spironolactone

Blood test for patients on acne medication deemed unnecessary .

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A study by researchers at Brigham and Women’s Hospital (BWH) has found that for young, healthy women taking spironolactone to treat hormonal acne, frequent office visits and blood draws are an unnecessary healthcare expense.

Dr Arash Mostaghimi

For the approximately 1,000 patients studied, blood tests to monitor potassium levels did not change the course of treatment, but the tests cumulatively totalled up to $80,000.

The research team suggests that routine potassium monitoring should no longer be recommended for this patient population in order to improve the patient care experience, decrease unnecessary office visits and reduce healthcare spending. Their results appear in JAMA Dermatology.

“The need for testing may be a deterrent for both physicians and patients alike,” said Dr Arash Mostaghimi, director of Dermatology Inpatient Service at BWH and senior author of the study. “By demonstrating that for young, healthy women, it’s safe to give spironolactone without close potassium monitoring, we hope that more patients will be able to benefit from this medication.”

Spironolactone, a generic drug that’s been used in the clinic since 1959, is commonly prescribed for treating hormonal acne – acne that tends to affect the jaw line most commonly around the time of the month when a woman gets her period. The medication addresses the root cause of these acne outbreaks by affecting the production of hormones as well as the way that hormones bind to the skin.

Spironolactone’s primary use is as a diuretic and antihypertensive treatment for patients with heart failure and liver failure. In these patients, spironolactone has been associated with an increased risk of hyperkalaemia – a dangerous elevation in potassium levels in the blood that can lead to abnormal heart rhythms.

Based on this risk, the US Food and Drug Administration recommends frequent potassium monitoring in patients with heart failure taking spironolactone, but it’s been unclear if these guidelines should apply to healthy patients taking spironolactone for the treatment of acne, and, if so, how frequently such patients should have their potassium levels tested.

Dr Mostaghimi and his colleagues evaluated clinical data from patients seen at Massachusetts General Hospital and Brigham and Women’s Hospital over a 15-year period. They calculated how frequently individual patients were tested and the rate of hyperkalaemia.

“Our goal was to understand the current screening practices of physicians taking care of young, healthy women on spironolactone for acne and to determine what the usefulness of the test was – what we found was that doctors checked potassium levels at different frequencies, suggesting an ambivalence about the tests,” said Dr Mostaghimi. “Of the more than 1,800 blood tests administered over that time period, we found no substantial problems or complications for these patients and no changes in their treatment based on what the tests showed.”

The researchers found just 13 cases of mild hyperkalaemia. When tested a second time, half of these patients had normal potassium levels, and none of the patients showed any signs or symptoms of hyperkalaemia.

The researchers note that a monthly dose of spironolactone costs $4.00; a serum electrolyte panel – frequently ordered along with potassium measurements – costs $43.51.

“There are two ways to think about cost,” said Dr Mostaghimi. “The first is in terms of money spent – that’s almost $80,000 worth of testing done without any benefit in terms of patient treatment. But there are also the time and psychological costs of being monitored while taking a medication. There’s time and lost work productivity to consider too. We hope that by presenting these data, we will begin to create a standard of practice that best serves patients and helps physicians who may be ambivalent about recommending these tests for otherwise healthy patients.”

Is Spironolactone a ‘Savior’ for Hemodialysis Patients?

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Is it possible that spironolactone could be the cardiovascular savoir of our hemodialysis patients? I know this is provocative, but during our journal club yesterday, one of the Fellows presented an interesting paper that Matsumoto and colleagues[1] published in the Journal of the American College of Cardiology in February 2014.

This was a randomized controlled trial of more than 300 patients who had been receiving hemodialysis for 2 years or more. It was an open-label study but a prospective, randomized controlled trial comparing spironolactone 25 mg once daily vs no therapy in the control group. Many patients in both groups were receiving angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or both. They were typical dialysis patients—middle aged to mid-60s, with diabetes, hypertension, cardiovascular disease, and so forth. Both groups had been on dialysis for 9 or 10 years, although the control group had been on dialysis a bit longer than the spironolactone group. The primary outcome of the study was death from cardiovascular disease or hospitalization for cardiovascular events, and the secondary outcome was death from any cause.

