Serious adverse reactions associated with ivermectin: A systematic pharmacovigilance study in sub-Saharan Africa and in the rest of the World

BackgroundIvermectin is known to cause severe encephalopathies in subjects infected with loiasis, an endemic parasite in Sub-Saharan Africa (SSA). In addition, case reports have described ivermectin-related serious adverse drug reactions (sADRs) such as toxidermias, hepatic and renal disorders. The aim of this study was to identify suspected sADRs reported after ivermectin administration in VigiBase, the World Health Organization’s global individual case safety reports database and analyze their frequency relative to the frequency of these events after other antinematodal drugs reported in SSA and other areas of the world (ROW).MethodsAll antinematodal-related sADRs were extracted from VigiBase. Disproportionality analyses were conducted to investigate nervous, cutaneous, psychiatric, respiratory, renal, hepatic and cardiac suspected sADRs reported after ivermectin and benzimidazole drug administration across the world, in SSA and RoW.Principal findings2041 post-ivermectin or post-benzimidazole suspected sADRs were identified including 667 after ivermectin exposure (208 in SSA and 459 in the RoW). We found an increased reporting for toxidermias, encephalopathies, confusional disorders after ivermectin compared to benzimidazole drug administration. Encephalopathies were not only reported from SSA but also from the RoW (adjusted reporting odds ratios [aROR] 6.30, 95% confidence interval: 2.68–14.8), highlighting the fact these types of sADR occur outside loiasis endemic regions.ConclusionWe described for the first time suspected sADRs associated with ivermectin exposure according to geographical origin. While our results do not put in question ivermectin’s excellent safety profile, they show that as for all drugs, appropriate pharmacovigilance for adverse reactions is indicated.     

Pinimenthol ointment in patients suffering from upper respiratory tract infections – A post-marketing observational study

In order to gain further experience regarding the tolerability of Pinimenthol^® ointment¹ in adolescents (⩾12 years) and adults suffering from upper respiratory tract infections, a post-marketing observational study was performed. In this study, data of 3060 patients were collected (64.9% prospectively over an individual observation period of 5–14 days, 35.1% retrospectively). The prospective documentation also comprised data concerning treatment effects.Sample size of the post-marketing observational study was calculated in the way that adverse drug reactions with an event probability of at least 1:1000 would occur within the study at least once with a probability of 95%.Most patients suffered from cold, acute or chronic bronchitis, bronchial catarrh or hoarseness. Pinimenthol^® ointment was prescribed to inunction (29.6%), inhalation (17.3%) or inunction and inhalation (53.1%), respectively. The mean duration of study participation was 8.0±3.4 days.The tolerability was rated as excellent or good by 96.7% of physicians and 95.7% of patients. A total of 22 patients (0.7%) reported adverse drug reactions which mostly affected the skin or mucus membrane and therefore correspond to the expected adverse effects profile of Pinimenthol^® ointment. The treatment effect was mostly judged as excellent or good (physicians: 88.3%; patients: 88.1%).In conclusion, the study confirms Pinimenthol^® ointment as a well tolerated therapy option for upper respiratory tract infections in both adolescents and adults.     

Differences between Drug-Induced and Contrast Media-Induced Adverse Reactions Based on Spontaneously Reported Adverse Drug Reactions

Objective

We analyzed differences between spontaneously reported drug-induced (not including contrast media) and contrast media-induced adverse reactions.

Methods

Adverse drug reactions reported by an in-hospital pharmacovigilance center (St. Mary’s teaching hospital, Daejeon, Korea) from 2010–2012 were classified as drug-induced or contrast media-induced. Clinical patterns, frequency, causality, severity, Schumock and Thornton’s preventability, and type A/B reactions were recorded. The trends among causality tools measuring drug and contrast-induced adverse reactions were analyzed.

