Medicine
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This repository contains the published and unpublished research of the Faculty of Medicine by the staff members of the faculty
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Item Efficacy and safety of a novel low-dose triple single-pill combination compared with placebo for initial treatment of hypertension(Elsevier Biomedical, 2024) Rodgers, A.; Salam, A.; Schutte, A.E.; Cushman, W.C.; De Silva, H.A.; Tanna, G.L.D.; Grobbee, D.; Narkiewicz, K.; Ojji, D.B.; Poulter, N.R.; Schlaich, M.P.; Oparil, S.; Spiering, W.; Williams, B.; Jr, J.T.W.; Gutierez, A.; Sanni, A.; Lakshman, P.; McMullen, D.; Ranasinghe, G.; Gianacas, C.; Shanthakumar, M.; Liu, X.; Wang, N.; Whelton, P.BACKGROUND Single-pill combinations of 3 or more low-dose blood pressure (BP)-lowering drugs hold promise for initial or early treatment of hypertension.OBJECTIVES We conducted a placebo-controlled trial of a new single-pill combination containing low doses of telmisartan, amlodipine, and indapamide in 2 dose options to assess efficacy and safety.METHODS This international, randomized, double-blind, placebo-controlled, parallel-group trial enrolled adults with hypertension receiving 0 to 1 BP-lowering drugs. After a 2-week placebo run-in during which any BP-lowering medication was stopped, participants were eligible if home systolic BP (SBP) was 130 to 154 mm Hg. Participants were randomized in a 2:2:1 ratio to GMRx2 ¼ dose (telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg), GMRx2 ½ dose (telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg), or placebo. The primary efficacy outcome was difference in change in home SBP from randomization to week 4, and primary safety outcome was treatment discontinuation due to an adverse event.RESULTS From June 14, 2021 to October 18, 2023, a total of 295 participants (mean age: 51 years; 56% female) were randomized and 96% completed the trial. Baseline mean home BP was 139/86 mm Hg and clinic BP was 138/86 mm Hg after placebo run-in. The placebo-corrected least square mean differences in home SBP at Week 4 were -7.3 mm Hg (95% CI: -4.5 to -10.2) for GMRx2 ¼ dose and -8.2 mm Hg (95% CI: -5.2 to -11.3) for GMRx2 ½ dose; reductions for clinic BP were 8.0/4.0 and 9.5/4.9 mm Hg. At Week 4, clinic BP control (<140/90 mm Hg) was 37%, 65%, and 70% for placebo, GMRx2 ¼ dose, and GMRx2 ½ dose, respectively (both doses P < 0.001 vs placebo). Placebo, GMRx2-triple ¼, and GMRx2 ½ treatment discontinuation due to an adverse event occurred in 1 (1.6%), 0, and 6 (5.1%), respectively; out of normal range serum sodium or potassium was observed in 4 (6.3%), 12 (10.6%), and 12 (10.1%), respectively, but no participant had a serum sodium <130/>150 mmol/L or potassium <3.0/>6.0 mmol/L. Serious adverse events were reported by 2 participants in the placebo and GMRx2 ½ groups and none in the GMRx2 ¼ group.CONCLUSIONS In a population with mild-to-moderate BP elevation, both dose versions of the novel low-dose triple single-pill combination showed good tolerability and clinically relevant BP reductions compared with placebo. (Efficacy and Safety of GRMx2 Compared to Placebo for the Treatment of Hypertension: NCT04518306).Item Inhaled beclomethasone in the treatment of early COVID-19: a double-blind, placebo-controlled, randomised, hospital-based trial in Sri Lanka(BMJ Publishing Group Ltd, 2023) Mettananda, C.; Peiris, C.; Abeyrathna, D.; Gunasekara, A.; Egodage, T.; Dantanarayana, C.; Pathmeswaran, A.; Ranasinha, C.OBJECTIVES: To study if early initiation of inhaled beclomethasone 1200 mcg in patients with asymptomatic, mild or moderate COVID-19 reduces disease progression to severe COVID-19. DESIGN: Double-blinded, parallel-groups, randomised, placebo-controlled trial. SETTING: A hospital-based study in Sri Lanka. PARTICIPANTS: Adults with asymptomatic, mild or moderate COVID-19, presenting within the first 7 days of symptom onset or laboratory diagnosis of COVID-19, admitted to a COVID-19 intermediate treatment centre in Sri Lanka between July and November 2021. INTERVENTIONS: All participants received inhaled beclomethasone 600 mcg or placebo two times per day, for 10 days from onset of symptoms/COVID-19 test becoming positive if asymptomatic or until reaching primary endpoint, whichever is earlier. PRIMARY OUTCOME MEASURE: Progression of asymptomatic, mild or moderate COVID-19 to severe COVID-19. SECONDARY OUTCOME MEASURES: The number of days with a temperature of 38°C or more and the time to self-reported clinical recovery. RESULTS: A total of 385 participants were randomised to receive beclomethasone(n=193) or placebo(n=192) stratified by age (≤60 or >60 years) and sex. One