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Article ; Online: Pharmacokinetics and Bioequivalence of Two Amoxicillin 500 mg Products: Effect of Food on Absorption and Supporting Scientific Justification for Biowaiver.

Thambavita, Dhanusha Dhananjani / Galappatthy, Priyadarshani / Jayakody, Raveendra Laal

2021 Volume 110, Issue 11, Page(s) 3735–3741

Abstract: Purpose: Aims of this study were to compare the bioequivalence of two formulations of amoxicillin 500 mg capsules under fasted and fed conditions in the same set of healthy volunteers, compare pharmacokinetics of amoxicillin under the two conditions and ...

Abstract	Purpose: Aims of this study were to compare the bioequivalence of two formulations of amoxicillin 500 mg capsules under fasted and fed conditions in the same set of healthy volunteers, compare pharmacokinetics of amoxicillin under the two conditions and to assess the possibility of predicting in vivo bioequivalence of the two formulations using in vitro dissolution data. Method: The innovator product of amoxicillin was used as the reference formulation and a test product, which showed in vitro equivalence after a biowaiver study with the same reference product was used in the bioequivalence study. Altogether 16 subjects were randomized to the reference and test products in the fasted study and 12 of them participated in the fed study. Plasma concentration of amoxicillin was analyzed by a validated Liquid chromatography coupled with two mass spectrometry (LC-MS/MS) method. Noncompartmental analysis was used to determine the pharmacokinetic parameters. Average bioequivalence method was used to evaluate the bioequivalence of the two formulations and statistical significance of the pharmacokinetic parameters were tested to study the effect of food on amoxicillin absorption. Results: The Geometric Mean Ratio (GMR) for the test/reference product for the maximum drug concentrations (C Conclusion: The test and the reference formulations were bioequivalent under both fasted and fed conditions. Although the C
MeSH term(s)	Amoxicillin ; Area Under Curve ; Chromatography, Liquid ; Cross-Over Studies ; Humans ; Tablets ; Tandem Mass Spectrometry ; Therapeutic Equivalency
Chemical Substances	Tablets ; Amoxicillin (804826J2HU)
Language	English
Publishing date	2021-06-13
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	3151-3
ISSN	1520-6017 ; 0022-3549
ISSN (online)	1520-6017
ISSN	0022-3549
DOI	10.1016/j.xphs.2021.06.011
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Article ; Online: A national survey on registered products, availability, prices, and affordability of 100 essential medicines in community pharmacies across Sri Lanka.

Liyanage, Chiranthi Kongala / Gunawardane, Mekala / Kumaradasa, Pamodee Panchalee / Ranasinghe, Priyanga / Jayakody, Raveendra Laal / Galappatthy, Priyadarshani

BMC health services research

2023 Volume 23, Issue 1, Page(s) 1121

Abstract: Introduction: Availability of essential medicines that meet the expected quality standards, in appropriate dosage forms at affordable prices is a fundamental prerequisite to fulfill healthcare needs of given a population. This study assessed available ... ...

Abstract	Introduction: Availability of essential medicines that meet the expected quality standards, in appropriate dosage forms at affordable prices is a fundamental prerequisite to fulfill healthcare needs of given a population. This study assessed available products, prices and affordability of essential medicines (EM) in community pharmacies in Sri Lanka with comparison of registration status from the National Medicines Regulatory Authority(NMRA). Methods: A cross-sectional island-wide survey of 80 pharmacies was conducted according to World Health Organization and Health Action International Manual (WHO/HAI). Hundred medicines were selected from the global core list(n = 14), regional core list(n = 16) and the Sri Lanka Essential Medicine List (SL-EML) (n = 70) based on healthcare needs. Number of registered products in 2015 and 2021 were compared. Findings: Average availability was 85.4%(± 12.31) and availability was lowest in the Northern province (69.38 ± 21.18%)(p = 0.008). Availability between the state owned, franchise and privately owned pharmacies was not significantly different (p > 0.05). 89.4% medicines were affordable except for amiodarone, hydroxychloroquine, sitagliptin, soluble insulin, isophane insulin, losartan, levodopa carbidopa combination, clonazepam and ceftriaxone. The median price ratio (MPR) of 33.7% of medicines was less than 1 and MPR of 37.1% originator brands (OB) was over 3. Median number of generic brands in the market was 8(range 2-44), 9% of medicines had 20 or more products in the market and 72.7% medicines had more products available than the number registered in 2015. The average number of registered products were similar in 2015 (8.27) and 2021(7.59) (p = 0.15). Conclusion: The overall availability of EMs in Sri Lanka was high in all categories of community pharmacies. Medicines were largely affordable and reasonably priced in 2015, although OBs were generally more expensive. Majority of medicines had more products in the market than the number of registered products.
MeSH term(s)	Humans ; Health Services Accessibility ; Pharmacies ; Sri Lanka ; Cross-Sectional Studies ; Drugs, Essential ; Costs and Cost Analysis
Chemical Substances	Drugs, Essential
Language	English
Publishing date	2023-10-19
Publishing country	England
Document type	Journal Article
ZDB-ID	2050434-2
ISSN	1472-6963 ; 1472-6963
ISSN (online)	1472-6963
ISSN	1472-6963
DOI	10.1186/s12913-023-10137-y
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Article: Sex Difference in Risk Factors, GRACE Scores, and Management among Post-Acute Coronary Syndrome Patients in Sri Lanka.