Results

Of 1,335 reports, 636 drug-induced and contrast media-induced adverse reactions were identified. The prevalence of spontaneously reported adverse drug reaction-related admissions revealed a suspected adverse drug reaction-reporting rate of 20.9/100,000 (inpatient, 0.021%) and 3.9/100,000 (outpatients, 0.004%). The most common adverse drug reaction-associated drug classes included nervous system agents and anti-infectives. Dermatological and gastrointestinal adverse drug reactions were most frequently and similarly reported between drug and contrast media-induced adverse reactions. Compared to contrast media-induced adverse reactions, drug-induced adverse reactions were milder, more likely to be preventable (9.8% vs. 1.1%, p < 0.001), and more likely to be type A reactions (73.5% vs. 18.8%, p < 0.001). Females were over-represented among drug-induced adverse reactions (68.1%, p < 0.001) but not among contrast media-induced adverse reactions (56.6%, p = 0.066). Causality patterns differed between the two adverse reaction classes. The World Health Organization–Uppsala Monitoring Centre causality evaluation and Naranjo algorithm results significantly differed from those of the Korean algorithm version II (p < 0.001).

Conclusions

We found differences in sex, preventability, severity, and type A/B reactions between spontaneously reported drug and contrast media-induced adverse reactions. The World Health Organization–Uppsala Monitoring Centre and Naranjo algorithm causality evaluation afforded similar results.     

Livestock herding and Fulani ethnicity are a combined risk factor for development of early adverse reactions to antivenom treatment: Findings from a cross-sectional study in Nigeria

BackgroundAdverse reactions to antivenom considerably complicate the clinical management of snakebite envenomed patients because it necessitates a temporary suspension of life-saving antivenom, increases costs and can compromise patient outcomes. This study sought to explore the association between cattle-herding occupation and ethnic group and the occurrence of early adverse reactions to antivenom.MethodsThis cross-sectional study was conducted between the 25th April and 11th July 2011 at the Kaltungo General Hospital in north east Nigeria. The exposure variable of cattle-herding occupation showed a strong correlation with the ethnic group variable, thus these were combined into a new variable with three categories (Fulani and herder, either Fulani or herder, and neither Fulani nor herder). The outcome variable was the occurrence of early adverse reactions, defined as any new symptoms occurring within 6 hours of antivenom administration. Odds Ratios were estimated using multivariable logistic regression models controlling for potential confounders.ResultsAmong 231 envenomed snakebite victims, the overall incidence of early adverse reactions was 11.9% (95% confidence intervals: 8.0–16.9%). Patients who were Fulani and herders had a higher incidence of early adverse reactions compared to patients who were neither Fulani nor herders (20% vs 5.7%). After adjusting for age and gender, victims who were Fulani and herders were 5.9 times more likely to have an early adverse reaction, compared to victims who were neither Fulani nor herders (95% CI: 1.88–18.59; p = 0.002).InterpretationTo the best of our knowledge, this is the first study to provide evidence of higher odds of early adverse reactions among patients from a particular occupation and/or ethnic group. We recommend that snake envenomed patients of Fulani origin be especially closely monitored for adverse reactions, that hospitals receiving these patients be appropriately resourced to manage both envenoming and adverse reactions and that premedication with adrenaline should be considered. Our findings provide an argument for speculation on the influence of immunological or lifestyle-related differences on the occurrence of early adverse reactions to antivenom.     

Valproic Acid and Fatalities in Children: A Review of Individual Case Safety Reports in VigiBase

Introduction

Valproic acid is an effective first line drug for the treatment of epilepsy. Hepatotoxicity is a rare and potentially fatal adverse reaction for this medicine.

Objective

Firstly to characterise valproic acid reports on children with fatal outcome and secondly to determine reporting over time of hepatotoxicity with fatal outcome.

Methods

Individual case safety reports (ICSRs) for children ≤17 years with valproic acid and fatal outcome were retrieved from the WHO Global ICSR database, VigiBase, in June 2013. Reports were classified into hepatotoxic reactions or other reactions. Shrinkage observed-to-expected ratios were used to explore the relative reporting trend over time and for patient age. The frequency of polytherapy, i.e. reports with more than one antiepileptic medicine, was investigated.

Results

There have been 268 ICSRs with valproic acid and fatal outcome in children, reported from 25 countries since 1977. A total of 156 fatalities were reported with hepatotoxicity, which has been continuously and disproportionally reported over time. There were 31 fatalities with pancreatitis. Other frequently reported events were coma/encephalopathy, seizures, respiratory disorders and coagulopathy. Hepatotoxicity was disproportionally and most commonly reported in children aged 6 years and under (104/156 reports) but affected children of all ages. Polytherapy was significantly more frequently reported for valproic acid with fatal outcome (58%) compared with non-fatal outcome (34%).

