Altace plus hydrochlorothiazide – ho hum or tip of the iceberg?

Implications: Implications: • The clinical trial experience with combination Altace plus hydrochlorothiazide (HCT) indicates safety and efficacy satisfactory for FDA approval. • The combination of ACE inhibitor and thiazide is old and ho-hum, and not as novel as newer combinations like Exforge (Novartis). • The long track record and presumed lower cost of Altace plus HCT could enable this product from King to compete satisfactorily against the more novel combinations of big Pharma. • Given that combination products may be more acceptable by current hypertension treatment guidelines, look for more such products to appear, with the novel ones from big Pharma and the traditional ones from smaller companies. • The hypertension market is still huge, growing, and in need of new treatment options.

Analysis: This article reports the results of a rather conventional clinical trial that compared the effects of a combination of the ACE inhibitor ramipril (Altace, King Pharmaceuticals) plus a low dose (25 mg) of hydrochlorothiazide (HCT) to either component alone as treatment for hypertension. The combination was more effective than either component alone, and a single dose was effective for 24 hrs. The results easily satisfy FDA requirements for approval of a combination antihypertensive agent.

The combination of ACE inhibitor with HCT is not new and almost always produces effects superior to either agent alone. Thus, the present results are not surprising and should obtain FDA approval for the drug. Virtually every old ACE inhibitor has been used effectively with HCT, so there’s nothing new here. Unlike Exforge (Novartis), which is a novel combination that combines an ARB with a calcium blocker, Altace plus HCT is “same old, same old”, just ho-hum. It is difficult to see this combination competing very successfully against the more novel combinations supported by the marketing clout of big Pharma. On the other hand, for a company of King’s size, this may be a modestly successful product. It appears that we are seeing more combination products come to market for hypertension, probably reflecting recent guideline suggestions that the majority of patients with hypertension require more than one drug for adequate control. The option of using lower dose drug combinations has become more acceptable than using single drugs in higher doses which may increase the incidence of side effects. Thus, we may see more combinations, with big Pharma introducing the more esoteric and novel ones, while smaller companies use the more traditional, established, and cheaper combinations. The marketplace for hypertension is big enough for all, and will grow given the large number of undetected and/or inadequately treated hypertensive patients.