Galappatthy, Priyadarshani / Bataduwaarachchi, Vipula / Ranasinghe, Priyanga / Galappatthy, Gamini / Senerath, Upul / Wijeyaratne, Chandrika / Ekanayake, Ruwan

Cardiology research and practice

2020 Volume 2020, Page(s) 4560218

Abstract: Objective: To assess sex-based differences in the prevalence of risk factor, their management, and differences in the prognosis among acute coronary syndrome (ACS) in Sri Lanka.: Methods: Patients diagnosed with ACS were recruited from hospitals ... ...

Abstract	Objective: To assess sex-based differences in the prevalence of risk factor, their management, and differences in the prognosis among acute coronary syndrome (ACS) in Sri Lanka. Methods: Patients diagnosed with ACS were recruited from hospitals throughout the island. The Joint European Societies guidelines were used to assess recommended targets for coronary heart disease risk factors, and the GRACE score was used to assess the post-ACS prognosis. Age-adjusted regression was performed to calculate odds ratios for men versus women in risk factor control. Results: A total of 2116 patients, of whom 1242 (58.7%) were men, were included. Significant proportion of women were nonsmokers; OR = 0.11 (95% CI 0.09 to 0.13). The prevalence of hypertension ( Conclusions: Smoking is significantly lower among Sri Lankan women diagnosed with ACS. However, hypertension, diabetes, and dyslipidemia were more prevalent among them. There was no difference in primary and secondary preventive strategies and management in both sexes but could be further improved in both groups.
Language	English
Publishing date	2020-07-30
Publishing country	United States
Document type	Journal Article
ZDB-ID	2506187-2
ISSN	2090-0597 ; 2090-8016
ISSN (online)	2090-0597
ISSN	2090-8016
DOI	10.1155/2020/4560218
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Article ; Online: Core Prescribing Indicators and the Most Commonly Prescribed Medicines in a Tertiary Health Care Setting in a Developing Country.

Galappatthy, Priyadarshani / Ranasinghe, Priyanga / Liyanage, Chiranthi K / Wijayabandara, Maheshi / Warapitiya, Dinuka S / Jayasekara, Dilini / Jayakody, Raveendra L

Advances in pharmacological and pharmaceutical sciences

2021 Volume 2021, Page(s) 6625377

Abstract: Irrational prescribing is common, especially in developing countries. It is important to identify the magnitude of irrational use, to take necessary steps to promote rational prescribing. We identified core prescribing indicators and commonly prescribed ... ...

