ALLHAT Conclusions Questioned -Congressional Hearings Possible-

The Center for Medical Progress at the Manhattan Institute hosted a forum Wednesday morning at the National Press Club to analyze the conclusions of the Antihypertensive Lipid Lowering Heart Attack Trial (ALLHAT) conducted by the National Heart Lung and Blood Institute (NHLBI), a branch of the National Institutes of Health.

The NHLBI concluded from the ALLHAT study that patients on older diuretic drugs have fewer incidents of hypertension than patients on newer medications, including calcium channel blockers and ACE inhibitors. The panelists, some of whom were investigators in the study itself, refuted this finding and argued that the results have been misinterpreted and misstated by the media.

Dr. Mark Houston, Associate Clinical Professor of Medicine at Vanderbilt University and a principal investigator in the ALLHAT study, said diuretics may not be the preferred initial treatment in hypertension patients as the ALLHAT study seems to conclude. He cited 28 published and pending studies involving 140,000 patients that show contradictory results to the ALLHAT study. “Diuretics probably are not preferred initial antihypertensive therapy in most North American hypertensive patients and they may not be cheaper or more economical for the long-term treatment of patients with hypertension,” said Houston.

Houston pointed out some of the flaws associated with the ALLHAT study design and methods. The study used patients of above average age that were higher-risk individuals. But the biggest flaw, according to Houston, was the methods used to control blood pressure. Only one drug (ACE inhibitor) was used to control blood pressure levels, instead of a combination therapy. “Optimal control of blood pressure will require three to four antihypertensive drugs in many patients,” said Houston. When the effects of the flawed blood pressure treatment were controlled for, the ACE inhibitor outperformed the diuretic. Houston pointed out that reports of the study often neglect to tell the full story. The incidence of diabetes increased significantly with use of the diuretics, and use of diuretics was also associated with an elevation in cholesterol and had adverse consequences in kidney function.

Dr. Franz Messerli, Director of Clinical Hypertension at the Ochsner Clinic Foundation, echoed those comments adding, “Ten different independent studies have shown women who use diuretics have a five-fold increase in the risk of having renal cell carcinoma.” The reason, said Messerli, is because diuretics work at the renal tubular cells, the cells responsible for the disease.

Another principal investigator of the study, Dr. Michael Weber, said he was disappointed with the final ALLHAT report and the media coverage that followed. “The three drugs studied had the exact same effect on heart attack,” said Weber. He agreed that the ACE inhibitor would have performed better in the prevention of heart attacks and overall mortality if the study had been designed correctly. He cited a recent Australian study which showed ACE inhibitors having an 11% reduction in heart attack and 32% reduction in mortality compared to diuretics. “Diuretics are a necessary treatment in many patients,” said Weber. “But [they] should be one component of treatment, not the sole basis for treatment.”

Dr. Ralph Hawkins of the Hypertension Institute in Nashville examined the results of the ALLHAT study from an economic perspective. He said there is a strong correlation between the use of diuretics and the occurrence of end-stage renal disease, although the correlation does not imply direct causation. The cost of treating end-stage renal disease is about five times spending on diuretics. Hawkins’ own analysis shows every dollar spent on new diuretics increases lifetime health care costs by $28. “Diuretics might be a subtle environmental toxin,” said Hawkins.

Dr. Weber commented on the political aspects. “I’m disappointed that a government agency has used a flawed study to put out false and misleading statements,” he said. “Putting out wrong and misleading information is highly irresponsible.” Peter Rizik of the Health Subcommittee of the House Ways and Means Committee said there may be a need to hold a congressional hearing on this issue.

–Joe Moser
Galen Institute

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The Center for Medical Progress at the Manhattan Institute hosted a forum Wednesday morning at the National Press Club to analyze the conclusions of the Antihypertensive Lipid Lowering Heart Attack Trial (ALLHAT) conducted by the National Heart Lung and Blood Institute (NHLBI), a branch of the National Institutes of Health.

The NHLBI concluded from the ALLHAT study that patients on older diuretic drugs have fewer incidents of hypertension than patients on newer medications, including calcium channel blockers and ACE inhibitors. The panelists, some of whom were investigators in the study itself, refuted this finding and argued that the results have been misinterpreted and misstated by the media.

Dr. Mark Houston, Associate Clinical Professor of Medicine at Vanderbilt University and a principal investigator in the ALLHAT study, said diuretics may not be the preferred initial treatment in hypertension patients as the ALLHAT study seems to conclude. He cited 28 published and pending studies involving 140,000 patients that show contradictory results to the ALLHAT study. “Diuretics probably are not preferred initial antihypertensive therapy in most North American hypertensive patients and they may not be cheaper or more economical for the long-term treatment of patients with hypertension,” said Houston.

Houston pointed out some of the flaws associated with the ALLHAT study design and methods. The study used patients of above average age that were higher-risk individuals. But the biggest flaw, according to Houston, was the methods used to control blood pressure. Only one drug (ACE inhibitor) was used to control blood pressure levels, instead of a combination therapy. “Optimal control of blood pressure will require three to four antihypertensive drugs in many patients,” said Houston. When the effects of the flawed blood pressure treatment were controlled for, the ACE inhibitor outperformed the diuretic. Houston pointed out that reports of the study often neglect to tell the full story. The incidence of diabetes increased significantly with use of the diuretics, and use of diuretics was also associated with an elevation in cholesterol and had adverse consequences in kidney function.

Dr. Franz Messerli, Director of Clinical Hypertension at the Ochsner Clinic Foundation, echoed those comments adding, “Ten different independent studies have shown women who use diuretics have a five-fold increase in the risk of having renal cell carcinoma.” The reason, said Messerli, is because diuretics work at the renal tubular cells, the cells responsible for the disease.

Another principal investigator of the study, Dr. Michael Weber, said he was disappointed with the final ALLHAT report and the media coverage that followed. “The three drugs studied had the exact same effect on heart attack,” said Weber. He agreed that the ACE inhibitor would have performed better in the prevention of heart attacks and overall mortality if the study had been designed correctly. He cited a recent Australian study which showed ACE inhibitors having an 11% reduction in heart attack and 32% reduction in mortality compared to diuretics. “Diuretics are a necessary treatment in many patients,” said Weber. “But [they] should be one component of treatment, not the sole basis for treatment.”

Dr. Ralph Hawkins of the Hypertension Institute in Nashville examined the results of the ALLHAT study from an economic perspective. He said there is a strong correlation between the use of diuretics and the occurrence of end-stage renal disease, although the correlation does not imply direct causation. The cost of treating end-stage renal disease is about five times spending on diuretics. Hawkins’ own analysis shows every dollar spent on new diuretics increases lifetime health care costs by $28. “Diuretics might be a subtle environmental toxin,” said Hawkins.

Dr. Weber commented on the political aspects. “I’m disappointed that a government agency has used a flawed study to put out false and misleading statements,” he said. “Putting out wrong and misleading information is highly irresponsible.” Peter Rizik of the Health Subcommittee of the House Ways and Means Committee said there may be a need to hold a congressional hearing on this issue.

–Joe Moser
Galen Institute

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About the author