Efficacy and Safety of Omega-3 Fatty Acids in Patients Treated with Statins for Residual Hypertriglyceridemia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

BACKGROUND: Cardiovascular risk remains increased despite optimal low density lipoprotein cholesterol (LDL-C) level induced by intensive statin therapy. Therefore, recent guidelines recommend non-high density lipoprotein cholesterol (non-HDL-C) as a secondary target for preventing cardiovascular events. The aim of this study was to assess the efficacy and tolerability of omega-3 fatty acids (OM3-FAs) in combination with atorvastatin compared to atorvastatin alone in patients with mixed dyslipidemia.METHODS: This randomized, double-blind, placebo-controlled, parallel-group, and phase III multicenter study included adults with fasting triglyceride (TG) levels ≥200 and <500 mg/dL and LDL-C levels <110 mg/dL. Eligible subjects were randomized to ATOMEGA (OM3-FAs 4,000 mg plus atorvastatin calcium 20 mg) or atorvastatin 20 mg plus placebo groups. The primary efficacy endpoints were the percent changes in TG and non-HDL-C levels from baseline at the end of treatment.RESULTS: After 8 weeks of treatment, the percent changes from baseline in TG (−29.8% vs. 3.6%, P<0.001) and non-HDL-C (−10.1% vs. 4.9%, P<0.001) levels were significantly greater in the ATOMEGA group (n=97) than in the atorvastatin group (n=103). Moreover, the proportion of total subjects reaching TG target of <200 mg/dL in the ATOMEGA group was significantly higher than that in the atorvastatin group (62.9% vs. 22.3%, P<0.001). The incidence of adverse events did not differ between the two groups.CONCLUSION: The addition of OM3-FAs to atorvastatin improved TG and non-HDL-C levels to a significant extent compared to atorvastatin alone in subjects with residual hypertriglyceridemia.

Valsartan 160 mg/Amlodipine 5 mg Combination Therapy versus Amlodipine 10 mg in Hypertensive Patients with Inadequate Response to Amlodipine 5 mg Monotherapy

BACKGROUND AND OBJECTIVES: When monotherapy is inadequate for blood pressure control, the next step is either to continue monotherapy in increased doses or to add another antihypertensive agent. However, direct comparison of double-dose monotherapy versus combination therapy has rarely been done. The objective of this study is to compare 10 mg of amlodipine with an amlodipine/valsartan 5/160 mg combination in patients whose blood pressure control is inadequate with amlodipine 5 mg. SUBJECTS AND METHODS: This study was conducted as a multicenter, open-label, randomized controlled trial. Men and women aged 20-80 who were diagnosed as having hypertension, who had been on amlodipine 5 mg monotherapy for at least 4 weeks, and whose daytime mean systolic blood pressure (SBP) ≥135 mmHg or diastolic blood pressure (DBP) ≥85 mmHg on 24-hour ambulatory blood pressure monitoring (ABPM) were randomized to amlodipine (A) 10 mg or amlodipine/valsartan (AV) 5/160 mg group. Follow-up 24-hour ABPM was done at 8 weeks after randomization. RESULTS: Baseline clinical characteristics did not differ between the 2 groups. Ambulatory blood pressure reduction was significantly greater in the AV group compared with the A group (daytime mean SBP change: -14±11 vs. -9±9 mmHg, p<0.001, 24-hour mean SBP change: -13±10 vs. -8±8 mmHg, p<0.0001). Drug-related adverse events also did not differ significantly (A:AV, 6.5 vs. 4.5%, p=0.56). CONCLUSION: Amlodipine/valsartan 5/160 mg combination was more efficacious than amlodipine 10 mg in hypertensive patients in whom monotherapy of amlodipine 5 mg had failed.

A Case of Left Brachiocephalic Vein Total Occlusion Due to Acute Thrombosis Soon after Permanent Pacemaker Insertion

Symptomatic pacing lead-associated thrombosis is very uncommon occurring in 0.5-3.5% of pacemaker implants. Especially thrombisis-induced total occlusion occures almost in late stage over several months to years but acute thrombosis occurring several days after venous pacing has not been reported. In this case, We performed upper limb venography in the patient who presented edema and pain of neck, left upper limb and headache as well as intermittent cough occurring in bending forward. A venogram confirmed acute thrombus completely occluding the left brachiocephalic vein and the patient received intravenous heparin and was maintained on warfarin. Repeated veno- graphy after treatment for 30 days revealed persistent thrombus with total occlusion which not be improved signi- ficantly copmpared to previous venogram and collateral veins diverting the blood to the contralateral side and into the superior vena cava was developed. The patient's symptoms resolved almost and that is likely to be due to the development of collateral venous channels.