Abstract	Irrational prescribing is common, especially in developing countries. It is important to identify the magnitude of irrational use, to take necessary steps to promote rational prescribing. We identified core prescribing indicators and commonly prescribed medicines at ward settings (IW) and outpatients' clinics (OPC) in a tertiary care hospital in Sri Lanka. A descriptive cross-sectional study was carried out at IW and OPC settings. Prescriptions were obtained from 5 major specialties (Clinical Medicine (CM), Gynaecology and Obstetrics (GO), Paediatrics, Psychiatry, and Surgery). The WHO core prescribing indicators were used to describe the pattern of prescribing, and the most commonly prescribed medicines were identified. A total of 1,318 prescriptions were analyzed. The five most commonly prescribed medicines were paracetamol (31.0%), omeprazole (20.6%), folic acid (18.3%), atorvastatin (16.2%), and salbutamol (15.3%). The average number of medicines per encounter was 4.8 ± 3.6 (IW: 5.7 ± 4; OPC: 3.8 ± 2.8;
Language	English
Publishing date	2021-01-29
Publishing country	England
Document type	Journal Article
ZDB-ID	3026687-7
ISSN	2633-4690 ; 2633-4682 ; 2633-4690
ISSN (online)	2633-4690 ; 2633-4682
ISSN	2633-4690
DOI	10.1155/2021/6625377
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Article ; Online: Safety monitoring of treatment in bipolar disorder in a tertiary care setting in Sri Lanka and recommendations for improved monitoring in resource limited settings.

Mannapperuma, Uthpali / Galappatthy, Priyadarshani / Jayakody, Raveendra Laal / Mendis, Jayan / de Silva, Varuni Asanka / Hanwella, Raveen

BMC psychiatry

2019 Volume 19, Issue 1, Page(s) 194

Abstract: Background: Safety monitoring of medicines is essential during therapy for bipolar disorder (BD). We determined the extent of safety monitoring performed according to the International Society for Bipolar Disorders (ISBD) guidelines in patients with BD ... ...

Abstract	Background: Safety monitoring of medicines is essential during therapy for bipolar disorder (BD). We determined the extent of safety monitoring performed according to the International Society for Bipolar Disorders (ISBD) guidelines in patients with BD attending the main tertiary care psychiatry clinics in Sri Lanka to give realistic recommendations for safety monitoring in resource limited settings. Methods: Patients diagnosed with BD on mood stabilizer medications for more than 1 year were recruited. Data were collected retrospectively from clinic and patient held records and compared with the standards of care recommended by ISBD guidelines for safety monitoring of medicines. Results: Out of 256 patients diagnosed with BD, 164 (64.1%) were on lithium. Only 75 (45.7%) had serum lithium measurements done in the past 6 months and 96 (58.5%) had concentrations recorded at least once in the past year. Blood urea or creatinine was measured in the last 6 months only in 30 (18.3%). Serum electrolytes and thyroid-stimulating hormone (TSH) concentrations were measured in the last year only in 34 (20.7%) and 30 (18.3%) respectively. Calcium concentrations were not recorded in any patient. None of the patients on sodium valproate (n = 119) or carbamazepine (n = 6) had blood levels recorded to establish therapeutic concentrations. Atypical antipsychotics were prescribed for 151 (59%), but only 13 (8.6%) had lipid profiles and only 31 (20.5%) had blood glucose concentration measured annually. Comorbidities experienced by patients influenced monitoring more than the medicines used. Patients with diabetes, hypothyroidism and hypercholesterolemia were more likely to get monitored for fasting blood glucose and (p < 0.001), TSH (p < 0.001) and lipid profiles (p < 0.001). Lithium therapy was associated with TSH monitoring (p < 0.05). Therapy with atypical antipsychotics was not associated with fasting blood glucose or lipid profile monitoring (p > 0.05). A limitation of the study is that although some tests were performed, the results may not have been recorded. Conclusions: Safety monitoring in BD was suboptimal compared to the ISBD guidelines. ISBD standards are difficult to achieve in resource limited settings due to a multitude of reasons. Realistic monitoring benchmarks and recommendations are proposed for methods to improve monitoring in resource limited settings based on our experience.
MeSH term(s)	Adolescent ; Adult ; Aged ; Antipsychotic Agents/blood ; Antipsychotic Agents/economics ; Antipsychotic Agents/therapeutic use ; Bipolar Disorder/blood ; Bipolar Disorder/drug therapy ; Bipolar Disorder/economics ; Bipolar Disorder/epidemiology ; Drug Monitoring/economics ; Drug Monitoring/methods ; Female ; Follow-Up Studies ; Health Resources/economics ; Humans ; Lithium/blood ; Lithium/economics ; Lithium/therapeutic use ; Male ; Middle Aged ; Retrospective Studies ; Sri Lanka/epidemiology ; Tertiary Healthcare/economics ; Tertiary Healthcare/methods ; Treatment Outcome ; Young Adult
Chemical Substances	Antipsychotic Agents ; Lithium (9FN79X2M3F)
Language	English
Publishing date	2019-06-24
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	1471-244X
ISSN (online)	1471-244X
DOI	10.1186/s12888-019-2183-7
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Article ; Online: Zinc supplementation in prediabetes: A randomized double-blind placebo-controlled clinical trial.

