A Prospective Noninterventional, Observational Study to Describe the Effectiveness and Safety of Trandolapril and Verapamil Single-Pill Combination in the Management of Patients with Hypertension and Type 2 Diabetes Mellitus: A Harvest TR Study.

Maintaining regular blood pressure control usually requires multidrug regimens rather than monotherapy. The objective of this study was to describe the effectiveness and safety of an angiotensin-converting enzyme inhibitor and a nondihydropyridine calcium channel blocker in a single-tablet combination in patients with hypertension, a heart rate higher than 70 beats/min, and type 2 diabetes mellitus (T2DM). This study was conducted in Turkey as a prospective, noninterventional, observational study. At 22 clinical sites, the data of 200 patients with hypertension were used for efficacy analysis; however, 262 patients received at least one dose of trandolapril/verapamil fixed-dose combination at two dose strengths. Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate, PR interval, glycated haemoglobin (HbA1c), and albumin/creatinine ratios were recorded during 8 weeks of treatment. With treatment, the mean (±SD) SBP that was recorded as 162.8 (±14.642) mm Hg at baseline was reduced to 131.7 ± 11.1 mm Hg at week 8 (p < 0.05). Similarly, the mean DBP was reduced from 93.76 ± 9.16 mm Hg to 77.6 ± 7.6 mm Hg (p < 0.001). Following 8 weeks of treatment, SBP and DBP values were reduced below 140 mm Hg and 90 mm Hg in most patients (81.5%), respectively. The mean heart rate as evaluated using electrocardiography measurements was reduced to 78.25 beats/min at week 8 as compared with baseline during trandolapril/verapamil single-pill combination treatment (p < 0.001). Treatment with trandolapril and verapamil was well tolerated over 8 weeks with no unexpected safety signals. In conclusion, the single-pill combination of trandolapril and verapamil was considered effective in reducing and controlling blood pressure in patients with hypertension and T2DM. There was a significant improvement in HbA1c and ACR levels in a smaller subgroup of the patient cohort. The trandolapril/verapamil combination was evaluated as being safe and well-tolerated following a treatment period of 8 weeks. This trial was registered with NCT02298556.

The effect of orlistat and weight loss diet on plasma ghrelin and obestatin.

BACKGROUND: The objective of this study was to evaluate the effect of weight loss with hypocaloric diet and orlistat treatment in addition to hypocaloric diet on gut-derived hormones ghrelin and obestatin. MATERIALS AND METHODS: A total of 52, euglycemic and euthyroid, obese female patients were involved in the study. The patients were assigned to two groups: Group 1 (n = 26) received hypocaloric diet alone and Group 2 (n = 26) received orlistat in addition to hypocaloric diet for 12 weeks. Anthropometric measurements, serum lipid, insulin levels, and obestatin and ghrelin values were assessed at the beginning of the study and after 12 weeks of therapy. RESULTS: Baseline clinical characteristics and laboratory parameters including serum ghrelin and obestatin concentrations and ghrelin/obestatin ratio were similar between the two groups. After 12 weeks, mean change in BMI, fat mass, and fat-free mass (FFM) were -1.97 ± 1.56 kg/m2 (P = 0.003), -2.63% ±2.11% (P = 0.003), and -1.06 ± 0.82 kg (P = 0.003), respectively, in Group 1. In Group 2, mean change in BMI was -2.11 ± 1.24 kg/m2 (P = 0.001), fat mass was -3.09% ±2.28% (P = 0.002), and FFM was -1.26 ± 0.54 kg (P = 0.001). However, fasting glucose, lipid, and insulin levels did not change in Group 1. Furthermore, except serum high-density lipoprotein cholesterol and triglyceride levels, no significant change was observed in Group 2. Although serum ghrelin and obestatin concentrations increased significantly in both groups (Group 1: pGhrelin: 0.047, pobestatin: 0.001 and Group 2: pGhrelin: 0.028, pobestatin: 0.006), ghrelin/obestatin ratio did not change significantly. When the changes in anthropometric assessments and laboratory parameters were compared, no significant difference was observed between the two groups. Furthermore, no correlation was observed between ghrelin or obestatin and any other hormonal and metabolic parameters. CONCLUSION: Weight loss with diet and diet plus orlistat is both associated with increased ghrelin and obestatin concentrations.

Evaluation of circulating endothelial and platelet microparticles in men with ankylosing spondylitis.

