PubMed | Northwestern University, Seoul National University, Eastern Virginia Medical School, Yonsei University and 2 more.
Type: Journal Article | Journal: Annals of clinical and translational neurology | Year: 2015
To evaluate the safety and efficacy of a plasmid (VM202) containing two human hepatocyte growth factor isoforms given by intramuscular injections in patients with painful diabetic neuropathy.In a double-blind, placebo-controlled study, patients were randomized to receive injections of 8 or 16mg VM202 per leg or placebo. Divided doses were administered on Day 0 and Day 14. The prospective primary outcome was change in the mean pain score measured by a 7day pain diary. Secondary outcomes included a responder analysis, quality of life and pain measures, and intraepidermal nerve fiber density.There were no significant adverse events attributable to VM202. Eighty-four patients completed the study. Patients receiving 8mg VM202 per leg improved the most in all efficacy measures including a significant (P=0.03) reduction at 3months in the mean pain score and continued but not statistically significant reductions in pain at 6 and 9months. Of these patients, 48.4% experienced a 50% reduction in pain compared to 17.6% of placebo patients. There were also significant improvements in the brief pain inventory for patients with diabetic peripheral neuropathy and the questionnaire portion of the Michigan Neuropathy Screening Instrument. Patients not on pregabalin or gabapentin had the largest reductions in pain.VM202 was safe, well tolerated and effective indicating the feasibility of a nonviral gene therapy approach to painful diabetic neuropathy. Two days of treatment were sufficient to provide symptomatic relief with improvement in quality of life for 3months. VM202 may be particularly beneficial for patients not taking gabapentin or pregabalin.
Rezaee M.E.,University of New Hampshire |
Nichols E.L.,The Dartmouth Institute for Health Policy and Clinical Practice |
Sidhu M.,Albany Medical Center Albany |
Brown J.R.,Dartmouth Hitchcock Medical Center
Clinical Cardiology | Year: 2016
Background: Pulmonary hypertension (PH) is a well-recognized complication of left ventricular heart failure (HF). Hypothesis: Differences exist in demographic, clinical, hemodynamic, and survival characteristics of patients with left ventricular HF who have combined postcapillary and precapillary PH (CpcPH), isolated postcapillary PH, or no PH. Methods: A secondary data analysis was conducted using a large prospective database of patients undergoing right heart catheterization from 1994 to 2012. One-year mortality postcatheterization was assessed between PH groups using Kaplan-Meier and log-rank techniques, as well as a multivariate Cox proportional hazards model adjusted for age, sex, diabetes, chronic kidney disease, atrial fibrillation, and chronic obstructive pulmonary disease. Mortality rates were calculated for each group as deaths per 100 person-years. Results: Of the 724 patients identified, 29.4% (n=213) had no evidence of PH, 63.1% (n=457) had isolated postcapillary PH, and 7.5% (n=54) had CpcPH. Compared with no PH, there was an increased mortality rate within 1 year for CpcPH patients (crude hazard ratio: 5.22, 95% confidence interval: 2.06-13.22), but not for isolated postcapillary PH patients (crude hazard ratio: 2.12, 95% confidence interval: 0.99-4.57). Adjusted analyses revealed similar results. Mortality rates per 100 person-years were 3.9, 8.4, and 21.0 for no PH, isolated postcapillary PH, and CpcPH patients, respectively. Conclusions: Heart failure patients with CpcPH are associated with increased death rate 1 year post-cardiac catheterization, compared with patients without PH. They are a high-risk PH group and should be evaluated and diagnosed earlier in the disease state. © 2016 Wiley Periodicals, Inc.