Real-World Evaluation of the Safety and Effectiveness of 2.3% Hypertonic Saline Soft Mist Spray for Sino-Nasal Symptoms.

Introduction and aims Mildly hypertonic saline is more effective in relieving symptoms of nasal congestion compared to placebo or isotonic saline. Recently, a unique device, delivering a soft mist of 2.3% hypertonic sea-salt saline (Nasoclear PureHaleTM; Zydus Healthcare Ltd., India) has been introduced in India. The device uses a power-less manual technique to release the saline as a soft mist at 1 ml/min. Methods This is a retrospective, multi-centric, single-arm study to evaluate the safety and effectiveness of 2.3% hypertonic sea-salt saline nasal irrigation delivered through a soft mist device in patients with sino-nasal symptoms. This is an analysis of data of 130 patients collected from the medical records of 11 practicing pediatricians across India. Results The mean age of the patients was 5.23 ± 4.24 years; 63 % were boys and 37% were girls (n = 130). The mean reduction in total nasal symptom score (TNSS) at follow-up from baseline was 6.28 ± 0.18 (median days = 7) (95% CI = 5.92 to 6.64; p<0.0001; mean TNSS at baseline = 7.75 ± 2.01, mean TNSS at follow-up = 1.47± 1.30). Out of 130 patients, 33 patients (25.3%) showed complete improvement in TNSS, 93 patients (71.5%) had ≥ 50% improvement in TNSS while 4 patients (3.07%) showed <50% improvement in TNSS. The effectiveness of the device was rated as excellent (75%-100% improvement) and very good (50%-75% improvement) in 41 and 74 patients, respectively. It was rated as very easy to use and easy to use by 62 patients and 57 patients, respectively. One hundred nineteen patients (91.5%) were compliant with the prescribed frequency of the device and 110 patients (84.6%) were compliant with the prescribed duration of use of the device. No serious adverse events were reported; two patients reported mild side effects - stinging and irritation of the throat. Conclusions The 2.3% hypertonic sea-salt saline nasal irrigation delivered through the soft mist device was found to be well-tolerated and effective in patients with sino-nasal symptoms in real-world clinical settings. Clinical trial number The clinical trial number of this study is CTRI/2022/07/043751.

Efficacy and safety of Once-Daily Vilanterol/Fluticasone furoate MDI in persistent asthma: Phase 3 OD-INHALE Study.

INTRODUCTION: Once-daily inhalers have been shown to improve adherence leading to lesser discontinuation compared to twice- or thrice-daily inhalers in management of asthma. Combination of Vilanterol and Fluticasone Furoate (VI/FF) is approved for management of asthma and COPD and is available as a dry powder inhaler. Pressurized-Metered Dose Inhalers (pMDIs) offer ease-of-use and therapy alternatives for patients with low inspiratory flow. This study assessed the efficacy and safety of a new once-daily pMDI containing VI/FF in individuals diagnosed with persistent asthma. METHODS: This phase 3, double-blind, randomized controlled study assessed the non-inferiority of VI/FF (12.5 mcg/50 mcg & 12.5 mcg/100 mcg; 2 puffs once-daily) over Formoterol Fumarate and Fluticasone Propionate (FOR/FP, 6 mcg/125 mcg & 6 mcg/250 mcg; 2 puffs twice-daily) in patients with persistent asthma. Primary outcome was change from baseline in trough FEV1 at the end of study (12 weeks). Adverse events and number of exacerbations were used to evaluate safety. RESULTS: A total of 330 patients were randomized into VI/FF (165) and FOR/FP (165). Trough FEV1 significantly improved in both the groups at week 12, with a mean difference (VI/FF minus FOR/FP) being 54.75 mL (95% CI, 8.42-101.08 mL, p = 0.02). The low dose VI/FF had similar efficacy to that of low dose FOR/FP and high dose VI/FF had similar efficacy to high dose FOR/FP. No serious adverse events were reported during the study. CONCLUSION: Once daily VI/FF pMDI was non-inferior to twice daily FOR/FP pMDI in patients with persistent asthma.

