Strong potential for cross risk-factor single pill therapies

Recently published data from the GENOA study has demonstrated that dyslipidemia is highly prevalent in hypertensive adults and that this condition is insufficiently treated in more than half of the cases. As Datamonitor's Laurent Chanroux explains, the results lend further support to cross risk-factor, single pill combination therapies such as Pfizer's Caduet...

Less than one third of hypertensive adults with dyslipidemia are drug-treated, according to findings from the Genetic Epidemiology Network of Arteriopathy (GENOA) study. In addition, the research also showed that fewer than half of those treated achieve recommended lipid levels. This suggests a need for a more aggressive treatment of dyslipidemic hypertensives and highlights the potential of cross risk-factor single-pill combination therapies such as Caduet (atorvastatin/amlodpine).

Contrasting treatments

Investigators studied 1,286 non-Hispanic black hypertensive subjects and 1,070 non-Hispanic white hypertensive subjects who participated in the GENOA study. Subjects were categorized according to presence of coronary heart disease (CHD) and risk factors for CHD.

The prevalence of dyslipidemia was significantly greater among white participants than among black participants (women, 64.7% versus 49.5%; and men, 78.4% vs 56.7%) and among men versus women.

Furthermore, among all dyslipidemic subjects, data showed that treatment with lipid-regulating drugs was significantly more common among white than black subjects (women, 25.4% versus 16.4%; and men, 32.6% versus 12.8%). Additionally, among white patients, treatment was significantly more common among men than women. Control of dyslipidemia in subjects receiving drug treatment varied from 33.9% in white men to 51.9% in black men, but the differences among ethnic-sex groups were not statistically significant.

Risk factors

Hypertension and dyslipidemia are important risk factors and their combined presence puts patients at a significantly higher risk of experiencing myocardial infarction or stroke. Therefore, improved diagnosis and treatment with existing therapies is likely to considerably improve patients' outcomes and prevent CHD.

On the basis of these findings, investigators recommend that hypertensive patients have their lipid levels monitored, and state that hypertensives with co-morbid dyslipidemia should receive aggressive treatment for both conditions.

Furthermore, this data shows that despite the synergistic effect of hypertension and dyslipidemia on cardiovascular risk, targeting dyslipidemic hypertensives remains problematic for clinicians. This is principally due to reluctance on the part of patients to medicate for a chronic, asymptomatic condition and the inherent pill burden associated with the treatment of co-morbidities.

Meeting demand

However, these issues may be resolved by the development and growing use of single-pill combination therapies such as Pfizer's Caduet (amlodipine/atorvastatin).

Approved by the FDA in February 2004, Caduet combines two of the world's highest selling cardiovascular drugs, the anti-dyslipidemic, Lipitor (atorvastatin) and the anti-hypertensive Norvasc (amlodipine).

The drug is the first single-pill combination to target both dyslipidemia and hypertension and has the potential to lessen the pill burden associated with treating two concomitant conditions by offering patients a convenient one-pill dosage that can be taken at any time, with or without food. This therapeutic alternative is likely to improve patient compliance with treatment and thereby reduce patients' overall cardiovascular risk.

Caduet has strong commercial potential as Pfizer is well established in the cardiovascular market and both Lipitor and Norvasc lead their respective therapeutic classes. Therefore, the provision of a single pill combination treatment should further improve the company's already strong position and allow it to maximize revenue streams from its two blockbusters in preparation for generic competition.

Related Datamonitor research:

• Landmark Anti-dyslipidemic Trials Update - How Low Can You Go?
• Commercial Perspectives: Anti-dyslipidemics - A tale of two launches
• Stakeholder Insight: Dyslipidemia - Titration versus Combination Therapy

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