participant from each arm withdrew from the study. All participants were included in final analysis. Primary outcome occurred in 24 participants in the beclomethasone group and 26 participants in the placebo group (RR 0.90 ; p=0.763). The median time for self-reported clinical recovery in all participants was 5 days (95% CI 3 to 7) in the beclomethasone group and 5 days (95% CI 3 to 8) in the placebo group (p=0.5). The median time for self-reported clinical recovery in patients with moderate COVID-19 was 5 days (95% CI 3 to 7) in the beclomethasone group and 6 days (95% CI 4 to 9) in the placebo group (p=0.05). There were no adverse events. CONCLUSIONS: Early initiation of inhaled beclomethasone in patients with asymptomatic, mild or moderate COVID-19 did not reduce disease progression to severe COVID-19. TRIAL REGISTRATION NUMBER: Sri Lanka Clinical Trials Registry; SLCTR/2021/017.Item The quality of controlled clinical trial reporting in five leading Sri Lankan medical journals(Sri Lanka Medical Association, 2012) Pathirana, T.I.; Abeysena, C.INTRODUCTION: The Consolidated Standards of Reporting Trials (CONSORT) statement and the Transparent Reporting of Evaluations with Non-randomized Designs (TREND) checklist help improve the quality of reporting of trials. Report quality is often used as a surrogate measure of methodological quality. AIMS: To assess the quality of reporting of clinical trials published in five leading Sri Lankan medical journals METHODS: Five medical journals published between 1982-2011 were hand searched for randomized (RCT) and non-randomized clinical trials (NRCT) conducted in humans. These were evaluated by two independent observers to assess them against a checklist developed based on CONSORT and TREND recommendations. Outcome measures were presence of checklist items in published reports. Results: Twenty two RCT and 16 parallel group NRCT from 160 journals were included. Out of them, Thirty six (94.7%) clearly described the objectives, 13 (34.2%) the periods of recruitment, 7(18.4%) sample size determination, 12(31.6%) the flow of participants through each stage,19 (50%) baseline demographic and clinical characteristics of each group. Twenty one (55.3%) used statistical methods to compare groups for primary outcome, 21(55.3%) effect size, 4 (10.5%) its precision. Twenty (52.6%) interpreted the results in the context of current evidence. Five (13.2%) described the generalizability of the findings. Of the 22 RCT, only one (4.5%) reported sequence generation, 3(13.6%) allocation concealment, 7(31.8%) blinding status of participants or investigators and 2(9.1%) intention to treat analysis. CONCLUSIONS: Reporting of several essential criteria of remain suboptimal. Awareness of the CONSORT and TREND statements may improve matters quality of reporting.Item Awareness of clinical trial registration(Sri Lanka Medical Association, 2012) Wimalachandra, B.C.M.; Ranawaka, U.K.; de Abrew, K.A.G.; Wanigatunga, C.A.; Rajapaksa, L.C.; Goonaratna, C.INTRODUCTION: Prospective registration in a freely accessible public domain is mandatory for clinical trials. Little is known regarding awareness of clinical trial registration among the scientific community. AIMS: To assess awareness of clinical trial registration among participants attending a scientific meeting in Sri Lanka. METHODS: Knowledge of trial registration was assessed using a self-administered questionnaire. Results: Only 251 out of 714 participants (35.6%) returned completed valid questionnaires. Of them, 53.4% were males, 74.9% were below the age of 40 years, and 49% had less than 5 years of professional experience. Majority (56.6%) were currently involved in research. Registration was considered necessary for trial publication by 73.3%, for presentation of findings by 56.2%, and for ethics approval by 54.6%. Over 70% agreed that trials should be registered prospectively. Majority felt it was beneficial to have research findings freely accessible to other researchers (81.3%), clinicians (84.5%) and research participants (76.7%). Many agreed on the positive effects of trial registration - access to findings of all trials (61.4%), access to negative results (47.8%), preventing trial duplication (69.3%) and preventing multiple publications (70.1%). Increasing research workload (49.8%), additional restrictions on research (52.2%) and possibility of'intellectual theft' (56.2%) were seen as potential negative effects. Awareness of access to registration mechanisms for trials conducted in Sri Lanka (49%), and a Sri Lankan trial registry (31.5%) was poor. CONCLUSIONS: Awareness of clinical trial registration was satisfactory in some aspects, but several areas need improvement.