A Real-World Observational Study to Evaluate the Safety and Effectiveness of Fluticasone Furoate-Oxymetazoline Fixed Dose Combination Nasal Spray in Patients with Allergic Rhinitis.

BACKGROUND: Allergic rhinitis (AR) has shown an increasing prevalence leading to a considerable medical and social burden. Nasal congestion is the cardinal symptom of AR, and the upper respiratory tract is most affected by this long-lasting ailment. Intranasal corticosteroids alleviate nasal congestion, along with other symptoms of AR, but their effect is not evident immediately. Oxymetazoline has a rapid onset of action, but its use should be limited to 3-5 days. OBJECTIVE: The study aimed to evaluate the safety and effectiveness of the fixed-dose combination nasal spray containing fluticasone furoate and oxymetazoline hydrochloride (FF + OXY) 27.5/50 mcg once daily in patients with AR in a real-world clinical setting. METHODS: The study was a prospective, open-label, single-arm, multicenter, real-world observational study conducted in patients with AR for a period of 28 days. Patients (n = 388) with a diagnosis of AR were treated with a combination of FF + OXY nasal spray. Total nasal symptom score (TNSS), total ocular symptom score (TOSS) and total symptom score (TSS) were documented at baseline and at the end of study period. The overall effectiveness of treatment with FF + OXY was rated by the investigators as very good/good/satisfactory/poor (4-point Likert scale) for each patient. RESULTS: Treatment with FF + OXY resulted in significant reduction in the TNSS, TOSS and TSS, from 7.18 ± 3.38 at baseline to 0.20 ± 0.84 (p < 0.001), from 2.34 ± 2.29 at baseline to 0.09 ± 0.53 (p < 0.001), from 9.51 ± 4.94 at baseline to 0.29 ± 1.32 (p < 0.001) at 28 days respectively. With respect to effectiveness, the investigators reported very good effectiveness in 52.12% of patients. No serious adverse events were reported. CONCLUSION: The fixed-dose combination of once-daily fluticasone furoate and oxymetazoline hydrochloride nasal spray 27.5/50 mcg was effective in relieving the nasal congestion and reduction of TNSS, TOSS and TSS in patients suffering from AR. The combination was safe and well tolerated with no rebound congestion throughout the treatment period.

The Safety and Effectiveness of Decapeptide in Patients With Vitiligo: A Real-World Study.

Background Vitiligo, a chronic autoimmune depigmenting skin disease, affects a significant portion of the global population. One of the topical treatment options for vitiligo is basic fibroblast growth factor (bFGF)-related decapeptide (bFGFrP) 0.1% solution. This study aimed to assess the real-world effectiveness and safety of decapeptide in treating vitiligo. Methods This retrospective analysis utilized data collected from routine clinical practice in the management of vitiligo, focusing on patients treated with topical decapeptide lotion (Melgain™, manufactured by Zydus Healthcare Ltd., Ahmedabad, India). The primary outcome measures included the extent of re-pigmentation (EOR) and the grade of re-pigmentation (GOR) assessed at each follow-up visit. Results The analysis included data from 65 patients (24 males and 41 females) with an average age of 30.83 years. Segmental vitiligo was present in 52.31% of cases, with the face being the most commonly affected site. Among the patients, 33 received decapeptide as monotherapy, while 32 received decapeptide alongside adjuvant drug/phototherapy. The mean duration of treatment was five months. The first, second, and final follow-ups were observed to be at a mean of 45 days, two months, and five months, respectively. During the second and final follow-up, a significant response (>75% re-pigmentation) was observed in 12% (eight) and 71% (46) of the patients. A mild response (<50% re-pigmentation) was noted in 45% (29) of the patients during the first follow-up visit, 15% (10) during the second follow-up visit, and 6% (four) during the final follow-up visit. Grade 6 and 7 re-pigmentation occurred in a higher number of patients at the final visit, indicating treatment effectiveness. Overall, nearly all patients (96.92%) reported excellent tolerability of the decapeptide lotion based on the global assessment of tolerability. Conclusion This real-world study demonstrates that decapeptide promotes re-pigmentation and improves patient outcomes in vitiligo. Both decapeptide regimens, as monotherapy or in combination with other therapies, were effective and well tolerated by most patients. Thus, decapeptide represents a safe and effective therapeutic option for vitiligo treatment.