Ranasinghe, Priyanga / Wathurapatha, Wasundara S / Galappatthy, Priyadarshani / Katulanda, Prasad / Jayawardena, Ranil / Constantine, Godwin R

Journal of diabetes

2018 Volume 10, Issue 5, Page(s) 386–397

Abstract: Background: This study evaluated the effects of zinc supplementation on glycemic control, other cardiometabolic and anthropometric parameters, and disease progression in prediabetes.: Methods: A randomized double-blind placebo-controlled Phase 2 ... ...

Abstract	Background: This study evaluated the effects of zinc supplementation on glycemic control, other cardiometabolic and anthropometric parameters, and disease progression in prediabetes. Methods: A randomized double-blind placebo-controlled Phase 2 clinical trial was conducted over a 12-month period in 200 subjects (43% male; mean [± SD] age 51.8 ± 7.3 years), randomly assigned (1: 1) to the treatment or control group. The treatment group received zinc (20 mg daily). Subjects were evaluated at baseline and at 1, 3, 6, and 12 months. The primary outcome was the change in glycemic control from baseline. Multiple regression analyses were performed, with change in outcome variables after intervention from baseline used as continuous dependent variables. Results: In both groups, mean serum zinc concentrations prior to the trial were below normal (15.29-21.41 μmol/L). During the 12-month follow-up, a significantly higher percentage of participants developed type 2 diabetes in the control compared with zinc-treated group (25.0% vs 11.0% respectively; P = 0.016). Fasting plasma glucose (FPG), 2-h glucose levels in the oral glucose tolerance test (OGTT), homeostasis model assessment of insulin resistance (HOMA-IR), total cholesterol (TC), and low-density lipoprotein cholesterol (LDL-C) were significantly lower in the treated group, with significant improvement in β-cell function. In all four regression models, the best predictor of the dependent variables (i.e. change in FPG, 2-h glucose in the OGTT, HOMA-IR, and homeostatic model assessment of β-cell function) was zinc treatment. Conclusions: Zinc supplementation reduced blood glucose and insulin resistance while improving β-cell function. Furthermore, supplementation reduced disease progression to diabetes and had beneficial effects on TC and LDL-C.
MeSH term(s)	Adult ; Aged ; Biomarkers/blood ; Blood Glucose/drug effects ; Blood Glucose/metabolism ; Diabetes Mellitus, Type 2/blood ; Diabetes Mellitus, Type 2/diagnosis ; Diabetes Mellitus, Type 2/etiology ; Diabetes Mellitus, Type 2/prevention & control ; Dietary Supplements/adverse effects ; Disease Progression ; Double-Blind Method ; Female ; Glucose Tolerance Test ; Health Status ; Humans ; Insulin/blood ; Insulin Resistance ; Lipids/blood ; Male ; Middle Aged ; Prediabetic State/blood ; Prediabetic State/complications ; Prediabetic State/diagnosis ; Prediabetic State/drug therapy ; Risk Factors ; Sri Lanka ; Time Factors ; Treatment Outcome ; Zinc/administration & dosage ; Zinc/adverse effects
Chemical Substances	Biomarkers ; Blood Glucose ; Insulin ; Lipids ; Zinc (J41CSQ7QDS)
Language	English
Publishing date	2018-01-03
Publishing country	Australia
Document type	Clinical Trial, Phase II ; Journal Article ; Randomized Controlled Trial
ZDB-ID	2503337-2
ISSN	1753-0407 ; 1753-0393
ISSN (online)	1753-0407
ISSN	1753-0393
DOI	10.1111/1753-0407.12621
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Article ; Online: Pregnancy outcomes and contraceptive use in patients with systemic lupus Erythematosus, rheumatoid arthritis and women without a chronic illness: a comparative study.

