Clinical Pattern and Causality Assessment of Drug-induced Cutaneous Reactions in a Tertiary Care Hospital in India: A Prospective Study.

BACKGROUND: Cutaneous Adverse Drug Reactions (ADRs) are common and pose a serious challenge to physicians, especially in cases when the patient has many comorbidities, is polypharmacy, or self-administers over-the-counter medications. OBJECTIVE: The objective of this study is to analyze the clinical pattern and incidence of cutaneous ADRs and perform causality assessment using the WHO-UMC scale and Naranjo's scale. The severity of the reactions was determined by the Hartwig scale. METHODS: This was conducted as a prospective observational study in patients admitted to SRM Medical College, Kattankulathur, Tamil Nadu, India, between November 2016 to August 2018 after obtaining Institutional Ethics Committee clearance of all adverse drug reactions reported at the hospital. RESULTS: Of the 158 ADRs reported during the time period, 101 were cutaneous ADRs, of which the most common presentation was maculopapular rash (n=42; 41.58%). The most common drugs which produced cutaneous adverse reactions were antimicrobials (n=58; 57.42%) followed by NSAIDs (n=35; 34.6%). The causality assessment as per the Naranjo scale yielded 3.96% (4) cases as definite, 81.18% (82) as probable, and 14.85% (15) as possible, whereas the WHO scale yielded 9 (89.10%) certain, 64 (63.36%) probable and 28 (27.72%) possible cases. The severity of the cases determined as per the Hartwig scale yielded 82.17% cases as mild and 17.82% as moderate. CONCLUSION: It is important to recognise the ADRs at the right time and exert caution in future use. This can minimise harm to the patient both physically and financially and improve the outcome of the treatment.

Loratadine vs Rupatadine: Unearthing the Capital Choice in Chronic Idiopathic Urticaria (CIU) - A Randomized Controlled Trial.

Background: Chronic Idiopathic Urticaria (CIU) is a debilitating disease characterised by almost daily presence of urticarial symptoms like short-lived wheals, itching, and erythema for at least 6 weeks without an identifiable cause there by leading to impairment of quality of life of the patient. Aim: To evaluate the efficacy and safety of loratadine and rupatadine in chronic idiopathic urticaria. Methods: This is a prospective, randomized, single-blind, parallel arm study conducted to evaluate the efficacy and safety of loratadine and rupatadine in patients with CIU. The study was registered prospectively with Clinical Trial registry of India (CTRI/2017/05/008624). Institutional Ethics Committee clearance was obtained. Written informed consent was obtained from all the participants before enrolment into the trial. The study was conducted in the outpatient department of Dermatology, SRM Medical College, Kattankulathur, Tamil Nadu, India, during the period from June 2017 to August 2018. Patients with CIU enrolled into the study based on inclusion-exclusion criteria were given the intervention drugs; Loratadine 10 mg once daily or rupatadine10 mg once daily orally for 6 weeks. Results: Rupatadine is more efficacious than loratadine in the reduction of Total Leucocyte Count, Differential Count and Absolute Eosinophil Count, the key determinants of allergy. Rupatadine also produced better improvement in Total symptom Score, Dermatology Life Quality Index in patients with CIU. Conclusion: Analysis of all the parameters of efficacy and safety establishes the probable superiority of rupatadine over loratadine for the treatment of urticaria.

Memantine Ameliorates Migraine Headache.

BACKGROUND AND OBJECTIVE: A significant number of migraine patients do not find effective and safe treatment to reduce the frequency and severity of their migraine attacks. Hence, a need for newer therapeutic agent exists. In this study, we examined the efficacy and safety of memantine for the treatment of migraine. MATERIALS AND METHODS: It was a randomized, placebo-controlled, double-blind study including adult patients with 3-12 migraine headache for the last 6 months conducted in India. Patients received memantine (10 mg/day, once a day) or placebo for the period of 24 weeks after a washout period. Migraine frequency per month, the 50% responder rate, rescue medication use, and adverse events were recorded every 4 weeks. RESULTS: Among 81 patients screened, 60 were enrolled for the study. Thirty patients received memantine and other 30 received placebo. Data were analyzed for 28 patients in memantine group and 29 patients in placebo group. At the baseline, all the parameters were similar in both groups. By 24 weeks, migraine frequency/4 weeks was memantine group versus placebo; 2.57 (±0.38) versus 5.07 (±0.69), P = 0.003 and rescue medication use was 0.75 (±0.23) versus 3.72 (±0.63) P = 0.0001. The 50% responder rate was 85.7% versus 51.7% (P = 0.005). Only a few mild adverse events were recorded in both the groups. No severe adverse events and death were recorded during the study. CONCLUSION: Memantine (10 mg oral, once daily) is effective, well tolerated, and safe for patients with migraine.

Evaluating the efficacy of memantine on improving cognitive functions in epileptic patients receiving anti-epileptic drugs: A double-blind placebo-controlled clinical trial (Phase IIIb pilot study).

OBJECTIVES: People with epilepsy have greater cognitive and behavioral dysfunction than the general population. There is no specific treatment available for cognitive impairment of these patients. We aimed to evaluate the effects of memantine, an N-methyl-D-aspartate-type glutamate receptor noncompetitive antagonist, on improving cognition and memory functions in epileptic patients with cognitive and memory impairment, who received anti-epileptic drugs (AEDs). METHODS: We did a randomized, double-blind, placebo-controlled parallel group trial, in SRM Medical College Hospital and Research Centre, Kattankulathur, Kancheepuram, Tamil Nadu, India between April 2013 and September 2013. Fifty-nine epileptic patients taking AEDs with subjective memory complaints were recruited and randomized to either Group 1 to receive 16 weeks of once-daily memantine, (5 mg for first 8 weeks, followed by memantine 10 mg for next 8 weeks) or Group 2 to receive once daily placebo. This trial is registered with Clinical Trial Registry of India CTRI/2013/04/003573. RESULTS: Of 59 randomized patients, 55 patients completed the study (26 memantine and 29 placebo). Memantine group showed statistically significant improvement in total mini mental state examination score from baseline (P = 0.765) to 16(th) week (P < 0.001) in comparison with the placebo. The Weshler's Memory Scale total score in memantine group improved significantly after 8 weeks (P = 0.002) compared with baseline (P = 0.873) and highly significant at the end of 16(th) week (P < 0.001). The self-rated quality of life and memory in memantine group also significantly improved at the study end. CONCLUSION: We conclude that once-daily memantine (10 mg) treatment significantly improved cognition, memory and quality of life in epileptic patients with mild to moderate cognitive impairment and was found to have a favorable safety profile.