Biochemical findings in sudden unexpected death in epilepsy: Hospital based case-control study.

PURPOSE: A review study on the biochemistry of epilepsy showed that in epileptic patients, serum glucose and cholesterol concentrations are low, sodium is unaffected, potassium increases, glucose is high and mild hypocalcemia. We have conducted a biochemical study on sudden unexpected death in epilepsy (SUDEP) cases in an attempt to establish the characteristic biochemical values to diagnose these deaths. METHODS: This was a hospital based case-control study done at All India Institute of Medical Sciences, New Delhi for one year. Twenty SUDEP cases and 20 age- and sex-matched controls were included in the study. Femoral blood, cerebrospinal fluid, vitreous humor, and pericardial fluid were biochemically analyzed for sodium, potassium, calcium, glucose, N-acetyl- cysteine activated creatine kinase (CK-NAC) and isoenzyme CK-MB. RESULT: Serum sodium, CK-MB and CK-NAC level was found significantly increased and potassium level was found decreased in SUDEP cases in comparison to non-epileptic deaths. Likewise, in CSF, sodium and CK-NAC was found increased and potassium level was found decreased in SUDEP cases. In vitreous humor, sodium and CK-MB level was found increased and potassium level was found decreased in SUDEP cases in comparison to non-epileptic deaths. In pericardial fluid, sodium, CK-NAC and CK-MB level was found increased and potassium level was found decreased in SUDEP cases in comparison to non-epileptic deaths. CONCLUSION: It concludes that high sodium level and low potassium level could be associated with SUDEP. However, this is a small size study, a larger study is needed to verify the findings. Furthermore, it is difficult to conclude whether these findings are exclusive to SUDEP.

New dual peroxisome proliferator activated receptor agonist-Saroglitazar in diabetic dyslipidemia and non-alcoholic fatty liver disease: integrated analysis of the real world evidence.

BACKGROUND: Saroglitazar, a novel dual peroxisome proliferator activated receptor (PPAR) agonist, in clinical trials, has shown an improvement in lipid and glycemic parameters through the PPAR-α and γ agonist actions, respectively. It was granted marketing authorization in India in 2013 for diabetic dyslipidemia. This review was conducted to summarize the effects of Saroglitazar in patients with diabetic dyslipidemia in real world clinical studies conducted after marketing authorization in India. METHODS: In this review, we selected real world clinical studies of Saroglitazar published as manuscripts and abstracts presented at scientific conferences. In all these studies, patients with diabetic dyslipidemia were treated with Saroglitazar 4 mg once daily for at least 12 weeks and different lipid and glycemic parameters were measured at the baseline and end of the study. RESULTS: In 18 selected studies (5 published manuscripts and 13 abstracts), a total of 5824 patients with diabetic dyslipidemia were prescribed Saroglitazar 4 mg for a duration ranging from 12 to 58 weeks. Across all the studies, mean age of patients ranged from 49.6 to 59.1 years and the proportion of female patients ranged from 22% to 42%. Across all the studies, there was a consistent mean reduction in triglyceride levels (~ 45% to 62%), total cholesterol levels (~ 17% to 26%), non-high-density lipoprotein cholesterol levels (~ 21% to 36%), low-density lipoprotein cholesterol levels (~ 11% to 27%), and glycosylated hemoglobin levels (~ 0.7% to 1.6%) with an increase in mean high-density lipoprotein cholesterol levels (up to 9%) from baseline to end of the study. Saroglitazar also improved alanine aminotransferase levels and fatty liver (evaluated by FibroScan™) in non-alcoholic fatty liver disease patients with diabetic dyslipidemia. Body weight remained unchanged and no significant adverse events (AEs) were reported in the studies. CONCLUSION: Saroglitazar effectively improved lipid and glycemic parameters without significant AEs in patients with diabetic dyslipidemia in real-world clinical studies of up to 58 weeks duration.