Study Outcomes

In all, 5.7% of the spironolactone-treated patients and 12.5% of the control group met the primary outcome of cardiovascular death or other cardiovascular hospitalizations, a 60% reduction in cardiovascular events for the spironolactone-treated group. This difference began to appear after about 6 months of therapy and increased during the course of the 3-year study. The secondary outcome, all-cause death, occurred in 6.4% of spironolactone-treated patients and nearly 20% of patients in the control group, for a 67% reduction in all-cause death.

Of interest, blood pressures did not change in the patients who received spironolactone. Also of interest, hyperkalemia was quite rare. The major adverse event was breast pain or gynecomastia in men.

Dramatic Impact With Unclear Mechanism

These results are astounding. I cannot think of anything that has conferred this degree of mortality or cardiovascular disease reduction in patients on hemodialysis. This dramatic outcome was not diminished after adjusting for differences between the groups, such as years of dialysis and so forth. The mechanism for this is not clear, whether it has to do with myocardial fibrosis, alterations in endothelial dysfunction, cardiac autonomic function, or heart rate variability issues. It may be none of these or some combination of them. We do not really know.

We always are concerned about the risk for hyperkalemia. Indeed, these patients were selected for having had a predialysis potassium level of less than 6.5 or 6.4 mmol/L. The study population was not atypical.
As we left the journal club, some of the faculty said, “This is wonderful. We should put all of our patients on spironolactone.” Others said that it is too soon to tell. The study was not conducted in the United States and it was not a double-blind study, although it is hard to argue with death as an endpoint. Nonetheless, at least two other studies are being conducted. One is the Mineralocorticoid Receptor Antagonists in End Stage Renal Disease (MiREnDa) study, which is primarily looking at intermediate cardiovascular outcomes such as LV mass index, LV geometry, LV function, and so forth. Another study, called ALCHEMIST, is being conducted in Belgium, using spironolactone 25 mg daily and looking at harder cardiovascular outcomes.

N-acetylcysteine attenuates the progression of chronic renal failure

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Background

 

Lipid peroxidation impairs renal function. Aldosterone contributes to renal injury in the remnant kidney model. This study aimed to determine the effects of the antioxidant N-acetylcysteine (NAC) on renal function and aldosterone levels in chronic renal failure.

Methods

 

Adult male Wistar rats were submitted to 5/6 nephrectomy or laparotomy (sham-operated) and received NAC (600 mg/L in drinking water, initiated on postoperative day 7 or 60), spironolactone (1.5 g/kg of diet initiated on postoperative day 7), the NAC-spironolactone combination or no treatment. Clearance studies were performed on postoperative days 21, 60, and 120.

Results

 

Mean daily NAC and spironolactone ingestion was comparable among the treated groups. Mean weight gain was higher in NAC-treated rats than in untreated rats. A significant decrease in urinary thiobarbituric acid reactive substances (TBARS) concentrations, a lipid peroxidation marker, was observed in NAC-treated rats. By day 120, glomerular filtration rate (GFR), which dropped dramatically in untreated rats, was stable (albeit below normal) in NAC-treated rats, which also presented lower proteinuria, glomerulosclerosis index, and blood pressure, together with attenuated cardiac and adrenal hypertrophy. These beneficial effects, observed even when NAC was initiated on postnephrectomy day 60, were accompanied by a significant reduction in plasma aldosterone and urinary sodium/potassium ratio. The NAC-spironolactone combination lowered blood pressure and improved GFR protection.

Conclusion

 

The NAC-spironolactone combination improves renal function more than does NAC alone. In the remnant kidney model, early or late NAC administration has a protective effect attributable to decreased plasma aldosterone and lower levels of lipid peroxidation.

CONCLUSION

Our data demonstrate that NAC attenuates drops in GFR, as well as lowering proteinuria and blood pressure in nephrectomized rats. This is accompanied by a significant reduction in aldosterone levels. Our results indicate that ROS play an important role in the progression of chronic renal failure. It is evident that NAC has potential utility in preventing glomerulosclerosis and loss of kidney function in patients with chronic renal failure. The findings that NAC attenuated GFR drop and lowered proteinuria, even in end-stage chronic renal failure, and that the combination of NAC and spironolactone improves renal function more than does NAC alone have significant clinical implications.

Source: Nature Kidney