Since the US Food and Drug Administration issued guidance requiring cardiovascular safety for all antidiabetic drugs in 2008 (US FDA industry guidance for licensing of antidiabetic drugs), the number of cardiovascular outcome trials in diabetes has remarkably increased. Cardiovascular outcome trial is considered a gold standard for establishing the cardiovascular safety of antidiabetic agents. However, there are possible limitations in information gained from cardiovascular outcome trials and other issues such as cost. In this review, we summarize recent cardiovascular outcome trials in type 2 diabetes and provide an overview of the implications and limitations of those trials.
Cardiovascular Diseases ; Diabetes Mellitus ; Hypoglycemic Agents ; Licensure ; United States Food and Drug Administration

Cardiovascular Diseases ; drug therapy ; prevention & control ; Humans ; Hypolipidemic Agents ; administration & dosage ; therapeutic use ; Risk Reduction Behavior

Diabetes is a well-known risk factor of cardiovascular morbidity and mortality, and the beneficial effect of improved glycemic control on cardiovascular complications has been well established. However, the rosiglitazone experience aroused awareness of potential cardiovascular risk associated with diabetes drugs and prompted the U.S. Food and Drug Administration to issue new guidelines about cardiovascular risk. Through postmarketing cardiovascular safety trials, some drugs demonstrated cardiovascular benefits, while some antidiabetic drugs raised concern about a possible increased cardiovascular risk associated with drug use. With the development of new classes of drugs, treatment options became wider and the complexity of glycemic management in type 2 diabetes has increased. When choosing the appropriate treatment strategy for patients with type 2 diabetes at high cardiovascular risk, not only the glucose-lowering effects, but also overall benefits and risks for cardiovascular disease should be taken into consideration.
Cardiovascular Diseases ; Diabetes Mellitus ; Heart Failure ; Humans ; Hypoglycemic Agents ; Mortality ; Risk Assessment ; Risk Factors ; United States Food and Drug Administration

Treatment of cardiac disease via the epicardium fell under the domain of cardiac surgery due to the need for an open thoracotomy. Since an open thoracotomy is invasive in nature and has the potential for complications, a minimally invasive and percutaneous approach would be more attractive for suitable patients. The recent success of epicardial ablation of refractory arrhythmia via the percutaneous pericardial approach has increased the potential for delivery of epicardial therapies. Epicardial ablation has increased the success and safety since anti-coagulation and transseptal catheterization for left atrial arrhythmias is not required. The pericardial space has also been used to deliver therapy for several cardiac diseases. There are reports on successful delivery of drugs and their efficacy. Even though there was a wide range of efficacies reported in those studies, the reported complication rates are strikingly low, which suggests that direct delivery of drugs to the epicardium via the pericardial space is safe. Furthermore, recent animal studies have supported the feasibility of epicardial delivery of biological agents, including genes, cells, and even genetically engineered tissue for therapeutic purposes. In conclusion, percutaneous pericardial cannulation of closed pericardial space can play a significant role in providing non-surgical therapy for cardiovascular diseases. However, it requires skills and operator experiences. Therefore, there is need to further develop new tools, safer techniques, and effective procedure environment before generalizing this procedure.
Animals ; Arrhythmias, Cardiac ; Biological Agents ; Cardiovascular Diseases ; Catheterization ; Catheters ; Drug Administration Routes ; Heart Diseases ; Humans ; Pericardium ; Thoracic Surgery ; Thoracotomy

Obesity is a chronic disorder that is a significant risk factor for diabetes, cardiovascular diseases, malignancy, and other chronic diseases. Lifestyle modifications form the basis of most treatments for obesity, but it has become clear that such modifications alone are not enough for many obese patients. When a behavioral approach is insufficient, pharmacological treatment may be recommended. In recent years, the US Food and Drug Administration (FDA) has withdrawn several therapeutic options for obesity due to their side effects, but has approved four novel anti-obesity agents. Until recently, orlistat was the only drug approved for the management of long-term obesity, but the US FDA approved the novel anti-obesity drugs lorcaserin and phentermine/topiramate in 2012, and naltrexone/bupropion and liraglutide in 2014. The present review discusses the different pharmacotherapeutic options for the treatment of obesity.
Anti-Obesity Agents* ; Cardiovascular Diseases ; Chronic Disease ; Humans ; Life Style ; Liraglutide ; Obesity ; Risk Factors ; United States Food and Drug Administration

Cardiovascular disease is a major cause of morbidity and mortality in people with type 2 diabetes. Therefore, the prevention of cardiovascular diseases is of great importance in these patients. Antidiabetic drugs may have cardiovascular effects independent of their glycemic effects. The highly publicized meta-analysis of rosiglitazone has triggered much concern about the cardiovascular effects of antidiabetic drugs. Since 2008, the US Food and Drug Administration (FDA) has required that all new antidiabetic drugs show proof of an acceptable cardiovascular risk profile. Because there is a lack of well-designed definitive studies, the cardiovascular risk/benefit is not definite in many drugs. Large randomized trials assessing the cardiovascular risk of antidiabetic drugs have been recently completed or are ongoing. The first novel drug class designated after 2008 is the dipeptidyl peptidase-4 (DPP-4) inhibitors. Trials of DPP-4 inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists have shown a neutral effect on cardiovascular disease. Empagliflozin, a sodium-glucose co-transporter 2 inhibitor, significantly decreased the incidence of the primary cardiovascular end point, especially decreasing cardiovascular death and hospital admission for heart failure. Ongoing and future studies will provide better insight about the effects of each class and individual drug on cardiovascular disease.
Cardiovascular Diseases ; Glucagon-Like Peptide 1 ; Heart Failure ; Humans ; Hypoglycemic Agents* ; Incidence ; Mortality ; United States Food and Drug Administration

