Upfront liquid next-generation sequencing in treatment-naïve advanced non-small cell lung cancer patients: A prospective randomised study in the Taiwanese health system.

BACKGROUND: Next-generation sequencing (NGS) of plasma cell-free DNA identifies driver mutations in advanced non-small cell lung cancer (NSCLC) and may complement routine molecular evaluation. The utility of liquid NGS at the start of tumour workup is undetermined. METHODS: This is a randomised study of patients with suspected advanced NSCLC. All patients received blood liquid NGS testing at their first clinic visit and underwent standard histological diagnosis and tissue genotyping, encompassing polymerase chain reaction based methods for EGFR mutation, immunohistochemical (IHC) staining for ALK fusion and BRAF V600E mutation, and an IHC screening followed by confirmation using fluorescence in situ hybridization confirmation for ROS1 fusion. They were then randomly assigned to receive NGS results either after tissue genotyping (Group A) or as soon as possible after histological diagnosis of advanced NSCLC (Group B). The study measured time to start of systemic treatment as the primary endpoint and secondary endpoints included biomarker discovery rate, objective response rate (ORR), and progression-free survival (PFS). RESULTS: This study enroled 180 patients with suspected advanced NSCLC, randomised into two groups. 63 patients in Group A and 59 in Group B with advanced NSCLC were confirmed as advanced NSCLC and analysed. Most had adenocarcinoma (Group A: 77.8%, Group B: 79.7%). The prevalence of EGFR mutations in the two groups was similar (Group A: 57.1%; Group B: 56.6%). Other driver alterations were rare. The median time to treatment was shorter in Group B (20 days) than in Group A (28 days). ORR and PFS did not differ between groups significantly. Liquid NGS had high concordance with tissue testing and identified driver mutations in 42.6% (20/47) of tissue-negative cases. CONCLUSION: Performing liquid NGS at the initial clinic visit for suspected advanced NSCLC identifies more patients suitable for targeted therapies and shortens time to the start of treatment.

Clinical utility of a plasma-based comprehensive genomic profiling test in patients with non-small cell lung cancer in Korea.

OBJECTIVES: Plasma-based comprehensive circulating cell-free DNA (cfDNA) next generation sequencing (NGS) has shown utility in advanced non-small cell lung cancer (aNSCLC). The aim of this study was to determine the feasibility of cfDNA-based NGS to identify actionable gene alterations in patients with aNSCLC. PATIENTS AND METHODS: This single-center non-interventional retrospective study evaluated Korean patients with biopsy-confirmed stage III/IV non-squamous aNSCLC. Tissue biopsy samples were collected at baseline, and/or at progression and analysed with Standard of Care (SOC) testing; cfDNA was analyzed by NGS in some patients concurrently. RESULTS: aNSCLC patients with cfDNA test results (n = 405) were categorized into three groups: treatment naïve (n = 182), progressive aNSCLC after chemotherapy and/or immunotherapy (n = 157), and progressive aNSCLC after tyrosine kinase inhibitors (TKIs) (n = 66). Clinically informative driver mutations were identified for 63.5% of patients which were classified as OncoKB Tiers 1 (44.2%), 2 (3.4%), tier 3 (18.9%), and 4 (33.5%). Concordance between cfDNA NGS and tissue SOC methods for concurrently collected tissue samples (n = 221) with common EGFR mutations or ALK/ROS1 fusions was 96.9%. cfDNA analysis identified tumor genomic alterations in 13 patients that were unidentified with tissue testing, enabling initiation of targeted treatment. CONCLUSIONS: In clinical practice, results of cfDNA NGS are highly concordant with those of tissue SOC testing in aNSCLC patients. Plasma analysis identified actionable alterations that were missed or not evaluated by tissue testing, enabling the initiation of targeted therapy. Results from this study add to the body of evidence in the support routine use of cfDNA NGS for patients with aNSCLC.

FGFR Fusions as an Acquired Resistance Mechanism Following Treatment with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR TKIs) and a Suggested Novel Target in Advanced Non-Small Cell Lung Cancer (aNSCLC).

