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Medical Files
Of young doctors and new drugs

By Rafael Castillo, MD
Philippine Daily Inquirer
First Posted 00:29:00 02/28/2009

Filed Under: Medicines, Medical staff, Health

I ALWAYS have a soft spot in my heart for young doctors who are passionate and dedicated in what they do, be it in caring for patients, doing research, and lecturing to us?older doctors?about landmark clinical trials and new drugs.

Dr. Cyril Joseph Tolosa is one such young doctor, who I?m sure would have been a good clinician, but he chose to take the corporate path and is currently the medical scientific liaison of Novartis Philippines.

Mastery of trials

During a recent lecture of top kidney specialist Dr. Agnes Mejia, Cyril showed his mastery of all clinical trials on the new class of drug for high blood pressure?the direct renin inhibitors or DRIs, as he gave his share of clinical data on DRIs and its prototype aliskiren during the open forum. The result was a highly informative symposium.

Agnes, who is currently the chair of the Department of Medicine at the UP-PGH Medical Center, gave her usual brilliant presentation and the discussion during the open forum was lively with Dr. Rody Sy, director of Cardinal Santos Memorial Hospital, chairing the session.

Continuing research yields us with a new class of drug for hypertension every 10 years or so; and for this decade, the latest addition to the doctors? antihypertensive ammunition is aliskiren. The renin-angiotensin system (RAS) has been identified as a major culprit for secreting substances or hormones in the body which cause the blood vessels to constrict, raising the blood pressure. A normally functioning RAS is essential to the body, but once it becomes overactive, the circulation can go haywire and all sorts of complications such as hypertension, heart disease, kidney failure and stroke can happen.

?Direct renin inhibition is a novel way of controlling the renin-angiotensin system,? Agnes said. She presented various clinical trials showing the efficacy and safety of aliskiren in controlling the BP alone and in combination with other drugs. There is an ongoing clinical trial program on the drug which, according to Dr. Mejia, has shown potential heart- and kidney-protective effects of aliskiren in high-risk patients including heart failure cases, diabetic patients, the elderly and obese individuals.

?With aliskiren, we can finally have more complete control of the RAS by blocking it at the point of activation,? Cyril explained. ?In already 60 clinical trials of more than 14,000 patients, aliskiren is well-tolerated and has demonstrated significant blood pressure reductions when used alone or in combination with other antihypertensive drugs,? he added.

Rare mechanism of action

Because of its unique mechanism of action, cardiovascular experts suggest that aliskiren may confer additional benefits in certain groups of patients, such as those with diabetes and albuminuria or spillage of proteins in the urine. These patients require an optimal blockade of the RAS to prevent them from going into end-stage kidney disease requiring dialysis or kidney transplantation. This is a certain fate for many diabetics and hypertensives if they are not adequately treated.

The angiotensin converting enzyme (ACE) inhibitors and the angiotensin receptor blockers (ARBs) are now being used to preserve kidney function among diabetics. It?s good to have a third drug like the DRIs to help spare diabetics and other patients with albuminuria and kidney damage the specter of a future requiring regular dialysis.

Detecting albuminuria requires only a very simple urine test. All diabetics and hypertensive individuals should have it done. It was previously thought of as a benign finding, but recent research data have shown that it increases the risk, not only of kidney failure, but also of developing serious cardiovascular complications and even premature death. The worse the protein spillage is, the worse the outcome. But the good news is, there are drugs which can help reduce it, or even prevent it, especially in diabetics and hypertensives.

In patients with albuminuria, the BP should be reduced lower than the usual BP goal for hypertensive patients. The ideal BP should be in the range of 110/70 to 125/75 mmHg. Seven to eight out of 10 hypertensive patients will require drug combination to control their BP to optimal level. Sometimes three to four drugs for hypertension may be required to achieve the BP goal. So, don?t complain if your doctor has to prescribe you several drugs if your BP does not go down with one or two drugs.

Adequately controlled

In the Philippines, only one out of 10 hypertensive patients is adequately controlled; many have the false sense of assurance that they?re taking something for their elevated BP without checking if their BP is truly controlled or not. So there?s room on the market for additional drugs which have been proven to be effective and safe.

With so many drugs now available on the market, we tend to think that we don?t need new drugs. Until such time that we?ve already achieved a 100 percent control of hypertension, there will still be a place for new drugs which can offer additional benefits?either in efficacy or tolerability?to more than a billion hypertensive individuals worldwide.



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