Galappatthy, Priyadarshani / Jayasinghe, Jayan D D / Paththinige, Sampath C / Sheriff, Rezvi M H / Wijayaratne, Lalith S

International journal of rheumatic diseases

2017 Volume 20, Issue 6, Page(s) 746–754

Abstract: Objectives: To compare the pregnancy outcomes and contraceptive practices in systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) and women with no chronic illness (WNCI) in a tertiary care referral center in Colombo, Sri Lanka.: Methods: ... ...

Abstract	Objectives: To compare the pregnancy outcomes and contraceptive practices in systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) and women with no chronic illness (WNCI) in a tertiary care referral center in Colombo, Sri Lanka. Methods: Patients with SLE satisfying American College of Rheumatology criteria for diagnosis and history of pregnancies were recruited from university lupus clinic, National Hospital of Sri Lanka (NHSL). Age-matched women with history of pregnancy and RA were recruited from the rheumatology clinic, NHSL and WNCI from a surgical clinic. Results: In 71 patients with SLE, 79 pregnancies occurred in 38 patients. The number of total pregnancies in SLE, RA and WNCI (79, 80 and 85 respectively) were not significantly different (P > 0.05), but most occurred before diagnosis of SLE and RA. Pregnancies occurring after diagnosis were significantly higher in SLE compared to RA (P = 0.013, χ Conclusions: More pregnancies occur in SLE than in RA after diagnosis of illness. Unplanned pregnancies and adverse pregnancy outcomes need to be addressed more in SLE than in RA or in WNCI.
Language	English
Publishing date	2017-06
Publishing country	England
Document type	Journal Article
ZDB-ID	2426924-4
ISSN	1756-185X ; 1756-1841
ISSN (online)	1756-185X
ISSN	1756-1841
DOI	10.1111/1756-185X.12996
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Article ; Online: Zinc and diabetes mellitus: understanding molecular mechanisms and clinical implications.

Ranasinghe, Priyanga / Pigera, Shehani / Galappatthy, Priyadarshani / Katulanda, Prasad / Constantine, Godwin R

Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences

2015 Volume 23, Page(s) 44

Abstract: Background: Diabetes mellitus is a leading cause of morbidity and mortality worldwide. Studies have shown that Zinc has numerous beneficial effects in both type-1 and type-2 diabetes. We aim to evaluate the literature on the mechanisms and molecular ... ...

Abstract	Background: Diabetes mellitus is a leading cause of morbidity and mortality worldwide. Studies have shown that Zinc has numerous beneficial effects in both type-1 and type-2 diabetes. We aim to evaluate the literature on the mechanisms and molecular level effects of Zinc on glycaemic control, β-cell function, pathogenesis of diabetes and its complications. Methods: A review of published studies reporting mechanisms of action of Zinc in diabetes was undertaken in PubMed and SciVerse Scopus medical databases using the following search terms in article title, abstract or keywords; ("Zinc" or "Zn") and ("mechanism" or "mechanism of action" or "action" or "effect" or "pathogenesis" or "pathology" or "physiology" or "metabolism") and ("diabetes" or "prediabetes" or "sugar" or "glucose" or "insulin"). Results: The literature search identified the following number of articles in the two databases; PubMed (n = 1799) and SciVerse Scopus (n = 1879). After removing duplicates the total number of articles included in the present review is 111. Our results show that Zinc plays an important role in β-cell function, insulin action, glucose homeostasis and the pathogenesis of diabetes and its complications. Conclusion: Numerous in-vitro and in-vivo studies have shown that Zinc has beneficial effects in both type-1 and type-2 diabetes. However further randomized double-blinded placebo-controlled clinical trials conducted for an adequate duration, are required to establish therapeutic safety in humans.
MeSH term(s)	Animals ; Antioxidants/pharmacology ; Antioxidants/therapeutic use ; Carbohydrate Metabolism/drug effects ; Diabetes Mellitus, Type 1/drug therapy ; Diabetes Mellitus, Type 2/drug therapy ; Humans ; Islets of Langerhans/drug effects ; Islets of Langerhans/metabolism ; Lipid Metabolism/drug effects ; Zinc/pharmacology ; Zinc/therapeutic use
Chemical Substances	Antioxidants ; Zinc (J41CSQ7QDS)
Language	English
Publishing date	2015-09-17
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2129183-4
ISSN	2008-2231 ; 1560-8115
ISSN (online)	2008-2231
ISSN	1560-8115
DOI	10.1186/s40199-015-0127-4
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Article ; Online: Leg edema with (S)-amlodipine vs conventional amlodipine given in triple therapy for hypertension: a randomized double blind controlled clinical trial.