BACKGROUND: FGFR1/2/3 fusions have been reported infrequently in aNSCLC, including as a rare, acquired resistance mechanism following treatment with EGFR TKIs. Data regarding their prevalence and therapeutic implications are limited. METHODS: The Guardant Health (GH) electronic database (ED) was evaluated for cases of aNSCLC and FGFR2/3 fusions; FGFR2/3 fusion prevalence with and without a co-existing EGFR mutation was assessed. The ED of Tel-Aviv Sourasky Medical Center (TASMC, June 2020-June 2021) was evaluated for cases of aNSCLC and de novo FGFR1/2/3 fusions. Patients with EGFR mutant aNSCLC progressing on EGFR TKIs and developing an FGFR1/2/3 fusion were selected from the ED of Davidoff Cancer Center (DCC) and Oncology Department, Bnei-Zion hospital (BZ) (April 2014-April 2021). Clinicopathological characteristics, systemic therapies, and outcomes were assessed. RESULTS: In the GH ED (n = 57,445), the prevalence of FGFR2 and FGFR3 fusions were 0.02% and 0.26%, respectively. FGFR3-TACC3 fusion predominated (91.5%). In 23.8% of cases, FGFR2/3 fusions co-existed with EGFR sensitizing mutations (exon 19 del, 64.1%; L858R, 33.3%, L861Q, 2.6%). Among samples with concurrent FGFR fusions and EGFR sensitizing mutations, 41.0% also included EGFR resistant mutations. In TASMC (n = 161), 1 case of de novo FGFR3-TACC3 fusion was detected (prevalence, 0.62%). Of three patients from DCC and BZ with FGFR3-TACC3 fusions following progression on EGFR TKIs, two received EGFR TKI plus erdafitinib, an FGFR TKI, with clinical benefit duration of 13.0 and 6.0 months, respectively. CONCLUSIONS: Over 23% of FGFR2/3 fusions in aNSCLC may be associated with acquired resistance following treatment with EGFR TKIs. In this clinical scenario, a combination of EGFR TKIs and FGFR TKIs represents a promising treatment strategy.

Genomic Landscape of Non-Small Cell Lung Cancer (NSCLC) in East Asia Using Circulating Tumor DNA (ctDNA) in Clinical Practice.

Plasma-based next-generation sequencing (NGS) has demonstrated the potential to guide the personalized treatment of non-small cell lung cancer (NSCLC). Inherent differences in mutational genomic profiles of NSCLC exist between Asian and Western populations. However, the published mutational genomic data of NSCLC has largely focused on Western populations. We retrospectively analyzed results from comprehensive NGS of plasma (Guardant360®) from patients with advanced non-squamous NSCLC, as seen in clinical practice. Tests were ordered between January 2016 and December 2020 in Hong Kong, Korea, Taiwan, Japan and Southeast Asia. The assay identified single-nucleotide variants (SNV), insertions and deletions, and fusions and amplifications in 74 genes. In total, 1608 plasma samples from patients with advanced non-squamous NSCLC were tested. The median turnaround time for test results was 7 days. Of the samples with detectable ctDNA (85.6%), 68.3% had alterations in at least one NCCN-recommended NSCLC biomarker. EGFR driver mutations were most frequent (48.6%), followed by alterations of KRAS (7.9%), ERBB2 (4.1%) and ALK (2.5%). Co-mutations of EGFR and KRAS occurred in 4.7% of samples. KRAS G12C was identified in 18.6% of all samples with KRAS mutations. Common mutations, such as exon 19 deletions and L858R, accounted for 88.4% of EGFR driver mutations. Among the samples with any EGFR driver mutation, T790M was present in 36.9%, including 7.7% with additional alterations associated with osimertinib resistance (MET amplification, C797X). Comprehensive plasma-based NGS provided the timely and clinically informative mutational genomic profiling of advanced non-squamous NSCLC in East Asian patients.

Safety and Effectiveness of Dapoxetine On Demand in Chinese Men With Premature Ejaculation: Results of a Multicenter, Prospective, Open-Label Phase IV Study.