Conclusion

Hepatotoxicity remains a considerable problem. The risk appears to be greatest in young children (6 years and below) but can occur at any age. Polytherapy is commonly reported and seems to be a risk factor for hepatotoxicity, pancreatitis and other serious adverse drug reactions with valproic acid.     

普萘洛尔与阿替洛尔治疗增殖期婴幼儿血管瘤的临床疗效及安全性对比

目的:对比普萘洛尔与阿替洛尔对增殖期婴幼儿血管瘤临床疗效及安全性。方法:选择2015年2月至2016年7月符合入选标准的血管瘤婴儿患者173例,分为普萘洛尔组91例和阿替洛尔组82例,分别给予普萘洛尔与阿替洛尔连续治疗24周。初始1周为每天随访,之后为每月随访一次。治疗6个月后,比较两组婴儿血管瘤的消退面积、不良反应率、反应的频率和严重程度。结果:普萘洛尔组57例(63%)患者治愈(瘤体缩小75%-100%),阿替洛尔组46例(56.3%)患者治愈(瘤体缩小75%-100%),两组治愈率对比差异无统计学意义(P0.05)。普萘洛尔组有11例因不能耐受药物不良反应及患者家属原因退出治疗,阿替洛尔组有2例因不能耐受药物不良反应及患者家属原因退出治疗,阿替洛尔组重度不良反应率显著低于普萘洛尔组(P=0.025)。普萘洛尔组轻中度不良事件为85例(94%),阿替洛尔组为62例(75%),两组比较差异无统计学意义(P0.05)。阿替洛尔组治疗时间较普萘洛尔缩短(314天vs 297天)(P0.05)。结论:普萘洛尔与阿替洛尔治疗婴幼儿血管瘤的临床疗效和安全性相当,但阿替洛尔的耐受性和依从性更好,重度不良反应明显减少。     

A systematic review and an individual patient data meta-analysis of ivermectin use in children weighing less than fifteen kilograms: Is it time to reconsider the current contraindication?

BackgroundOral ivermectin is a safe broad spectrum anthelminthic used for treating several neglected tropical diseases (NTDs). Currently, ivermectin use is contraindicated in children weighing less than 15 kg, restricting access to this drug for the treatment of NTDs. Here we provide an updated systematic review of the literature and we conducted an individual-level patient data (IPD) meta-analysis describing the safety of ivermectin in children weighing less than 15 kg.Methodology/Principal findingsA systematic review was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) for IPD guidelines by searching MEDLINE via PubMed, Web of Science, Ovid Embase, LILACS, Cochrane Database of Systematic Reviews, TOXLINE for all clinical trials, case series, case reports, and database entries for reports on the use of ivermectin in children weighing less than 15 kg that were published between 1 January 1980 to 25 October 2019. The protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO): CRD42017056515. A total of 3,730 publications were identified, 97 were selected for potential inclusion, but only 17 sources describing 15 studies met the minimum criteria which consisted of known weights of children less than 15 kg linked to possible adverse events, and provided comprehensive IPD. A total of 1,088 children weighing less than 15 kg were administered oral ivermectin for one of the following indications: scabies, mass drug administration for scabies control, crusted scabies, cutaneous larva migrans, myiasis, pthiriasis, strongyloidiasis, trichuriasis, and parasitic disease of unknown origin. Overall a total of 1.4% (15/1,088) of children experienced 18 adverse events all of which were mild and self-limiting. No serious adverse events were reported.Conclusions/SignificanceExisting limited data suggest that oral ivermectin in children weighing less than 15 kilograms is safe. Data from well-designed clinical trials are needed to provide further assurance.     

Treatment of acute ischemic stroke by minimally manipulated umbilical cord-derived mesenchymal stem cells transplantation: A case report

BACKGROUNDStroke is one of the major causes of disability and death worldwide. Some treatments for stroke exist, but existing treatment methods have limitations such as difficulty in the regeneration of damaged neuronal cells of the brain. Recently, mesenchymal stem cells (MSCs) have been studied as a therapeutic alternative for stroke, and various preclinical and case studies have been reported.CASE SUMMARYA 55-year-old man suffered an acute stroke, causing paralysis in the left upper and lower limbs. He intravenously transplanted the minimally manipulated human umbilical cord-derived MSCs (MM-UC-MSCs) twice with an 8-d interval. At 65 wk after transplantation, the patient returned to his previous occupation as a veterinarian with no adverse reactions.CONCLUSIONMM-UC-MSCs transplantation potentially treats patients who suffer from acute ischemic stroke.     

