(medpagetoday.com) The FDA has approved a combination of three hypertension drugs — olmesartan medoxomil, amlodipine, and hydrochlorothiazide (Tribenzor) — to treat patients whose blood pressure is not controlled on angiotensin receptor blockers, calcium channel blockers, or diuretics.
The new polypill is not approved as an initial therapy for hypertension.
Approval was based on the results of a 2,492-patient clinical trial, which found the new drug produced a significant reduction in systolic and diastolic blood pressures after eight weeks of treatment compared with each of its dual-drug components, according to a press release from Daiichi Sankyo, maker of the polypill.
The polypill reduced patient systolic/diastolic blood pressures compared with amlodipine/hydrochlorothiazide, olmesartan/hydrochlorothiazide, and olmesartan/amlodipine by an average of 8.1/5.4 mm Hg, 7.6/5.4 mm Hg, and 8.4/4.5 mm Hg respectively (P<0.0001 versus each dual combination) from the 168.5/100.9 mm Hg average baseline, according to the press release.
The FDA warned that pregnant patients should not take the new combination drug; those who become pregnant while on the polypill should discontinue therapy immediately.
The agency also issued the following safety warnings:
- Patients with impaired renal function and hepatic impairment should avoid the polypill; the drug may increase the likelihood of azotemia in people with renal disease.
- Patients with severely impaired renal function (creatinine clearance ≤30 mL/min) should avoid the new drug.
- Patients with an activated renin-angiotensin system should be monitored for symptomatic hypotension. Treatment should start under close medical supervision.
- The drug may increase the risk of angina and myocardial infarction once calcium channel blocker therapy has started or after a dose increase, particularly in patients with severe obstructive coronary artery disease.
- All patients should be monitored for signs of fluid or electrolyte imbalance.
- Activation or exacerbation of systemic lupus erythematosus may occur in those patients taking thiazide diuretics.
- Patients on the polypill should not take lithium.
Adverse reactions include dizziness, peripheral edema, headache, fatigue, nasopharyngitis, muscle spasm, nausea, upper respiratory tract infection, diarrhea, urinary tract infection, and joint swelling.
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Great one! Shot gun approach.
Target achieved after a grand eight weeks trial! Wow!
This may be the ideal pill for patients with malignant hypertension who need urgent treatment, but what are the long term consequences of this pill?
Long term = 30 years!
As for the adverse reaction: In hypertensive treatment terms and medication these are probably regarded as ‘minor, see doctor (who is unable to do anything about them) if symptoms persist.’
Many existing hypertensive meds come with these adverse reactions already! And they are still on the market.
In Australia most prescription medications come without any patient information whatsoever. That’s what pharmaceutical companies get away with these days.
It is absolutely essential that patients with hypertension follow a strictly healthy diet, lose weight and exercise. And remember exercise may become more difficult once on medication. Beta Blockers slow you down, others make you dizzy, others reduce the recovery heart rate, hence your capacity to exercise will be gradually reduced and it becomes a vicious downward spiral.
Having said all this, see you doctor if you are overweight, have moderate to severe hypertension and plan to start an exercise regimen.
Hypertension builds up over many years. If you are otherwise healthy you may have time to try to reduce the factors that contributed to hypertension by natural means, thereby reducing the need for the most potent treatment by medication, or be able to take a more moderate approach when medication is needed.
A friend has been on medication for ten years and his blood pressure now has gone up to a higher level than when he commenced treatment. Why? Because blood pressure is not controlled by pills, it is merely suppressed. Whatever caused it in the first place is still cooking underneath. Now he needs more potent drugs, or additional drugs. And he still drinks, eats fatty food, and only exercises occasionally – because he knows for the next ten years another pill may ‘fix’ him again.
People really need to wake up to themselves and look very seriously at their lifestyle.
But that does not make any money for pharmaceutical companies and doctors who prescribe the pills.
Marmotte, your last two paragraphs really hit home on this issue of lack of responsibility on the part of the patient. Most people want the easy way out of not taking this responsibility for their chosen lifestyle. Bad habits are extremely difficult to break and especially when emotional rewards are tied to not eating, not exercising, and lowering their stress levels.