INTRODUCTION: Dapoxetine on demand has been approved for premature ejaculation (PE) management in China; however, studies on the efficacy and safety of this treatment in the Chinese population are scarce. AIM: The aim of this study was to evaluate the safety and effectiveness of dapoxetine 30 mg and 60 mg on demand in Chinese men with PE. METHODS: Phase IV real-world study on 1,252 patients with PE. If men reported no response to dapoxetine 30 mg after 4 weeks treatment, dapoxetine has been uptitrated at 60 mg for 4 weeks more. MAIN OUTCOME MEASURE: Self-reported data were collected for demographics, general and sexual health characteristics, PE severity, and treatment safety and effectiveness, as measured by the PE profile questionnaire. RESULTS: Adverse events (AEs), such as nausea, thirst, headache, and dizziness, similarly to previous literature, were detected. The treatment-emergent AEs rate was higher in the patients treated with 30 and 60 mg (n = 192) compared with those treated with the dapoxetine 30 mg only (n = 1060) (34.4% vs 15.8%, respectively). No new safety concerns were observed. The overall effectiveness rates were 88.2% in subjects using 30 mg of dapoxetine, whereas a rescue from the previous failure was in 55.7% in the patients who received 60 mg after the initial 30 mg. Overall, 83.2% responded to dapoxetine at dosages equal to or lower than 60 mg. CONCLUSION: The results in this study demonstrated in a large Chinese population that on-demand dapoxetine is a safe and effective symptomatic treatment in patients with PE. J Peng, L Yang, L Liu, et al. Safety and Effectiveness of Dapoxetine On Demand in Chinese Men With Premature Ejaculation: Results of a Multicenter, Prospective, Open-Label Phase IV Study. Sex Med 2021;9:100296.

Malar reshaping technique using bidirectional barb thread suspension procedure for 3-dimensional aging in Asian faces.

Background: Aging is a natural process that causes skin texture changes, facial volume loss, and altered 3-dimensional topography of the underlying tissues. Objective: The aim of this study is to assess the malar reshaping strategy in Asian patients using bidirectional suspension-barbed threads. Methods: A prospective interventional study was conducted on Asian patients presenting with mild-to-moderate facial aging who were treated with the Definisse double-needle thread in the Hong Kong Special Administrative Region. The primary endpoint was assessed using the Global Aesthetic Improvement Scale and scoring the benefit of anterior projection using a questionnaire. Patient safety was the secondary endpoint measured. Results: Twenty Asian patients (4 men [20%] and 16 women [80%]; age <45 to ≥45 years) were included in the study. The patients experienced marked improvement (score 2) in their appearance, except for the follow-up after 1 month. One month after the procedure, patients scored 1 for optimal cosmetic improvement in their looks. The nasolabial fold disappeared in all patients (n = 20 [100%]) and the face looked slimmer. Nine patients (45%) reported that the focus seemed centralized. Four patients (20%) reported prominence of the nose and chin. Redness, swelling, and bruising were the most common adverse events experienced by 75% of patients (n = 15), followed by pain (n = 6; 30%). All adverse events resolved within 4 weeks after their incidence. Because 80% of our patients were women, these positive cosmetic outcomes may be of interest across the aging female population. Conclusion: Overall, 3-dimensional facial rejuvenation with the Definisse thread seems to be an effective, safe, and minimally invasive office-based procedure to achieve immediate and long-term effects. These absorbable barbed sutures used in the malar reshaping technique can result in satisfactory esthetic enhancement of 3-dimensional aging, including sagginess, jowling, central facial heaviness, and tissue descent in female and male Asian patients.

Pixel Objectness: Learning to Segment Generic Objects Automatically in Images and Videos.

We propose an end-to-end learning framework for segmenting generic objects in both images and videos. Given a novel image or video, our approach produces a pixel-level mask for all "object-like" regions-even for object categories never seen during training. We formulate the task as a structured prediction problem of assigning an object/background label to each pixel, implemented using a deep fully convolutional network. When applied to a video, our model further incorporates a motion stream, and the network learns to combine both appearance and motion and attempts to extract all prominent objects whether they are moving or not. Beyond the core model, a second contribution of our approach is how it leverages varying strengths of training annotations. Pixel-level annotations are quite difficult to obtain, yet crucial for training a deep network approach for segmentation. Thus we propose ways to exploit weakly labeled data for learning dense foreground segmentation. For images, we show the value in mixing object category examples with image-level labels together with relatively few images with boundary-level annotations. For video, we show how to bootstrap weakly annotated videos together with the network trained for image segmentation. Through experiments on multiple challenging image and video segmentation benchmarks, our method offers consistently strong results and improves the state-of-the-art for fully automatic segmentation of generic (unseen) objects. In addition, we demonstrate how our approach benefits image retrieval and image retargeting, both of which flourish when given our high-quality foreground maps. Code, models, and videos are at: http://vision.cs.utexas.edu/projects/pixelobjectness/.

Efficient removal of Acid Green 25 dye from wastewater using activated Prunus Dulcis as biosorbent: Batch and column studies.

