A cardiovascular polypill for secondary stroke prevention in a tertiary centre in Ghana (SMAART): a phase 2 randomised clinical trial.

BACKGROUND: A cardiovascular polypill containing generic drugs might facilitate sustained implementation of and adherence to evidence-based treatments, especially in resource-limited settings. However, the impact of a cardiovascular polypill in mitigating atherosclerotic risk among stroke survivors has not been assessed. We aimed to compare a polypill regimen with usual care on carotid intima-media thickness (CIMT) regression after ischaemic stroke. METHODS: In SMAART, a phase 2 parallel, open-label, assessor-masked, randomised clinical trial, we randomly allocated individuals (aged ≥18 years) who had an ischaemic stroke within the previous 2 months, using a computer-generated randomisation sequence (1:1), to either a polypill or usual care group at a tertiary centre in Ghana. The polypill regimen was a fixed-dose pill containing 5 mg ramipril, 50 mg atenolol, 12·5 mg hydrochlorothiazide, 20 mg simvastatin, and 100 mg aspirin administered as two capsules once per day for 12 months. Usual care was tailored guideline-recommended secondary prevention medications. The primary outcome was the change in CIMT over 12 months with adjustment for baseline values, compared using ANCOVA in all participants with complete data at month 12. Safety was analysed in all randomly assigned participants. This trial is registered at ClinicalTrials.gov, NCT03329599, and is completed. FINDINGS: Between Feb 12, 2019, and Dec 4, 2020, we randomly assigned 148 participants (74 to the usual care group and 74 to the polypill group), 74 (50%) of whom were male and 74 (50%) female. CIMT was assessed in 62 (84%) of 74 participants in the usual care group and 59 (80%) of 74 participants in the polypill group; the main reason for loss to follow-up was participants not completing the study. The mean CIMT change at month 12 was -0·092 mm (95% CI -0·130 to -0·051) in the usual care group versus -0·017 mm (-0·067 to 0·034) in the polypill group, with an adjusted mean difference of 0·049 (-0·008 to 0·109; p=0·11). Serious adverse events occurred among two (3%) participants in the usual care group, and eight (11%) participants in the polypill group (p=0·049). INTERPRETATION: The polypill regimen resulted in similar regression in subclinical atherosclerosis and many secondary and tertiary outcome measures as the tailored drug regimen, but with more serious adverse events. Larger, longer-term, event-based studies, including patients with stroke in primary care settings, are warranted. FUNDING: US National Institutes of Health. TRANSLATION: For the Akan (Twi) translation of the abstract see Supplementary Materials section.

Reduction mammaplasty in a developing country: a guideline for plastic surgeons for patient selection.

BACKGROUND: In Ghana and most developing countries there has been no standardized study of reduction mammaplasty (RM) in patients with symptomatic macromastia (SM), despite its debilitating effects. This study aimed to analyze the physical and psychological effects associated with female patients who underwent reduction mammaplasty and to develop a guideline for plastic surgeons in developing countries to know the most important signs and symptoms to consider in SM patients. METHODS: From 2003 to 2009, all females with SM who visited Komfo Anokye Teaching Hospital (KATH) in Kumasi, Ghana, for RM were given a questionnaire designed to evaluate SM-related physical and psychological effects. These patients were then provided the same questionnaire at their final visit 5 months postoperatively to assess the effects of RM on SM. RESULTS: Sixty-three patients who underwent RM were evaluated, with a mean age of 28.5 years. Twenty-seven (42.9%) patients reported that their macromastia started during puberty, with 3 (4.8%) patients associating the onset with pregnancy. Thirty (47.6%) patients reported having SM for more than 10 years. Multiple regression analysis revealed upper- and lower-back pain (p=0.0005), painful bra strap grooves (p=0.0041), teasing (p=0.01), and poor self-image (p=0.021) to be significant factors for which patients underwent RM. Postoperatively, most of the patients' physical symptoms resolved, while 2 (3.2%) patients complained of residual psychological effects. CONCLUSION: RM offers substantial symptomatic relief for patients with SM and results in significant improvement in the patient's quality of life. This study conclusively demonstrates that, upper- and lower-back pain, painful bra strap grooves, teasing, and poor self-image should be considered by plastic surgeons before deciding which SM patient to treat when confronted with numerous SM patients.

Atherosclerotic event risk and risk reduction therapies among Ghanaian hemorrhagic stroke survivors.