Galappatthy, Priyadarshani / Waniganayake, Yasindu C / Sabeer, Mohomad I M / Wijethunga, Thusitha J / Galappatthy, Gamini K S / Ekanayaka, Ruvan Ai

BMC cardiovascular disorders

2016 Volume 16, Issue 1, Page(s) 168

Abstract: Background: Leg edema is a common adverse effect of dihydropyridine Calcium Channel Blockers (CCB) that may need dose reduction or drug withdrawal, adversely affecting the antihypertensive efficacy. Leg edema is reported to occur less often with (S)- ... ...

Abstract	Background: Leg edema is a common adverse effect of dihydropyridine Calcium Channel Blockers (CCB) that may need dose reduction or drug withdrawal, adversely affecting the antihypertensive efficacy. Leg edema is reported to occur less often with (S)-amlodipine compared to conventional racemic amlodipine. We aimed to find the incidence of leg edema as a primary outcome and antihypertensive efficacy with (S)-amlodipine compared to conventional amlodipine. Methods: This prospective, double-blind, controlled clinical trial randomized 172 hypertensive patients, not controlled on beta-blockers (BB) and angiotensin converting enzyme inhibitors/angiotensin receptor blockers (ACEI/ARB), to either conventional amlodipine (5-10 mg; n = 86) or (S)-amlodipine (2.5-5 mg; n = 86), while continuing their previous anti-hypertensive medications. Sample was sufficient to find a difference in edema between the interventions with 80 % power at 5 % significance level. Intension to treat analysis (ITT) for safety data and per protocol analysis for efficacy data was performed. Fischer's exact test was applied to observe difference between responder rates and proportions of subjects having peripheral edema in the two groups. Pitting edema test scores were compared using Mann-Whitney test. Results: Altogether 146 patients (amlodipine, n = 76 and (S)-amlodipine, n = 70) completed 120 days treatment. Demographic variables and treatment adherence were comparable in the two groups. Incidence of new edema after randomization was 31.40 % in test group and 46.51 % in control group [p = 0.03; absolute risk reduction (ARR) = 15.1 %; Number Needed to Treat (NNT) = 7, ITT analysis]. Pitting edema score and patient rated edema score increased significantly in the control compared to test group (p = 0.038 and 0.036 respectively) after treatment period. Edema scores increased significantly in the control group from baseline (p < 0.0001). Responders in blood pressure were 98.57 % in test and 98.68 % in control group. Most common adverse events (AE) were pitting edema and increased urinary frequency. Incidence of all AEs other than edema was similar in both groups. Two serious AEs occurred unrelated to therapy. Biochemical and ECG parameters in the two groups were comparable. Conclusions: In hypertensive patients not controlled on prior BB and ACEI/ARB therapy, addition of (S)-amlodipine besylate at half the dose of conventional amlodipine provides better tolerability with reduced incidence of peripheral edema, and equal antihypertensive efficacy compared to amlodipine given at usual doses. Trial registration: Sri Lanka Clinical Trials registry: www.slctr.lk, SLCTR/2013/006.
MeSH term(s)	Adult ; Amlodipine/administration & dosage ; Amlodipine/adverse effects ; Angiotensin-Converting Enzyme Inhibitors ; Antihypertensive Agents/administration & dosage ; Blood Pressure/drug effects ; Blood Pressure/physiology ; Calcium Channel Blockers/administration & dosage ; Calcium Channel Blockers/adverse effects ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Therapy, Combination ; Edema/chemically induced ; Edema/epidemiology ; Female ; Follow-Up Studies ; Humans ; Hypertension/drug therapy ; Hypertension/physiopathology ; Incidence ; Male ; Middle Aged ; Prospective Studies ; Sri Lanka/epidemiology ; Time Factors
Chemical Substances	Angiotensin-Converting Enzyme Inhibitors ; Antihypertensive Agents ; Calcium Channel Blockers ; Amlodipine (1J444QC288)
Language	English
Publishing date	2016-09-01
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial
ZDB-ID	2059859-2
ISSN	1471-2261 ; 1471-2261
ISSN (online)	1471-2261
ISSN	1471-2261
DOI	10.1186/s12872-016-0350-z
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Article ; Online: Management, characteristics and outcomes of patients with acute coronary syndrome in Sri Lanka.