Red Eccrine Chromhidrosis with Review of Literature.

A 22-year-old male presented with reddish discoloration of the vest following perspiration for 6 months. He was a habituated consumer of cranberry juice. The peak absorption on spectrophotometric analysis of the extracted sweat coincided approximately with the peak absorption of diluted distillate of the juice. A diagnosis of eccrine chromhidrosis, probably due to the coloring agents in the juice, was considered. This rare case report emphasizes the possible side effect of the various coloring agents used as food additives.

Granuloma faciale: An unusual diascopic finding.

Granuloma faciale (GF) is a benign, chronic inflammatory disorder, characterized by reddish brown plaques with prominent follicular orificesand telangeictasia, usually occurring over the face. The condition often presents a problem in differential diagnosis. Herein we describe a case of GF with an unusual diascopic finding of an apple jelly appearance on diascopy.

Assessment of efficacy, safety, and tolerability of 4-n-butylresorcinol 0.3% cream: an Indian multicentric study on melasma.

INTRODUCTION: Melasma is one of the commonly reported pigmentory disorders in the Indian population. Numerous therapeutic modalities are available. However, very few have produced complete satisfactory response. 4-n-Butylresorcinol 0.3% cream has recently been introduced in India as a new hypopigmenting agent. It is a resorcinol derivative and acts by inhibiting both tyrosinase and tyrosinase-related protein-1. OBJECTIVE: The available published literatures are with 4-n-butylresorcinol 0.1% cream, and there is paucity of clinical studies with 4-n-butylresorcinol 0.3% cream. Furthermore, considering the fact that Indian skin is more prone to irritation with hypopigmenting agents, our study explores the efficacy, safety, and tolerability of 4-n-butylresorcinol 0.3% cream in Indian subjects with melasma. METHODS: Fifty-two subjects with melasma participated in this open-label, single arm, observational study. All the patients were advised twice daily application of 4-n-butylresorcinol 0.3% cream for 8 weeks over the areas of melasma. Assessment parameters included modified Melasma Area Severity Index (mMASI) score. Digital photographs of all the patients at baseline, week 4, and week 8 were taken. During this 8-week study period, all the adverse events were observed and recorded. RESULTS: All the 52 subjects completed the study. Out of 52 subjects, 90.38% were females. The mean age of patients was 38.5±7.8 years. Mean ± standard error of MASI score measurements showed a significant decrease from baseline score of 14.73±0.59 to 11.09±0.53 after week 4 (P<0.001) and 6.48±0.43 at week 8 (P<0.001). The digital photographs of the study subjects taken at week 4 and week 8 also showed decrease in melasma pigmentation compared to baseline photograph and correlated with the changes in the mMASI score. The treatment was well tolerated by all the study subjects. No adverse reactions were reported throughout the study period. CONCLUSION: Our data suggest that the 4-n-butylresorcinol 0.3% cream is safe, effective, and well tolerated in Indian patients with melasma.

Keloids: an unwanted spontaneity in rubinstein-taybi syndrome.

Rubinstein-Taybi syndrome (RTS) is a rare developmental disorder comprising of mental retardation, unusual facial appearance, broad thumbs, and big toes. It is frequently associated with molecular lesions in the cAMP response element binding protein. Many cutaneous abnormalities are associated with RTS. Multiple spontaneous keloids are some of them. We hereby report a case of this rare syndrome associated with keloids without any preceding trauma.

Porokeratosis - Head to toe: An unusual presentation.

Porokeratosis is a disorder of epidermal proliferation in which many different clinical variants can be distinguished. Herein we report a rare case of porokeratosis involving almost all parts of the body with simultaneous occurrence of various forms of the disease in the same individual (classical porokeratosis of Mibelli, disseminated superficial actinic porokeratosis, hypertrophic porokeratosis, and genital porokeratosis).

Observational study to evaluate the safety and efficacy of saroglitazar in Indian diabetic dyslipidemia patients.