Biosorbent synthesized from dead leaves of Prunus Dulcis with chemical activation during the synthesis was applied for the removal of Acid Green 25 dye from wastewater. The obtained biosorbent was characterized using Brunauer-Emmett-Teller analysis, Fourier transform-infrared spectroscopy and scanning electron microscopy measurements. It was demonstrated that alkali treatment during the synthesis significantly increased surface area of biosorbent from 67.205 to 426.346 m2/g. The effect of various operating parameters on dye removal was investigated in batch operation and optimum values of parameters were established as pH of 2, 14 g/L as the dose of natural biosorbent and 6 g/L as the dose of alkali treated biosorbent. Relative error values were determined to check fitting of obtained data to the different kinetic and isotherm models. It was established that pseudo-second order kinetic model and Langmuir isotherm fitted suitably to the obtained batch experimental data. Maximum biosorption capacity values were estimated as 22.68 and 50.79 mg/g for natural biosorbent and for alkali activated Prunus Dulcis, respectively. Adsorption was observed as endothermic and activation energy of 6.22 kJ/mol confirmed physical type of adsorption. Column experiments were also conducted to probe the effectiveness of biosorbent for practical applications in continuous operation. Breakthrough parameters were established by studying the effect of biosorbent height, flow rate of dye solution and initial dye concentration on the extent of dye removal. The maximum biosorption capacity under optimized conditions in the column operation was estimated as 28.57 mg/g. Thomas and Yoon-Nelson models were found to be suitably fitted to obtained column data. Reusability study carried out in batch and continuous column operations confirmed that synthesized biosorbent can be used repeatedly for dye removal from wastewater.

Restoring the voids of voices by signs and gestures, in dentistry: A cross-sectional study.

AIMS: To help dentists to communicate with the hearing impaired patients, reach an accurate diagnosis and explain the treatment plan by learning some signs and gestures used in the nonverbal communication (NVC) and by devising some new signs and gestures related to dentistry which shall be easy to learn and understand both by the hearing impaired patients and the dentists. SETTINGS AND DESIGN: The study was carried out on 100 hearing impaired students in the age group of 10-14 years in two special schools for hearing impaired children located in two different states of India, where different spoken languages and different sign languages are used. One dentist (expert dentist) was trained in the NVC and the other dentist (non expert dentist) had no knowledge of this type of communication, communicated the same sets of statements related to dentistry, to the hearing impaired children. One1 translator was assigned to judge their interactions. Students were asked to tell the interpreter at the end of each signed interaction what they understood from the statement conveyed to them by both the dentists. STATISTICAL ANALYSIS USED: All data collected were subjected to statistical analysis using Chi-square test and odds ratio test. RESULTS: In the special school of 1st state, the nonexpert dentist conveyed only 36.3% of the information correctly to the students, whereas the expert dentist conveyed 83% of the information correctly. In the special school of 2nd state, the nonexpert dentist conveyed only 37.5% of the information correctly to the students, whereas the expert dentist conveyed 80.3% of the information correctly. CONCLUSIONS: Dentists should be made aware of the NVC and signs and gestures related to dentistry should be taught to the hearing impaired students as well as the dental students.

Influence of symmetric and asymmetric alterations of maxillary canine gingival margin on the perception of smile esthetics among orthodontists, dentists, and laypersons.

INTRODUCTION: Esthetics is one of the major concerns among people seeking orthodontic treatment, and its perception varies from person to person. Our objective was to determine the differences in the perception of smile esthetics among orthodontists, general dentists, and laypersons with respect to alteration in the maxillary canine gingival margin in close-up smile analyses. MATERIALS AND METHODS: Close-up photograph of an ideal Indian female smile was selected. The images were digitally altered to create symmetrical images with the gingival margin levels of maxillary canine matching the central incisors. Twelve alterations were created in the gingival margin of the canine with discrepancies of 1, 2, and 3 mm in relation to the most superior point on the labial gingival margin of patient's central incisor and divided under four groups. Finally, close-up images of the smile were assessed by orthodontist, general dentist, and layperson who indicated the level of attractiveness of each smile on a visual analogue score. The data collected were then statistically analyzed by one-way analysis of variance followed by Newman-Keul's range test. RESULTS: Most evaluators considered all the three components, i.e., lips, teeth, and gingiva while assessing the smile's attractiveness. Statistically significant differences were observed between different evaluator groups when considering bilateral increase in crown height by 2 and 3 mm. The perceptions of asymmetries in the gingival margin levels of the maxillary canines were 1.0 mm for orthodontists and 2.0 mm for laypersons. CONCLUSION: The result of this study suggested that the orthodontists were more critical than dentist and layperson in evaluating smile esthetics.

