E. coli was the major cause of bacteremia without localizing signs in this group. In children 3 to 59 months of age, Streptococcus pneumoniae (54.2%), S. aureus (20.5%), and Salmonella spp. (14.4%) were the most common pathogens. S. pneumoniae was the leading cause of pneumonia (86.0%), meningitis (65.0%), and bacteremia without localizing signs (49.0%) in this group. In children ≥ 5 years of age, S. aureus (62.8%) was the predominant pathogen, followed by Salmonella species (12.4%) and S. pneumoniae (11.5%). Salmonella species (43.0%) was the most common cause of bacteremia without localizing signs in this group. The relative proportion of S. aureus increased significantly over the 15-year period (1996–2010) in children ≥ 3 months of age (P < 0.001), while that of Haemophilus influenzae decreased significantly in both < 3 months of age group (P = 0.036) and ≥ 3 months of age groups (P < 0.001). CONCLUSION: S. agalactiae, E. coli, S. pneumoniae, and S. aureus are common etiologic agents of invasive bacterial infections in Korean children.

Overview of the Management of Chronic Non-Cancer Pain in Patients with Spinal Disease

OBJECTIVES@#The objective of this study was to investigate the pain status, pain management methods, and pain experience after treatment among patients suffering from chronic non-cancer pain due to spinal disease.SUMMARY OF LITERATURE REVIEW: No thorough investigation of the current status of chronic non-cancer pain management in patients with spinal disease has recently been reported.@*MATERIALS AND METHODS@#We surveyed 330 patients with chronic non-cancer pain who visited spine clinics in Korea.@*RESULTS@#Prior to treatment, 86.7% of the patients had severe pain and 99.4% of the patients had taken oral analgesics for pain control. After treatment, the percent of patients with severe pain was reduced to 42.1%, and 52.4% of patients responded that they experienced intermittent pain. End of dose failure was experienced by 29.1% of patients, and 41.7% of patients experienced pain again 3–6 hours after taking analgesics. Furthermore, 8.2% of patients experienced breakthrough pain, and 29.1% of patients experienced pain that interfered with sleeping.@*CONCLUSIONS@#Many patients with chronic pain reported experiencing pain due to end of dose failure after medication. As the causes of chronic pain are complex, appropriate analgesics should be considered and selected for effective pain management.

Analgesic Efficacy and Safety of Prolonged-Release Oxycodone/Naloxone in Korean Patients with Chronic Pain from Spinal Disorders

BACKGROUND: A prolonged-release formulation of oxycodone/naloxone has been shown to be effective in European populations for the management of chronic moderate to severe pain. However, no clinical data exist for its use in Korean patients. The objective of this study was to assess efficacy and safety of prolonged-release oxycodone/naloxone in Korean patients for management of chronic moderate-to-severe pain. METHODS: In this multicenter, single-arm, open-label, phase IV study, Korean adults with moderate-to-severe spinal disorder-related pain that was not satisfactorily controlled with weak opioids and nonsteroidal anti-inflammatory drugs received prolonged-release oral oxycodone/naloxone at a starting dose of 10/5 mg/day (maximum 80/40 mg/day) for 8 weeks. Changes in pain intensity and quality of life (QoL) were measured using a numeric rating scale (NRS, 0–10) and the Korean-language EuroQol-five dimensions questionnaire, respectively. RESULTS: Among 209 patients assessed for efficacy, the mean NRS pain score was reduced by 25.9% between baseline and week 8 of treatment (p < 0.0001). There was also a significant improvement in QoL from baseline to week 8 (p < 0.0001). The incidence of adverse drug reactions was 27.7%, the most common being nausea, constipation, and dizziness; 77.9% of these adverse drug reactions had resolved or were resolving at the end of the study. CONCLUSIONS: Prolonged-release oxycodone/naloxone provided significant and clinically relevant reductions in pain intensity and improved QoL in Korean patients with chronic spinal disorders. (ClinicalTrials.gov identifier: NCT01811238)

Increased Serum Antibody Titer against HPV-16 Antigen in Patients with Behçet's Disease

Quadrivalent human papillomavirus (HPV) vaccine has been reported to be significantly associated with Behçet's disease (BD). However, no reports have described HPV infection as a possible cause for the development of BD. The objective of this study was to evaluate whether anti-HPV immunoglobulin G (IgG) antibody titer is increased in BD. Serum samples from 93 Korean BD patients, who fulfilled the diagnostic criteria of the International Study Group for BD, were used in an enzyme-linked immunosorbent assay (ELISA). The clinical activity of BD was evaluated at the time of blood sampling. HPV-16 L1 virus-like particle (VLP) antigen was used in this study for the ELISA. Patients with BD had significantly higher antibody titers against HPV-16 (optical density [OD], 0.210–3.675; mean 0.992) than that of healthy controls (OD, 0.248–0.762; mean 0.517; P < 0.001). Using a receiver operating characteristic (ROC) analysis, a cut-off value of 0.578 OD for the anti-HPV antibody titer was determined that differentiated BD patients from healthy controls. When we compared the clinical features of BD between the 2 groups, articular involvement of BD was more likely in patients with an anti-HPV-16 antibody titer < 0.578 OD (P = 0.035). In addition, patients with an anti-HPV-16 antibody titer < 0.578 were significantly younger than those with a titer ≥ 0.578 OD. HPV itself may be a possible extrinsic triggering infectious agent causing the development of BD.