PURPOSE: Cardiovascular adverse events (AEs) after use of dipeptidyl peptidase-4 (DPP4) inhibitors have been reported and suspected since the launch of DPP-4 inhibitors in 2006. However, few studies have investigated the association between cardiovascular AEs and DPP-4 inhibitors. The objective of this study is to detect the signals of cardiovascular AEs after use of DPP-4 inhibitors by analyzing the Korea Institute of Drug Safety & Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD). MATERIALS AND METHODS: Data on the use of oral antidiabetic drugs from 2008 to 2016 were extracted from KIDS-KD, and analyzed descriptively. Data mining was conducted by calculating three indices, which were proportional reporting ratios, reporting odds ratios, and information components, to detect signals from use of all oral antidiabetic drugs including DPP-4 inhibitors. Then, the suspected adverse drug reactions (ADRs) were confirmed by signal detection, and drug label information between the Korea Ministry of Food and Drug Safety and the U.S. Food and Drug Administration were compared. RESULTS: Cardiovascular AEs after taking DPP-4 inhibitors were detected in only three (1.0%) out of a total of 307 AE reports. Two of the three cardiovascular AEs were reported after using sitagliptin and one using gemiglipitin, but these were not statistically significant. CONCLUSION: Analysis of spontaneous ADR reports data on the use of DPP-4 inhibitors could not showed the association between DPP-4 inhibitors and cardiovascular AEs, due to a small number of cardiovascular AEs reports.
Cardiovascular Diseases ; Data Mining ; Drug-Related Side Effects and Adverse Reactions ; Hypoglycemic Agents ; Korea ; Odds Ratio ; Pharmacovigilance ; Sitagliptin Phosphate ; United States Food and Drug Administration

Obesity is one of the most significant risk factor for diabetes, cardiovascular disease, malignancy and other chronic diseases. The obesity and its associated conditions is one of the most urgent health concerns worldwide. Lifestyle modifications comprising diet modification, exercise, and behavior therapy are basic to the treatment for obesity. However, it has become apparent that lifestyle modifications alone will not be enough for many patients with obesity. Therefore, apractical approach includes consideration of pharmacotherapeutic options. Until 2012, orlistat was the only approved medication for long-term obesity management. In 2012, lorcaserin and phentermine/topiramate were approved by the USA Food and Drug Administration as new anti-obesity drugs, and in 2014, two additional medications were added, naltrexone/bupropion and liraglutide. This review discusses the different pharmacotherapeutic options for the treatment of obesity.
Anti-Obesity Agents* ; Behavior Therapy ; Cardiovascular Diseases ; Chronic Disease ; Food Habits ; Humans ; Life Style ; Obesity ; Risk Factors ; United States Food and Drug Administration ; Liraglutide

Objective: To evaluate the effect of comprehensive intervention program on hypertension control in workplaces in China. Methods: The study design was a non-randomized controlled trial. First, 20 sub-centers were selected across China, then hypertension patients in 2-4 workplaces were selected as the intervention group, and hypertension patients in 1 comparable workplace selected, as the control group in each sub-center. The comprehensive intervention strategy which integrating workplace primary prevention of cardiovascular diseases and standardized management of hypertension was adopted in the intervention group for at least 2 years. Patients in the control group continued their usual health care, and only baseline data and 2-year data was collected. Analyses were conducted for hypertension patients in 30 stated-owned enterprises (SOEs), including 20 for the intervention group and 10 for the control group. The primary outcome was the control rate ofhypertension while the intervention effect (IE) was estimated by using the formula: differential value of intervention group[rate (mean)]-differential value of control group[rate (mean)]. Results: Overall, 2 622 patients completed the 2-year follow-up, of which 2 055 were in the intervention group and 567 in the control group, respectively. After 2 years of intervention, the IE on the level of SBP and DBP for intervention group and control group were-7.5 and-3.9 mmHg, respectively (P<0.05). BMI decreased by 0.4 kg/m(2), with the regular exercise rate as 36.4% and alcohol consumption rate decreased by 14.0%, respectively (P<0.05). The smoking rate decreased by 6.1% (P>0.05). The overall hypertension control rate was 25.0%, and further subgroup analysis showed that our intervention program was particularly effective for those with high education level (27.6%), white-collar employees (41.9%), and those from SOEs whose affiliated hospital had been separated away (41.9%). Conclusion: The comprehensive intervention program could greatly improve the hypertension control in the workplaces in China.
Antihypertensive Agents/therapeutic use* ; Blood Pressure Determination ; Cardiovascular Diseases/prevention & control* ; China ; Female ; Health Promotion/organization & administration* ; Humans ; Hypertension/prevention & control* ; Male ; Program Development ; Program Evaluation ; Smoking ; Workplace

In order to go deeply into the researches on the theory of hemodynamics for interventional treatment of lung cancer, we have designed a simulating experimental system. Using the experimental system, we can simulate the operation process and test the effect of drug infusion under a variety of physiological parameters. The parameters that admit of adjustment are: cardiac output, blood pressure of aorta, waveform of pressure, pulse period, blood flow in bronchial artery and different types of catheter, injecting velocity, injecting technique, etc. In addition, the entrance position and blood vessel diameter of small embranchment artery can be changed. In this paper are presented the application of our pH-testing method to natural infusion region and the determined representational shape and size.
Antineoplastic Agents ; administration & dosage ; Bronchial Arteries ; physiology ; Cardiac Output ; Catheterization ; Computer Simulation ; Heart Rate ; Hemodynamics ; Humans ; Infusions, Intra-Arterial ; Lung Neoplasms ; drug therapy ; physiopathology ; Models, Cardiovascular