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New trial sparks debate over treatment of diabetic hypertensives
July 21, 2004A major new international study published in the Journal of Hypertension (July 21 2004) has challenged traditional thinking by revealing that the thiazide-like diuretic indapamide SR (Natrilix SR) has equivalent efficacy to enalapril in reducing microalbuminuria (MA) in patients with type 2 diabetes.
The NESTOR (Natrilix SR versus Enalapril Study in Type 2 diabetic hypertensives with micrOalbuminuRia) study is the first randomised study over one year in duration to prove the efficacy of a diuretic on MA, and establishes indapamide SR as the first diuretic to show efficacy in MA reduction.
The implications of NESTOR for UK practice are potentially very significant. MA is an established risk factor in diabetic patients, but its importance, according to leading diabetologist Professor Anthony Barnett, Professor of Medicine at the University of Birmingham, may be underrated.
'There is increasing evidence to show that microalbuminuria is a sensitive marker of organ damage, and its importance as a renal and cardiovascular risk factor is often under-recognised,' he commented.
Current guidelines recommend first-line use of an ACE inhibitor or, if contraindicated, an angiotensin II receptor blocker (ARB) in patients with type 2 diabetes and MA. The NESTOR authors, however, believe that their findings are 'consistent with the use of indapamide SR as first-line therapy in hypertensive type 2 diabetic patients.'
NESTOR is a multinational randomised trial involving 570 patients with essential hypertension, type 2 diabetes and MA, who were randomised to receive either enalapril 10mg or indapamide SR 1.5mg once daily. After one year, there was a significant and equivalent reduction in MA in both the indapamide SR (35%) and enalapril (39%) groups. However, SBP reduction in the indapamide group (-23.8 mmHg) was significantly greater than in the enalapril group (-21.0 mmHg). No significant difference occurred in DBP reduction (-13.0 vs -12.1 mmHg). 24-Hour ambulatory blood pressure measurement (24-h ABPM) in a subgroup of 99 patients showed a non-significant mean arterial pressure (MAP) difference of only -0.63 mmHg between treatments over the 24-hour period.
Both regimens were also very well tolerated throughout the 1-year follow-up, with 98% of study participants complying with treatment.
Commenting on NESTOR, Professor Barnett said: 'These findings add further weight to the evidence behind indapamide SR. While there is a good body of evidence to support the use of ACEIs or ARBs for diabetic patients with hypertension and microalbuminuria, indapamide SR has emerged as another agent that may be suitable first-line in relevant individuals within this patient group, such as older or Afro-Caribbean patients.'
Growing evidence base
NESTOR is the latest trial in a growing evidence base for indapamide SR. The recent European Society of Hypertension meeting unveiled the findings of X-CELLENT, which showed indapamide SR to be as effective as the angiotensin II receptor blocker (ARB) candesartan and the calcium channel blocker (CCB) amlodipine in reducing blood pressure, more effective than amlodipine in reducing systolic blood pressure (SBP) when measured over 24-hours, and superior to either comparator in controlling pulse pressure in patients with isolated systolic hypertension (ISH).
NESTOR has also added considerable weight to the distinction between thiazide and thiazide-like diuretics, since an earlier study comparing an ACE inhibitor and a conventional thiazide diuretic (hydrochlorothiazide), which is pharmacologically different from indapamide, positioned the diuretic as an inferior treatment.
Dr Douglas Robertson, Consultant in Endocrinology, Sandwell General Hospital, West Bromwich commented:
'The NESTOR findings provide further evidence to differentiate indapamide SR from ordinary thiazides. The interesting thing would be how much additive effect there is between an ACEI and indapamide on MA, but the assumption of this effect supports the use of the two drugs in combination for this group of patients.'
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'There is increasing evidence to show that microalbuminuria is a sensitive marker of organ damage, and its importance as a renal and cardiovascular risk factor is often under-recognised,' he commented.
Current guidelines recommend first-line use of an ACE inhibitor or, if contraindicated, an angiotensin II receptor blocker (ARB) in patients with type 2 diabetes and MA. The NESTOR authors, however, believe that their findings are 'consistent with the use of indapamide SR as first-line therapy in hypertensive type 2 diabetic patients.'
