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Effi cacy of drugs in controlling microalbuminuria of diabetic nephropathy

The number of cases of diabetes worldwide in 2000 among adults more than 20 years of age is estimated to be 171 million. Prevalence is estimated to be 0.19% in population less than 20 years, 8.6% in those above 20 years and reaching 20.1% in those more than 65 years.1 Globally, diabetes prevalence is similar in men and women, but it is slightly higher in men 60 years of age and in women at older ages. By 2030, it is estimated that the number of people with diabetes 64 years of age will be 82 million in developing countries and 48 million in developed countries.1 India tops the list with 31.7 million people with diabetes and is estimated to grow up to 79.4 million diabetics by 2030.1 Diabetes mellitus (DM) remains the leading cause of endstage renal disease, the world over. In persons with type 2 DM, hypertension and increased urinary albumin excretion are features of diabetic nephropathy. Increased urinary protein excretion is the earliest clinical fi nding of diabetic nephropathy. Diabetic patients with this complication are at increased risk for cardiovascular events and, if untreated, have a relentless decline in renal function leading to renal failure.


INTRODUCTION
The number of cases of diabetes worldwide in 2000 among adults more than 20 years of age is estimated to be 171 million. Prevalence is estimated to be 0.19% in population less than 20 years, 8.6% in those above 20 years and reaching 20.1% in those more than 65 years. 1 Globally, diabetes prevalence is similar in men and women, but it is slightly higher in men 60 years of age and in women at older ages. By 2030, it is estimated that the number of people with diabetes 64 years of age will be 82 million in developing countries and 48 million in developed countries. 1 India tops the list with 31.7 million people with diabetes and is estimated to grow up to 79.4 million diabetics by 2030. 1 Diabetes mellitus (DM) remains the leading cause of endstage renal disease, the world over. In persons with type 2 DM, hypertension and increased urinary albumin excretion are features of diabetic nephropathy. Increased urinary protein excretion is the earliest clinical fi nding of diabetic nephropathy. Diabetic patients with this complication are at increased risk for cardiovascular events and, if untreated, have a relentless decline in renal function leading to renal failure.
Angiotensin converting enzyme (ACE) inhibitors competitively block renin angiotensin system, decrease glomerular capillary pressure and prevent progression of microalbuminuria to overt proteinuria. 1 A similar benefi cial effect of angiotensin II receptor blockers (ARB) in regression of microalbuminuria to overt proteinuria has been seen in various studies. [2][3][4] There is a need for head-to-head comparison of ACE inhibitors and ARB in diabetic nephropathy.
The study is to evaluate and compare the effi cacy of ACE Inhibitor versus ARB in controlling microalbuminuria of diabetic nephropathy

METHODS
It is prospective, randomized, double-blind study with 100 patients of type 2 DM with evidence of microalbuminuria (urine albumin excretion rate of 30-300 mg/24 hrs) were chosen for the study. They were randomized into two groups of 50 each (Group A and Group B) in a double blind fashion. Group A patients received ACE inhibitor (ramipril 5 mg), Group B patients received ARB (losartan 50 mg) and the mean age group of 45-60 years (both males and females). Type I DM, overt proteinuria, history of hypertension, history of coronary heart disease, non-diabetic renal disease were excluded.
Subjects were followed up over a period of 3 months from the day of start of treatment. Albumin in 24 hrs urine was tested by the radio immuno-assay method -at the start of the study and at the end of 3 months of treatment with either an ACE inhibitor or an ARB. Diabetes was controlled with diet, oral hypoglycemic drugs or insulin.
At the end of 3 months, the collected data were analyzed for; 1. Reduced/absent microalbuminuria or 2. Persistent microalbuminuria (microalbuminuria of same or increased amount as compared to before the start of treatment).

RESULTS
All the cases were randomized into either group (ACE inhibitor or ARB) and studied at the beginning and at the end of 3 months of treatment.

DISCUSSION
A decline in the glomerular filtration rate is a key determinant of end-stage renal disease. Preventing (or delaying) the development of microalbuminuria is the key treatment goal for renoprotection. Recent clinical trials suggest that inhibition of the renin angiotensin system may actually prevent nephropathy. The posthoc analyses of the reduction in hypertension in the Heart Outcomes Prevention Evaluation Study 5 and in the losartan intervention for the end point study, 6 found a lower incidence of overt nephropathy in subjects with type 2 diabetes who received therapy that inhibited the renin angiotensin system than in controls.
Trials have supported the clinical equivalence of ARB and ACE inhibitors in delaying the progression of nephropathy in type 2 diabetes and in conditions that place them at high risk for cardiovascular events. 7,8 There has been a clinical study that has directly compared the effect of an ARB (losartan) with that of an ACE inhibitor (ramipril) in subjects with type 2 diabetes and early nephropathy. 8 The present study is a similar study making head-tohead comparison of ACE inhibitor (ramipril) and ARB (losartan) in the regression of microalbuminuria in type 2 diabetics. The study has shown that both the drugsramipril and losartan reduce urinary albumin excretion (Table 1 & Figure 1) and within the group, the reduction in microalbuminuria is considerable and significant. However, the difference in reduction of microalbuminuria when compared between the two groups is statistically insignifi cant (Table 2).
Further, the study shows that losartan had better reduction in systolic blood pressure, as compared to the reduction seen with ramipril. (Table 2, 3 & Figure 2) though not signifi cant difference was seen in the reduction of diastolic blood pressure (  Figure 3). Despite this difference on blood pressure, both the drugs have shown a reduction in microalbuminuria which supports the fact that reduction in microalbuminuria is independent of the antihypertensive action of the ramipril or losartan. 9 The study also shows that antihypertensive treatment reduces microalbuminuria and decreases the progression of albuminuria even in normotensive patients. 10,11 This was a small study (100 subjects) done over a short follow-up period of 3 months duration. The two drug classes had an equivalent effect on the end point: Microalbuminuria reduction.
Diabetic nephropathy (progression of microalbuminuria) developed in eight of the patients -of which 6 were from the ramipril group (4 females, 2 male) and two (female) was from the losartan group. The non-superiority of either drug  could be due to the fi xed dose used -that is no titration to the maximum tolerated dose. 12 Two subjects on ramipril developed dry cough as an adverse effect, but there were no drop outs. No adverse effect was reported in the losartan group.
Our data indicate that losartan is not inferior to ramipril in providing renoprotection in subjects with type 2 diabetes and early nephropathy. This result is consistent with the emerging data that support the clinical equivalence of ARB