BACKGROUND: Intracerebral hemorrhage (ICH) stroke constitute up to 40% of incident strokes in Africa. While ICH patients are at high risk for atherosclerotic events, the risk-benefit of anti-atherosclerotic therapies in this patient population is uncertain. PURPOSE: To assess whether utility of statins and/or antithrombotic agents after surviving an ICH correlates with atherosclerotic risk of an observational cohort. METHODS: We analyzed data in a stroke registry prospectively collected on consecutively encountered stroke survivors seen at an out-patient clinic in Ghana between January 2018 and March 2020. We collected baseline demographic and clinical details, including diagnosis of ICH, co-morbidities, and key atherosclerotic risk reduction therapies (statins and anti-platelet drugs). We computed ischemic vascular risk using the Framingham Risk Score (FRS) to classify patients into low, intermediate and high vascular risk. RESULTS: Of 1101 stroke survivors seen during the period, 244 (22.2%) had ICH. Vascular risk profiles were low (n = 86; 35.2%), intermediate (n = 71; 29.1%) and high (n = 87; 35.7%). Utility of statin use was 76.7% (low risk), 84.5% (intermediate risk), and 87.4% (high risk), p = 0.16 while antiplatelet use trended with atherosclerotic risk being 9.3% (low risk), 25.4% (intermediate risk), and high risk (34.5%), p = 0.0004. Independent factors associated with statin use were hypertension (OR 8.80; 95% CI: 2.34-33.11) and cigarette smoking (OR 0.29; 95% CI: 0.09-0.89) while antiplatelet drug use was associated with age (OR 1.43; 95% CI: 1.06-1.92) and time from index stroke (OR: 1.02; 95% CI: 1.01-1.02). CONCLUSION: Approximately two-thirds of ICH survivors in this African sample had intermediate to high risk of future atherosclerotic events. Clinical trials on the timing, safety, and efficacy of statins and antiplatelet drugs among ICH survivors could help better guide risk mitigation in this population.

Prevalence and predictors of post-stroke epilepsy among Ghanaian stroke survivors.

BACKGROUND: Post-stroke epilepsy (PSE) is associated with poorer quality of life, higher mortality, and greater health expenditures. We are unaware of any published reports on the frequency of and factors associated with PSE in Africa. PURPOSE: To assess the frequency and factors associated with PSE among Ghanaian stroke survivors. METHODS: We conducted a cross-sectional study of consecutive stroke survivors seen at an out-patient Neurology clinic enrolled into a stroke registry at a tertiary medical center in Ghana between January 2018 and March 2020. We collected baseline demographic and clinical details including diagnosis of post-stroke epilepsy, anti-epileptic medications, presence, treatment and control of vascular risk factors. Multivariate logistic regression models were constructed to identify factors associated with PSE. RESULTS: Of 1101 stroke patients encountered, 126 had PSE (frequency of 11.4%; 95% CI of 9.6-13.5%). Mean (± SD) age among PSE vs. non-PSE patients was 57.7 (± 15.2) vs. 58.7 (± 13.9) years. Factors independently associated with PSE were being male (aOR 1.94; 95% CI: 1.32-2.86), cortical ischemic strokes (1.79; 1.12-2.87), blood pressure > 130/80 mmHg (OR 2.26; 1.06-4.79), use of antihypertensive treatment (OR 0.43; 0.23-0.79). There was an inverted J-shaped curve association between number of classes of antihypertensive drugs prescribed and occurrence of PSE, with the lowest inflection point at 3 classes (OR 0.34; 0.17-0.68). CONCLUSION: In this convenience sample of ambulatory Ghanaian stroke survivors, one in ten had PSE. Further investigations to confirm and clarify the associations between the identified demographic and clinical characteristics are warranted.

Frequency and factors linked to refractory hypertension among stroke survivors in Ghana.