Erratum: Diagnostic Performance of Intravascular Ultrasound-Derived Minimal Lumen Area to Predict Functionally Significant Non-Left Main Coronary Artery Disease: a Meta-Analysis

In the article, the weighted overall mean MLA cut-off value has been miscalculated. Tha authors deeply apologize for any inconvenience it may have caused.

Human Coronavirus in the 2014 Winter Season as a Cause of Lower Respiratory Tract Infection

PURPOSE: During the late autumn to winter season (October to December) in the Republic of Korea, respiratory syncytial virus (RSV) is the most common pathogen causing lower respiratory tract infections (LRTIs). Interestingly, in 2014, human coronavirus (HCoV) caused not only upper respiratory infections but also LRTIs more commonly than in other years. Therefore, we sought to determine the epidemiology, clinical characteristics, outcomes, and severity of illnesses associated with HCoV infections at a single center in Korea. MATERIALS AND METHODS: We retrospectively identified patients with positive HCoV respiratory specimens between October 2014 and December 2014 who were admitted to Severance Children’s Hospital at Yonsei University Medical Center for LRTI. Charts of the patients with HCoV infection were reviewed and compared with RSV infection. RESULTS: During the study period, HCoV was the third most common respiratory virus and accounted for 13.7% of infections. Coinfection was detected in 43.8% of children with HCoV. Interestingly, one patient had both HCoV-OC43 and HCoV-NL63. Mild pneumonia was most common (60.4%) with HCoV, and when combined with RSV, resulted in bronchiolitis. Two patients required care in the intensive care unit. However, compared with that of RSV infection, the disease course HCoV was short. CONCLUSION: Infections caused by HCoVs are common, and can cause LRTIs. During an epidemic season, clinicians should be given special consideration thereto. When combined with other medical conditions, such as neurologic or cardiologic diseases, intensive care unit (ICU) care may be necessary.

Combined Use of Neutrophil to Lymphocyte Ratio and C-Reactive Protein Level to Predict Clinical Outcomes in Acute Myocardial Infarction Patients Undergoing Percutaneous Coronary Intervention

BACKGROUND AND OBJECTIVES: Both neutrophil to lymphocyte ratio (NLR) and C-reactive protein (CRP) are biomarkers associated with poor prognosis of patients with acute myocardial infarction (AMI). However, the combined usefulness of NLR and CRP in predicting adverse outcomes has not been investigated. SUBJECTS AND METHODS: We analyzed 381 consecutive AMI patients who underwent percutaneous coronary intervention (PCI) from January 2012 to January 2014. The endpoints were all-cause mortality, recurrent myocardial infarction (MI), stent thrombosis, repeat revascularization, stroke, and major adverse cardiac and cerebrovascular events (MACCE) at 2-year follow-up. Included patients were divided into 4 groups according to the optimal cut-off values for NLR and CRP on receiver operating characteristic analysis predicting mortality. RESULTS: Patients with both high NLR (>6.30) and high CRP (>0.76) had significantly greater risk of all-cause death and MACCE at 24 months, with no significant increase in the risk of recurrent MI, stent thrombosis, or stroke compared with patients with either low NLR or low CRP, as well as those with low NLR and low CRP. Kaplan-Meier analysis revealed significantly lower survival in patients with high NLR-CRP. On Cox multivariate analysis, high NLR-CRP (hazard ratio 23.172, 95% confidence interval 6.575 to 81.671, p<0.001) was an independent predictor of all-cause death. CONCLUSION: Elevated levels of both NLR and CRP are associated with increased risk of long-term mortality in AMI patients who have undergone PCI.