UNLABELLED: Saroglitazar is a dual PPAR α/γ agonist approved in India for the management of diabetic dyslipidemia. AIMS: The objective of this study was to evaluate the safety and efficacy of saroglitazar 4 mg once daily in clinical practice. METHODS: This was an observational, multicenter, single-arm study. Patients with type 2 diabetes (with on-going antidiabetic medication), age above 18 years, and triglycerides ≥200 mg/dL were included. RESULTS: A total 2804 patients with a mean duration of diabetes 6.29 yrs were included in this analysis. The baseline demographic profile was: mean age of 53 yrs, mean body weight 72.3 kg and mean BMI of 27 kg/m(2). 62.5% patients were male and 57.8% were reported to be on statin therapy at baseline. All 2804 patients were on antidiabetic medications with 15.4% patients on monotherapy and rest were on two or more than two antidiabetic medications at baseline. The baseline triglycerides and HbA1C values were 312.3 mg/dL and 8.3% respectively. At 3 months follow-up, use of saroglitazar 4 mg led to significant reduction in TG (35.8%), LDL-C (16.4%), total cholesterol (19%) and non-HDL-C (23.4%). Addition of saroglitazar to baseline antidiabetic medications showed a significant 0.9% absolute reduction in HbA1c with significant improvement in fasting and post prandial plasma glucose. No serious adverse events, alteration in liver or renal enzymes and edema or weight gain were reported. CONCLUSION: Saroglitazar is a potential therapeutic option in type 2 diabetic patients with high TG levels, not controlled by statins, for comprehensive control of lipid and glycemic parameters with acceptable safety profile.

Unusual presentation of cutaneous leiomyoma.

Herein, we report a case of leiomyoma cutis because of its rarity and unusual presentation. The case presented with a solitary leiomyoma lesion which was painless. However, the adjacent normal appearing area was tender. A biopsy of the lesion as well as of a portion of the adjacent normal appearing area was taken, which confirmed the diagnosis of cutaneous leiomyoma. This may suggest the dormant nature of the disease which has not yet become apparent.

Gynaecothelia--a common yet ignored sign of multibacillary leprosy in males: a case series with review of literature.

Leprosy is one of the causes of gynaecothelia (enlargement of nipples), however little has been published about this common but usually ignored sign. Herein, we report nine male patients with multibacillary leprosy who had gynaecothelia although only two of them had associated gynaecomastia. None of these patients was aware of gynaecothelia until it was detected by the treating doctor during examination. This study is presented to highlight this common but ignored sign, which may occur specifically in multibacillary leprosy.

Effect of antihypertensive therapy on cognitive functions of patients with hypertension.

OBJECTIVES: Hypertension is known to be associated with cognitive decline. Many studies revealed that control of hypertension with antihypertensive therapy controls the cognitive decline associated with hypertension. While there are reports that suggest that antihypertensive drugs do not provide protection from cognitive decline, the present study is designed to evaluate the cognitive status of patients recently diagnosed as hypertensive and effect of 3 month long antihypertensive therapy on cognitive functions. MATERIALS AND METHODS: A predesigned pretested questionnaire was used to collect the information. The PGI memory scale (PGIMS) was employed to assess memory function of patients. Baseline memory functions were evaluated before starting the treatment with antihypertensive and compared with the cognitive function scores of healthy volunteers. After the 3 months of treatment, cognitive functions were evaluated again by the same scale. The unpaired t-test was used to compare the cognitive functions between case and control and the paired t-test was used to compare pre- and post-treatment score. RESULTS: This study revealed that mean scores of six subtests of cognitive functions were less in cases as compared to subjects in comparison group. After 3 months of antihypertensive therapy, scores of five sub-tests were found to be increased. Among these five subtests, four were those which were found declined at the baseline. CONCLUSION: This suggests that antihypertensive therapy given for 3 months improved the score of those cognitive function tests in which hypertensive patients perform poorly during recruitment and there was no deterioration of any test after 3 months of antihypertensive therapy.