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Product Liability Lawsuits and Class Actions : Product Liability Blog Home : Paralysis Injuries : Article

High Blood Pressure Drugs in Clinical Trials Cause Paralysis

Leave it to big pharma to create two drugs that they say work together to lower high blood pressure; as if one prescription isn't already costly enough. The combination of aliskiren and valsartan at maximum recommended doses provides significantly greater reductions in blood pressure than does mono-therapy with either agent alone in patients with high blood pressure and the tolerability profile of the combined treatment is similar to the two-single agent treatments.

The findings are reported in an article in The Lancet. However an accompanying comment warns that the potentially life-threatening side effect of high blood potassium makes the treatment unlikely to make it to general practice or even primary prevention in specialist care. The University of Birmingham, Alabama study had 1,797 patients with hypertension, who were divided into four groups. The first group received once-daily aliskiren 150mg, the second once daily valsartan 160mg, the third a combination of aliskiren 150mg and valsartan 160mg once daily, and the fourth a placebo. The treatment was given for four weeks, followed by four weeks of double doses in each of the four groups, which represented the maximum recommended dose.

A total of 196 patients, spread across the four groups, discontinued treatment before the end of the trial, with lack of therapeutic effect being the most common reason for discontinuation for placebo-treated patients and the least common for combination-treated patients. The researchers found that the group receiving the maximum doses of aliskiren and valsartan combined experienced a mean drop in their sitting diastolic blood pressure but that it could also cause severe complications such as paralysis, arrhythmias, and cardiac arrest.

Because of potential life-threatening side effects, which require biochemical monitoring, this concept of treatment is unlikely to make to general practice or even to primary prevention in specialist care.

http://www.sciencedaily.com/releases/2007/07/070722204216.htm

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