The Relationships between Body Mass Index and Left Ventricular Diastolic Function in a Structurally Normal Heart with Normal Ejection Fraction

BACKGROUND: We conducted research to determine the effect of the weight on left ventricular (LV) diastolic function in Asians, who are at greater risk of cardiovascular events compared to individuals from Western countries with similar body mass indices (BMIs). METHODS: We studied 543 participants with structurally normal hearts and normal ejection fractions. Participants were classified as normal-weight (BMI < 23.0 kg/m²), overweight (BMI 23.0–27.4 kg/m²), or obese (BMI ≥ 27.5 kg/m²). Peak E velocity, peak A velocity, and E′ velocity were measured and E/E′ was calculated. RESULTS: Overweight participants had lower E than normal-weight participants (p = 0.001). E′ velocities in overweight and obese participants were less than those in normal weight participants (both p < 0.001). The E/E′ ratio in obese participants was higher compared to the value in normal-weight participants (p < 0.001) and overweight participants (p = 0.025). BMI was associated with E (R = −0.108), A (R = 0.123), E′ (R = −0.229), and E/E′ ratio (R = 0.138) (all p < 0.05). In multivariate analyses, BMI was independently associated with higher A, lower E′, and higher E/E′. The risk of diastolic dysfunction was significantly higher among overweight [adjusted odds ratio: 2.088; 95% confidence interval (CI): 1.348–3.235; p = 0.001] and obese participants (adjusted odds ratio: 5.910; 95% CI: 2.871–12.162; p < 0.001) compared to normal-weight participants. CONCLUSION: Obesity and overweight independently predicted diastolic dysfunction. An optimal body weight lower than the universal cut-off is reasonable for preventing LV heart failure in Asians.

24-Hour blood pressure response to lower dose (30 mg) fimasartan in Korean patients with mild to moderate essential hypertension

BACKGROUND/AIMS: Fimasartan is an angiotensin type 1 receptor blocker (ARB) which has comparable efficacy and tolerability with other ARBs. The aim of this study was to evaluate 24-hour blood pressure (BP) lowering efficacy and the tolerability of the low dose fimasartan compared with valsartan in patients with mild to moderate hypertension. METHODS: This study was a phase II, prospective, multicenter, randomized, double-blind, parallel-grouped trial. A total of 75 hypertensive patients, whose mean ambulatory BP monitoring values were ≥ 135/85 mmHg, were randomized to either fimasartan 30 mg or valsartan 80 mg daily. The primary efficacy endpoint was the change in the mean 24-hour systolic BP (SBP) values from the baseline and at the week 8. Secondary endpoints included the change in the mean 24-hour diastolic BP values, the daytime and the nighttime mean BP values at week 8, the trough-to-peak (T/P) ratio and the smoothness index. RESULTS: At week 8, the mean 24-hour SBP values significantly decreased in both groups; –10.5 ± 11.9 mmHg (p < 0.0001) in the fimasartan group and –5.5 ± 11.6 mmHg (p = 0.0307) in the valsartan group. The difference between two groups was 4.3 ± 2.9 mmHg but there was no statistical significance (p = 0.1392). The global T/P ratio in the fimasartan 30 mg groups were 0.48 and 0.40 in the valsartan 80 mg group, respectively (p = 0.3411). The most frequent adverse events (AEs) were acute pharyngitis and there were no cases of severe AEs. CONCLUSIONS: In mild-to-moderate hypertensive patients, low dose (30 mg) fimasartan showed comparable 24-hour BP lowering efficacy compared with valsartan (80 mg). There was no difference in tolerability between two groups.

Fracture Preventing Effects of Maxmarvil® Tablets (Alendronate 5 mg + Calcitriol 0.5 µg) in Patients with Osteoporosis

BACKGROUND: The purpose of this prospective, open-label, observational study was to assess the fracture preventing effect of Maxmarvil® tablets (alendronate 5 mg + calcitriol 0.5 µg) in patients with osteoporosis and to evaluate the change in bone mineral density (BMD) at the minimum 1-year follow-up. METHODS: In this multicenter observational study, 691 patients with osteoporosis (aged 50 years or older) were treated with alendronate 5 mg + calcitriol 0.5 µg/day during their normal course of care. Patients were assessed at baseline and at 6 and 12 months. Baseline characteristics (including age, gender, concomitant disease, and baseline fractures) were evaluated. RESULTS: From among the 848 participants, 149 individuals were lost to follow-up at the time of the study and 8 people had died. The 691 participants (54 men and 637 women) finished the follow-up study and completed the questionnaire. The mean age of the participants was 71.5 years (range, 50–92 years; mean age, 72.3 years for men and 71.4 years for women). Osteoporotic fracture occurred in 19 patients (2.7%). BMD of the lumbar spine and hip was improved by 5% and 1.5% at the latest follow-up. At the latest follow-up, 24 patients (3.5%) complained of drug-related complications such as dyspepsia, constipation, and nausea. CONCLUSIONS: This prospective observational study demonstrated that alendronate 5 mg + calcitriol 0.5 µg/day had a preventive effect on osteoporotic fracture and it increased the BMD of the lumbar spine by 5% at the latest follow-up.