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The World Health Organization declared coronavirus disease 2019 a pandemic on 11th March 2020. There is concern regarding performing endonasal surgical procedures because of a high viral load in the nasopharynx. This paper describes our experience in conducting emergency and urgent endonasal operations during the peak of the coronavirus disease 2019 pandemic in the UK.
To show the outcome of endonasal surgery during the peak of the coronavirus disease 2019 pandemic and to assess the post-operative rate of nosocomial coronavirus disease 2019 infection.
A retrospective cohort study was conducted of all patients who underwent high priority endoscopic nasal surgery or anterior skull base surgery between 23rd March and 15th June 2020 at University Hospitals Birmingham NHS Trust.
Twenty-four patients underwent endonasal surgery during the study period, 12 were males and 12 were females. There was no coronavirus-related morbidity in any patient.
This observational study found that it is possible to safely undertake urgent endonasal surgery; the nosocomial risk of coronavirus disease 2019 can be mitigated with appropriate peri-operative precautions.
The coronavirus disease 2019 (COVID-19) pandemic has led to significant strain on front-line healthcare workers.
In this multicentre study, we compared the psychological outcomes during the COVID-19 pandemic in various countries in the Asia-Pacific region and identified factors associated with adverse psychological outcomes.
From 29 April to 4 June 2020, the study recruited healthcare workers from major healthcare institutions in five countries in the Asia-Pacific region. A self-administrated survey that collected information on prior medical conditions, presence of symptoms, and scores on the Depression Anxiety Stress Scales and the Impact of Events Scale-Revised were used. The prevalence of depression, anxiety, stress and post-traumatic stress disorder (PTSD) relating to COVID-19 was compared, and multivariable logistic regression identified independent factors associated with adverse psychological outcomes within each country.
A total of 1146 participants from India, Indonesia, Singapore, Malaysia and Vietnam were studied. Despite having the lowest volume of cases, Vietnam displayed the highest prevalence of PTSD. In contrast, Singapore reported the highest case volume, but had a lower prevalence of depression and anxiety. In the multivariable analysis, we found that non-medically trained personnel, the presence of physical symptoms and presence of prior medical conditions were independent predictors across the participating countries.
This study highlights that the varied prevalence of psychological adversity among healthcare workers is independent of the burden of COVID-19 cases within each country. Early psychological interventions may be beneficial for the vulnerable groups of healthcare workers with presence of physical symptoms, prior medical conditions and those who are not medically trained.
African animal trypanosomiasis (AAT) affects the livestock of 12.3 million Somalis and constrains their development and wellbeing. There is missing data on AAT in the country after the civil war of the 1990s. Therefore, this study has aimed to assess the prevalence of Trypanosoma spp. in 614 blood samples from cattle (n = 202), goats (n = 206) and sheep (n = 206) in Afgoye and Jowhar districts, Somalia using parasitological and molecular methods. Twenty-one out of 614 (3.4%; 95% CI: 2.1–5.2%) and 101/614 (16.4%; 95% CI: 13.6–19.6%) ruminants were positive for Trypanosoma spp. by buffy coat technique (BCT) and internal transcribed spacer 1 (ITS1)-polymerase chain reaction (PCR), respectively. Using ITS1-PCR, the highest prevalence was observed in cattle (23.8%; 95% CI: 18.4–30.1%) followed by goats (17.5%; 95% CI: 12.9–23.3%) and sheep (8.3%; 95% CI: 5.1–12.9%). A total of 74/101 (73.3%; 95% CI: 63.5–81.6%) ruminants were shown coinfection with at least two Trypanosome species. The four T. brucei-positive samples have tested negative for T. b. rhodesiense, by the human-serum-resistance-associated-PCR. Trypanosoma evansi, T. godfreyi, T. vivax, T. brucei, T. simiae and T. congolense were the Trypanosoma species found in this study. This is the first study on the molecular detection of Trypanosoma sp. in ruminants in Somalia. Further investigations and control measures are needed to manage Trypanosomiasis spreading in the country. Studies should also focus on the detection of T. b. rhodesiense in the country.
To determine the prevalence and predictors of hypocalcaemia in under-five children (1–59 months) hospitalised with severe acute malnutrition (SAM).
A cross-sectional study was designed to determine the prevalence of hypocalcaemia among children hospitalised with SAM. Serum Ca and 25-hydroxycholecalciferol (25-(OH)D) were estimated. Hypocalcaemia was defined as serum Ca (albumin-adjusted) <2·12 mmol/l. To identify the clinical predictors of hypocalcaemia, a logistic regression model was constructed taking hypocalcaemia as a dependent variable, and sociodemographic and clinical variables as independent variables.