NESTOR is a multinational randomised trial involving 570 patients with essential hypertension, type 2 diabetes and MA, who were randomised to receive either enalapril 10mg or indapamide SR 1.5mg once daily. After one year, there was a significant and equivalent reduction in MA in both the indapamide SR (35%) and enalapril (39%) groups. However, SBP reduction in the indapamide group (-23.8 mmHg) was significantly greater than in the enalapril group (-21.0 mmHg). No significant difference occurred in DBP reduction (-13.0 vs -12.1 mmHg). 24-Hour ambulatory blood pressure measurement (24-h ABPM) in a subgroup of 99 patients showed a non-significant mean arterial pressure (MAP) difference of only -0.63 mmHg between treatments over the 24-hour period.
Both regimens were also very well tolerated throughout the 1-year follow-up, with 98% of study participants complying with treatment.
Commenting on NESTOR, Professor Barnett said: 'These findings add further weight to the evidence behind indapamide SR. While there is a good body of evidence to support the use of ACEIs or ARBs for diabetic patients with hypertension and microalbuminuria, indapamide SR has emerged as another agent that may be suitable first-line in relevant individuals within this patient group, such as older or Afro-Caribbean patients.'
Growing evidence base
NESTOR is the latest trial in a growing evidence base for indapamide SR. The recent European Society of Hypertension meeting unveiled the findings of X-CELLENT, which showed indapamide SR to be as effective as the angiotensin II receptor blocker (ARB) candesartan and the calcium channel blocker (CCB) amlodipine in reducing blood pressure, more effective than amlodipine in reducing systolic blood pressure (SBP) when measured over 24-hours, and superior to either comparator in controlling pulse pressure in patients with isolated systolic hypertension (ISH).
NESTOR has also added considerable weight to the distinction between thiazide and thiazide-like diuretics, since an earlier study comparing an ACE inhibitor and a conventional thiazide diuretic (hydrochlorothiazide), which is pharmacologically different from indapamide, positioned the diuretic as an inferior treatment.
Dr Douglas Robertson, Consultant in Endocrinology, Sandwell General Hospital, West Bromwich commented:
'The NESTOR findings provide further evidence to differentiate indapamide SR from ordinary thiazides. The interesting thing would be how much additive effect there is between an ACEI and indapamide on MA, but the assumption of this effect supports the use of the two drugs in combination for this group of patients.'
Phase IV Communications
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As a result of successful events organised last year, a second Joint Scientific Forum, organised by the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD), two of the most respected professional medical organisations in Europe, will be held from 27-29 November at three venues across China - Beijing, Shanghai and Guangzhou.
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For the first time, scientists have demonstrated that stem cells found in amniotic fluid meet an important test of potential to become specialized cell types, which suggests they may be useful for treating a wider array of diseases and conditions than scientists originally thought.
First reconstitution of an epidermis from human embryonic stem cells
Stem cell research is making great strides. This is yet again illustrated by a study carried out by the I-STEM* Institute (I-STEM/ Inserm UEVE U861/AFM), published in the Lancet on 21 November 2009. The I-STEM team, directed by Marc Peschanski has just succeeded in recreating a whole epidermis from human embryonic stem cells.
An atomic-level look at an HIV accomplice
Since the discovery in 2007 that a component of human semen called SEVI boosts infectivity of the virus that causes AIDS, researchers have been trying to learn more about SEVI and how it works, in hopes of thwarting its infection-promoting activity.
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A team led by scientists at The Scripps Research Institute have discovered a direct link between insulin-a hormone long associated with metabolism and metabolic disorders such as diabetes-and core body temperature.
Scientists find molecular trigger that helps prevent aging and disease
Researchers at Mount Sinai School of Medicine set out to address a question that has been challenging scientists for years: How do dietary restriction-and the reverse, overconsumption-produce protective effects against aging and disease?
Pivotal study for PSD502 -- the first potential treatment for premature ejaculation
At the annual meeting of the Sexual Medicine Society of North America (SMSNA), Inc. in San Diego, Sciele Pharma, Inc., a Shionogi Company and Plethora Solutions Limited, a wholly owned subsidiary of Plethora Solutions Holdings PLC ("Plethora" - AIM:PLE)., today presented data from its second positive pivotal study of PSD502 for the treatment of premature ejaculation (PE).
Night Beat, Overtime and a Disrupted Sleep Pattern Can Harm Officers' Health
A police officer who works the night shift, typically from 8 p.m. to 4 a.m., already is at a disadvantage when it comes to getting a good "night's" sleep.
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