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Novartis rivals find VALUE in landmark Diovan trial

Published on 01/07/04 at 05:59pm

A landmark study comparing Novartis' Diovan with Pfizer's calcium channel blocker Istin has ended with both sides claiming superiority for their drugs.

The Novartis-sponsored VALUE (Valsartan Antihypertensive Long-term Use Evaluation Trial) study compared valsartan (Novartis' Diovan) with amlodipine (Pfizer's Istin Norvasc in the US) and backed the use of the whole angiotensin receptor blocker (ARB) class of antihypertensives drugs to prevent heart attacks.

The head-to-head trial involved over 15,000 patients and was intended to prove the newer drug's superiority, but its results have provided Pfizer with ammunition of its own in a fierce marketing battle.

Novartis has declared its aim of making Diovan the number one hypertension treatment in the US - a feat it can only achieve by overtaking Istin, currently the leading drug in the field, with $4.5 billion global sales in 2003.

Novartis' drug is catching up with Istin, sales of Diovan rising 29% in the first quarter of this year compared to just 7% growth for Istin and the company has prepared an integrated marketing campaign, including a US direct to consumer and physician marketing campaign budget of $25 million for the second quarter. Novartis is offering a money back guarantee to patients, a consumer-style tactic being spearheaded by chief executive Thomas Ebeling, a former Pepsi executive.

The VALUE trial was designed to see whether or not Diovan reduced cardiac morbidity and mortality more than Istin in hypertensive patients at high cardiovascular risk, with the assumption that the products would lower blood pressure equally well.

Overall, the results were somewhat disappointing for Novartis, not only showing Diovan to be no better than its rival in cutting heart disease and fatal heart attacks, but also unexpectedly showing  Istin to be superior in lowering blood pressure.

Istin showed a significantly lower incidence of myocardial infarction but higher rate of new-onset diabetes than Diovan in the study.

The most consistent and statistically significant difference between the groups found in the study was in blood pressure control, at which Istin was significantly more effective in reducing, especially during the early phases of treatment.

More generally, the findings re-emphasised the importance of prompt blood pressure control in hypertensive patients at high cardiovascular risk.

Writing in The Lancet, Lars Lindholm, chair of the Swedish Council on Technology Assessment Working Group on High Blood Pressure, said: "[ARBs] seem to be at least as effective as other types of antihypertensives in preventing cardiovascular events, provided blood pressure is equally well lowered."

Both drugs were found to lower blood pressure effectively but the study found Istin more effective than Diovan in this respect, although Novartis dismissed the difference as statistically insignificant.

Pfizer has been quick to promote the findings which favoured its drug, including the fact that patients on Istin suffered fewer non-fatal heart attacks. For Novartis, the clearest benefit its product demonstrated over Istin is the lower incidence of new-onset diabetes in patients.

Joerg Reinhardt, head of development at Novartis, said: "The additional finding that Diovan may be associated with the reduction in the onset of diabetes in a population at high risk is very exciting. The long-term benefits and clinical implications of this finding are being investigated in the ongoing NAVIGATOR trial which is fully enrolled and expected to report in 2008."

Pfizer's product is approaching patent expiry in most markets by 2007, having already lost its UK exclusivity in March this year.

Pfizer recently launched Caduet in the US, an Istin/Lipitor combination pill which it hopes will continue to capitalise on the success of the two blockbusters.

Boehringer Ingelheim, marketers of rival ARB drug Micardis has also claimed superiority for their product, saying forthcoming trial results showed Micardis more effective in blood pressure control compared to Diovan for up to 48-hours after an active dose.

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