A tertiary care hospital in Delhi, between November 2017 and April 2019.
One-hundred and fifty children (1–59 months) hospitalised with SAM were enrolled.
Hypocalcaemia was documented in thirty-nine (26 %) children hospitalised with SAM, the prevalence being comparable between children aged <6 months (11/41, 26·8 %) and those between 6 and 59 months (28/109, 25·7 %) (P = 0·887). Vitamin D deficiency (serum 25-(OH)D <30 nmol/l) and clinical rickets were observed in ninety-eight (65·3 %) and sixty-three (42 %) children, respectively. Hypocalcaemia occurred more frequently in severely malnourished children with clinical rickets (OR 6·6, 95 % CI 2·54, 17·15, P < 0·001), abdominal distension (OR 4·5, 95 % CI 1·39, 14·54, P = 0·012) and sepsis (OR 2·6, 95 % CI 1·00, 6·57, P = 0·050).
Rickets and hypocalcaemia are common in children with SAM. Routine supplementation of vitamin D should be considered for severely malnourished children. Ca may be empirically prescribed to severely malnourished children with clinical rickets, abdominal distension and/or sepsis.
Chronic aflatoxin exposure has been associated with childhood stunting (length-for-age/height-for-age < –2 sd), while data lacks for Bangladesh, a country with substantial burden of childhood stunting. This paper examined the association between aflatoxin exposure and childhood stunting in a slum setting of Dhaka city.
In this MAL-ED aflatoxin birth cohort study, plasma samples were assayed for aflatoxin B1-lysine adduct (AFB1-lys) by MS at 7, 15, 24 and 36 months of age for 208, 196, 173 and 167 children to assess chronic aflatoxin exposure. Relationship between aflatoxin exposure and anthropometric measures was examined by mixed-effects logistic regression models.
Setting and participants:
The study was conducted in Mirpur, Dhaka, where children were followed from birth to 36 months.
Prevalence of stunting increased from 21 % at 7 months to 49 % at 36 months of age. Mean AFB1-lys concentrations at 7, 15, 24 and 36 months were 1·30 (range 0·09–5·79), 1·52 (range 0·06–6·35), 3·43 (range 0·15–65·60) and 3·70 (range 0·09–126·54) pg/mg albumin, respectively, and the percentage of children with detectable AFB1-lys was 10, 21, 18 and 62 %, respectively. No association was observed between aflatoxin exposure and stunting in multivariable analyses. Factors associated with childhood stunting were age, low birth weight, maternal height, stool myeloperoxidase and number of people sleeping in one room.
A relatively lower exposure to aflatoxin may not influence the linear growth of children. This finding indicates a threshold level of exposure for linear growth deficit and further investigation in other areas where higher concentrations of aflatoxin exposure exist.
This mixed-methods study aimed to assess health-related quality of life in young adults with CHD following surgery in a low middle-income country, Pakistan. Despite the knowledge that geographic, cultural and socio-economic factors may shape the way health and illness is experienced and managed and consequently determine a person’s health-related quality of life, few health-related quality of life studies are conducted in low middle-income countries. This deficit is pronounced in CHD, so there is little guidance for patient care.
The study utilised concurrent, mixed methods. Adults with CHD (n = 59) completed health-related quality of life surveys (PedsQLTM 4.0 Generic Core Scale, PedsQLTM Cognitive Functioning Scale and PedsQLTM 3.0 Cardiac Module). Semi-structured interview data were collected from a nested sub-sample of 17 participants and analysed using qualitative content analysis, guided by the revised Wilson–Cleary model of health-related quality of life.
The lowest health-related quality of life domain was emotional with the mean score (71.61 ± 20.6), followed by physical (78.81 ± 21.18) and heart problem (79.41 ± 18.05). There was no statistical difference in general or cardiac-specific health-related quality of life between mild, moderate or complex CHD. Qualitative findings suggested low health-related quality of life arose from a reduced capacity to contribute to family life including family income and gender. A sense of reduced marriageability and fear of dependency were important socio-cultural considerations.
CHD surgical patients in this low-income country experience poor health-related quality of life, and contributing factors differ to those reported for high-income countries. Socio-cultural understandings should underpin assessment, management and care-partnering with young adults with CHD following surgical correction.