Assessment of Dental Caries and Periodontal Disease Status among Elderly Residing in Old Age Homes of Madhya Pradesh.

BACKGROUND: A descriptive cross-sectional study was carried out to assess the dental caries and periodontal disease status of elderly residing in old age homes of Madhya Pradesh, India. MATERIALS AND METHODS: The study was carried out on 599 elderly people residing in old age homes of Madhya Pradesh, India using cluster sampling methodology. The clinical findings were recorded using modified WHO Oral Health Assessment form (1997) to assess periodontal status as per community periodontal index, loss of attachment, WHO dentition status, and treatment needs. RESULTS: In the present study, the caries prevalence among dentate subjects was found among 41.9% of the dentate subjects and the mean decayed, missed, and filled teeth was found to be 8.28 ± 4.779 with the mean number of decayed being 1.51. In the dentate population, 0% had healthy periodontal tissue, 0.26% had bleeding, and 24.5% had calculus, 52.1% had shallow pockets and 23.1% had deep pockets as their highest score and this difference was statistically significant (P < 0.05). In the current study, 37.9% inmates were completely edentulous. This study also showed that as age advanced the prevalence increased from 23.1% to 55.4%. The difference was statistically significant (P < 0.05). CONCLUSION: The oral health status of elderly people was found to be poor. Hence, it is concluded from this study that tooth loss is higher among the geriatric group residing in old age homes and is associated with many demographic and behavioral risk indicators.

Evaluation of brimonidine-timolol fixed combination in patients of primary open-angle glaucoma.

The aim of present study was to compare the efficacy and safety of fixed combination of brimonidine and timolol with individual components used as monotherapy in patients of primary open angle glaucoma. Patients were randomly assigned to receive brimonidine or timolol or brimonidine-timolol fixed combination, with 30 patients in each group. The mean reduction in intraocular pressure in brimonidine, timolol, and brimonidine-timolol group were 4.29 ± 1.97 mm Hg, 4.34 ± 1.21 mm Hg, and 5.54 ± 1.87 mm Hg respectively at 2 weeks and 4.86 ± 1.16 mm Hg, 5.42 ± 1.50 mm Hg, and 7.36 ± 2.58 mm Hg respectively at 6 weeks. When values of mean reduction in intraocular pressure were compared between brimonidine-timolol fixed combination with brimonidine and timolol, it was found to be statistically significant ( P < 0.05) at 2 weeks and highly significant (0.001) at 6 weeks. The overall frequency of adverse effects was similar in all three groups.

Clinical characteristics of polycystic ovary syndrome in Indian women.

BACKGROUND: Polycystic ovary syndrome (PCOS) is common diagnosis in women presenting with infertility. All the dimensions of PCOS have not been completely explored. Many studies have tried to characterize the exact presentation of the disease. In this study we studied clinical features of PCOS in Indian women to characterize different phenotypes of this syndrome. Prevalence of acanthosis nigricans (AN) as surrogate marker of insulin resistance, obesity, hirsutism and hypothyroidism in PCOS women have been simultaneously studied. MATERIALS AND METHODS: Present work is a non comparative cross-sectional open label study carried out over a period of 18 months in an endocrinology hospital in western Maharashtra, India. RESULTS AND CONCLUSION: Authors conclude that PCOS occurs both in obese and non-obese women; AN and hirsutism occur in equal proportion of patients. AN is correlated with obesity. Hormonal dysfunctions in PCOS manifested together or independently. PCOS women can be sub grouped based on clinical features suggestive of endocrinological malfunctions and can be investigated accordingly for selection of appropriate treatment modalities.

Selective thyroid hormone receptor modulators.

Thyroid hormone (TH) is known to have many beneficial effects on vital organs, but its extrapolation to be used therapeutically has been restricted by the fact that it does have concurrent adverse effects. Recent finding of various thyroid hormone receptors (TR) isoforms and their differential pattern of tissue distribution has regained interest in possible use of TH analogues in therapeutics. These findings were followed by search of compounds with isoform-specific or tissue-specific action on TR. Studying the structure-activity relationship of TR led to the development of compounds like GC1 and KB141, which preferentially act on the ß1 isoform of TR. More recently, eprotirome was developed and has been studied in humans. It has shown to be effective in dyslipidemia by the lipid-lowering action of TH in the liver and also in obesity. Another compound, 3,5-diiodothyropropionic acid (DITPA), binds to both α- and ß-type TRs with relatively low affinity and has been shown to be effective in heart failure (HF). In postinfarction models of HF and in a pilot clinical study, DITPA increased cardiac performance without affecting the heart rate. TR antagonists like NH3 can be used in thyrotoxicosis and cardiac arrhythmias. However, further larger clinical trials on some of these promising compounds and development of newer compounds with increased selectivity is required to achieve higher precision of action and avoid adverse effects seen with TH.

