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Abouzeid M, Wyber R, La Vincente S, Sliwa K, Zuhlke L, Mayosi B, Et Al Professor Bongani Mayosi: Bibliography 2019 Abouzeid M, Wyber R, La Vincente S, Sliwa K, Zuhlke L, Mayosi B, et al. Time to tackle rheumatic heart disease: Data needed to drive global policy dialogues. Glob Public Health. 2019;14(3):456–468. doi: 10.1080/17441692.2018.1515970. Full text not freely available. Rheumatic heart disease (RHD) is an avoidable disease of poverty that persists predominantly in low resource settings and among Indigenous and other high-risk populations in some high-income nations. Following a period of relative global policy inertia on RHD, recent years have seen a resurgence of research, policy and civil society activity to tackle RHD; this has culminated in growing momentum at the highest levels of global health diplomacy to definitively address this disease of disadvantage. RHD is inextricably entangled with the global development agenda, and effective RHD action requires concerted efforts both within and beyond the health policy sphere. This report provides an update on the contemporary global and regional policy landscapes relevant to RHD, and highlights the fundamental importance of good data to inform these policy dialogues, monitor systems responses and ensure that no one is left behind. Chasseuil E, McGrath JA, Seo A, Balguerie X, Bodak N, Chasseuil H, et al. Dermatological manifestations of hereditary fibrosing poikiloderma with tendon contractures, myopathy and pulmonary fibrosis (POIKTMP): A case series of 28 patients. Br J of Dermatol. 2019. doi: 10.1111/bjd.17996. Full text not freely available. Hereditary Fibrosing Poikiloderma with Tendon Contractures, Myopathy and Pulmonary Fibrosis (POIKTMP [MIM 615704]) is a recently described autosomal dominant disorder due to missense mutations in the FAM111B gene. Key features are early-onset poikiloderma, muscle contractures in particular of the triceps surae, diffuse progressive fatty myopathy, pulmonary fibrosis in adulthood and exocrine pancreatic insufficiency. Dermatological manifestations seem to be constant and early however, a precise description is lacking. Karthikeyan G, Devasenapathy N, Zuhlke L, Engel ME, Rangarajan S, Teo KK, et al. Digoxin and clinical outcomes in the Global Rheumatic Heart Disease Registry. Heart. 2019;105(5):363–369. doi: 10.1136/heartjnl-2018-313614. Full text available here. Objective: Digoxin is widely used in patients with rheumatic heart disease (RHD) despite a lack of data on its https://openbooks.uct.ac.za/uct/catalog/book/978-0-7992-2546-4 1 Professor Bongani Mayosi: Bibliography impact on clinical outcomes. We aimed to determine the association of digoxin use on clinical outcomes in patients with RHD. Methods: We performed a retrospective analysis of the association of digoxin use with mortality at 2 years in a large RHD registry. Secondary outcomes were recurrent heart failure (HF) and hospitalisation for any cause. We assessed associations using multivariable logistic regression in the entire cohort and in subgroups of patients with atrial fibrillation (AF) and HF. We also estimated average treatment effects from propensity-adjusted analyses using inverse probability treatment weighting. Results: Information on digoxin use at baseline was available for 98.7% (3298/3343) of patients. In the overall population, digoxin was significantly associated with mortality (OR 1.63, 95% CI 1.30 to 2.04, p<0.0001) and recurrent HF (OR 1.48, 95% CI 1.07 to 2.04, p=0.019). On propensity-weighted analyses, this effect was markedly attenuated (OR 1.05, 95% CI 1.01 to 1.09, p=0.005). Patients in sinus rhythm without HF had a higher propensity- adjusted odds of death with digoxin use (OR 1.06, 95% CI 1.01 to 1.12, p=0.015), but those with both AF and HF had lower mortality (OR 0.88, 95% CI 0.80 to 0.98, p=0.019). Conclusion: Digoxin use is associated with higher mortality in patients with RHD, but this is greatly attenuated on propensity adjustment, indicating the presence of substantial treatment bias. The adjusted estimates may therefore not be reliable, and large randomised trials are needed to determine the true effect of digoxin in patients with RHD. Mweemba O, Musuku J, Mayosi BM, Parker M, Rutakumwa R, Seeley J, et al. Use of broad consent and related procedures in genomics research: Perspectives from research participants in the Genetics of Rheumatic Heart Disease (RHDGen) study in a university teaching hospital in Zambia. Glob Bioeth. 