Galappatthy, Priyadarshani / Bataduwaarachchi, Vipula R / Ranasinghe, Priyanga / Galappatthy, Gamini K S / Wijayabandara, Maheshi / Warapitiya, Dinuka S / Sivapathasundaram, Mythily / Wickramarathna, Thilini / Senarath, Upul / Sridharan, Sathasivam / Wijeyaratne, Chandrika N / Ekanayaka, Ruvan

Heart (British Cardiac Society)

2018 Volume 104, Issue 17, Page(s) 1424–1431

Abstract: Background: Ischaemic heart disease is the leading cause of in-hospital mortality in Sri Lanka. Acute Coronary Syndrome Sri Lanka Audit Project (ACSSLAP) is the first national clinical-audit project that evaluated patient characteristics, clinical ... ...

Abstract	Background: Ischaemic heart disease is the leading cause of in-hospital mortality in Sri Lanka. Acute Coronary Syndrome Sri Lanka Audit Project (ACSSLAP) is the first national clinical-audit project that evaluated patient characteristics, clinical outcomes and care provided by state-sector hospitals. Methods: ACSSLAP prospectively evaluated acute care, in-hospital care and discharge plans provided by all state-sector hospitals managing patients with ACS. Data were collected from 30 consecutive patients from each hospital during 2-4 weeks window. Local and international recommendations were used as audit standards. Results: Data from 87/98 (88.7%) hospitals recruited 2177 patients, with 2116 confirmed as having ACS. Mean age was 61.4±11.8 years (range 20-95) and 58.7% (n=1242) were males. There were 813 (38.4%) patients with unstable angina, 695 (32.8%) with non-ST-elevation myocardial infarction (NSTEMI) and 608 (28.7%) with ST-elevation myocardial infarction (STEMI). Both STEMI (69.9%) and NSTEMI (61.4%) were more in males (P<0.001). Aspirin, clopidogrel and statins were given to over 90% in acute setting and on discharge. In STEMI, 407 (66.9%) were reperfused; 384 (63.2%) were given fibrinolytics and only 23 (3.8%) underwent primary percutaneous coronary intervention (PCI). Only 42.3 % had thrombolysis in <30 min and 62.5% had PCI in <90 min. On discharge, beta-blockers and ACE inhibitors/angiotensin II receptor blockers were given to only 50.7% and 69.2%, respectively and only 17.6% had coronary interventions planned. Conclusions: In patients with ACS, aspirin, clopidogrel and statin use met audit standards in acute setting and on discharge. Vast majority of patients with STEMI underwent fibrinolyisis than PCI, due to limited resources. Primary PCI, planned coronary interventions and timely thrombolysis need improvement in Sri Lanka.
MeSH term(s)	Acute Coronary Syndrome/diagnosis ; Acute Coronary Syndrome/mortality ; Acute Coronary Syndrome/therapy ; Aged ; Cardiovascular Agents/classification ; Cardiovascular Agents/therapeutic use ; Female ; Hospital Mortality ; Humans ; Male ; Medical Audit ; Medication Therapy Management/standards ; Medication Therapy Management/statistics & numerical data ; Middle Aged ; Needs Assessment ; Outcome and Process Assessment (Health Care) ; Patient Care Management/statistics & numerical data ; Patient Discharge/statistics & numerical data ; Percutaneous Coronary Intervention/statistics & numerical data ; Sri Lanka/epidemiology ; Thrombolytic Therapy/statistics & numerical data ; Time-to-Treatment
Chemical Substances	Cardiovascular Agents
Language	English
Publishing date	2018-02-16
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1303417-0
ISSN	1468-201X ; 1355-6037
ISSN (online)	1468-201X
ISSN	1355-6037
DOI	10.1136/heartjnl-2017-312404
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