BACKGROUND: Refractory hypertension (RfH) is a rare, severe phenotype of resistant hypertension, linked to higher risk of adverse cardiovascular outcomes. Little is known about the association of RfH with stroke type and subtype. OBJECTIVE: To determine the prevalence and predictors of RfH among stroke survivors in Ghana. METHODS: We interrogated the dataset of a prospectively collected registry of hypertensive patients seen between July 2015 and June 2019, at five hospitals in Ghana. We compared stroke survivors to stroke-free controls. Clinic-based blood pressure was measured using a standardized protocol and antihypertensive medications were assessed via review of medical records and inspection of pills. Refractory hypertension was defined as office BP ≥140/90 mmHg on ≥5 classes of antihypertensive medications. Multivariate logistic regression models were constructed to assess factors associated with RfH. RESULTS: Of 3927 hypertensive patients (1169 stroke survivors, 2758 controls), 86 had RfH for an overall prevalence of 2.2% (95% CI: 1.8-2.7%). Among patients with RfH, 5.8% (4.5-7.3%) were stroke survivors vs. 0.7% (0.4-1.0%) were stroke-free (p < .0001). Adjusted odds ratio (95% CI) for factors associated with RfH were being male (1.81, 1.15-2.85), age < 60 years (2.64, 1.59-4.40), chronic kidney disease (2.09, 1.21-3.60), and known stroke (7.53, 4.35-13.04). RfH was associated with intracerebral hemorrhage, (11.43, 5.65-23.14), ischemic stroke (9.76, 5.47-17.42), lacunar stroke (13.58, 6.45-28.61), and non-lacunar ischemic stroke (3.67, 1.04-13.02). CONCLUSION: Presence of RfH is significantly accentuated among stroke survivors. Intensified efforts are warranted to identify and aggressively address barriers to control in these patients to avert subsequent vascular events.

The dynamics of Poststroke depression among Ghanaians.

OBJECTIVE: The very few published data on post-stroke depression (PSD) among indigenous Africans have covered its prevalence and predictors. We sought to evaluate the dynamics of PSD in a cohort of Ghanaian stroke survivors followed for 9 months after an acute stroke. METHODS: Stroke survivors in this prospective cohort were adults aged >18 years with CT scan confirmed stroke, recruited into a randomized controlled trial to assess the feasibility of an mHealth technology-enabled, nurse guided intervention for blood pressure control. PSD was assessed a secondary outcome measure using the Hamilton Depression Rating Scale (HDRS) at enrollment, months 3, 6, and 9. Those with a score of >7 points on HDRS were categorized as depressed. A multivariate logistic regression analysis was performed to identify independent predictors of PSF. RESULTS: Mean age of study participants was 55.1 ±â€¯12.7 years with 65% being males. Ischemic strokes comprised 76.6% of study population. Prevalence of PSD at baseline was 78.6%, 43.6% at month 3, 41.1% at month 6 and 18.2% at month 9 (p < .0001). Factors significantly associated with PSD at baseline were higher NIH Stoke Scale score (adjusted OR 1.51, 95% CI: 1.03-2.23) and pain (adjusted OR 7.18, 95% CI: 1.52-33.89). NIHSS score (adjusted OR, 1.99, 95% CI: 1.12-3.52) as associated with PSD at month 9. CONCLUSION: 80% Ghanaian stroke survivors have early PSD declining to 20% at month 9. Stroke severity is the persistent factor associated with PSD at baseline and follow-up, and good be a target for screening and promptly treating PSD.

Pediatric burns mortality risk factors in a developing country's tertiary burns intensive care unit.

AIM: This study aimed at identifying risk factors related to pediatric burns mortality in a middle income country such as Ghana. METHODS: The data for the three years retrospective study (May 2009 - April 2012) was obtained from the pediatric burn admissions records and patients' folders of the Reconstructive Plastic Surgery & Burns Unit (RPSBU), Komfo Anokye Teaching Hospital (KATH), Ghana. Data retrieved included: Demographic features, Total Burned Surface Area (TBSA) incurred; Aetiology of burns; Duration of the admission; Outcome of admission; Part of the body affected and Cost incurred. Ethical approval for this study was obtained from the KNUST-SMS/KATH Committee on Human Research, Publications and Ethics. Data analyses were performed with SPSS 17.0 version. RESULTS: Information on 197 patients was completely retrieved for the study. Burns mortality rate for the study was identified to be 21.3% (N=42). The mean age of the 42 dead patients was 3.7±0.3 years, ranging from 0-13 years, while, males (54.8%, N= 23) outnumbered females (45.2%, N=19). The TBSA burned interquartile range was 48%. In terms of etiology of burns Scald (73.8%, N=31) was the commonest cause of injury. Mortality risk factors identified were Age <6 years (P=0.028); Scald especially hot water and soup (P=0.016); TBSA >36% (P=0.028) and Inhalation injury (P=0.040). CONCLUSION: Age, scald, TBSA and Inhalation Injury were identified as pediatric burns mortality risk factors in a developing country such as Ghana's RPSBU. These identified factors will serve as a guideline for plastic surgeons and other health professionals practicing in countries such as Ghana.