2019. doi: 10.1080/11287462.2019.1592868. Full text available here. The use of broad consent for genomics research raises important ethical questions for the conduct of genomics research, including relating to its acceptability to research participants and comprehension of difficult scientific concepts. To explore these and other challenges, we conducted a study using qualitative methods with participants enrolled in an H3Africa Rheumatic Heart Disease genomics study (the RHDGen network) in Zambia to explore their views on broad consent, sample and data sharing and secondary use. In-depth interviews were conducted with RHDGen participants (n = 18), study staff (n = 5) and with individuals who refused to participate (n = 3). In general, broad consent was seen to be reasonable if reasons for storing the samples for future research use were disclosed. Some felt that broad consent should be restricted by specifying planned future studies and that secondary research should ideally relate to original disease for which samples were collected. A few participants felt that broad consent would delay the return of research results to participants. This study echoes findings in other similar studies in other parts of the continent that suggested that broad consent could be an acceptable consent model in Africa if careful thought is given to restrictions on re-use. https://openbooks.uct.ac.za/uct/catalog/book/978-0-7992-2546-4 2 Professor Bongani Mayosi: Bibliography Ojji DB, Mayosi B, Francis V, Badri M, Cornelius V, Smythe W, et al. Comparison of dual therapies for lowering blood pressure in black Africans. N Engl J Med. 2019;380(25):2429−2439. doi: 10.1056/NEJMoa1901113. Full text not freely available. Background: The prevalence of hypertension among black African patients is high, and these patients usually need two or more medications for blood-pressure control. However, the most effective two-drug combination that is currently available for blood-pressure control in these patients has not been established. Methods: In this randomized, single-blind, three-group trial conducted in six countries in sub-Saharan Africa, we randomly assigned 728 black patients with uncontrolled hypertension (≥140/90 mm Hg while the patient was not being treated or taking only one antihypertensive drug) to receive a daily regimen of 5 mg of amlodipine plus 12.5 mg of hydrochlorothiazide, 5 mg of amlodipine plus 4 mg of perindopril, or 4 mg of perindopril plus 12.5 mg of hydrochlorothiazide for 2 months. Doses were then doubled (10 and 25 mg, 10 and 8 mg, and 8 and 25 mg, respectively) for an additional 4 months. The primary end point was the change in the 24-hour ambulatory systolic blood pressure between baseline and 6 months. Results: The mean age of the patients was 51 years, and 63% were women. Among the 621 patients who underwent 24-hour blood-pressure monitoring at baseline and at 6 months, those receiving amlodipine plus hydrochlorothiazide and those receiving amlodipine plus perindopril had a lower 24-hour ambulatory systolic blood pressure than those receiving perindopril plus hydrochlorothiazide (between-group difference in the change from baseline, −3.14 mm Hg; 95% confidence interval [CI], −5.90 to −0.38; P=0.03; and −3.00 mm Hg; 95% CI, −5.8 to −0.20; P=0.04, respectively). The difference between the group receiving amlodipine plus hydrochlorothiazide and the group receiving amlodipine plus perindopril was −0.14 mm Hg (95% CI, −2.90 to 2.61; P=0.92). Similar differential effects on office and ambulatory diastolic blood pressures, along with blood- pressure control and response rates, were apparent among the three groups. Conclusions: These findings suggest that in black patients in sub-Saharan Africa, amlodipine plus either hydrochlorothiazide or perindopril was more effective than perindopril plus hydrochlorothiazide at lowering blood pressure at 6 months. (CREOLE ClinicalTrials.gov number, NCT02742467). Owolabi MO, Akpa OM, Made F, Adebamowo SN, Ojo A, Adu D, et al. Data resource profile: Cardiovascular H3Africa Innovation Resource (CHAIR). Int J Epidemiol. 2019;48(2):366–367g. doi: 10.1093/ije/dyy261. Full text available here. No abstract available. https://openbooks.uct.ac.za/uct/catalog/book/978-0-7992-2546-4 3 Professor Bongani Mayosi: Bibliography Shenje J, Gumbo T, Wiesner L, Ntsekhe M, Mayosi B, Ross I. Detectable prednisolone is delayed in pericardial fluid, compared with plasma of patients with tuberculous pericarditis: A pilot study. Int J Cardiol Heart Vasc. 2019;22:105–110. doi: 10.1016/j.ijcha.2018.12.008. Full text available here. Background: In patients with tuberculous pericarditis [TBP] adjunctive prednisolone reduces the incidence of constrictive pericarditis. It is unknown whether prednisolone permeates adequately into pericardial fluid. Drug measurements in pericardial fluid require invasive procedures, and thus less invasive methods are needed to perform full pharmacokinetic characterization of prednisolone in large numbers of patients. We sought to evaluate the relationship between prednisolone concentrations in pericardial fluid, plasma, and saliva. Methods: Plasma, pericardial fluid, and saliva samples were collected at 7 timepoints from TBP patients randomized to 120mg prednisolone or placebo. Compartmental pharmacokinetic parameters, peak concentration [Cmax], and 0–24 h area under the concentration-time curve [AUC0–24] were identified in plasma, saliva and pericardial fluid. Results: There were five patients each in the prednisolone and placebo groups. Prednisolone concentrations were best described using a one compartment model. The absorption half-life into plasma was 1 h, while that into pericardial fluid was 9.4 h, which led to a median time-to-maximum concentration in plasma of 2.0 h versus 5.0 h in pericardial fluid [p = 0.048].
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