The coronavirus disease 2019 pandemic requires urgent modification to existing head and neck cancer diagnosis and management practices. A protocol was established that utilises risk stratification, early investigation prior to clinical review and a reduction in aerosol generating procedures to lessen the risk of coronavirus disease 2019 spread.
Two-week wait referrals were stratified into low, intermediate and high risk. Low risk patients were referred back to primary care with advice; intermediate and high risk patients underwent investigation. Clinical encounters and aerosol generating procedures were minimised. A combined diagnostic and therapeutic surgical approach was undertaken where possible.
Forty-one patients were used to assess feasibility. Thirty-one per cent were low risk, 35 per cent were intermediate and 33 per cent were high risk. Thirty-three per cent were discharged with no imaging.
Implementing this protocol reduces the future burden on tertiary services, by empowering primary care physicians to re-refer low risk patients. The protocol is applicable across the UK and avoids diagnostic delay.
Big data provides high volume of data to inform product customisation. Understanding which data is relevant remains a challenge. A method is proposed to identify relevant data to inform data-driven customisation. A case study regarding customisation of orthoses was conducted. Verbal protocol analysis was employed to extract time spent on major fabrication phases. Data related to patients, therapists and fabrication time was analysed. Results showed that the number of stabilised joints, experience of therapists and whether the design is for in- or out-patient are key factors for customisation.
Introduction: eCTAS is a real time electronic triage decision-support tool designed to improve patient safety and quality of care by standardizing the application of the Canadian Triage and Acuity Scale (CTAS). The tool dynamically calculates a recommended CTAS score based on the presenting complaint, vital signs and selected clinical modifiers. The primary objective was to assess consistency of CTAS score distributions across 35 emergency departments (EDs) by 16 presenting complaints pre and post eCTAS implementation. Methods: This retrospective cohort study used population-based administrative data from January 2016 to December 2018 from all hospital EDs in Ontario that had implemented eCTAS with at least 9 months of data. Following a 3-month stabilization period, we compared data for 6 months post-eCTAS implementation to the same 6-month period the previous year (pre-implementation) to account for potential seasonal variation, patient volume and case-mix. We included triage encounters of adult (≥18 years) patients if they had one of 16 pre-specified high-volume, presenting complaints. A paired-samples t-test was used to determine consistency by estimating the absolute difference in CTAS distribution for each presenting complaint, by each hospital, pre and post eCTAS implementation, compared to the overall average of the 35 EDs. Results: There were 183,231 triage encounters in the pre-eCTAS cohort and 179,983 in the post-eCTAS cohort from 35 EDs across the province. Triage scores were more consistent with the overall average after eCTAS implementation in 6 (37.5%) presenting complaints: chest pain (cardiac features) (p < 0.001), extremity weakness/symptoms of cerebrovascular accident (p < 0.001), fever (p < 0.001), shortness of breath (p < 0.001), syncope (p = 0.02), and hyperglycemia (p = 0.03). Triage consistency was similar pre and post eCTAS implementation for the presenting complaints of altered level of consciousness, anxiety/situational crisis, confusion, depression/suicidal/deliberate self-harm, general weakness, head injury, palpitations, seizure, substance misuse/intoxication or vertigo. Conclusion: A standardized, electronic approach to performing triage assessments increased consistency in CTAS scores across many, but not all, high-volume CEDIS complaints. This does not reflect triage accuracy, as there are no known benchmarks for triage accuracy. Improvements in consistency were greatest for sentinel presenting complaints with a minimum allowable CTAS score.
This study describes the social, demographic and clinical characteristics of all the new referrals in a mental health catchment area. This study aims to compare Irish and non-Irish service users in terms of their mental health needs and service utilization.
Case notes were reviewed retrospectively to investigate demographic, clinical and service utilization parameters among new referrals to the psychiatric services in Galway, Ireland over a six-month period.
One hundred and fifty four new referrals, of whom 41 were non-Irish, presented over a sixmonth period. Results showed no difference between Irish and non-Irish patients in terms of sociodemographic variables. Alcohol problems and subsequent need for detoxification and counseling were significantly increased among service users from the new EU accession states with a significant impact on the duration of their hospital stay and the need for intensive psychiatric care.
There is an urgent need for enhanced resources for the delivery of mental healthcare to immigrants. Service utilization and mental health needs are not explained merely by illness-related aspects in immigrant service users. Social and cultural factors have to be recognized in order to prevent disadvantages in psychiatric care.
