BackgroundLeg 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.MethodsThis 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.ResultsAltogether 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.ConclusionsIn 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 registrationSri Lanka Clinical Trials registry: www.slctr.lk, SLCTR/2013/006

BackgroundDiabetic retinopathy (DR) is one of the leading causes for complete loss of vision among working-aged adults around the world. The present study aims to evaluate the rate of DR and its risk factors among the adults with young-onset diabetes from a tertiary care setting in Sri Lanka.MethodsA consecutive sample of 1,007 individuals referred from multiple centers, were invited for the study. Ophthalmological evaluation was done, with dilated indirect ophthalmoscopy by an Ophthalmologist. Retinopathy was classified according to the International Clinical DR Disease Severity Scale. An interviewer-administered questionnaire was used to collect socio-demographic and anthropometric details. Seated blood pressure, Fasting Blood Glucose (FBG), HbA1c and urine microalbumin were also measured. Data were analysed using SPSSv14. A binary logistic regression analysis was performed in all patients, with ‘presence of DR’ as the dichotomous dependent variable and other independent covariates.ResultsSample size was 684 (response rate–67.9%), mean age was 37.1 ± 5.9 years and 36.0% were males. Mean duration of diabetes was 5.2 ± 4.0 years. Previous retinal screening had been done in 51.0% by a non-specialist doctor and in 41.5% by a consultant ophthalmologist. Rate of any degree of DR in the study population was 18.1% (Males 16.4%, Females 20.0%; P = NS). In patients with DR, majority had mild Non-Proliferative DR (NPDR) (57.2%), while 32.2% had moderate NPDR, 0.8% had severe NPDR and 9.7% had maculopathy. Mean age, duration of diabetes, systolic (SBP) and diastolic blood pressure (DBP), FBG, HbA1c and urine microalbumin levels were significantly higher amongst the patients with DR. The results of the binary logistic regression indicate that the duration of diabetes (OR:1.24), HbA1c (OR:1.19), age (OR:1.11), urine Microalbumin (OR:1.11) and DBP (OR:1.04) all were significantly associated with DR.ConclusionsIn this large multi center study, nearly one in five adults with young-onset diabetes was found to have retinopathy. Age, duration of diabetes, HbA1C and urine Microalbumin levels were significantly associated with the presence of retinopathy, while HbA1c was also a significant factor determining severity. Nearly 50% of the study population has never undergone retinal screening by an ophthalmologist, highlighting the need for well organized screening programs.

The 6 minute walk test (6MWT) is well established in the clinical assessment of heart failure, pulmonary hypertension and COPD. Its value as a submaximal stress test in the risk stratification of chronic stable ischaemic syndromes is as yet not validated. 95 patients undergoing coronary angiography for assessment of chronic stable angina performed the 6MWT according to a modified protocol. The gamma correlation test indicated a moderately significant relationship between ECG changes plus symptoms at the end of the 6MWT and multi vessel coronary arterial disease. The T wave changes showed no significant correlation. Hence the 6MWT is a useful tool in the risk stratification of stable ischaemic syndromes which can be safely performed in a general ward prior to hospital discharge. It would be a useful preliminary test before planning a programme of cardiac rehabilitation.

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