Constipation and diarrhoea - common adverse drug reactions? A cross sectional study in the general population

Background  

Constipation and diarrhoea are common complaints and often reported as adverse drug reactions. This study aimed at finding associations between drugs and constipation and diarrhoea in a general population.     

The Quality of Reports on Cervical Arterial Dissection following Cervical Spinal Manipulation

BackgroundCervical artery dissection (CAD) and stroke are serious harms that are sometimes associated with cervical spinal manipulation therapy (cSMT). Because of the relative rarity of these adverse events, studying them prospectively is challenging. As a result, systematic review of reports describing these events offers an important opportunity to better understand the relation between adverse events and cSMT. Of note, the quality of the case report literature in this area has not yet been assessed.Purpose1) To systematically collect and synthesize available reports of CAD that have been associated with cSMT in the literature and 2) assess the quality of these reports.MethodsA systematic review of the literature was conducted using several databases. All clinical study designs involving CADs associated with cSMT were eligible for inclusion. Included studies were screened by two independent reviewers for the presence/absence of 11 factors considered to be important in understanding the relation between CAD and cSMT.ResultsOverall, 43 articles reported 901 cases of CAD and 707 incidents of stroke reported to be associated with cSMT. The most common type of stroke reported was ischemic stroke (92%). Time-to-onset of symptoms was reported most frequently (95%). No single case included all 11 factors.ConclusionsThis study has demonstrated that the literature infrequently reports useful data toward understanding the association between cSMT, CADs and stroke. Improving the quality, completeness, and consistency of reporting adverse events may improve our understanding of this important relation.     

Percentage of patients with preventable adverse drug reactions and preventability of adverse drug reactions--a meta-analysis

Background

Numerous observational studies suggest that preventable adverse drug reactions are a significant burden in healthcare, but no meta-analysis using a standardised definition for adverse drug reactions exists. The aim of the study was to estimate the percentage of patients with preventable adverse drug reactions and the preventability of adverse drug reactions in adult outpatients and inpatients.

Methods

Studies were identified through searching Cochrane, CINAHL, EMBASE, IPA, Medline, PsycINFO and Web of Science in September 2010, and by hand searching the reference lists of identified papers. Original peer-reviewed research articles in English that defined adverse drug reactions according to WHO’s or similar definition and assessed preventability were included. Disease or treatment specific studies were excluded. Meta-analysis on the percentage of patients with preventable adverse drug reactions and the preventability of adverse drug reactions was conducted.

Results

Data were analysed from 16 original studies on outpatients with 48797 emergency visits or hospital admissions and from 8 studies involving 24128 inpatients. No studies in primary care were identified. Among adult outpatients, 2.0% (95% confidence interval (CI): 1.2–3.2%) had preventable adverse drug reactions and 52% (95% CI: 42–62%) of adverse drug reactions were preventable. Among inpatients, 1.6% (95% CI: 0.1–51%) had preventable adverse drug reactions and 45% (95% CI: 33–58%) of adverse drug reactions were preventable.

Conclusions

This meta-analysis corroborates that preventable adverse drug reactions are a significant burden to healthcare among adult outpatients. Among both outpatients and inpatients, approximately half of adverse drug reactions are preventable, demonstrating that further evidence on prevention strategies is required. The percentage of patients with preventable adverse drug reactions among inpatients and in primary care is largely unknown and should be investigated in future research.     