Autosomal recessive ataxia of Charlevoix-Saguenay (ARSACS) is characterized by early onset cerebellar ataxia, lower limb spasticity, and sensorimotor axonal polyneuropathy. Early atrophy of the superior cerebellar vermis is always present. Molecular linkage analysis found that the ARSACS gene is located on chromosome 13q12. Cloning of the gene, SACS, demonstrated that it encodes the protein sacsin.
Systematic evaluation of neurological, neuropsychiatric and neuropsychological features in two male siblings.
Investigation of the putative relationship between cerebellar dysfunction and affective symptoms.
Detailed neuropsychiatric and neuropsychological assessment.
The first patient, aged 55, the disease started in early infancy and a severe progressive cerebellar syndrome with spasticity of the legs and axonal polyneuropathy developed. In his brother, aged 50, the debut of neurological symptoms was in preadolescence with a less severe deterioration over time. Cognitive functioning was only marginally impaired in the latter patient, whereas behavioural aberrations were present in the first patient only. Both patients showed a reduced cognitive and emotional responsivity to environmental events leading to impairments in several areas of daily life, such as lack of effort and strategic planning, as well as impulsivity and impoverished social interaction with emotional indifference. This symptom profile typically points towards the presence of an apathy syndrome.
In ARSACS, in addition to the motor impairments, it may be postulated that the cerebellar cognitive affective syndrome is present. Thus, this hereditary form of ataxia may be accompanied by a series of non-motor symptoms of which motivational and affective signs dominate. \
Risperidone has been recommended for the management of disruptive behaviour disorders in children with learning disabilities. This study explored the effects of Risperidone on absolute body weight in children with learning disabilities who received Risperidone for disruptive behaviour disorders.
Data was collected for children (n = 70) with learning disabilities who were prescribed Risperidone for disruptive behaviour disorders in out patient clinic. Weight, height and BMI were recorded at the first appointment and at the follow up for up to one year. Data was analysed to find any changes in weight and BMI during the course of treatment with Risperidone.
Mean weight gain for the sample was 6.1 kg (sd = 2.7), 1.7 kg more than expected in one year which was statistically significant (t = 6.2, df = 69, p < 0.001). Mean BMI change was 1.51 kg; significantly larger than the mean expected BMI change of 0.62 of this sample (t = 4.98, df = 1.6, P = 0.001). Change in BMI was more for girls, 2.17 (sd = 1.00) compared with boys 1.36 (sd = 1.18), but this was not significant (t = 1.90, df = 49, p = 0.06). There is no significant relationship between Risperidone dose and weight gain (Pearson's r = 0.21, p = 0.42) and BMI (Pearson's r = 0.03, p = 1.00).
Risperidone should be used with caution in children where weight gain could have long lasting impact. Prescribing clinicians should obtain baseline measures of weight, height, BMI and monitor them at regular intervals. Emphasis should be placed on life style interventions such as diet, physical activities etc. Further comparable studies with larger sample sizes using more homogenous diagnostic samples are needed.
Prior meta-analyses have suggested superior efficacy of venlafaxine compared to SSRIs. In this meta-analysis we compared the efficacy of venlafaxine and SSRIs in patients with MDD classified according to baseline severity
Data from 31 venlafaxine studies were pooled and remission rates defined as <8 on the HAM-D17- score were analyzed. Subjects were divided into two groups based on their baseline HAM-D-17 total score ≥30 / < 30. Fisher's exact test was used to compare the treatment effects on the remission rates for each subgroup. All of the analyses were based on intent-to-treat patients, LOCF and completer analysis were performed using standardized measurements.
5836 patients with a baseline HAM-D17 <30 could be identified. The LOCF analysis revealed, that the OR is 1.31 (95%CI 1.18, 1.46), p<0.001 and the NNT is 16, whereas the completer analysis revealed, that the OR is 1.25 (95%CI 1.09, 1.43), p=0.001 and the NNT is 16. Remission data for 656 patients with a baseline HAM-D17 >30 were available. The LOCF analysis revealed, that the OR is 1.55 (95%CI 1.10, 2.18), p=0.015 and the NNT is 11, whereas the completer analysis revealed, that the OR is 1.93 (95%CI 1.25, 2.97), p=0.003 and the NNT is 7.
This analysis demonstrates that venlafaxine is superior to SSRIs in both the mild/moderate and severe depression in achieving remission. However, the magnitude of superiority was higher in the subgroup of patients with a baseline HAM-D17 >30 suggesting a pronounced clinical benefit for the treatment of severely depressed patients.
To assess the efficacy of desvenlafaxine succinate (DVS) treatment in patients with major depressive disorder (MDD).
