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Jairia Dela Cruz, 15 May 2019
Postmenopausal women with hormone receptor (HR)-positive breast cancer fare well with the addition of denosumab to aromatase inhibitors, with data from the phase III ABCSG-18 trial showing that the antiresorptive drug cuts the risk of fractures and confers a modest but significant improvement in disease-free survival with a favourable tolerability profile.
14 May 2019
At the recent GLYCEMIC GUARDIANS™ dinner symposium, three eminent speakers spoke on theindispensable role of medical nutrition therapy (MNT) in improving outcomes for patients with type2 diabetes (T2D).
Rachel Soon, 22 Jun 2018

“Every patient is unique.” For compounding pharmacist Sarah Abdullah, tailoring medicines to a person’s needs is nothing new after years of working in the clean rooms of Putrajaya Hospital. Now managing her own enterprise, the also-council member of the Malaysian Community Pharmacy Guild (MCPG) spoke to MIMS Pharmacist about her experiences in the field to date.

Pearl Toh, 24 Apr 2019
Adding high-dose vitamin D3 to standard chemotherapy for metastatic colorectal cancer (mCRC) may confer potential benefit to previously untreated patients in terms of progression-free survival (PFS) compared with supplemental standard-dose vitamin D3, suggests the phase II SUNSHINE* study.

Oral lefamulin a giant LEAP for CABP treatment

Pearl Toh
10 May 2019

The novel pleuromutilin antibiotic lefamulin again shows a favourable safety and tolerability profile, now in an oral therapy form for community-acquired bacterial pneumonia (CABP), reveals the LEAP* 2 study.

Being a new class of antibiotic, lefamulin may offer an empiric treatment option for CABP in an era of increasing antibiotic resistance, according to principal investigator Dr Jennifer Schranz in a company press release. “[The LEAP 2 study] shows that a 5-day short course of lefamulin was noninferior to a 7-day course of moxifloxacin and this is really important for antibiotic stewardship.”

Topline data of the LEAP 2 study has previously shown that oral lefamulin was noninferior to moxifloxacin for both the US FDA primary efficacy endpoint of early clinical response at 96 ± 24 hours after treatment initiation (90.8 percent for both drugs, but treatment with lefamulin was only for 5 days compared with 7 days of moxifloxacin), and the EMA** coprimary endpoint of investigator assessment of clinical response at 5–10 days after the end of treatment (87.5 percent vs 89.1 percent).

In the recent ECCMID 2019 Meeting, the investigators reported on the safety and tolerability data for the second double-blind phase III study of lefamulin in CABP patients, the first one being LEAP 1.

Unlike LEAP 1 which compared intravenous (IV) lefamulin (with an oral switch option) with intravenous moxifloxacin, the current LEAP 2 study randomized patients 1:1 to receive oral lefamulin (600 mg q12h for 5 days) or oral moxifloxacin (400 mg q24h for 7 days). Subjects were 738 patients with CABP of severity PORT risk class II–IV CABP. [ECCMID 2019, abstract O1068]

Overall, treatment-emergent adverse events (TEAE) occurred in 32.6 percent of patients treated with lefamulin and 25.0 percent of those receiving moxifloxacin. The rates of serious TEAEs (4.6 percent vs 4.9 percent) and TEAEs leading to discontinuation (3.3 percent vs 2.4 percent) were similar between the two groups.

Although gastrointestinal (GI) TEAEs occurred more frequent in the lefamulin group vs the moxifloxacin group (17.9 percent vs 7.6 percent), the events were generally mild and transient. The two most common GI-related TEAEs, diarrhoea (12.2 percent vs 1.1 percent) and nausea (5.2 percent vs 1.9 percent), did not lead to study discontinuation.

Two lefamulin-treated patients and one moxifloxacin-treated patient discontinued due to vomiting. There was one report of Clostridium difficile infection during an extended hospitalization in one patient who had been successfully treated with lefamulin.

“This contrasts with the IV-to-oral switch profile [in LEAP 1] in which higher rates of GI events occurred with moxifloxacin,” the researchers noted.

Incidence of both hepatobiliary TEAEs (1.1 percent vs 0.5 percent) and cardiac TEAEs (2.2 percent vs 2.4 percent) were low in the lefamulin and the moxifloxacin groups. While prolonged QTcF interval was observed in both the lefamulin (four cases) and the moxifloxacin groups (seven cases), “QTcF prolongation was shorter with lefamulin than moxifloxacin with no associated cardiac arrhythmias,” the researchers reported.

“Oral lefamulin monotherapy was generally safe and well tolerated with low discontinuation rates due to TEAEs,” said the researchers. “These results add to the developing favourable safety/tolerability profile of IV and oral lefamulin.”

 

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Most Read Articles
Jairia Dela Cruz, 15 May 2019
Postmenopausal women with hormone receptor (HR)-positive breast cancer fare well with the addition of denosumab to aromatase inhibitors, with data from the phase III ABCSG-18 trial showing that the antiresorptive drug cuts the risk of fractures and confers a modest but significant improvement in disease-free survival with a favourable tolerability profile.
14 May 2019
At the recent GLYCEMIC GUARDIANS™ dinner symposium, three eminent speakers spoke on theindispensable role of medical nutrition therapy (MNT) in improving outcomes for patients with type2 diabetes (T2D).
Rachel Soon, 22 Jun 2018

“Every patient is unique.” For compounding pharmacist Sarah Abdullah, tailoring medicines to a person’s needs is nothing new after years of working in the clean rooms of Putrajaya Hospital. Now managing her own enterprise, the also-council member of the Malaysian Community Pharmacy Guild (MCPG) spoke to MIMS Pharmacist about her experiences in the field to date.

Pearl Toh, 24 Apr 2019
Adding high-dose vitamin D3 to standard chemotherapy for metastatic colorectal cancer (mCRC) may confer potential benefit to previously untreated patients in terms of progression-free survival (PFS) compared with supplemental standard-dose vitamin D3, suggests the phase II SUNSHINE* study.