ST LOUIS (MD Consult) - On August 27, 2010, Novartis announced that the US Food and Drug Administration (FDA) has approved Tekamlo for the treatment of hypertension. Tekamlo is a single-pill combination of aliskiren, a direct renin inhibitor, and amlodipine, a calcium channel blocker.

Tekamlo is approved as initial therapy for hypertension in patients who are likely to need multiple drugs to achieve their blood pressure goals. The drug is also indicated as a replacement therapy for patients whose blood pressure is not adequately controlled with either aliskiren or amlodipine alone.

The FDA approval of Tekamlo was granted on the basis of clinical trial data involving more than 5,000 patients with mild-to-moderate hypertension. Results from an 8-week, randomized, double-blind, placebo-controlled, multi-factorial study showed that use of the combination of Tekturna (aliskiren) and amlodipine resulted in decreases in systolic/diastolic blood pressure at trough of 14-17/9-11 mm Hg, compared with 4-9/3-4 mm Hg for Tekturna alone, and 9-14/6-8 mm Hg for amlodipine alone.

In 2 additional double-blind, active-controlled studies of similar design that included participants with moderate-to-severe hypertension (ie, with systolic blood pressure readings of 160-200 mm Hg), patients receiving Tekamlo demonstrated significantly greater reductions in systolic and diastolic blood pressures compared with patients receiving amlodipine alone. In a study involving 443 black patients, the systolic/diastolic treatment difference between Tekamlo and amlodipine was 5.2/3.8 mm Hg at the primary end point of 8 weeks. In another study of 484 patients, the treatment difference between Tekamlo and amlodipine was 7.1/3.8 mm Hg at the study end point.

According to Novartis, the blood pressure–lowering effects of Tekamlo are largely attained within 1 to 2 weeks.

圣路易斯(MD Consult)—2010年8月27日，诺华公司宣布美国食品药品管理局(FDA)已批准Tekamlo用于治疗高血压。Tekamlo是直接肾素抑制剂阿利吉仑与钙拮抗剂氨氯地平的复方片剂。

 

Tekamlo获准用作可能需要多种降压药才可达到目标血压的高血压患者的初步治疗。此药也适宜作为单用阿利吉仑或氨氯地平无法充分控制血压者的替代治疗。

 

FDA批准Tekamlo的依据是包括5000例以上轻中度高血压患者的临床试验数据。一项历时8周、随机、双盲、安慰剂对照、多因素研究的结果表明，联用Tekturna(阿利吉仑)与氨氯地平使收缩压/舒张压谷水平下降14~17/9~11mmHg，而单用Tekturna或单用氨氯地平分别下降4~9/3~4 mmHg和9~14/6~8 mmHg。

 

另有2项设计相近、双盲、阳性对照、受试者为中重度高血压患者(即收缩压为160~200 mmHg)的研究表明，与单用氨氯地平组相比，Tekamlo治疗组的收缩压和舒张压下得降更为显著。一项对443例黑人患者进行的研究表明，Tekamlo组与氨氯地平组的收缩压/舒张压在8周主要研究终点时相差5.2/3.8 mmHg。另一项涉及484例患者的研究表明，Tekamlo组与氨氯地平组在研究终点时相差7.1/3.8 mmHg。

 

据诺华公司表示，Tekamlo主要在用药后的1~2周内达到降压效果。