Musculoskeletal Adverse Events Associated with PCSK9 Inhibitors: Disproportionality Analysis of the FDA Adverse Event Reporting System

Table 3

Outcome distribution in terms of each PT^$ for cases with MAEs^$ because of PCSK9 inhibitors and statins.

	DE^#	LT^#	HO^#	DS^#	CA^#	RI^#	OT^#	%
PCSK9 inhibitors +statins
Rhabdomyolysis		1	4				6	12.09%
Blood CPK increased			1				15	17.58%
Myalgia			11	1			51	69.23%
Myositis							1	1.10%
%	0.00%	1.10%	17.58%	1.10%	0.00%	0.00%	80.22%
PCSK9 inhibitor monotherapy
Myalgia	4	5	83	31		3	438	80.92%
Rhabdomyolysis	1	1	10				30	6.03%
Myopathy			2	2			9	1.87%
Blood CPK increased			12				58	10.04%
Myositis			2				6	1.15%
%	0.72%	0.86%	15.64%	4.73%	0.00%	0.43%	77.62%
Statins monotherapy
Blood CPK increased	24	104	620	74	1	11	759	14.07%
Rhabdomyolysis	285	490	2298	138	3	45	1789	44.59%
Myopathy	20	70	376	95	1	8	540	9.81%
Myositis	12	25	140	25		4	182	3.43%
Myalgia	59	137	735	406		33	1811	28.10%
%	3.53%	7.30%	36.83%	6.52%	0.04%	0.89%	44.89%

^$PT: preferred term; MAEs: musculoskeletal adverse events; CPK: creatine phosphokinase; ^#DE: death; LT: life-threatening; HO: required hospitalization or prolongation of existing hospitalization; DS: disability; CA: congenital anomaly or birth defect; RI: required intervention to prevent permanent impairment/damage; OT: other serious medical events.