End Of Follow-up Phase Research Articles

Efficacy and durability of multifactorial intervention on mortality and MACEs: a randomized clinical trial in type-2 diabetic kidney disease

BackgroundMultiple modifiable risk factors for late complications in patients with diabetic kidney disease (DKD), including hyperglycemia, hypertension and dyslipidemia, increase the risk of a poor outcome. DKD is associated with a very high cardiovascular risk, which requires simultaneous treatment of these risk factors by implementing an intensified multifactorial treatment approach. However, the efficacy of a multifactorial intervention on major fatal/non-fatal cardiovascular events (MACEs) in DKD patients has been poorly investigated.MethodsNephropathy in Diabetes type 2 (NID-2) study is a multicentre, cluster-randomized, open-label clinical trial enrolling 395 DKD patients with albuminuria, diabetic retinopathy (DR) and negative history of CV events in 14 Italian diabetology clinics. Centres were randomly assigned to either Standard-of-Care (SoC) (n = 188) or multifactorial intensive therapy (MT, n = 207) of main cardiovascular risk factors (blood pressure < 130/80 mmHg, glycated haemoglobin < 7%, LDL, HDL and total cholesterol < 100 mg/dL, > 40/50 mg/dL for men/women and < 175 mg/dL, respectively). Primary endpoint was MACEs occurrence by end of follow-up phase. Secondary endpoints included single components of primary endpoint and all-cause death.ResultsAt the end of intervention period (median 3.84 and 3.40 years in MT and SoC group, respectively), targets achievement was significantly higher in MT. During 13.0 years (IQR 12.4–13.3) of follow-up, 262 MACEs were recorded (116 in MT vs. 146 in SoC). The adjusted Cox shared-frailty model demonstrated 53% lower risk of MACEs in MT arm (adjusted HR 0.47, 95%CI 0.30–0.74, P = 0.001). Similarly, all-cause death risk was 47% lower (adjusted HR 0.53, 95%CI 0.29–0.93, P = 0.027).ConclusionMT induces a remarkable benefit on the risk of MACEs and mortality in high-risk DKD patients.Clinical Trial Registration ClinicalTrials.gov number, NCT00535925. https://clinicaltrials.gov/ct2/show/NCT00535925

Prospective study on comparison of efficacy of topical anti-fungal agents: clotrimazole 1% and sertaconazole 2% in treatment of tinea cruris

&lt;p class="abstract"&gt;&lt;strong&gt;Background:&lt;/strong&gt; Tinea cruris is a common superficial dermatophytic infection of the skin occurring in 20-25% population worldwide. The various types of antifungal agents are available for topical use in treatment of tinea cruris. Clotrimazole is conventional imidazole antifungal drug whereas sertaconazole is newer imidazole antifungal claimed to be superior to clotrimazole in tinea infection. The aim of the study was to determine and compare the efficacy of potent topical azole agents 1% clotrimazole and 2% sertaconazole in patients diagnosed with tinea cruris attending out-patient department of skin and VD of tertiary care hospital in Vadodara.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Methods:&lt;/strong&gt; A total of 71 patients diagnosed with tinea cruris were divided into two groups. Group A received topical clotrimazole (1% cream), and Group B received topical sertaconazole (2% cream). Outcome parameters such as erythema, scaling, itching, margins of lesions and size of lesions were noted atthe time of hospital visit, by 3rd week and by 6th week for the assessment of efficacy. The statistical test used was independent student t-test and software used was SPSS 20.0.&lt;strong&gt;&lt;/strong&gt;&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Results:&lt;/strong&gt; At the end of follow-up phase, both the drugs were found to be effective with no recurrence or relapse of tinea cruris. However, compared to clotrimazole 1% cream, sertaconazole 2% cream had statistically significant rapid relief in terms of reduction in clinical parameters such as erythema (p&amp;lt;0.001), scaling (p&amp;lt;0.001), itching (p&amp;lt;0.001), size of lesion (p&amp;lt;0.001) and margin of lesion (p&amp;lt;0.011).&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Conclusions:&lt;/strong&gt; Topical sertaconazole 2% cream was found to be highly efficacious and superior to clotrimazole 1% cream in improvement of clinical parameters of tinea cruris.&lt;/p&gt;

Behavioural and cognitive effects during vagus nerve stimulation in children with intractable epilepsy – A randomized controlled trial

Background/AimsIn addition to effects on seizure frequency in intractable epilepsy, multiple studies report benefits of vagus nerve stimulation (VNS) on behavioural outcomes and quality of life. The present study aims to investigate the effects of VNS on cognition, mood in general, depression, epilepsy-related restrictions and psychosocial adjustment in children with intractable epilepsy, as well as the relation between these effects and seizure reduction. MethodsWe conducted a randomized, active-controlled, double-blinded, add-on study in 41 children (age 4–18) with medically refractory epilepsy. We performed cognitive and behavioural testing at baseline (12 weeks), at the end of the blinded phase (20 weeks) in children receiving either high-output or low-output (active control) stimulation, and at the end of the open label phase (19 weeks) with all children receiving high-output stimulation. Seizure frequency was recorded using seizure diaries. ResultsVNS did not have a negative effect on cognition nor on psychosocial adjustment. At the end of the follow-up phase we noted an improvement of mood in general and the depression subscale for the entire group, unrelated to a reduction of seizure frequency. At the end of the blinded phase a ≥50% reduction of seizure frequency occurred in 16% of the high-stimulation group and 21% of the low-stimulation group. At the end of the open-label follow-up phase, 26% of the children experienced a seizure frequency reduction of 50% or more (responders). ConclusionsVNS has additional beneficial effects in children with intractable epilepsy. As opposed to anti-epileptic drugs, there are no negative effects on cognition. Moreover, we observed an improvement of mood in general and depressed feelings in particular, irrespective of a reduction in seizure frequency. These beneficial effects should be taken into account when deciding whether to initiate or continue VNS treatment in these children.