康复新液与他克莫司联合沙利度胺治疗口腔扁平苔藓的疗效及安全性分析

目的:探讨康复新液与他克莫司联合沙利度胺治疗口腔扁平苔藓(oral lichen planus,OLP)的临床疗效及安全性。方法:选择2017年12月-2020年1月就诊于我院的80例OLP患者,采用随机数字表法将其分为联合组和对照组,每组40例。两组均进行常规治疗,对照组使用0.1%的他克莫司软膏与康复新液治疗,联合组在对照组的基础上加用沙利度胺片,比较两组的临床疗效、治疗前后糜烂面大小、疼痛程度的变化以及不良反应的发生情况。结果:治疗后,联合组总有效率为90.00%,显著高于对照组(72.5%,P0.05);与治疗前相比,两组口腔糜烂面积和疼痛程度均显著降低(P 0.05),且联合组口腔糜烂面积和疼痛程度显著低于对照组(P 0.05);治疗期间,对照组出现1例不良反应,具体表现为轻微的黏膜烧灼痛,停药后两天后症状消失,不良反应发生率为2.5%,联合组出现2例不良反应,其中1例病变部位出现黏膜萎缩,1例出现色素沉着,不良反应发生率为5.0%,两组不良反应的发生率比较无显著差异(P0.05)。结论:康复新液与他克莫司联合沙利度胺治疗口腔扁平苔藓的临床疗效明显优于康复新液与他克莫司治疗,其能明显降低粘膜糜烂面积和疼痛程度,且安全性高。     

When pharmacogenomics goes public

So far the post-marketing bioethical implications of pharmacogenomics have been largely overlooked. Developing on a critical literature review, this paper argues that the post-marketing implications of pharmacogenomics will crystallize the bioethical implications of genetics in general to a wider public, and that these implications will be stretched to their limits when commonly used pharmaceuticals also appear to become public genetic information markers owing to their therapeutic specificity. Scientists, politicians and regulatory agencies need to focus heavily on these post-marketing issues. Otherwise, there is a substantial risk that the positive therapeutic prospects of pharmacogenomics will not survive, owing to a lack of acceptance and understanding, and fear on the part of the general public.     

替考拉宁在感染的血液病患者中血药浓度的监测与应用价值分析

目的:探讨替考拉宁在感染的血液病患者中血药浓度的监测与应用价值。方法:回顾分析2017年12月-2019年12月来我院治疗的42例革兰氏阳性球菌引起感染的血液病患者临床资料,按照临床替考拉宁的给药剂量分A组和B组,每组21例。利用高效液相色谱法(HPLC)检测患者第5天用药前30 min的血药浓度,利用酶联免疫荧光法检测患者降钙素原(PCT)水平。比较两组血药浓度,临床疗效及PCT水平的差异,并记录不良反应。结果:B组患者血药浓度(15.12±4.68)mg/L高于A组的(11.76±5.31)mg/L,且B组患者PCT水平(0.86±1.21)ng/mL低于A组的(2.23±1.63)ng/mL,差异均有统计学意义(P<0.05)。B组患者临床有效率为95.24%(20/21),A组临床有效率为71.43%(15/21),两组临床有效率比较差异有统计学意义(P<0.05)。A组发生不良反应发生率为23.81%(5/21),B组不良反应发生率为19.05%(4/21),两组患者不良反应发生率比较差异无统计学意义(P>0.05)。有效组患者血药浓度(17.21±6.64)mg/L高于无效组的(10.14±5.48)mg/L;且有效组患者PCT水平(0.65±1.31)ng/mL低于无效组的(2.63±1.87)ng/mL,差异均有统计学意义(P<0.05)。结论:对感染的血液病患者,提高替考拉宁初始负荷剂量可以达到较高的有效血药浓度,临床疗效更好,且不良反应未见增加。对感染的血液病患者进行血药浓度监测,能够一定程度上反映出临床治疗效果,具有临床参考价值。     

Sleep quality in pregnancy during treatment with Bryophyllum pinnatum: An observational study

IntroductionPoor sleep quality in pregnancy is frequent. A treatment with sedatives is problematic due to possible adverse effects for mother and embryo/foetus. In the present study, we investigated the sedative effect of Bryophyllum pinnatum, a phytotherapeutic medication used in anthroposophic medicine. In previous clinical studies on its tocolytic effect, B. pinnatum showed a good risk/benefit ratio for mother and child. A recent analysis of the prescribing pattern for B. pinnatum in a network of anthroposophic physicians revealed sleep disorders as one of the most frequent diagnoses for which these preparations are prescribed.Materials and methodsIn this prospective, multi-centre, observational study, pregnant women suffering from sleep problems were treated with B. pinnatum (350 mg tablets, 50% leaf press juice, Weleda AG, Arlesheim, dosage at physician's consideration). Sleep quality, daily sleepiness and fatigue were assessed with the aid of standardised questionnaires, at the beginning of the treatment and after 2 weeks. Possible adverse drug reactions perceived by the patients during the treatment were recorded.ResultsThe number of wake-ups, as well as the subjective quality of sleep was significantly improved at the end of the treatment with B. pinnatum. The Epworth Sleeping Scale decreased, indicating a decrease of the tiredness during the day. There was, however, no evidence for prolongation of the sleep duration, reduction in the time to fall asleep, as well as change in the Fatigue Severity Scale after B. pinnatum. No serious adverse drug reactions were detected.ConclusionB. pinnatum is a suitable treatment of sleep problems in pregnancy. The data of this study encourage further clinical investigations on the use of B. pinnatum in sleep disorders.     