The Effects of Abciximab on Left Ventricular Remodeling in Patient with Acute Myocardial Infarction Treated with Primary Percutaneous Coronary Intervention

BACKGROUND AND OBJECTIVE: Abciximab has been shown to have beneficial effects beyond the improvement in the patency of an infarct-related artery and the microvascular integrity. However, it remains uncertain whether abciximab may lead to beneficial effects on the left ventricular remodeling in patients with an acute myocardial infarction, treated with primary percutaneous coronary intervention (PCI). Therefore, whether abciximab is effective in the left ventricular remodeling in patients with acute myocardial infarction, treated with primary PCI, was investigated. SUBJECTS AND METHODS: The study included 28 patients with an acute myocardial infarction (1 vessel disease) that had received either a primary PCI alone (group A, n=14) or an abciximab+primary PCI (group B, n=14). The baseline characteristics of the two groups were similar, with the exception of a thrombusburden lesion. All patients were examined by echocardiography within 72 hours, and at an average 11.7 months after the acute myocardial infarction. The change in the left ventricular end-diastolic volume index, end-systolic volume index and ejection fraction, between the two groups, were compared. RESULTS: At an average follow-up of 11.7 months, the left ventricular volume indices were smaller, and the left ventricular ejection fraction higher, compared with those at the baseline in each group. The change of the left ventricular end-diastolic volume index (-7+/-3 mL/m2 vs. -9+/-2 mL/m2, p=0.56), the left ventricular end-systolic volume index (-8+/-3 mL/m2 vs. -9+/-2 mL/m2, p=0.73) and the left ventricular ejection fraction (7+/-3% vs. 9+/-2%, p=0.49) did not show significant differences between groups A and B. CONCLUSION: These results suggest that abciximab does not improve the left ventricular remodeling in patient with an acute myocardial infarction, treated with primary PCI.

Comparison of Efficacy and Safety of Simvastatin, 10 mg and 20 mg in the Treatment of Hypercholesterolemia Patients Over 60-Year Old

BACKGROUND: Elevated serum cholesterol level is a major risk factor for cardiovascular morbidity and mortality. Simvastatin is effective for treating hypercholesterolemia. The aim of the study was to evaluate efficacy and safety of 6-month therapy with simvastatin with relatively low dose, 10 mg and 20 mg/day over 60-year-old patients. METHODS: Seventy-senven patients with hyperlipidemia(triglycerides 130 mg/dL) were randomized to receive either simvastatin 10 mg/day(n=32) or 20 mg/day(n=45). Efficacy was determined by measuring changes from baseline in lipid parameters including LDL cholesterol, total cholesterol, triglycerides and high-density lipoprotein(HDL) cholesterol. RESULTS: Of the senventy-seven patients randomized to treatment, eighteen patients were men and fiftynine patients were women. sixty-five percent of patients had hypertension, eighteen percent coronary artery disease and fourteen percent type 2 diabetes mellitus. Mean baseline lipid concentrations were 254 (total cholesterol), 291(triglycerides), 50(HDL) and 166 mg/dL(LDL). Both 10 mg and 20 mg of simvastatin produced statistically significant improvements in all measured serum lipid parameters(p<0.001). Compared with 10 mg of simvastatin, 20 mg of simvastatin produced significantly greater(p<0.001) reductions from baseline LDL cholesterol(32.9 mg/dL vs 24.2 mg/d). There was no significant difference in both doses at improving total cholesterol and HDL cholesterol level and TG cholesterol level. Percentage of patients at goal LDL as recommended by NCEP guideline(ATP III) were 100% and 89% for patients in low risk but 25% and 38.5% for patients in coronary heart disease and its risk equivalents, taking 10 mg and 20 mg/day respectively. Both doses were well tolerated. Only 3 patients(6.6%) in the 20 mg group and one patient(3. 1%) in the 10 mg group experienced mild adverse events. Most patients contacted by telephone wanted to take 10 mg of simvastatin. CONCLUSION: In patients with hypercholesterolemia over 60 year old in Korea, both doses(10 mg, 20 mg) of simvastatin were effective in improving serum lipid parameters and well-tolerated. We recommend, considering patients preference, that 10 mg of simvastatin be intial dosage and in patients with coronary heart disease, higher doses than 20 mg should be prescribed to allow most patients to reach their NCEP target levels.