Pathogenesis and treatment of human immunodeficiency virus lipodystrophy.

Enhanced understanding about the way human immunodeficiency virus (HIV) infects and causes infection in humans has led to invention and use of newer more effective antiretroviral drugs. As treatment for HIV is long term, side effects of the antiretrovirals become an important area of research focus. Antiretrovirals can cause severe metabolic abnormalities, collectively known as HIV lipodystrophy syndrome. If untreated, these metabolic abnormalities have the potential to increase stroke and cardiac ischemia. Management includes choice of nonoffending drugs, switch over to less toxic drugs, hypolipidemics, oral antidiabetics including thiazolidinediones, metformin and growth hormone analogs and finally facial surgeries. Updated knowledge about HIV lipodystrophy, and the hormone-related drugs used to treat it, is essential for physicians and endocrinologists to be able to diagnose the patients and effectively treat them.

Evaluation of the efficacy and safety of bromocriptine QR in type 2 diabetes.

CONTEXT: Diabetes mellitus is a chronic metabolic disorder of endocrinal origin with multiorgan involement. Today's physician has a lot many options to choose for treating type 2 diabetes, but does not always manages to achieve optimal glycemic control. The newer drug bromocriptine acts by novel hypothalamic circadian rhythm resetting mechanism. OBJECTIVE: To evaluate the efficacy and safety of bromocriptine QR in type 2 diabetes. MATERIALS AND METHODS: 105 patients according to inclusion and exclusion criteria were randomized into three groups by simple randomization. Group 1 received bromocriprine 2.4 mg once daily, group 2 received metformin 500 mg twice daily while group 3 received bromocriprine 1.6 mg daily and metformin 500 mg twice daily. Baseline measurement of fasting and postprandial blood sugar, HbA1(C) and BMI were followed up at 6(th) and 12(th) weeks. Safety evaluation was done by questioning the patient and also through routine hematological and biochemical parameters. Z test was used for analysis. RESULTS: Group 1 showed significant reduction in fasting and postprandial sugar and HbA(1c) at 12 weeks. While groups 2 and 3 showed even higher reduction in these parameters albeit with slightly more adverse drug events like nausea, vomiting compared to group 1. CONCLUSION: Bromocriptine QR is an effective and safe antidiabetic drug which can be employed as monotherapy or in conjuction with metformin to achieve and maintain optimal glycemic control.

Evaluation of efficacy and safety of orlistat in obese patients.

CONTEXT: Rapidly rising prevalence of obesity is alarming. Obesity predisposes to co-morbidities like hypertension, type 2 diabetes mellitus, dyslipidemias, thus substantially rising healthcare expenditure. Lifestyle modifications alone have very limited success, necessitating the addition of pharmacotherapy to it. OBJECTIVE: Present study was carried out to evaluate the efficacy and safety of orlistat in obese patients. MATERIALS AND METHODS: Eighty obese (BMI>30) patients according to inclusion and exclusion criteria were randomized into either of the two groups. Group 1 received orlistat 120 mg three times a day and group 2 received placebo three times a day. Weight, waist circumference, BMI, total cholesterol, triglycerides, HDL, LDL were measured at baseline and then at 8(th), 16(th) and 24(th) week. ADR reported by patients were recorded. For safety evaluation various hematological and biochemical parameters were assessed. Z test was used for analysis of data. RESULTS: Compared to placebo, orlistat caused significant reduction (P<0.05) in weight (4.65 kg vs 2.5 kg; orlistat vs placebo, respectively), BMI (1.91 kg/m(2) vs 0.64 kg/m(2)) and waist circumference (4.84 cm vs 2 cm), cholesterol (10.68 mg vs 6.18 mg) and LDL level (5.87 mg vs 2.33 mg). In the orlistat group, the GI side effects like loose stools, oily stools/spotting, abdominal pain and fecal urgency were observed. CONCLUSION: Orlistat is an effective and well-tolerated antiobesity drug, which can be employed as an adjunct to therapeutic lifestyle changes to achieve and maintain optimal weight.