Seven randomized, double-blind, placebo-controlled, short-term studies were pooled to evaluate the efficacy of DVS in MDD. Adult outpatients with DSM-IV MDD were enrolled in all studies. Eligible patients were randomly assigned to DVS (n=1186) at doses of 100–400 mg/d, or placebo (n=797) for 8 weeks. The 17-item Hamilton Depression Rating Scale (HAM-D17) was the primary efficacy variable. Other efficacy variables were the Clinical Global Impressions scale (CGI), HAM-D6, Montgomery Åsberg Depression Rating Scale (MADRS), Covi Anxiety scale, Sheehan Disability Scale (SDS), WHO-5 Well-Being Index, and the Visual Analog Scale–Pain Intensity (VAS-PI). A mixed-effect model for repeated measures (MMRM) analysis was used to analyze continuous variables. Logistic regression was used to analyze response and remission rates.
An adjusted mean difference of –2.8 points on HAM-D17 total score at end point for DVS vs placebo (95% confidence limits: –2.2, –3.4; P<0.001) was demonstrated. Response and remission rates were significantly elevated for DVS-treated patients compared with placebo (P<0.001) across rating scales (HAM-D17, MADRS, and CGI). For other secondary measures at end point, including the CGI, HAM-D6, MADRS, Covi, SDS, WHO-5, and VAS-PI, significant differences from placebo were also observed. No additional benefit was observed for DVS doses above 100 mg/d in analyses of fixed-dose studies.
DVS was efficacious in treating MDD based on standard depression rating scales and measures of anxiety, global severity/improvement, functioning, well being, and pain.
A study of adolescents with diabetes found that one third had psychiatric disorders, most involving internalizing symptoms; other studies have shown that diabetic youth have greater rates of depression and that those with depression have poor glycemic control.
To investigate the effect of cognitive and emotional response to disease and treatment on diabetes self-management behavior. To study the effect of psychosocial factors as self-esteem, body image, different coping strategies and family factors on diabetes self-management behavior and subsequent glycemic control in diabetic adolescents.
Cross-sectional study which includes 37 controlled and 30 uncontrolled diabetic adolescents recruited from Abou El-Rich Hospital, All participants were subjected to Semi structured interview, Personal Models of Diabetes Questionnaire, Body Image Scale, Coopersmith Self Esteem Inventory, Taxonomy of Children's Coping Strategies and assessment of Glycosylated Hemoglobin.
Perceived seriousness of diabetes is higher in the group of uncontrolled diabetes (p < 0.001). Higher self-esteem in the group of controlled diabetes (14.91 ± 3.43) compared to the group of uncontrolled diabetes (10.33 ± 4.74). There was highly statistical significant difference regarding Coopersmith Self- Esteem Inventory (p < 0.001).
Lower self-esteem was more prevalent among uncontrolled diabetic adolescents. In the group of uncontrolled diabetes early age of onset, and longer duration of illness were associated significantly with lower self-esteem.
To analyze baseline scores on individual items of the 17-item Hamilton Rating Scale for Depression (HAM-D17) in depressed outpatients by age groups approximating menopausal status.
This post-hoc, pooled analysis was conducted with populations from 7 double-blind, placebo-controlled desvenlafaxine succinate (DVS) trials in patients with major depressive disorder. The age groups, chosen as a proxy for pre-, peri-, and postmenopausal status, respectively, were 18-39, 40-55, and >55 years of age. Data from male patients were used to differentiate effects due to menopausal status from those related to age. Analysis of variance with Bonferroni adjustments was used to compare differences in baseline scores on individual HAM-D17 items.
A total of 1203 women (18-39 years [n=525]; 40-55 years [n=513]; >55 [n=165]) and 780 men (18-39 years [n=321]; 40-55 years [n=354]; >55 [n=105]) were included in this analysis. When analyzing these data by gender, women had significantly higher scores on HAM-D17 total (P=0.002), anxiety (P<0.001) and retardation subscales (P<0.001), and the somatic–anxiety (P<0.001), genital (P<0.001), and hypochondriasis (P=0.007) items. A significant age effect was observed for the HAM-D17 insomnia scale (P=0.004), and guilt (P<0.001), all insomnia items (P≤0.001), somatic–general (P<0.001), genital (P=0.019), and hypochondriasis (P≤0.001) individual items. An age effect among women was observed on the guilt (P=0.017), all insomnia items (P<0.05), somatic–general (P=0.022), and hypochondriasis (P=0.001) items.