Recognizing and reporting adverse drug reactions.

Although physicians in practice are most likely to see patients with adverse drug reactions, they may fail to recognize an adverse effect or to attribute it to a drug effect and, when recognized, they may fail to report serious reactions to the US Food and Drug Administration (FDA). To recognize and attribute an adverse event to a drug effect, physicians should review the patient''s clinical course, looking at patient risk factors, the known adverse reactions to the suspected drug, and the likelihood of a causal relationship between the drug and the adverse event-based on the temporal relationship, response to stopping or restarting the drug, and whether other factors could explain the reaction. Once an adverse drug reaction has been identified, the patient should be informed and appropriate documentation made in the patient''s medical record. Serious known reactions and all reactions to newly released drugs or those not previously known to occur (even if the certainty is low) should be reported to the FDA.     

超声引导内侧与外侧入路持续髂筋膜间隙阻滞在全髋关节置换术中应用效果的对比研究

摘要 目的：对比持续髂筋膜间隙阻滞（FICB）采用超声引导内侧或外侧入路在全髋关节置换术（THA）中应用效果。方法：选择2019年6月～2021年6月期间在我院接受治疗的THA患者97例作为研究对象。根据随机数字表法将患者分为外侧组和内侧组,例数分别为48例和49例。对比两组围术期指标,术后阻滞相关指标、疼痛介质、应激反应指标和不良反应。结果：两组术中出血量、舒芬太尼使用量、术后拔管/手术/住院/第一次下床活动、复苏室停留等状态时间组间对比无差异（P>0.05）,内侧组术后48h 视觉疼痛模拟（VAS）评分小于外侧组（P<0.05）。两组穿刺注药时间对比无明显差异（P>0.05）,内侧组置管时间短于外侧组,导管重新固定例数少于外侧组,置管深度长于外侧组（P<0.05）。两组术后24h的 P物质（SP）、前列腺素E₂（PGE₂）、神经肽Y（NPY）、5-羟色胺（5-HT）均升高,但内侧组低于外侧组（P<0.05）。两组术后24h皮质醇（Cor）、C反应蛋白（CRP）、去甲肾上腺素（NE）均升高,但内侧组低于外侧组（P<0.05）。外侧组、内侧组的不良反应发生率组间比较无差异（P>0.05）。结论：经超声引导内侧与外侧入路FICB均可为THA患者提供良好的镇痛阻滞,促进患者术后恢复,内侧入路在减轻疼痛刺激、应激反应、置管操作等方面更具优势。     

TULIP study: Trail of Lurasidone in bipolar disorder in Pakistan

BackgroundThis study examined usefulness and efficiency of Lurasidone in appraisal with the placebo as for the treatment of Bipolar Disorders.MethodsSeven treatment centers in Pakistan were selected for the purpose of starting a six week-long control trial (randomized and double-blind placebo). 76 subjects, already diagnosed with Bipolar I or II based on DSM 5 diagnosis, were selected after randomization. Patients were allocated in one of the two groups. Primary efficacy of the drug was measured using Young Mania Rating Scale. Positive response of the drug was defined as 50% reduction in symptoms from the baseline/13 point less than the baseline score on Young Mania Rating Scale. Efficacy and safety of the drug was assessed using variety of markers such as administering extra-pyramidal symptoms rating scale, adverse side effects reported, electrocardiograms, body weight, vital signs changes, and laboratory investigations.ResultsPatients treated with Lurasidone showed enhanced improvement in their overall health and symptoms manifestation in comparison to patients who were given placebo. Lurasidone treated patients showed a better response to the drug (66%), in comparison with the placebo treated patients (42%).LimitationsStudy was conducted on small scale due to complexity.ConclusionPatients treated with Lurasidone showed reduction in bipolar symptoms and tolerate the drug well.