OBJECTIVE: To evaluate the profiles of endothelial microparticles (EMP) and platelet microparticles (PMP) in men with ankylosing spondylitis (AS) and healthy subjects. We also aimed to determine whether microparticles (MP) correlate with disease activity, function, and spinal mobility indices. METHODS: There were 82 men with AS and 53 healthy controls. Subjects with a history of chronic diseases including coronary artery disease, hypertension, diabetes mellitus, and dyslipidemia were excluded. MP were stained with monoclonal antibodies against platelets and endothelial cells and quantified using flow cytometry. MP that were positive for both CD42a+/CD31+ and total CD42a+ were identified as PMP; and MP consisting of CD42a-/CD31+ and total CD144+ were considered EMP. RESULTS: EMP and PMP were similar between the patient and control groups (p > 0.05). Comparison of patients with AS in the active disease state (BASDAI ≥ 4) and in the inactive state showed that EMP and PMP were not different between the groups (p > 0.05). Correlation analysis revealed no correlation with Bath Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Functional Index, or Bath Ankylosing Spondylitis Metrology Index. C-reactive protein was significantly correlated with PMP and CD42a-/CD31+ EMP (p < 0.05). Comparison of patients with AS treated with anti-tumor necrosis factor (anti-TNF) drugs, subjects treated conventionally, and healthy controls revealed that PMP and CD42a-/CD31+ EMP were significantly downregulated in patients receiving biological agents. CONCLUSION: Circulating EMP and PMP, known to be indicators and mediators of vascular injury, were not significantly altered in men with AS who did not have classical cardiovascular risk factors. Significantly downregulated MP in patients receiving biological agents suggested that anti-TNF treatment may have a beneficial effect on vascular function in AS.

Comparative levels of macrophage migration inhibitory factor, procalcitonin, osteoprotegerin, interleukin-8, hs-C reactive protein, D-dimer in febrile neutropenia, newly diagnosed cancer patients, and infectious fever.

BACKGROUND: The purpose of this study is to determine the levels of procalcitonin (PCT), IL-8 (interleukin-8), MIF (macrophage migration inhibitory factor), osteoprotegerin (OPG), hs-CRP and D-dimer during fever above 38.3°C due to various causes. MATERIAL AND METHODS: Blood samples taken from a total of consecutive 65 hospitalized patients during fever were prospectively tested for hsCRP, PCT, IL-8, OPG, MIF and D-dimer. Of these patients, there were 26 patients presenting with chemotherapy-induced neutropenia who had no infectious agents found; 23 patients, who had a malignancy with a febrile episode which was neither a microbiologically documented infection nor a chemotherapy-induced neutropenia, and 16 patients who did not have a malignancy and were considered to have a clinically and microbiologically documented infection. RESULTS: IL-8 and D-dimer levels were higher in patients with febrile neutropenia than in the other two groups. Although MIF and OPG were higher in patients with newly diagnosed cancers, there were no differences among the three groups regarding PCT and hs-CRP values. CONCLUSION: High serum IL-8 and D-dimer levels can be useful markers to identify hospitalized chemotherapy-induced neutropenia patients. MIF and OPG were found to be higher in patients with newly diagnosed cancer.

Comparison of conventional dose steroid treatment and high dose steroid treatment as run-in regime for splenectomy in immune thrombocytopenic purpura (ITP).

BACKGROUND: Splenectomy is a treatment procedure for ITP which is being used for more that 50years and is still considered as the best option for the treatment of the condition. The facts that frequent monitoring is not required and that medical treatment is not indicated following splenectomy in most cases are among the major advantages of the procedure. AIM OF THE STUDY: To compare the conventional dose steroid and high dose steroid treatments as run-in regime for splenectomy in patients diagnosed with ITP. METHODS: The conventional dose steroid (1mg/kg, n=20) and high dose steroid treatments (30mg/kg, n=30) were applied to 50 cases with ITP between 1998 and 2008 in our clinic. RESULTS: High dose steroid produced higher platelet count on days 3, 5, and 7 compared to conventional dose steroid. There were no differences between the groups in terms of adverse effects. Treatments were discontinued after the operation by rapidly reducing the dose. Postoperative values regarding response to splenectomy were comparable in both groups. CONCLUSIONS: Both higher and earlier responses obtained with high dose steroid may be significant in reducing hospitalization period of patients and eliminating life-threatening platelet values within the shortest time possible.