Women in age groups approximating peri- and postmenopausal status had significantly higher baseline scores than younger women for the hypochondriasis, insomnia–middle and insomnia–late items of the HAM-D17.
In this meta-analysis we compared the effects of venlafaxine and SSRIs on work activity in MDD patients classified according to baseline severity
Data from the work and activity item 7 of the HAMD17 of 31 pooled studies comparing venlafaxine with SSRIs were used. Subjects were divided into two groups based on their baseline HAMD17 total score ≥30/< 30.Score distributions and the proportions of patients achieving full work functionality were summarized for both LOCF and Completers at week 8. Fisher's exact test was used to compare the treatment effects..
5836 patients with a baseline HAMD17 <30 were identified. The OR for all subjects achieving full work functionality is 1.22 (95%CI 1.08, 1.36), p<0.001 for LOCF and 1.19 (95%CI 1.04, 1.38), p=0.015 for completers. The OR for subjects with work impairment at baseline is 1.17 (95%CI 1.02, 1.35), p=0.029 for LOCF and 1.13 (95%CI 0.95, 1.35), p=0.18 for completers. 656 patients with a baseline HAMD17 >30 were identified. The OR for all subjects achieving full work functionality is 1.80 (95%CI 1.24, 2.63), p=0.002 for LOCF and 1.64 (95%CI 1.05, 2.58), p=0.032 for completers. The OR for subjects with work impairment at baseline is 1.93 (95%CI 1.30, 2.87), p=0.001 for LOCF and 1.81 (95%CI 1.12, 2.92), p=0.017 for completers.
This analysis demonstrates that venlafaxine is superior to SSRIs in improving work functionality in both mild/moderate and even more pronounced in severe depression. These results emphasize the impact of the treatment with venlafaxine on patients returning to normal social life.
To review current practice of Antipsychotics prescribing in patients with Behavioural and Psychiatric symptoms of Dementia in secondary care hospital.
This was a retrospective audit targeting all patients who were diagnosed with a dementing illness in a large secondary care hospital from September 2008 to December 2008 inclusive. Data was collected from patients’ health care records and central computer database. Current practice was then compared with the standards proposed by the NICE Guidelines (National Institute of Clinical Excellence, 2006).
Out of 18 patients who were diagnosed with dementia, 66% (n = 12) were prescribed antipsychotics. Out of these, 66%(n = 8) were males and 34%(n = 4) were females. 75%(n = 9) had explicitly documented indications for antipsychotics use in their health care records with only 25% cases (n = 3) alternative treatment options such as psychosocial interventions were considered.
with patients and/or the carers’ were documented in 50%(n=6) cases. Periodic reviews were carried out in 66% (n = 8) cases.
Antipsychotics are commonly used in behavioural and psychiatric symptoms of dementia. Considering higher risk of morbidity and mortality with antipsychotics use in this population group, it is of paramount importance that reasons for prescribing and discussion with patients and/or their carers should be clearly documented. If antipsychotics are prescribed patients should be reviewed on regular basis.
The efficacy of venlafaxine extended-release (XR) at doses between 75 mg/d and 300 mg/d has been demonstrated in patients with recurrent major depressive disorder (MDD) over 2.5 years. This analysis evaluated the long-term efficacy of venlafaxine XR ≤225 mg/d, the approved dosage in many countries.
In the primary multicenter, double-blind trial, outpatients with recurrent MDD (N=1096) were randomized to receive 10-week acute-phase treatment with venlafaxine XR (75 mg/d to 300 mg/d) or fluoxetine (20 mg/d to 60 mg/d), followed by a 6-month continuation phase. Subsequently, at the start of 2 consecutive, double-blind, 12-month maintenance phases, venlafaxine XR responders were randomized to receive venlafaxine XR or placebo. Data from the 24 months of maintenance treatment were analyzed for the combined end point of maintenance of response (ie, no recurrence of depression and no dose increase above 225 mg/d), and each component individually. Time to each outcome was evaluated with Kaplan-Meier methods using log-rank tests for venlafaxine XR-placebo comparisons.
The analysis population included 114 patients who had received venlafaxine XR doses less than or equal to 225 mg/d prior to maintenance phase baseline (venlafaxine XR: n=55; placebo: n=59). Probability estimates for maintaining response were 70% for venlafaxine XR and 38% for placebo (P=0.007), for no dose increase were 76% and 58%, respectively (P=0.019), and for no recurrence were 87% vs 65%, respectively (P=.099).
These data confirm venlafaxine XR is effective maintaining response at doses ≤225 mg/d for up to 2.5 years in patients with MDD.