A Case of Gastric Mucormycosis Associated with Diabetes Mellitus and Uremia / 대한소화기내시경학회지

Mucormycosis is an infection caused by fungi of the class Zygomycetes, order Mucorales. These are usual ubiquitous saprophytes but occasionally cause opportunistic infection in immunocompromised patients. Typically, these fungi invade blood vessels, and produce thrombosis and tissue infarction, so causing host fatality. These infections can be categorized into rhinocerebral, pulmonary, widely disseminated, gastrointestinal, cutaneous and miscellaneous form. Most of mucormycosis cases reported in Korea were rhinocerebral form except for three cases, which were gastrointestinal mucormycosis, accompanied with hematologic malignancy or immunosuppressing treatment. We experienced a 58-year-old male with gastric mucormycosis, who had diabetes and mild uremia without hematologic malignancy and immunosuppressive treatments. His chief complaints were abdominal pain and melena, and gastroscopy showed a 3 3 cm irregular edged ulcer considering malignancy. Its histological findings showed large, thin-walled, non-septate and right-angled branching fungal hyphae in necrotic tissue, diagnosed as mucormycosis. Finally he was dead due to severe hematemesis.

Effect of eradication of Helicobacter pylori on the benign gastric ulcer recurrence - a 24 month follow-up study

OBJECTIVES: To evaluate the effect of eradication of Helicobacter pylori (H. pylori) on the recurrence of benign gastric ulcer (BGU) in the patients with BGU. METHODS: This study was performed for 40 H. pylori-positive BGU patients cured of BGU and H. pylori eradicated, and for 25 H. pylori-positive patients (non-eradicated group) who were not treated with H. pylori eradication regimen or H. pylori was not eradicated. Four different methods--CLOtest, microscopy of Gram stained mucosal smear, culture and histology of modified Giemsa staining--were taken for identifying colonization of H. pylori before treatment, and 4 weeks after completion of triple therapy. For the control group in which triple therapy was not tried, follow-up gastroscopy was done to confirm the healing of the ulcer. To detect BGU recurrence, the gastroscopy was performed at 6, 12, 18, and 24 months after therapy. RESULTS: In the non-eradicated group, the BGU recurrence rate was 16% within 6 months, 40% within 1 year, 56% within 18 months and 60% within 2 years. The respective recurrence rates in the 40 patients in whom the bacteria had been eradicated were 0%, 7.5%, 10% and 10% (4 patients), respectively. Among the four BGU-recurred patients in whom H. pylori had been eradicated, one patient was found to have BGU recurring with H. pylori positive again in one year, and another two patients had NSAIDs ingestion history. CONCLUSION: The eradication of H. pylori in patients with BGU reduces the recurrence of BGU. In addition, the major causes of BGU recurrence look like NSAIDs ingestion and reinfection of H. pylori.

A Case of Acute Renal Failure and Other Symptoms Associated with Phytolacca Radix Poisoning / 대한신장학회잡지

Phytolaccae had been used as a pharmaceutical drug or food But nowadays, due to its toxicity, Phytolaccae is rarely used and cases of patients poisoned with it are seldom reported. The case presented here was of 43 year-old male who after ingesting extract of Phytolacca esculenta suffered from abdominal pain, diarrhea, nausea, vomiting, tachycardia, hypotension, pruritus, paresthesia, oliguria and azotemia. Kidney biopsy revealed tubular necrosis and some protein casts in tubular lumens. These findings suggested that acute renal failure was mainly caused by nephrotoxicity of Phytolacca extracts. Through continuous arteriovenous hemofiltration and two times of hemodialysis, he was completely recovered from acute renal failure. Other symptoms also disappeared by symptomatic management, but paresthesia of both lower extremities still remained. So we reported this case with a brief review of literature.