SAFETY AND EFFICACY OF SUBLINGUAL SPECIFIC IMMUNOTHERAPY TO HOUSE DUST MITE USING A DIFFERENT DOSAGE: A PILOT STUDY.

The aim of this randomized open study was to evaluate the safety and efficacy of different dosages (2000 UI vs 4000 UI) of sublingual immunotherapy (SLIT) in patients with allergic diseases such as asthma associated to rhinitis and rhinoconjunctivitis sensitized to house dust mites. We enrolled 61 patients with a history of allergic asthma, and a positive skin prick test for Dermatophagoides (D.) pteronyssinus/farinae. Patients were randomly assigned to receiving SLIT at dosage of 2000 UI (Group A) or 4000 UI (Group B) maintenance dose. We evaluated: subjective symptoms using a Visual Analogic Scale (VAS), the amount of prescribed symptomatic drugs, bronchial reactivity to methacoline and side effects using a specific questionnaire. A significant improvement in symptoms, assessed by VAS, was observed with both SLIT doses with no significant differences between groups. The provocation dose of methacoline inducing a 20% fall of FEV1 significantly increased after 12 months only in the 4000 UI dose group. In conclusion, both monomeric allergoid dosages of SLIT (2000 UI and 4000 UI) are a safe and efficacy option to reduce symptoms in patients with allergic asthma caused by house dust mites. Moreover, both dosages are efficacious even to protect against airway reactivity but it seems that monomeric allergoid of SLIT at higher dosage (4000 UI) is better than at the lower dosage (2000 UI).

Effect of two doses of carbamylated allergoid extract of dust mite on nasal reactivity.

Background and Objective. Single SLIT studies with native allergen extracts support a dose-response effect for clinical and immunological outcomes. Conversely for carbamylated allergoids this dose-response effects is less evident, likely because the threshold for efficacy is more easily reached through the enhanced bioavailability of the extract consequent to the selective chemical modification. Thus this pilot study investigates the dose-response effect on nasal specific reactivity and safety of two unusual doses of carbamylated allergoid in patients mono-sensitized to house dust mites. Methods. A prospective open randomized study involved 6-65 year-old Italian patients with clinically relevant sensitization to house dust mites and positive response to nasal provocation challenge. Monomeric carbamylated allergoid was delivered once daily at the dose of 1000 AU or 2000 AU from June to September 2009, during the lowest level of mites exposure. Primary outcomes were the change of the threshold of allergen concentration for a positive nasal provocation test (NPT) before and after the treatment and the product safety. Secondary outcome was the change  in the mean percentage fall of peak nasal inspiratory flow (PNIF) following nasal challenge. Results. Thirty-four patients were enrolled. Fifteen in group 1 and 14 in group 2 concluded the study. After 12 weeks all patients treated in group 1 and all but one in group 2 showed an increase in the threshold dose provoking a positive NPT. Those with no symptoms onset with the highest dose delivered were 80% in group 1 and 78.6% in group 2 (p=0.92). From first to second challenge, the mean percentage fall of PNIF  was reduced with no statistical difference between groups (p=0.95), and with no difference between the final mean percentage falls (p=0.65). No serious adverse reactions occurred and the frequency of events, all mild, was similar in the two groups. Conclusions. Twelve weeks of carbamylated sublingual allergoid delivered at 1000AU or 2000AU once daily appear equally safe and show comparable effect in increasing  the threshold of allergen concentration for a positive nasal provocation test, confirming the apparent absence of a dose response effect for the used doses.

Low glucose blood levels are associated with abnormal cardiac sympatho-vagal balance in type 2 diabetic patients with coronary artery disease.

BACKGROUND AND OBJECTIVES: Glycemic control has been suggested to improve prognosis in diabetic patients, but recent trials failed to show benefits from intensive glycemic control. Hypoglycaemic episodes or large variability in glucose blood levels causing a sympatho-vagal imbalance of cardiac autonomic function (CAF) might play a role in this result. In our study we assessed whether blood glucose fluctuation may be related to variations in CAF during daily life in diabetic patients with coronary artery disease (CAD). MATERIALS AND METHODS: Twelve patients with type 2 diabetes mellitus with CAD (65+/-4 years, 2 women) underwent simultaneous 48-hour ECG Holter monitoring and continuous interstitial glucose measurements. The highest and lowest glucose levels for each 3-hour segments of the day were identified and heart rate variability (HRV) parameters were measured on Holter recordings on 5-minute intervals centred on these times. RESULTS: Overall, 294 glucose levels were available for analysis. In the whole population several HRV indices were significantly lower in correspondence of the lowest glucose blood levels and this difference was much more evident in patients who were not taking beta-blockers, than in patients who were taking beta-blockers. A significant, although mild, correlation was found between glucose blood levels and several time-and frequency domain HRV variables in patients not taking beta-blockers, but not in these on beta-blockers therapy. DISCUSSION: Our data suggest that, in type 2 diabetic patients with CAD, hypoglycaemic episodes are associated with depressed HRV and that beta-blocking agents are able to contrast this relation. These interesting results merit to be investigated in a larger population of patients.

Bioresorbable scaffolds: focus on vascular response and long-term safety.

Bioresorbable vascular scaffolds (BVS) are considered the fourth revolution in Interventional Cardiology, thus promising to address some of the pending issues with current-generation drug eluting stents (DES). Notably, most of the potential advantages of BVS over other current devices are due to a peculiar vascular response, called "vascular restoration therapy". The emerging data from real-world expanded use registries suggest that BVS use is feasible in a wide variety of patients (from low- to high- risk), and lesions (from simplex to complex). However, few safety concerns with currently available BVS have arised from initial experiences all over the word. Data from ongoing large-scale randomized controlled trials will be able to demonstrate whether BVS improve patient early and long-term outcomes compared to best-in-class DES.

RAndomized Comparison of raDIal vs. femorAL Access for Routine Catheterization of Heart Transplant Patients (RADIAL-heart transplant study).

Although a transradial approach (TRA) is considered feasible in many clinical situations, no data are available in patients undergoing orthotopic heart transplantation (OHT). Our goal was to randomly compare TRA versus a transfemoral approach (TFA) in this clinical setting. This single-center, prospective, randomized trial was conducted from January to November 2006, and all OHT patients scheduled for a control coronary angiography were randomized to receive TRA or TFA. The primary endpoint was the amount of contrast used during the procedure. The participating interventional cardiologists were intermediate-volume radial operators, and this was their initial experience of TRA in OHT patients. The analysis was performed according to the intention-to-treat principle. Overall, 49 patients (mean age, 55 ± 13 years; 74% male) were included in the trial: 26 patients were assigned to TRA, and 23 were assigned to TFA. A higher amount of contrast (147 mL [range, 113-175 mL] vs 105 mL [range, 86-127 mL]; P = .009), a longer fluoroscopy time (9.2 minutes [range, 6-12 minutes] vs 3.5 minutes [range, 3-5 minutes]; P < .001), a trend toward increased number of catheters used for left ostium cannulation, and a higher crossover rate (19% vs 0%; P = .03) were associated with TRA compared with TFA. Furthermore, patients treated with TRA exhibit a shorter hospital stay (6 [range 4-8]) compared with the other group (26 [range 24-28]) (P < .001). There were no significant differences between the 2 groups regarding total procedural time, and no vascular complications were reported in either group. For these operators with their first experience of TRA in OHT patients, TFA seemed to be more efficient.